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In the pharmaceutical industry, where the stakes are exceptionally high, the pillars of safety, efficacy, and consistency are non-negotiable. Every drug that reaches a patient must perform exactly as intended, without compromise. This is where life science testing becomes indispensable. It is the scientific backbone that ensures pharmaceutical products meet stringent quality standards from development through distribution. Whether it’s verifying the integrity of packaging, detecting impurities in raw materials, or ensuring batch-to-batch consistency, life science testing provides the data-driven assurance that products are safe, stable, and therapeutically effective.

How Life Science Testing Improves Consumer Confidence?

Consumer trust in pharmaceutical products is built on the assurance that every dose is safe, effective, and free from contamination or defects. Life science testing—spanning from raw material analysis to final product validation—serves as the backbone of this trust. Rigorous testing protocols verify that medications meet regulatory standards and perform as intended, reducing the risk of product recalls, adverse reactions, or inefficacy.

As new therapies and biologics emerge, the role of life science testing becomes even more vital. Consumers are increasingly aware of the risks involved in medication use, making them more selective about the brands and products they trust. Transparent testing processes and certifications help build trust, ensuring that only safe and effective products reach the hands of consumers. Moreover, life science testing supports regulatory compliance, reducing the risk of product recalls, adverse events, or compromised brand reputation. By adhering to stringent quality control measures, pharmaceutical companies can demonstrate their commitment to patient safety and product integrity. This transparency in testing and quality assurance fosters long-term trust, ultimately improving consumer confidence in the entire healthcare ecosystem. Through these rigorous testing practices, the pharmaceutical industry strengthens its credibility, providing consumers with peace of mind.

Advanced Quality Control Testing Measures in Pharmaceuticals 

• MicroCurrent HVLD

MicroCurrent HVLD is a non-invasive, non-destructive Container Closure Integrity Testing (CCIT) technology that leverages unique voltage characteristics to evaluate a wide variety of parenteral products, including complex combination systems. It is ideal for testing formats such as pre-filled syringes, vials, cartridges, ampoules, BFS containers, bottles, and pouches. This method accurately identifies defects like pinholes, micro-cracks, stopper or plunger leaks, and invisible breaches beneath the crimping area.

The system operates by applying a high voltage to the container and measuring the resulting current through the packaging. If a defect exists, the electrical current escapes through the flaw, signaling a compromise in the container closure system. With the ability to detect leaks as small as a few microns, MicroCurrent HVLD is especially valuable for testing biologics, where even the tiniest leak can lead to contamination or reduced product potency.

• Vacuum Decay Technology

Vacuum Decay leak testing is a highly sensitive and widely accepted leak detection method that has been trusted for decades. It operates on straightforward physical principles to evaluate the integrity of containers. Recognized by the FDA as a consensus standard and outlined in ASTM F2338, this method is also included in ISO 11607 and referenced in USP Chapter 1207 on Container Closure Integrity (CCI).

During the test, the package is placed inside a sealed test chamber connected to a leak detection system. A vacuum is applied, and advanced single or dual transducer technology is used to monitor the chamber’s vacuum levels. Any fluctuations in pressure over a defined period are carefully measured. Changes in absolute or differential vacuum levels indicate the presence of leaks or defects in the package, offering a reliable and non-destructive way to ensure container integrity.

• Helium Leak Detection

Helium leak detection is a reliable method for assessing the integrity of various pharmaceutical and parenteral products. It involves introducing helium gas into a sealed system and measuring its concentration as it escapes through leaks. This approach is commonly used for pre-filled syringes, cold form blister packs, foil pouches, and other packaging formats. By detecting leaks between specific container closure system components, it provides a precise evaluation of package integrity.

The process starts with filling the package with helium, followed by exposure to a vacuum. A helium leak detector then quantifies the escaping gas, determining the leak rate. Beyond leak testing, this technology is valuable for package design, failure analysis, tooling qualification, packaging line setup, validation, and product quality monitoring.

As the pharmaceutical landscape continues to evolve, driven by technological advancements, regulatory reforms, and increasingly informed consumers, the role of life science testing is also expanding. Innovations such as deterministic testing are transforming traditional quality control processes. These advanced approaches not only enhance efficiency and minimize human error but also deliver quicker, more accurate insights into product quality.

Ensuring the quality and safety of nutraceutical packaging depends on effective leak detection methods. Traditional techniques have been widely used but often lack efficiency, accuracy, and sustainability. These approaches can be time-consuming, inconsistent, and destructive, leading to material waste and higher costs. As packaging standards evolve, there is a growing need for solutions that deliver greater precision and repeatability without disrupting productivity. The VeriPac Series offers an alternative that overcomes these challenges while improving quality control. This blog examines the limitations of traditional leak testing and how VeriPac enhances package integrity testing to support product safety and compliance.

Limitations of Traditional Leak Testing Methods

Leak testing methods, such as dye ingress, bubble emission, and water bath testing, have been widely used across industries but come with several limitations.

• Destructive Testing – Requires sample destruction, leading to material waste and increased costs.
• Operator Dependence – Relies on human interpretation, making results inconsistent and subjective.
• Limited Sensitivity – Struggles to detect microleaks below 10 microns, which are critical in many applications.
• Contamination Risks – Exposure to water, dyes, or chemicals may introduce contamination risks.
• Slow and Labor-Intensive – Manual processes take time and are not suitable for high-volume testing.
• Lack of Quantifiable Data – Provides only a pass/fail result with no precise measurement or digital record.
• Inconsistent Repeatability – Results may vary between tests due to environmental factors and operator skill.
• Non-Compliance with Modern Standards – Many traditional methods do not meet evolving regulatory requirements for pharmaceuticals and medical devices.

The VeriPac Series: A Non-Destructive Alternative

The VeriPac Series provides an advanced, non-destructive approach to leak detection, offering superior accuracy and efficiency in nutraceutical package testing. This system utilizes Vacuum decay leak testing, a highly sensitive method for detecting leaks in flexible and rigid packaging. VeriPac Series minimize waste while providing operators clear insights into package quality. The VeriPac test system delivers real-time results through precise quantitative measurements, allowing early detection of packaging defects before process issues escalate. Tests can be conducted in any order and repeated on the same sample without damage. Good packages can be returned to the production line, making the process more reliable, sensitive, and efficient than destructive testing methods.

Technology Overview

VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The absolute transducer technology is used to monitor the test chamber for both, the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package.

VeriPac systems are capable of detecting microleaks as small as single-digit microns, making them ideal for applications where sterility, product stability, and moisture protection are critical. Designed to comply with ASTM and FDA standards, the VeriPac Series supports a wide range of packaging formats, including pouches, sachets, and blister packs.

By offering fast, and accurate package integrity testing, VeriPac helps manufacturers enhance quality control, reduce waste, and maintain regulatory compliance in industries such as pharmaceuticals, nutraceuticals, and medical devices.

Ensuring a secure seal in transdermal patch packaging helps maintain product stability, prevents contamination, and supports consistent drug delivery. A well-sealed package protects patches from moisture, oxygen, and other environmental factors that could affect adhesion and active ingredient effectiveness. Factors influencing seal integrity include material selection, sealing process parameters, and storage conditions. Inconsistent sealing can lead to leaks, microchannel defects, or compromised barrier properties. Advanced inspection methods, such as non-destructive testing, help detect seal defects early without damaging the package. By implementing effective quality control measures, manufacturers can improve packaging reliability and ensure transdermal patches remain safe and effective for use.

Challenges in Transdermal Patch Packaging

Transdermal patch packaging presents several challenges that can impact product efficacy, stability, and patient safety. Here are some key considerations:

• Barrier Protection - Packaging must protect against moisture, oxygen, and light to prevent degradation of the active pharmaceutical ingredient (API).
• Package Integrity - Leaks, microchannel defects, or poor seals can compromise drug delivery. Non-destructive testing methods like vacuum decay and helium leak detection help ensure integrity.
• Peel Strength & Usability - Packaging should be easy to open without excessive force, while still ensuring a secure seal to protect the patch.
• Material Compatibility - Packaging materials must not absorb or leach active ingredients, requiring careful selection of laminates and films.
• Regulatory Compliance - Packaging must meet FDA and EMA standards, requiring extensive stability testing and container closure integrity (CCI) validation.
• Sustainability Concerns - With growing environmental awareness, manufacturers are exploring recyclable and eco-friendly materials while maintaining protective properties.

Addressing these challenges demands innovative packaging solutions, rigorous testing, and compliance with regulatory guidelines to ensure transdermal patches remain effective and safe.

Package Integrity Testing for Transdermal Patch Packaging Using Force Decay Technology

Force decay technology is a quantitative leak detection technique used for seal quality testing of flexible packaging, ensuring product safety and stability. This technique is particularly effective for applications such as blister packs, transdermal patch sachets, and low headspace suture packs, where maintaining a secure seal is essential. As a non-destructive testing method, force decay technology allows sample packages to remain intact. Once testing is complete, packages can be returned to the batch without requiring disposal.

The system utilizes nested tooling to consistently position the package and restrict unmeasured expansion. During testing, a vacuum is applied to the test chamber, causing the package to expand. Vacuum levels are continuously monitored using the ASTM F2338 vacuum decay leak testing method to evaluate package integrity. As the package expands, force is applied to the VeriPac force measurement system, allowing for precise evaluation.

The force decay system can test multiple packages per cycle, detecting any defective samples. A defective package is identified by a decrease in expansion force or vacuum level during the test cycle, and the system pinpoints the specific location of the defect. This makes force decay technology an ideal solution for testing multi-cavity package formats, ensuring accurate and efficient leak detection.

Benefits of Force Decay Technology

• Non-destructive, non-invasive, no sample preparation
• Accurate and repeatable results
• Test multiple packages in a single test cycle
• Identifies which package is defective
• Simplifies the inspection and validation process
• Supports sustainable packaging initiatives
• ASTM test method and FDA consensus standard
• Cost effective with rapid return on investment
• Scalable from the laboratory to production line automated testing

Reliable seal integrity in transdermal patch packaging helps protect product quality throughout its shelf life. Consistent sealing processes, along with advanced inspection methods, contribute to packaging performance and regulatory compliance. Detecting defects early enhances efficiency and reduces material waste, leading to improved production outcomes. As packaging standards advance, ongoing innovations in testing and quality assurance will further strengthen the ability to maintain secure and dependable transdermal patch packaging.

Ensuring the reliability of Continuous Glucose Monitors (CGMs) begins with the integrity of their packaging. Packaging serves as a barrier, protecting the device from external factors that could compromise its performance. As the demand for CGMs grows, so does the need for advanced methods to uphold packaging quality and sterility. Vacuum decay technology has emerged as a trusted solution, offering a way to verify the integrity of CGM packaging with precision and consistency. By embracing innovative testing methods, manufacturers can confidently deliver products that meet the expectations of users relying on CGMs for effective diabetes management.

The Importance of Packaging Integrity in CGMs

Packaging integrity directly impacts the reliability and performance of Continuous Glucose Monitoring Devices (CGMs). These devices are trusted by individuals managing diabetes for accurate, real-time glucose readings. Packaging acts as a barrier, protecting the device components from external elements like moisture, contaminants, and physical damage that could interfere with sensor functionality.

To maintain the quality and reliability of CGMs, advanced testing methods such as vacuum decay are employed to ensure leak-free packaging. This non-destructive technology detects even the smallest compromises, helping manufacturers meet high-quality standards while preserving product sterility and performance.

Reliable packaging safeguards CGMs throughout their shelf life, ensuring they operate as intended when needed most. By adopting comprehensive package integrity testing, manufacturers enhance the trust and confidence of users, reinforcing the dependability of CGMs in supporting effective diabetes management.

Ensuring Sterility in CGM Packaging Using Vacuum Decay Technology

Sterility in Continuous Glucose Monitor (CGM) packaging safeguards the device's performance and reliability. Any breach in packaging can allow contaminants or moisture to enter, which may affect sensor functionality and overall usability. Vacuum decay technology is a non-destructive testing method designed to detect even the smallest leaks in CGM packaging. Unlike manual inspection and other non-deterministic methods, vacuum decay leak testing delivers precise, measurable, and consistent results to verify package integrity. This method is compatible with a variety of packaging types, including filled and sealed rigid, semi-rigid, and flexible packages made from porous or non-porous materials.

The vacuum decay process involves placing the test package in a tightly sealed chamber connected to an external vacuum source. The test chamber is monitored using single or dual vacuum transducer technology for both the level of vacuum and the change in a vacuum throughout a defined test duration. Variations in absolute or differential vacuum levels indicate the presence of leaks or defects within the package. This method is ideal for offline laboratory testing and can be configured for manual or fully automated operations. Non-destructive to both the product and packaging, it completes testing in just a few seconds. By minimizing product waste, vacuum decay testing reduces costs and often delivers ROI within six months.

Benefits of Vacuum Decay Technology

• Non-destructive technology, non-subjective, no sample preparation
• Defect detection down to 0.05 ccm
• Accurate, reliable, and repeatable results
• Pass/fail results backed by quantitative test data
• No tools are required to evaluate alternative package formats
• Identifies which cavity is defective
• Supports sustainable packaging and zero waste initiatives
• FDA recognized standard for package integrity testing

Maintaining the integrity of CGM packaging is central to delivering reliable devices that meet user expectations. By adopting innovative testing solutions, manufacturers can uphold the quality and sterility required for these life-enhancing tools. Consistent and precise packaging evaluation supports the performance of CGMs, ensuring they remain dependable throughout their shelf life. This commitment to quality not only enhances user trust but also reinforces the value of CGMs in diabetes management. With advancements in testing methods, the packaging process can continue to evolve, meeting the growing demand for high-performing medical devices with confidence and reliability.

Packaging integrity for implantable devices ensures that the device remains safe and functional throughout its lifecycle. Effective packaging protects devices from external factors such as contaminants, moisture, and environmental changes that could affect their performance. Container Closure Integrity Testing (CCIT) methods help assess packaging quality by identifying defects or leaks. These non-destructive tests provide reliable results, verifying the packaging’s ability to maintain sterility and prevent contamination. By confirming that packaging is intact, manufacturers can reduce the risk of compromised devices, supporting patient safety and meeting regulatory standards for medical device packaging.

The Importance of Packaging Integrity in Implantable Devices

The integrity of packaging in implantable devices impacts patient safety and product performance. When packaging is compromised, the device may be exposed to harmful factors like moisture, oxygen, or contaminants, which could degrade its quality or function. Here’s why packaging integrity matters:

• Protection Against Contamination: Packaging prevents contamination during storage and transport. Breaches can introduce harmful bacteria, especially dangerous for devices implanted in the body.
• Preserving Sterility: Packaging ensures devices stay sterile until use. A compromised seal or leak risks sterility loss, making the device unsafe.
• Maintaining Functionality: Packaging preserves environmental conditions (e.g., moisture, temperature) needed for sensitive devices. Leaks can lead to degradation or malfunction.
• Regulatory Compliance: Packaging must meet strict FDA standards, and failure to do so can result in recalls or legal consequences.
• Long-Term Stability: Compromised packaging shortens the shelf life, potentially making the device unsafe for implantation.

Advanced testing methods like airborne ultrasound or vacuum decay leak testing help ensure packaging integrity, protecting device quality and patient safety.

CCIT Methods for Packaging Integrity: Vacuum Decay & Airborne Ultrasound

Airborne Ultrasound Technology

Airborne Ultrasound technology offers a precise, non-invasive approach to assessing the seal quality of pouches and flexible packaging. This advanced seal integrity test is compatible with various materials like Tyvek®, paper, foil, film, aluminium, plastic, and pol. As a non-destructive testing method, it ensures the package remains intact. Airborne Ultrasound provides accurate and reliable results without compromising the package.

Airborne Ultrasound technology works by transmitting ultrasonic waves through the package's seal area as it moves over a sensor. These waves interact with the materials, causing sound signals to reflect. When the seal is intact, the waves pass through efficiently. If a defect is present, the signal strength is notably reduced or entirely blocked, allowing for accurate defect detection. The level of sound reflection and transmission depends on the acoustic contrast between the materials in the seal, with higher contrast leading to more reflection, which enables a detailed analysis of the integrity of seal.

Vacuum Decay Technology

Vacuum Decay is a practical and sensitive vacuum-based leak test method. This is a simple test that challenges container integrity using basic physical principles. Vacuum Decay technology provides reliable, accurate, and quantitative results with a pass or fail outcome, offering a non-destructive, deterministic alternative to the blue dye test. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

In this method, the leak test instrument is connected to a test chamber designed to hold the package being tested. The package is placed inside the chamber, and a vacuum is applied. Using single or dual vacuum transducer technology, both the test chamber vacuum level and changes in vacuum over a set time are monitored. Variations in absolute and differential vacuum reveal the presence of leaks or defects within the package. This method is suitable for offline laboratory testing and can be configured for manual or fully automated operation. The test cycle is quick, non-destructive to both the product and packaging, taking only a few seconds.

Ensuring packaging integrity for implantable devices helps maintain both the device’s performance and patient safety. By utilizing reliable testing methods, manufacturers can detect potential leaks or defects in packaging, preventing contamination and sterility loss. Effective testing practices also allow manufacturers to maintain confidence in their products, safeguarding patients and avoiding unnecessary recalls. In the long run, maintaining robust packaging integrity helps streamline operations, enhance patient outcomes, and foster trust within the healthcare system, all while meeting required standards for medical device packaging.

Inhalers are widely used devices for delivering medication directly to the respiratory system, particularly for managing conditions like asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of an inhaler depends significantly on its ability to maintain airtight integrity, ensuring proper dosage delivery and optimal performance. Leaks in inhalers can lead to medication loss, reduced efficacy, and inconsistent drug delivery, which may impact patient health.

Leak testing inhaler devices is a quality assurance process designed to identify and address potential weak points in the device. This process evaluates seals, valves, and other components to detect potential issues such as micro-leaks, improper assembly, or material degradation. Advanced leak detection methods, such as vacuum decay, are often employed for package integrity testing. By prioritizing robust leak testing protocols, manufacturers can improve inhaler quality, enhance patient trust, and meet regulatory requirements.

Common Leak Issues in Inhalers

Several factors can lead to leaks in inhaler systems, potentially compromising their functionality and the efficacy of the medication. Below are the most common leak issues encountered in inhalers:

• Valve Leaks: Caused by improper sealing or wear, leading to propellant loss and inconsistent medication delivery.
• Seal Failures: Occur between the canister and actuator due to material degradation or manufacturing defects, resulting in medication leakage.
• Physical Damage: Cracks or dents in the canister or actuator compromise pressure, reducing the effectiveness of drug delivery.
• O-Ring and Gasket Deterioration: Misaligned or degraded components increase the risk of leaks and contamination.
• Temperature Sensitivity: Extreme storage or transportation conditions weaken seals, compromising the device's integrity.
• Manufacturing Defects: Incorrect assembly or insufficient quality control can introduce flaws that lead to leaks.
• Aging Components: Over time, wear and tear on parts like valves and seals can result in diminished functionality and leakage.

How VeriPac Vacuum Decay Detects Microscopic Leaks in Inhalers?

The VeriPac vacuum decay leak testing method offers a precise and non-destructive solution for detecting microscopic leaks in inhalers. These systems deliver real-time results through accurate quantitative measurements, enabling the identification of packaging defects before significant process issues arise. VeriPac series employs the ASTM-approved, patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

The process begins by placing the inhaler in a specialized test chamber connected to the VeriPac system. A vacuum is applied to the chamber, creating a pressure differential that highlights potential weak points in the packaging. The system continuously monitors the vacuum level and detects any pressure changes over a defined test period. Advanced vacuum transducer technology analyzes both absolute and differential pressure to identify even the smallest leaks with high accuracy. This method ensures the integrity of the inhaler packaging while preserving the product, eliminating waste associated with use of destructive testing methods.

Benefits of VeriPac Series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• FDA recognized ASTM test method
• Referenced in USP 1207 guideline
• Cost-effective with rapid return on investment
• Simplifies inspection and validation process

Consistent leak detection helps identify any packaging flaws or imperfections that may compromise the inhaler’s performance. By using the VeriPac vacuum decay method, manufacturers can verify the integrity of inhaler packaging, ensuring that it functions as intended throughout its shelf life. This approach not only enhances patient trust but also contributes to the overall quality and reliability of inhaler products. Regular leak testing helps maintain the effectiveness of medications and ensures that patients receive the full therapeutic benefit of their prescribed treatments.

Tyvek®-lidded trays are widely used in medical device packaging due to their durability, breathability, and ability to maintain sterility. However, ensuring the integrity of these trays require advanced leak detection methods tailored to their unique structure. Traditional testing techniques may not provide the precision needed to identify defects without damaging the packaging. Specialized non-destructive methods, such as vacuum decay leak testing technology, offer a reliable way to detect leaks while preserving the integrity of Tyvek® packaging. This ensures compliance with quality standards and safeguards the sterility of medical devices throughout the product lifecycle, from manufacturing, storage, transportation, and use.

The Role of Tyvek® in Medical Device Packaging

Tyvek® is widely recognized for its effectiveness in medical device packaging, offering a reliable solution for maintaining sterility and protection. Its structure acts as a strong barrier against microorganisms, moisture, and particulates while allowing sterilization gases such as ethylene oxide to penetrate efficiently. Lightweight yet durable, Tyvek® resists tears and punctures, making it suitable for safeguarding medical devices during handling, storage, and transportation. Tyvek® is commonly used in packaging for surgical instruments, implants, catheters, and diagnostic kits, ensuring these items remain sterile until use. Its flexibility allows for innovative packaging designs that meet regulatory requirements. Additionally, Tyvek® aligns with sustainability goals through recyclable options, balancing performance with environmental considerations. Manufacturers trust Tyvek® to deliver dependable packaging solutions for healthcare needs.

Why Traditional Leak Testing Methods Fall Short?

Traditional leak testing methods may not be sensitive enough to detect the small, often invisible defects that can occur in Tyvek® seals. These methods may include visual inspections, dye penetration tests, or vacuum testing, but they all have limitations when it comes to detecting very tiny leaks or defects that could have serious consequences. In addition, some of these methods may involve destructive testing, which is not only costly, but not ideal for sterile packaging that must remain intact for regulatory and safety reasons.

This is where specialized leak detection methods, like vacuum decay testing, become important. These techniques offer a high degree of sensitivity and precision, allowing manufacturers to detect even the smallest defects without compromising the integrity of the package.

VeriPac Vacuum Decay Technology for Tyvek® Lidded Tray Inspection

The VeriPac container closure integrity testing (CCIT) method provides a non-destructive alternative to traditional leak testing techniques like water bath, bubble leak, or blue dye tests. Designed for Tyvek and other porous packaging, VeriPac systems ensure products meet both regulatory and consumer quality standards. Introduced in 2003 as an ASTM test method, this vacuum decay technology was originally developed for testing Tyvek-lidded trays.

The VeriPac system operates by connecting its leak testers to a test chamber that houses the package sample. Once a vacuum is applied within the chamber, the system monitors the vacuum level and any changes over a specified duration using single or dual vacuum transducer technology. By analyzing both absolute and differential vacuum levels, the system achieves precise detection of leaks or defects in the packaging, delivering reliable and accurate results.

Vacuum Decay technology maintains the integrity and performance of Tyvek®-lidded trays. By effectively identifying leaks or defects, the method helps safeguard the sterility of medical devices and support their safe use throughout the supply chain. As Tyvek®-lidded trays remain a trusted choice for medical device packaging, investing in reliable and efficient leak detection technologies is a practical step toward delivering quality-assured products and maintaining confidence in healthcare packaging solutions.

When selecting a testing method for sterile medical devices, manufacturers need a solution that ensures packaging integrity and product safety. By considering factors such as regulatory requirements, operational efficiency, and the specific needs of the device, manufacturers can make informed decisions that enhance their quality control processes. The right testing method helps ensure that medical devices remain sterile and effective throughout their lifecycle. Adopting the right testing technology not only improves product reliability but also supports compliance, ultimately fostering trust with consumers and meeting industry standards for safe medical products.

Unique Challenges of Sterile Medical Devices

Sterile medical devices face a range of unique challenges that demand strict attention to detail in their design, packaging, and quality control. One of the primary concerns is maintaining sterility throughout the device's lifecycle, from production to end-use. This requires secure packaging that protects against contamination from environmental factors like moisture, temperature fluctuations, and physical damage. The packaging materials must be carefully selected to maintain sterile barrier integrity while ensuring compatibility with the sterilization process, whether through steam, radiation, or gas. Additionally, regulatory requirements for sterile devices are stringent, necessitating ongoing testing for packaging integrity, sterility, and functionality. Methods like Container Closure Integrity Testing (CCIT) are used to ensure that packaging is airtight and secure. Manufacturers must also consider the impact of storage, transportation, and handling, which can introduce risks of contamination or damage. These challenges require a careful balance of innovation, compliance, and rigorous testing to ensure safety and effectiveness.

Why Vacuum Decay Technology for Sterile Medical Devices?

Vacuum Decay leak testing Technology offers a reliable and non-destructive method for testing the integrity of sterile medical device packaging. Vacuum Decay Technology detects even the smallest leaks in packaging by monitoring vacuum levels during testing. This method is highly sensitive and effective for detecting micro-leaks in a wide range of packaging formats, including rigid, semi-rigid, and flexible materials. It also supports sustainability efforts, as it reduces the need for destructive testing and minimizes waste. Vacuum Decay Technology helps manufacturers ensure packaging integrity, meet regulatory requirements, and safeguard the sterility of medical devices throughout their lifecycle.

In this method, the leak testers are connected to a test chamber designed to hold the package being tested. A vacuum is applied to the package inside the chamber, and the test chamber's vacuum level is monitored using single or dual vacuum transducer technology. During a predetermined test period, any changes in the vacuum level, both absolute and differential, are observed. These variations indicate the presence of leaks or defects in the package. This testing approach is ideal for laboratory offline testing and can be configured for either manual or fully automated operation.

Key Benefits of Vacuum Decay Technology

• Non-destructive and non-invasive
• No sample preparation
• ASTM approved test method F2338
• FDA Recognized Consensus Standard
• ISO 11607 Standard
• Allows for increased sampling
• Quantitative results
• Eliminates cost and waste of destructive testing

Vacuum decay technology is capable of detecting leaks and defects in packaging, preserving sterility throughout the product's lifecycle. By providing accurate results, this method helps meet industry standards and regulatory requirements. As the demand for high-quality, safe medical products grows, vacuum decay technology offers a streamlined approach to evaluating packaging performance. Understanding how this technology works can assist manufacturers in making informed decisions when choosing the most suitable testing method for their sterile medical devices.

Pharmaceutical products are designed to enhance health and support effective treatment. Ensuring the quality and safety of these products relies on maintaining intact packaging that protects against contamination, moisture, and other external factors. Integrity testing methods, such as Vacuum Decay, helium leak detection, and high voltage leak detection, verify that packaging meets regulatory standards like USP <1207>. These methods identify even the smallest leaks, confirming that containers perform their intended function. Comprehensive integrity testing helps manufacturers achieve compliance, mitigate risks, and ensure product safety and reliability.

VeriPac Delta for Package Integrity Testing

VeriPac Delta is a dual technology non-destructive quantitative test system for pharmaceutical CCI applications. Capable of detecting leak rates as small as 5 microns, depending on package specifications, it provides a non-destructive, quantitative testing solution for pharmaceutical and food applications. It is specifically designed for testing gas leaks in dry product containers, such as lyophilized and powder-filled vials, as well as liquid leaks in liquid-filled vials and prefilled syringes.

The VeriPac Delta employs two primary technologies: Vacuum Decay and Pressure Decay. Vacuum Decay leak testing, based on ASTM F2338-09 and recognized by the FDA as a consensus method, delivers sensitivity down to 5 microns. Pressure Decay testing, compliant with ASTM F2095, achieves similar sensitivity with rapid test cycles of just 10 seconds. Together, these technologies provide precise, efficient, and reliable solutions for comprehensive package integrity assessments.

Technology Overview

The VeriPac Delta connects to a specially engineered test chamber. During testing, vacuum or pressure is applied to the package within the chamber. Using high-resolution absolute transducer technology, the system monitors the applied vacuum or pressure levels and detects changes over a specified test duration. This enables accurate detection of gross and micro leaks. The test cycle completes in a few seconds, delivering objective, non-destructive results that preserve both the product and its packaging.

The sensitivity of the test depends on factors such as transducer capability, package design, test fixture, and key parameters like time and pressure. The VeriPac Delta system can be configured for manual or semi-automatic operation, making it suitable for laboratory offline testing and QA/QC statistical process control.

Benefits of VeriPac Delta Technology

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Small footprint and modular portable design
• Defect detection down to 0.2 ccm (5 micron)
• ASTM test method and FDA standard
• High level of sensitivity, repeatability and accuracy

The integrity of pharmaceutical products relies on robust packaging that preserves quality and prevents contamination. The VeriPac Delta is an effective and versatile solution for pharmaceutical package integrity testing. By combining non-destructive methodologies, rapid testing cycles, and exceptional sensitivity, it offers more than just leak detection—it provides a comprehensive approach to safeguarding product integrity. Its adaptability across diverse packaging formats ensures its value in advancing quality assurance processes within the pharmaceutical industry.

Infant formula packaging is more than just a container; it is an essential shield that preserves quality and safety. These packages are available in various forms such as metal cans, flexible pouches, and portable sachets. They also prioritize convenience, providing user-friendly features like resealable closures and tamper-evident seals. Common options include airtight metal cans, resealable pouches, and single-serve sachets, each catering to specific consumer needs. Beyond protection, the packaging is engineered for convenience, offering ease of use and storage. Whether for everyday use or on-the-go feeding, infant formula packages provide a trusted solution for maintaining product integrity and delivering optimal nutrition.

Significance of Package Integrity in Infant Formula

The integrity of packaging in infant formula safeguards the product’s quality, safety, and nutritional value. Infant formula, often used as a primary source of nutrition for babies, is highly sensitive to environmental factors like moisture, oxygen, and microbial contamination. Properly sealed packaging prevents exposure to these elements, ensuring the formula remains uncontaminated and retains its intended composition. Moisture can cause clumping and bacterial growth, while oxygen exposure may degrade fats and essential nutrients, impacting the formula’s effectiveness.

Tamper-evident features in packaging provide reassurance to consumers about product safety, while durable materials protect against damage during transportation and storage. To maintain these standards, advanced testing methods, such as vacuum decay leak testing is employed to detect potential leaks or vulnerabilities in the packaging. These measures help manufacturers deliver a product that meets stringent quality and safety requirements, supporting infant health and giving parents confidence in their choice.

Infant Formula Package Testing Methods

Infant formula package testing methods, including VeriPac Flex and VeriPac SPX, ensure the reliability and safety of infant formula packaging through precise integrity checks.

1. VeriPac Flex

VeriPac FLEX systems offer a versatile and non-destructive solution for container closure integrity testing (CCIT), specifically tailored for flexible packaging, such as pouches and dry-filled products. This technology employs the ASTM F2338 vacuum decay leak testing method, which is included in ISO 11607 and recognized by the FDA as a consensus standard for package integrity evaluation. These systems are available in multiple configurations to suit diverse package specifications and sensitivity requirements. The configurators support testing a wide range of formats, from small sachets and stick packs to large bulk-size pouches and bags. A standout feature of VeriPac FLEX is its ability to perform tests without requiring changes to settings or tooling. This design ensures exceptional sensitivity, reliability, and ease of use, making it an effective choice for assessing the integrity of various flexible packaging formats used in infant formula.

2. VeriPac SPX

The VeriPac SPX series is an automated Statistical Process Control (SPC) mainly for rigid containers containing dry products including coffee. It is an ideal choice for ensuring the safety and integrity of infant formula packaging. With its advanced Statistical Process Control (SPC) capabilities, it provides actionable insights to maintain consistent quality across production. Automated testing enhances sampling rates, offering more frequent and accurate evaluations of packaging performance.

Engineered for seamless integration, the VeriPac SPX can be effortlessly added to existing production lines, minimizing downtime. Its precision in detecting breaches, sealing issues and identifying early deviations ensures superior process and quality control, helping manufacturers safeguard product reliability while meeting the rigorous standards of infant formula packaging.

Ensuring the quality of infant formula packaging involves diverse approaches tailored to maintain product safety and freshness. Each solution focuses on detecting potential vulnerabilities, such as leaks, weak seals, or compromised closures, that could affect the formula's integrity. Non-invasive and precise technologies allow for accurate evaluations without damaging the product. By combining advanced tools and thorough analysis, manufacturers achieve greater confidence in packaging reliability. These efforts uphold strict safety standards while meeting consumer expectations for premium care. The pursuit of excellence in packaging not only enhances product preservation but also reinforces trust in the care provided to infants.

Ophthalmic products, often packaged in single-use or multi-dose containers, require packaging that not only preserves sterility but also maintains the stability and effectiveness of the solution inside. However, packaging failures can arise from various factors, including seal integrity issues, material incompatibility, and improper storage conditions. To mitigate these risks, it is essential to implement rigorous quality control measures and utilize advanced testing techniques.

Packaging Failures in Ophthalmic Products

Packaging failures in ophthalmic products can pose significant risks to patient safety and product efficacy. These failures may occur due to factors such as inadequate seal integrity, material defects, or improper storage conditions. Key concerns include:

• Seal Integrity Issues: Ophthalmic products often come in single-use or multi-dose containers, where maintaining sterility is crucial. Seal integrity failures can lead to contamination, compromising the product's sterility and safety.
• Material Compatibility: The packaging material must be compatible with the ophthalmic solution. Incompatible materials can lead to chemical reactions, affecting the product's stability or causing leachables that may harm the patient.
• Improper Storage Conditions: Ophthalmic products are often sensitive to temperature and light. Packaging that fails to protect the product from environmental factors can lead to degradation of the active ingredients, reducing efficacy.

Preventing these failures requires rigorous quality control, appropriate material selection, and thorough testing of packaging components. Proper container closure integrity testing ensures the safety and efficacy of ophthalmic products.

Techniques for Evaluating Ophthalmic Packaging Integrity

1. Helium Leak Testing

Helium leak detection technology is a container closure integrity testing (CCIT) method that offers highly sensitive and accurate leak detection in vials. This method involves detecting leaks in sealed systems by introducing helium gas and measuring its concentration as it escapes through any leaks. Helium's exceptional properties make it an ideal tracer for this purpose, enabling manufacturers to conduct thorough testing that identifies even the smallest leaks, thereby improving the overall integrity of vial packaging.

Helium leak testing is commonly used for pre-filled syringes, cold-form blister packs, foil pouches, bottles, including plastic ophthalmic containers, and various other packaging formats. This technology precisely assesses the integrity between specific components of primary container closure systems, making it an excellent choice for pharmaceutical package testing.

2. Vacuum Decay Technology

Vacuum Decay technology is a deterministic Container Closure Integrity test method used to evaluate the quality of ophthalmic packaging. This non-destructive testing approach enhances packaging quality and reduces waste compared to destructive methods. By offering a cost-effective solution, it leads to higher returns on investment while ensuring product integrity. The technology functions by placing sample packages in a tightly sealed evacuation test chamber connected to an external vacuum source. A single or dual vacuum transducer monitors the chamber over a set test period, analyzing vacuum level changes to detect leaks and defects within the packaging.

Technologies like Helium Leak Testing and Vacuum Decay Technology play a vital role in evaluating the packaging integrity of ophthalmic products. Helium Leak Testing offers precise leak detection, making it ideal for various packaging formats, including plastic ophthalmic containers. Vacuum Decay Technology, on the other hand, provides a non-destructive, cost-effective solution that enhances packaging quality and reduces waste.

By integrating these advanced testing techniques, manufacturers can significantly reduce the likelihood of packaging failures, ensuring that ophthalmic products remain safe and effective for patients.

Maintaining container closure integrity (CCI) in radioactive pharmaceuticals safeguards safety and regulatory compliance. Even small leaks can result in contamination, radiation exposure, and decreased drug effectiveness. For these sensitive products, advanced CCI testing accurately detects any breaches that could compromise packaging integrity. The complexities of handling radioactive materials demand specialized approaches to ensure reliable assessments without affecting product quality. By applying precise and consistent testing methods, manufacturers protect the integrity of radioactive pharmaceuticals throughout their shelf life, supporting both patient safety and healthcare standards.

What are Radioactive Pharmaceuticals?

Radioactive pharmaceuticals, or radiopharmaceuticals, are specialized medications containing radioactive isotopes, used primarily in diagnostic imaging and targeted therapy. These compounds emit controlled radiation, enabling healthcare professionals to visualize internal organs, assess tissue function, and treat diseases like cancer with precision. In diagnostics, they emit radiation that is detected by imaging devices, offering detailed insights into organ function and disease. In treatment, radiopharmaceuticals deliver targeted radiation to diseased cells, particularly in cancer therapy, thereby reducing damage to surrounding healthy tissues. Their unique ability to target specific areas makes radiopharmaceuticals indispensable in modern medicine, providing accurate diagnoses and effective treatments while minimizing systemic side effects.

Challenges of CCI in Radioactive Pharmaceuticals

Container Closure Integrity (CCI) testing for radioactive pharmaceuticals presents unique challenges due to the specialized nature of these products. Here are some key challenges:

• Cost-Efficiency: Unlike more complex testing methods, this approach allows for immediate testing and precise data collection, reducing the time spent on preparation and analysis. This results in faster decision-making, quicker time-to-market, and lower overall costs, all while maintaining high levels of accuracy and reliability in detecting leaks.
• Radiation Safety: Handling radioactive materials requires strict safety protocols, complicating testing environments. Specialized containment may be necessary to reduce radiation exposure risks.
• Material Compatibility: Packaging must resist radiation-induced degradation over time. Selecting materials that maintain integrity despite exposure is crucial.
• Test Method Selection: Traditional CCI methods may not be suitable for radioactive products. Non-destructive techniques, such as vacuum decay or helium leak testing, are often preferred.
• Regulatory Compliance: Radiopharmaceuticals face stringent pharmaceutical and radiation safety standards. Meeting dual regulatory requirements can complicate CCI validation.
• Sterility Assurance: Maintaining sterility without compromising the product is essential. Traditional sterilization methods may not be suitable for radioactive pharmaceuticals.

Testing Integrity in Radioactive Pharmaceuticals Using Vacuum Decay Technology

Vacuum Decay leak testing is a non-destructive Container Closure Integrity Test (CCIT) method commonly used to detect leaks in sealed packaging. Known for its sensitivity and practicality, it can identify leaks in rigid, semi-rigid, or flexible packages, whether made from porous or non-porous materials. This method offers reliable, accurate, and consistent results, ensuring precise package integrity testing. As a non-destructive alternative to traditional water bath and dye ingress tests, vacuum decay provides an effective solution for leak detection in the pharmaceutical and medical device sectors.

Vacuum Decay operates on fundamental physical principles of container integrity. The package is placed inside a sealed vacuum chamber connected to an external vacuum source. A specific vacuum level is applied based on the packaging type and required sensitivity. The system then monitors the chamber and any dead space for a set duration. Sensitive differential pressure transducers track changes in vacuum levels over time. A pressure increase beyond the pre-defined pass/fail limit signals a leak in the container.

As the pharmaceutical industry continues to evolve, adopting specialized CCI testing enhances product quality and builds trust in the supply chain. Prioritizing precise and thorough CCI evaluations contributes to safer and more reliable radioactive pharmaceuticals in the market.

Packaging integrity is a critical factor for collagen-based products, particularly due to their sensitive nature and diverse applications in medical, cosmetic, and pharmaceutical fields. These products, whether used in wound healing, reconstructive surgery, or skincare, require stringent packaging standards to maintain sterility and efficacy throughout their lifecycle. Even the smallest compromise in packaging can lead to contamination, which poses serious risks to patient safety and product effectiveness.

Ensuring the integrity of packaging for collagen-based products is not only essential for preserving their quality but also for meeting strict regulatory requirements. As a result, advanced testing methods like Vacuum Decay have become crucial tools for verifying that the packaging is secure and free of leaks, ensuring the product remains uncontaminated from production to end-use.

Why Sterility is Critical in Collagen-Based Products?

Sterility is of utmost importance in collagen-based products, especially those intended for medical use, such as wound healing, tissue engineering, or reconstructive surgery. These products often interact directly with the human body, meaning that any contamination can lead to serious health risks such as infections or adverse reactions. For cosmetic applications like dermal fillers, contamination can affect the product’s performance and cause harm to the skin, resulting in potentially severe complications.

Due to their biological nature, collagen-based products are particularly susceptible to microbial contamination, which can degrade the product’s quality and reduce its effectiveness. Maintaining sterility ensures that the product remains safe for use throughout its shelf life. It also upholds the therapeutic and aesthetic benefits of collagen-based products. For manufacturers, ensuring sterility is not only a matter of product quality but also a key factor in meeting regulatory requirements for safety and efficacy.

Role of Vacuum Decay in Sterility Testing for Collagen Products

Collagen products, often used in medical applications such as wound healing and tissue regeneration, must maintain a sterile environment to preserve their safety and efficacy. Vacuum Decay plays a critical role in sterility testing for collagen-based products, ensuring that their packaging remains airtight and free from contamination. The Vacuum Decay leak testing works by detecting microleaks in sealed packaging. By applying a vacuum to the package and measuring any changes in pressure, it identifies breaches that could allow bacteria or contaminants to enter. This method is highly sensitive, capable of detecting even the smallest leaks, which is crucial for ensuring the sterility of collagen-based products. One of the key benefits of Vacuum Decay is its cost-effectiveness. As the leak test does not waste any product, it results in considerable savings.

By preventing compromised packaging, the Vacuum Decay helps manufacturers meet stringent regulatory standards while maintaining the quality of the product throughout its shelf life. This ensures that collagen products remain safe for use, protecting both patient health and the product’s effectiveness.

Benefits of Vacuum Decay Technology

• Non-destructive, non-subjective, no sample preparation.
• Capable of detecting defects down to 0.05 ccm.
• Accurate, reliable, repeatable results.
• Supports sustainable packaging and zero waste initiatives.
• FDA recognized standard for package integrity testing.

Vacuum Decay technology brings a new level of precision and reliability to packaging integrity testing for collagen-based products. Its non-invasive nature and exceptional leak detection capabilities help manufacturers safeguard the sterility and quality of these sensitive products. By reducing the risk of contamination and ensuring regulatory compliance, this technology not only enhances product safety but also strengthens consumer trust in collagen-based medical and cosmetic solutions. In an industry where quality is paramount, the Vacuum Decay is transforming how packaging integrity is maintained, ultimately benefiting both manufacturers and patients.

As the pharmaceutical industry continues to advance, the need for stringent packaging standards becomes increasingly critical. USP <382> has emerged as a pivotal guideline, specifically addressing the functional suitability of elastomeric components used in injectable drug packaging. These components, including stoppers, seals, and plungers, play a vital role in ensuring the sterility, safety, and efficacy of drug products throughout their lifecycle.

USP <382> sets forth comprehensive testing protocols to evaluate these components, influencing how pharmaceutical packaging is developed and validated. For manufacturers, understanding and adhering to this standard is not just about regulatory compliance - it's about safeguarding patient health by ensuring every aspect of the packaging performs to the highest standards.

USP <382>: An Overview

USP <382>, titled "Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems," is a chapter within the United States Pharmacopeia (USP) that establishes guidelines for testing the functional suitability of elastomeric components like stoppers, seals, and plungers. These components are essential in packaging systems for parenteral (injectable) drugs, as they ensure the drug product's sterility, stability, and delivery.

The chapter outlines rigorous testing protocols that elastomeric components must undergo to verify their safety and performance. These tests include evaluations for container closure integrity (CCI), extractables and leachables, and the components' ability to maintain functionality under various conditions.

Impact of USP <382> on Pharmaceutical Packaging

USP <382> significantly influences how pharmaceutical packaging is developed, tested, and validated. Its impact includes:

• Stricter Testing Protocols: Manufacturers must conduct comprehensive testing of elastomeric components to meet USP <382> standards. This often involves advanced methods for assessing container closure integrity, such as vacuum decay leak testing, to detect even the smallest leaks that could compromise the product.
• Increased Focus on Extractables and Leachables: The standard emphasizes the importance of testing for extractables and leachables, which are chemicals that can migrate from the packaging materials into the drug product. Ensuring these substances are within acceptable limits is crucial for patient safety.
• Enhanced Component Selection: USP <382> encourages manufacturers to carefully select materials and components that meet the stringent requirements of the standard. This leads to the development of packaging systems that are better suited to protect the drug product over its entire shelf life.

USP <382> is more than just a regulatory standard - it is a cornerstone of modern pharmaceutical packaging, ensuring that every elastomeric component used in injectable products meets the highest levels of safety and performance. By implementing the guidelines set forth in USP <382>, pharmaceutical companies not only comply with industry regulations but also demonstrate their commitment to patient safety and product integrity.

As the pharmaceutical landscape continues to innovate, the importance of robust packaging standards like USP <382> will only grow. Embracing these standards allows manufacturers to build confidence in their products, reduce the risk of contamination or failure, and ultimately deliver safe, reliable treatments that patients and healthcare providers can trust. Understanding and applying USP <382> is essential for any company aiming to lead in quality and patient care in an increasingly complex and demanding industry.

In the pharmaceutical industry, ensuring the integrity of packaging is crucial for maintaining the safety, efficacy, and quality of products. Dry-filled pouch packaging, commonly used for its convenience and cost-effectiveness, requires stringent quality assurance measures to protect the contents from contamination, moisture, and physical damage. One advanced solution that has significantly enhanced quality assurance in this area is the VeriPac Flex System. This system employs advanced technology to provide non-destructive package integrity testing, ensuring that each pouch meets the highest standards of quality and reliability.

Importance of Packaging Integrity

In today’s increasingly complex and globalized supply chains, maintaining packaging integrity has become more challenging and essential than ever. The rise of e-commerce and the demand for longer shelf lives necessitate advanced packaging solutions and rigorous testing protocols. Consequently, the importance of packaging integrity extends beyond mere containment—it plays a vital role in ensuring consumer satisfaction, fostering brand loyalty, and driving industry innovation. This is especially crucial in sectors such as pharmaceuticals, and food and nutrition, where the packaging serves not only as a container but also as a barrier against contamination, degradation, and tampering.

Effective packaging integrity assures products remain safe, effective, and of high quality throughout their shelf life, thereby safeguarding consumer health and maintaining trust. Moreover, it helps in complying with stringent regulatory standards, reducing economic losses due to product recalls and waste, and supporting sustainability efforts by minimizing environmental impact.

Dry-Filled Pouch Package Inspection Using VeriPac Flex

VeriPac FLEX Systems are versatile inspection solutions designed for pouches and flexible packaging. They provide a clear PASS or FAIL result along with quantitative data on leak rates. Renowned for their exceptional sensitivity, reliability, and ease of use, these systems work seamlessly across various package formats and sizes without needing adjustments or tooling changes. With multiple configurations available for both the inspection instrument and test chamber capacity, VeriPac FLEX Systems meets a wide range of package specifications and sensitivity needs. They accommodate everything from small sachets and stick packs to large bulk pouches and bags.

Utilizing the ASTM method for vacuum decay leak testing (F2338) and endorsed by the FDA, VeriPac FLEX Systems conforms to recognized standards for package integrity testing. By replacing subjective and wasteful destructive testing methods, they offer a more efficient and cost-effective alternative. The vacuum decay leak testing technology employed by VeriPac systems delivers rapid returns on investment compared to traditional destructive methods like water baths or blue dye tests. These systems reliably detect critical packaging failures while providing valuable insights into the packaging process. VeriPac FLEX technology has also been fully automated for production line inspection.

Why VeriPac Flex stands out for dry-filled pouches?

• Deterministic, quantitative test method
• Cost-effective with rapid return on investment
• Non-destructive, non-subjective, no sample preparation
• Supports sustainable packaging and zero-waste initiatives
• Test multiple packages in a single test cycle
• ASTM test method and FDA standard
• USP < 1207> compliant

In conclusion, the VeriPac Flex System significantly enhances quality assurance in dry-filled pouch packaging through its state-of-the-art non-destructive testing technology. This system leverages advanced vacuum decay methods to detect leaks and ensure the integrity of packaging, offering numerous advantages for pharmaceutical companies. Integrating the VeriPac Flex System into the quality assurance framework ensures that pharmaceutical companies can maintain high standards of product integrity and safety. This not only safeguards patient health but also strengthens regulatory compliance and operational efficiency, ultimately enhancing the company’s market position and consumer trust.

In the pharmaceutical industry, ensuring the integrity of vial is paramount for maintaining the sterility, efficacy, and safety of drug products. Traditional methods such as bubble emission, dye ingress, and microbial ingress have been used for years to test vial integrity. However, these methods often fall short in sensitivity, efficiency, and reliability. Vacuum decay testing has emerged as a superior alternative, offering numerous advantages that make it the preferred choice for container closure integrity testing. This method not only meets stringent regulatory requirements but also provides enhanced sensitivity, non-destructive testing capabilities, and operational efficiency, making it a vital tool in the pharmaceutical quality assurance process.

Vial Integrity Importance in Pharmaceuticals

Vial integrity is crucial in the pharmaceutical industry for several reasons:

• Product Safety: Ensuring the vial's integrity means the contents remain sterile and uncontaminated. Any breach can lead to contamination, which poses significant health risks to patients.
• Efficacy: The integrity of a vial ensures that the medication remains effective. Contaminants can degrade the drug, reducing its efficacy and making it less effective or even harmful.
• Regulatory Compliance: Regulatory bodies like the FDA have strict guidelines regarding the packaging and integrity of pharmaceutical products. Non-compliance can lead to recalls, legal issues, and loss of consumer trust.
• Shelf Life: A properly sealed vial protects the drug from environmental factors such as light, air, and moisture, which can affect its stability and shelf life.
• Cost Efficiency: Maintaining vial integrity reduces the risk of product loss due to contamination or degradation, which can be costly for pharmaceutical companies.

Why is Vacuum Decay Preferred Over Traditional Methods?

Vacuum decay is a non-destructive container closure integrity testing (CCIT) method used to detect leak and ensure package integrity. The test method is simple in principle and challenges container integrity based on fundamental physical properties. It provides accurate, repeatable, reproducible, and reliable quantitative results with a clear pass/fail determination. Referenced in the United States Pharmacopeia Chapter on CCI and listed in ISO 11607 (USP Chapter 1207), this test is conducted by drawing a vacuum on a package inside a test chamber and checking for any decay in the vacuum level, which would indicate a leak. This technique has become a preferred non-destructive alternative to the dye ingress test, preventing product waste and offering significant cost savings. For many products, it achieves a return on investment in less than six months.

Benefits of Vacuum Decay Technology

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.01 cc/min
• Results have proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method and FDA standard

Vacuum decay leak testing stands out as a premier method for ensuring vial integrity in the pharmaceutical industry. Its non-destructive nature preserves product viability while providing highly sensitive and accurate leak detection. The method’s ability to deliver consistent and repeatable results enhances quality assurance processes and regulatory compliance. Moreover, the efficiency and speed of Vacuum decay testing contribute to cost savings and operational efficiency, offering a rapid return on investment. By integrating Vacuum decay technology into their quality control systems, pharmaceutical companies can achieve superior product safety, efficacy, and reliability, ultimately ensuring the highest standards of patient care.

In this blog, we delve into various techniques employed to secure product integrity using Tyvek and porous packaging. These techniques encompass rigorous testing methods, innovative approaches, and industry best practices aimed at maintaining the quality, safety, and efficacy of packaged goods.

Overview of Tyvek and Porous Packaging

Tyvek is a brand of flash spun high-density polyethylene fibers, a synthetic material that's extremely durable and resistant to moisture, chemicals, punctures, and tears. Tyvek is valued for its combination of strength and breathability. It allows air and moisture vapor to pass through while blocking liquids, dust, and other contaminants. This makes it ideal for packaging items that need protection from moisture or dust buildup, such as medical devices, electronics, and sensitive documents.

Porous packaging, on the other hand, refers to packaging materials that are intentionally designed with tiny pores or perforations to allow airflow and gas exchange. These materials are often used for products that require a level of aeration or gas permeability, such as fresh produce, certain pharmaceuticals, and some types of chemicals. Porous packaging materials can include paperboard, certain types of plastics, and specialized membranes.

Both Tyvek and porous packaging serve specific purposes in different industries, offering protection and functionality tailored to the needs of the products being packaged.

Tyvek and Porous Package Integrity Testing Methods:

1. VeriPac Technology

VeriPac technology is a non-destructive system for Container Closure Integrity Testing (CCIT) that employs Vacuum Decay technology to identify leaks in packaging. This method, approved by ASTM (F2338), is recognized by the FDA as the consensus standard for assessing package integrity. VeriPac utilizes a vacuum chamber to meticulously test the integrity of packaging. The package is placed inside, and the chamber pressure is precisely lowered. VeriPac then monitors the rate of pressure change. Any leaks will cause the pressure to rise more rapidly, indicating a compromised seal. Vacuum decay leak testing technology is renowned for its high sensitivity and precision, capable of identifying leaks down to 20 microns.

2. Seal-Sensor Technology

Seal-Sensor™ utilizes Airborne Ultrasonic Technology to perform non-destructive inspections of the final pouch seal on the production line. It offers a deterministic, quantitative, rapid, and dependable approach to inspecting pouch seals for defects. Seal-Sensor identifies incomplete seals, areas of weakness or partiality, and various common faults in seals that may seem visually acceptable but harbor defects impacting product quality and shelf-life. The seal is positioned linearly between two transducers, and either the seal or the transducers are moved along its length. As the ultrasound encounters transitions between different materials, it is both transmitted and reflected. Greater differences in acoustic properties between the materials result in more sound being reflected and less being transmitted. Various configurations of Seal-Sensor are available including plug & play installations on existing conveyor lines and integrated solutions.

3. Seal-Scan Technology

On the other hand, Seal-Scan® is an Airborne Ultrasonic Technology (ABUS) designed for offline, non-destructive testing and analysis of pouch seal integrity. This method provides a deterministic, quantitative, and high-resolution inspection of pouch seal defects and consistency. It is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® features advanced digital imaging software tools for detailed analysis of seal quality. The system adheres to ASTM test method F3004-13. Seal-Scan technology is revolutionizing the way industries approach seal quality testing. By leveraging ultrasonic waves, Seal-Scan can detect inconsistencies and defects that are invisible to the naked eye and undetectable by other means. This capability ensures that every package leaving the production line meets stringent quality standards, safeguarding the end consumer and maintaining the manufacturer's reputation.

Through thorough testing, innovative sealing methods, and adherence to industry standards, manufacturers can effectively protect their goods from environmental hazards and contamination. As technology progresses, so will the methods for enhancing product integrity, ensuring that packaged items meet stringent quality requirements. By embracing these techniques, businesses can uphold consumer trust and deliver products of the highest standard.

Contact lenses are a popular vision correction solution used by millions of people worldwide. Whether for vision correction, cosmetic enhancement, or therapeutic purposes, contact lenses require careful packaging to ensure their safety, sterility, and effectiveness. Contact lens packaging serves as the primary means of preserving the quality of lenses from manufacturing to the hands of the user.

Contact lens packaging typically consists of individual blister packs, vials, or sachets, each containing a single lens. These packaging units are designed to maintain the sterility of the lenses, protect them from damage, and provide clear labeling with essential information such as prescription details, expiration dates, and care instructions.

In recent years, advancements in contact lens packaging have focused on improving convenience for users, enhancing sustainability through eco-friendly materials, reducing packaging waste, and ensuring compliance with stringent regulatory standards to uphold product safety and quality.

As contact lens technology continues to evolve and consumer demand grows, innovation in packaging solutions remains crucial. By prioritizing the development of packaging that meets the diverse needs of users while maintaining the highest standards of safety and quality, manufacturers can enhance the overall experience of contact lens wearers and contribute to the continued advancement of eye care technology.

Contact Lens Packaging Challenges

Contact lens packaging faces several notable challenges, including:

• Sterility Maintenance: Ensuring that contact lenses remain sterile until they reach the user is crucial for eye health. Packaging must provide an effective barrier against contaminants throughout manufacturing, distribution, and storage.
• User Convenience: Packaging should be easy to open, handle, and store, especially for daily disposable lenses. Users value packaging that facilitates quick and hygienic lens removal and insertion without causing damage to the lenses.
• Environmental Impact: Traditional contact lens packaging often involves significant plastic usage, contributing to environmental waste. Developing sustainable packaging alternatives, such as recyclable materials or reduced packaging, is essential for reducing the environmental footprint of contact lens products.
• Regulatory Compliance: Contact lens packaging must adhere to strict regulatory standards to ensure product safety and consumer protection. Meeting these requirements for labeling, quality control, and hygiene adds complexity to the packaging design and manufacturing process.
• Cost Considerations: Balancing the cost of packaging materials, production, and regulatory compliance with the need to deliver affordable products to consumers is a continual challenge for manufacturers.

Significance of VeriPac 410 in Contact Lens Package Testing

VeriPac 410 is a Container Closure Integrity Test (CCIT), that offers non-destructive detection of seal and leak issues in low headspace blister packs, sachets, and pouches. While various test methods are employed to assess package integrity in multi-cavity blister packs and packaging with limited headspace, most of these methods are destructive, subjective, and unreliable.

By utilizing the Vacuum Decay leak testing method and differential force measurement, the VeriPac 410 can effectively detect defective packages. It is capable of testing multiple packages within a single test cycle, depending on their specifications, and can pinpoint which package or blister cavity is faulty. The test results are quantitative, providing operators with a clear pass-or-fail result.

Quality assurance for packaging is ensured through accurate and reliable inspection methods that eliminate subjective factors from the testing process. With the VeriPac 410, tested products can seamlessly return to the production line, minimizing costs and waste typically associated with destructive leak testing methods. The VeriPac 410 provides comprehensive coverage for leak testing in low-volume flexible and semi-flexible packaging. Its return on investment (ROI) makes it an invaluable solution for the pharmaceutical industry.

Moving forward, the future of contact lens packaging holds exciting opportunities for further advancements in convenience, sustainability, and safety. By embracing technological innovations, adopting eco-friendly materials, and adhering to rigorous quality standards, manufacturers can continue to enhance the integrity and usability of contact lens packaging.

Ultimately, the goal of contact lens packaging is to ensure that users receive high-quality, safe, and comfortable products that meet their vision correction needs while also contributing to their overall eye health and well-being. With ongoing dedication to excellence in packaging design and production, the contact lens industry can continue to deliver superior products that enrich the lives of millions of users worldwide.

In the early days, coffee was often packaged in simple sacks or bags made from natural materials, such as burlap or hemp. These materials were not very airtight, so they could not keep coffee fresh for long periods of time. Vacuum sealed packaging was invented during the 1900s. This packaging removes all of the air from the packaging, which helps to keep coffee fresh for an extended period of time. Vacuum sealed packaging is also lightweight and relatively inexpensive, so it quickly became the most popular type of coffee packaging.

In recent years, there has been a growing trend towards more sustainable coffee packaging. This trend is driven by concerns about the environmental impact of traditional coffee packaging materials, such as plastic and tin.

Overview of Coffee Packaging

Coffee packaging refers to the process of packaging and presenting coffee beans or ground coffee for distribution, sale, and consumption. Coffee packaging serves several important purposes, including preserving the freshness and flavor of the coffee, protecting it from external elements such as light, moisture, and oxygen, and providing information to consumers.

Coffee packaging plays a crucial role in ensuring that coffee reaches consumers in optimal condition, with its flavor and aroma preserved. It also serves as a means of communication between coffee producers and consumers, conveying information about the coffee's characteristics and the values of the company that produces it.

Integrity testing of coffee packaging ensures that the packaging is free of leaks and defects that could compromise the quality of the coffee. This is important to do, as leaks can allow oxygen, moisture, and light to enter the packaging, which can all degrade the flavor of the coffee.

Here are some of the benefits of integrity testing for coffee packaging:

• It can help prevent coffee from going stale or developing off-flavors.
• It can help protect coffee from contamination.
• It can help ensure that coffee meets quality standards.
• It can help reduce product recalls.
• It can help improve customer satisfaction.

Quality Testing Using Vacuum Decay Technology

Vacuum decay technology is a non-destructive method for testing the integrity of coffee packaging. It is a Container Closure Integrity Test (CCIT) method with a proven capability of non-destructively testing packaging at the production line with unmatched reliability and sensitivity. Non-destructive testing not only allows a greater understanding of package quality, but also reduces waste as compared to destructive test methods. Waste reduction, in turn, results in a higher return on investment and brings operations closer to green initiatives.

Vacuum decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. VeriPac series is a practical alternative to destructive test methods and can precisely detect leaks as small as 5 microns, identifying process issues before they become critical, avoiding catastrophic quality deviations.

Benefits of Vacuum Decay Test System

• Non-destructive technology.
• ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines.
• Accurate, repeatable results.
• Pass/fail results backed by quantitative test data.
• Completely tool-less with no changeover to test different packaging formats.
• Identifies which cavity is defective.
• Eliminates destructive, subjective testing methods.

Vacuum decay technology is a valuable tool for ensuring the quality of coffee packaging. It can help prevent coffee from going stale or developing off-flavors. It can also help protect coffee from contamination. If you are a coffee roaster or retailer, integrity testing of coffee packaging is an important quality control measure that you should implement.

Automated pouch seal inspection is a technology-driven quality control process used to evaluate the integrity of seals on pouch packaging. It employs advanced machinery, sensors, and algorithms to detect and analyze seal defects, ensuring the quality, safety, and reliability of packaged products.

The purpose of automated pouch seal inspection is to identify and address any issues that may compromise the integrity of the seals. By automating the inspection process, manufacturers can achieve higher inspection speeds, greater accuracy, and improved overall efficiency compared to manual inspection methods. By implementing automated pouch seal inspection, manufacturers can improve their quality control processes, minimize the risk of product defects, and enhance customer satisfaction. The technology allows for increased inspection throughput, reduced labor costs, and the ability to detect even subtle seal defects that may be missed by manual inspection methods. Read on to learn more about the automated pouch seal inspection techniques offered by PTI.

Seal-Sensor Technology

Seal-Sensor™ is an airborne ultrasonic technique that inspects the final pouch seal 100% online non-destructively. The Seal-Sensor is an accurate, quantitative, fast and reliable method of testing pouch seals for defects. The Seal-Sensor detects incomplete seals, partial or weak areas of seals, and many other common defects in seals that appear visually acceptable but affect product quality, value and shelf life. In less than a second, a single linear scan (L-scan) of the pouch seal provides a pass/fail result and quantitative, traceable data.

Benefits of Seal-Sensor Technology

• Deterministic inspection method producing quantitative results.
• Non-destructive, non-invasive, no sample preparation.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable and reliable results.
• Eliminates subjective, manual vision inspection methods.
• Economical, cost-effective solution for seal integrity testing of the final pouch seal.

VeriPac LPX Technology

Based on decades of consistent performance in the pharmaceutical, biologics, and medical device sectors, VeriPac vacuum decay technology has been proven to be the most sensitive and reliable vacuum-based leak testing method available. It is a fully automated package quality inspection system for 100% inline testing. The LPX enables enhanced automated testing that offers a high degree of confidence in the efficiency of the packaging procedure. The LPX is an effective and reliable solution that enables process-related quality issues to be identified and resolved as soon as possible.

The VeriPac LPX has a dynamic robotic design that is adjusted to your production needs. To fulfill the demands of a manufacturing line, the LPX Series offers modular, scalable solutions. With the help of this flexible platform, a range of package forms may be reliably tested. Flexible packaging, rigid containers, and parenteral pharmaceuticals are some of the applications of LPX automation.

Benefits of VeriPac LPX Technology

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard, ISO 11607.
• Highly accurate test results - low false positives and false negatives.
• Non-destructive, non-subjective, no sample preparation.
• Pick-and-Place option back into the production line.
• Auto reject option of defects removed from the production line.
• USP <1207> compliant.

Automated pouch seal inspection relies on various technologies to ensure the quality and integrity of pouch seals. Manufacturers can achieve comprehensive and reliable pouch seal inspection, ensuring product quality and customer safety. The specific technologies employed may vary depending on the industry, application, and quality standards. Automated pouch seal inspection plays a crucial role in maintaining the integrity of packaged products and preventing issues such as leaks, contamination, or compromised freshness.

Parenteral preparations are sterile medicinal products that are administered by injection, infusion or implantation into the body. They are used to deliver medications directly into the bloodstream, bypassing the digestive system and providing a rapid onset of action. There are different types of parenteral preparations, including intravenous (IV) injections, intramuscular (IM) injections, subcutaneous (SC) injections, and intradermal (ID) injections. Each type of administration is chosen based on the specific medication being delivered and the patient's condition.

Parenteral preparations can be single-dose or multi-dose and are usually packaged in vials, ampoules, or pre-filled syringes. These products must be sterile, pyrogen-free, and free from any particulate matter to prevent infections and other adverse reactions in patients. Parenteral preparations can include a wide range of medications, including antibiotics, anticoagulants, vaccines, chemotherapy drugs, and many others. They are typically prepared in a controlled environment, such as a hospital or pharmacy, and are subject to strict quality control measures to ensure their safety and efficacy.

Overall, parenteral preparations play a critical role in modern medicine, allowing for the delivery of life-saving medications directly into the bloodstream.

Overview of Automated Parenteral CCI Solutions

1. E-Scan MicroCurrent RTX

E-Scan RTX is a practical, reliable and entirely automated container closure integrity test (CCIT) approach for pre-filled syringes. The dynamic robotic design of the RTX platform can be customized to meet your manufacturing requirements. The E-Scan RTX uses MicroCurrent HVLD technology, a ground-breaking variation of HVLD, the optimal CCI solution for high-risk biological fluids. It can be used for batch release testing in the lab, on the production line, or in both environments. The test cycle only lasts for a short period of time. The HVLDmc test method checks the entire package for small pinholes, microcracks and defects in the closing seal. This ensures the integrity of the product seal. The HVLDmc has proven to be a highly sensitive leak test method for a variety of liquid-filled pharmaceutical packaging types, including pre-filled syringes, vials, blow-fill-seal containers, and other liquid-filled packages.

Benefits of E-Scan MicroCurrent RTX

• MicroCurrent HVLD technology is effective across all parenteral products, including biologics and extremely low conductivity liquids including sterile water (WFI).
• Listed in USP Chapter 1207 as recommended method for parenteral liquid package inspection.
• Robust method and good Signal-Noise-Ratio between good and defective products.
• Low voltage exposure reduces production of ozone.

2. VeriPac LPX Technology

VeriPac LPX is an automated inspection solution for CCI testing of parenteral products. The VeriPac LPX series is a line of fully automated instruments for 100% inline testing of package quality inspection. The performance of the packing line may be highly assured due to the enhanced automated testing accessible by LPX. The dynamic robotic design of the VeriPac LPX can be customized according to manufacturing needs. The LPX series offers flexible and scalable solutions to satisfy manufacturing line needs. Rigid containers, parenteral products, and flexible packaging are some applications of LPX technology. Systems using VeriPac LPX use Vacuum Decay technology and ASTM Test Method F2338. The FDA recognizes the test technique as a consensus standard for pharmaceutical package testing and is listed in ISO 11607 and USP Chapter 1207 guidelines.

Benefits of VeriPac LPX Technology

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard, ISO 11607.
• Non-destructive, non-subjective, no sample preparation.
• Pick-and-Place option back into the production line.
• Auto reject option of defects removed from the production line.
• USP <1207> compliant.

Parenteral products are typically tested for their container closure integrity (CCI) to ensure that the product remains sterile and safe for use. Automated CCI solutions can provide a fast and reliable method for testing CCI in parenteral products. These solutions offer several benefits over traditional manual testing methods, including increased efficiency, consistency, and accuracy. Automated CCI solutions typically use non-destructive testing methods, such as vacuum decay or high voltage leak detection, to identify any leaks or defects in the container closure system. These methods are highly sensitive and can detect even the smallest leaks that may compromise the sterility of the product.

Automated Container Closure Integrity Testing (CCIT) is a process used to evaluate the integrity of containers for parenteral products, such as vials or pre-filled syringes, to ensure that they are free of defects or leaks. The goal of CCI testing is to ensure that the contents of the container remain sterile and protected from contamination.

There are several advantages to using automated CCI testing, including:

• Speed and Efficiency: Automated CCI testing is much faster and more efficient than manual operator testing, which can save time and resources for manufacturers.
• Accuracy: Automated CCI testing is less prone to human error, which can result in more accurate results and increased confidence in the integrity of the container.
• Reproducibility: Automated CCI testing is designed to be repeatable, allowing manufacturers to consistently and accurately monitor the integrity of containers.

Parenteral Products and its Advantages

Parenteral products are medical products that are administered directly into a patient's bloodstream, bypassing the digestive system. This means that the product is delivered into the body through a route other than the orally, such as intravenously, intramuscularly, subcutaneously, or through other routes. Examples of parenteral products include injectable drugs, intravenous solutions, intravenous nutrition products, blood transfusions, and others. These products are subject to strict quality control and regulatory standards to ensure their safety, efficacy, and sterility, and to maintain the integrity of their packaging to prevent contamination. The specific form of the parenteral product (e.g. solution, suspension, etc.) depends on the product and patient needs.

Advantages of Parenteral Products

Here are some advantages of parenteral products:

• Rapid onset of action: Parenteral products are delivered directly into the bloodstream, which allows for a faster onset of action compared to oral administration. This can be especially important in emergency or critical care situations.
• Measures and verifies container closure system integrity
• More effective for some conditions: Some drugs and therapies are more effective when delivered parenterally because they are absorbed more quickly or may not be well absorbed orally.
• Alternative for patients unable to take oral medications: Parenteral products provide an alternative for patients who are unable to take oral medications, such as patients with gastrointestinal issues or patients who are unconscious.

CCI Testing of Parenteral Products

CCI Testing is performed on parenteral products using a variety of methods, including vacuum decay leak testing, high-voltage leak detection, and others. The specific method used will depend on the type of product, the packaging material, and the desired level of sensitivity. The goal of CCI testing is to provide confidence in the integrity of the packaging and prevent any incidents of contamination or product failure.

The VeriPac LPX Series is a range of completely automated package quality inspection systems for container closure integrity inline testing. The VeriPac LPX has a dynamic robotic design that is customized to your production needs. To fulfil the demands of a production line, the LPX Series offers modular, scalable solutions. This adaptable platform offers a range of package forms that may be reliably automated. Flexible packaging, rigid containers, and parenteral pharmaceuticals are only a few examples of the applications for LPX automation.

The packages will be picked up and placed by a quick robotic gripper arm into the VeriPac LPX test chambers, where a quick vacuum-based test will be performed. Along with the quantitative test result data, a clear PASS/FAIL result is shown. In order to maintain continuous flow and seamless downstream processing, the packages will then be returned to the product line. Rejects are automatically taken off the production line.

Benefits of VeriPac LPX

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard.
• Highly accurate test results - low false positives and false negatives.
• Non-destructive, non-subjective, no sample preparation.
• USP <1207> complaint.

CCI testing is used to evaluate the sealing of the product container and detect any leaks, breaches, or defects in the packaging. This is important because parenteral products are sensitive to environmental factors such as temperature and pressure changes, and any breaches in the packaging could result in contamination or degradation of the product.

Overall, automated CCI testing is an important tool for ensuring the safety and quality of parenteral products, and is increasingly being used by manufacturers to ensure that their products meet regulatory requirements and industry standards.

Meat processors are relying on technologies to extend product shelf life more than ever before, which puts concerns like shelf-life stability and packaging quality to the forefront of challenges. Although meat-based snack products and pet products come in a variety of packaging formats, they all require package integrity assurance/container closure integrity testing for extended shelf life.

Flexible packaging, particularly pre-made pouches and form-fill-seal pouches and bags, is the most preferred format for meat-based snack foods and pet food products. With its capacity to provide shelf stability and ease of opening, flexible packaging makes for the best package appearance. The market for meat products for animals has grown rapidly, as consumers are willing to spend more and demand higher-quality products. Meat snacks intended for animal consumption as well as human use must be free of mold or product deterioration.

Modified Atmosphere Packaging (MAP) tray packs are a common packaging option for fresh beef, hog, and poultry products as well as many other processed meats. By significantly reducing spoilage and extending shelf life, the MAP method provides consumers with fresh items that look good. Once an MAP package is sealed, it is essential to maintain the seal integrity to avoid leaks that can let O2 or other environmental pollutants enter the package.

Explain MAP

Modified Atmosphere Packaging (MAP), which can detect leaks as small as 10 microns, is widely used for perishable products. Package integrity can be tested by monitoring the amount of residual oxygen in the headspace of the package. According to the method, the product must be set up for stability and the headspace must be measured at various time intervals. The six-day test, which frequently measures O2 levels over the maximum threshold (about 3%), is used for production purposes. A 50-micron defect significantly reduces a product's shelf life, but it typically passes a six-day O2 test with flying colors. Six days of output are already palletized and stored in case the O2 test identifies a quality issue. Vacuum Decay can find breaches as small as 10 microns, detect oxygen-critical defects in real time at the source, and prevent extensive quality issues.

VeriPac Series for Testing MAP Meat Packages

The VeriPac Vacuum Decay Series of inspection systems have a proven capacity to non-destructively test packaging down to O2 sensitive leak sizes, which reduces waste and enhances testing capabilities. By consistently detecting leakage as tiny as 10 microns, the technology may identify process issues before they become critical. VeriPac offers quantitative data that is correlated to leak rate and leak size in addition to a clear attribute result (PASS or FAIL).

The VeriPac D-Series uses a revolutionary FLEX-Chamber to test flexible packaging formats since it is resistant to package changes and removes the requirement for changeover when testing different size pouches. Additionally, more than one package may be tested during a single test cycle. The VeriPac Series utilizes a rigid packaging test chamber for MAP Meat Tray Package testing. Depending on the needs of the production, the test system operation can be set up for either semi-automatic or manual operation.

Advantages of VeriPac Series

• Non-destructive, no sample preparation.
• Deterministic, quantitative test method.
• Defect detection down to 0.2 ccm.
• High level of sensitivity, repeatability and accuracy.
• Short cycle time provides operators with PASS/FAIL results.
• Small footprint and modular portable design.
• ASTM test method and FDA standard.
• Referenced in USP 1207 guidance.

Since it eliminates subjective results, the VeriPac series is a practical alternative to destructive testing. Case studies have proven that Vacuum decay leak testing technology offers a rapid return on investment when evaluating the dramatic decrease in waste created by destructive test techniques.

The sensitivity of a test method is necessary for several reasons, but it is most crucial in ensuring the final product is of high quality. Powdered dairy products (milk powders, infant formula, protein-based powders) are kept in a modified environment to avoid spoilage and maintain the nutritional value of the product throughout its shelf life. Before usage, the product will quickly deteriorate due to oxygen and moisture intrusion, affecting the flavor and texture and finally converting any desirable commodity into a liability. The quantity and impact of oxygen ingress depend on a number of variables, and it will occur in the presence of tiny leaks. Leaks as small as 10 microns will have an immediate impact on the product for smaller packaging types. Current conventional test techniques are completely insufficient for identifying such defects, leaving manufacturing operations exposed to severe quality variations. Applying techniques with greater sensitivity provides the highest level of quality assurance, rather than just locating minor leakage.

Ensuring Dairy Products Package Integrity with VeriPac FLEX Series

For pouches and other flexible packaging, VeriPac FLEX systems are versatile non-destructive package inspection systems. These are available in a variety of configurations for the leak test instrument and the test chamber capacity, with solutions to accommodate small format sachets and stick packs up to bulk size pouches and bags. This is done to accommodate different package specifications and test sensitivity requirements. The Food and Drug Administration (FDA) has recognized the ASTM technique for Vacuum Decay leak testing (F2338) defined in ISO 11607 as a consensus standard for pharmaceutical package testing. This approach is used by VeriPac FLEX Systems.

VeriPac inspection systems are the best alternative for destructive testing since they eliminate the subjectivity of test results and reduce the waste and costs associated with these techniques. Comparing Vacuum Decay leak testing technology to destructive techniques like the water bath or blue dye leak test, it has been found to offer a quick return on investment. The VeriPac test provides reliable critical packaging failure detection and useful packaging process insight.

Technology Overview

The VeriPac test instrument is attached to the appropriate FLEX chamber based on the size range of the packages. Depending on the application, two VeriPac systems combined with the FLEX chamber offer varying levels of leak detection capabilities. The Integrated Flexible test chamber (IFC) is designed for low-headspace sachets or stick packs. Depending on the package size and requirements, the Drawer Style test chamber (D-Series) comes in two common sizes, the Small (D) or Large (DXL). Custom designs are capable of being produced for huge package forms and bulk products. The manner in which the package is tested is the unique difference with VeriPac FLEX systems. Multiple packages can also be tested in a single test cycle.

VeriPac FLEX Series Benefits

• Non-destructive, deterministic and quantitative test method.
• Does not require any sample preparation.
• Perform a single test cycle for several packages.
• USP < 1207> compliant.
• Promote zero-waste initiatives and sustainable packaging.
• Makes the inspection and validation procedure easier.
• Reliable and repeatable outcomes.
• FDA standard and ASTM test methods.
• Inexpensive with a quick return on investment.

Flexible packaging is highly susceptible to routine microleaks that reduce shelf life and contaminate dairy proteins, considered a very high-risk product. VeriPac FLEX is an optimal solution for powdered dairy products package integrity testing. They offer a definite PASS or FAIL in addition to quantitative data corresponding to a leak rate.

Vacuum Decay is a non-destructive method for testing the integrity of container closures for package integrity and leak path detection. The technology provides quantitative, deterministic, and reliable test results to assure package integrity in comparison to manual inspection and other non-deterministic test techniques. The vast range of package types that may be accommodated by Vacuum Decay technology includes filled and sealed rigid, semi-rigid, and flexible packaging consisting of non-porous or porous materials.

Vacuum Decay Technology

Vacuum Decay is one of the most efficient and accurate vacuum-based leak detection methods. The method operates by placing the package within a properly outfitted evacuation test chamber that contains an external vacuum source. To detect any deviations from a predetermined targeted vacuum level, the vacuum levels are continually monitored. If there is a defect in the packaging, air or liquid will leak into the chamber from the package and cause a change in pressure. On the other hand, non-defective packages do not leak any pressure into the chamber, maintaining the chamber vacuum level constant. The test cycle is quick, non-invasive, and non-destructive to both the product and the container. The Vacuum decay system can detect both major and minor defects, regardless of where they are located. The system has various applications in the field of pharmaceuticals and medical devices.

Applications of Vacuum Decay Technology in Various Industries

• Pharmaceutical

Pharmaceutical products are a range of substances used for treating, diagnosing, or changing organic processes to help the management of public health. Pharmaceutical products are tested to make sure they adhere to strict safety and quality requirements. Previously, pharmaceutical packaging was only subjected to sterility testing. However, the United States has recognized that sterility testing alone is not sufficient to maintain the integrity of pharma products. FDA (Food and Drug Administration) has published guidance related to pharma industry on submission of documentation for sterilization process evaluation in human and veterinary drug products.

Container closure integrity (CCI) testing is a non-destructive package inspection technology for finding leaks and avoiding potential contamination. A test like this is necessary since any defect in the container might allow foreign particles to enter the product and thereby reduce its shelf life. Since it impacts both the product and the patient, a manufacturer places high priority on implementing the proper container closure system. Thus, the relevance of container closure integrity testing in the pharmaceutical industry has increased substantially over time. Vacuum Decay and MicroCurrent HVLD are the most chosen technologies for testing pharmaceuticals.

• Medical Device

Maintaining medical device package integrity is essential to make sure the product is delivered to the end user unharmed. Medical device packaging and delivery options range from rigid non-porous containers to flexible porous packaging. Every packaging format has a different set of characteristics and requirements, so choosing the right inspection technique requires a thorough approach. Package challenges have risen along with packaging format and material innovations. Among all medical equipment, Class III devices produce the greatest risk to maintaining package integrity. These implanted devices preserve or maintain life. Pacemakers, cardiovascular stents, respiratory ventilators, and breast implants are a few examples of Class III medical devices. Since these devices are inserted into human bodies directly, even a small packaging defect puts patient’s safety at risk. Therefore, it is essential to evaluate the container closure integrity of medical devices.

Vacuum Decay Technology Benefits

• Non-destructive, non-subjective and does not require sample preparation.
• Detection of defects down to 0.01 cc/min.
• Results show that they are more accurate than dye ingress.
• Quantitative, deterministic testing technique.
• Supports initiatives for waste reduction and sustainable packaging.
• ASTM test method and FDA recognized standard.

When determining the integrity of pharmaceutical and medical devices, Vacuum decay leak testing is the best non-destructive option. The test measurement generates a reliable and accurate quantitative result, as well as a pass or fail decision. The FDA recognizes the standard Vacuum Decay leak test technique (ASTM F2338) as a consensus standard for evaluating container closure integrity (CCI). The test technique is referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and listed in ISO 11607.

The difficulty of maintaining shelf life for packaged snack foods never end. The majority of snack foods are oxygen and moisture sensitive. Package integrity issues can lead to mold growth, oxidation, taste loss, and spoilage. Leaks smaller than 10 microns can contaminate a product with bacteria, and comparable leak sizes might allow moisture or oxygen in. Snack foods come in a wide range of packaging types, but they all require package integrity assurance for extended shelf life.

Even a tiny leak in the container might cause microbial contamination or oxygen penetration, and traditional test methods may not be able to find such leaks. The sensitivity of the testing method is crucial for preserving the quality of the product during its shelf life. In this blog, we will discuss how VeriPac Vacuum Decay technology can efficiently leak test snack food packages.

VeriPac Vacuum Decay Series for Snack Food Package Integrity Testing

VeriPac Vacuum Decay technology is an ASTM-approved, FDA-recognized test technique with the ability to deliver reliable, consistent, repeatable, and accurate quantitative data. It is a non-destructive container closure integrity testing method that can identify micro leaks while taking into consideration a variety of packaging types, including filled and sealed rigid, semi-rigid, and flexible packaging composed of non-porous or porous materials.

Vacuum Decay leak testing is recognized as an efficient alternative for destructive testing techniques like water bath or dye intrusion because it removes subjectivity and lowers waste and costs. It is proven to provide a short-term return on investment. Critical packaging defects are consistently found by the VeriPac test systems, which also provide useful packaging process insights. The VeriPac Series will evaluate a wide range of high-risk packaging applications and ensure that the final product satisfies consumer and regulatory requirements. The suitable VeriPac model is chosen, based on the intended package type and leak test sensitivity. Depending on the application, configurations can be optimized and customized.

Working Principle

Under this technique, VeriPac leak testers are connected to a test chamber specially designed to hold the sample package. The package that has been put inside the test chamber is subjected to vacuum. A single or dual vacuum transducer technology is used to monitor the vacuum level as well as how the vacuum changes during a predefined test period. The existence of leaks and other defects within the package is determined by monitoring variations in an absolute and differential vacuum.

VeriPac Inspection System Benefits

• FDA Consensus Standard and ASTM Test Method F2338.
• Cost-effective and quick return on investment.
• Simplifies the inspection and validation procedure.
• Non-destructive, non-subjective, no sample preparation.
• Supports sustainable packaging and zero waste initiatives.
• Referenced in USP Chapter 1207.

Flexible packaging such as sachets, stick packs, and pouches, composite cans, and modified atmosphere packaging (MAP) are common types for snack food packaging. For snacks like nuts, savory snacks, chips, crackers, cookies, beef jerky, nutrients, and granola bars, they provide the ideal packaging appearance. They offer shelf stability and simplicity of quick opening. While every packaging offers a different set of advantages and product appeal, every format also has a different set of difficulties for maintaining the integrity of the package and seal.

To assure the safety of pharmaceutical products, during their distribution and storage, manufacturers perform Container Closure Integrity testing (CCI testing). CCIT helps in evaluating the integrity and stability of packaging or containers till they reach their destination. Although destructive CCI techniques such as water bath, and dye tests can find leaks, they are time-consuming, inaccurate, and provide subjective test results. Furthermore, they cause considerable product loss and waste. This leads to an increase in the demand for non-destructive deterministic CCI methods such as Vacuum Decay, MicroCurrent HVLD and Airborne Ultrasound.

Vacuum Decay is a non-destructive CCI testing method that focuses on package integrity and leak path detection. Unlike manual inspection and other non-deterministic testing techniques, Vacuum Decay provides quantitative, deterministic, and accurate test results to assure package integrity. Vacuum Decay technology can handle a wide range of package types, including filled and sealed rigid, semi-rigid, and flexible packaging comprised of non-porous or porous materials.

Technology Overview

The Vacuum Decay method operates by enclosing sample packages in a tightly fitted evacuation test chamber with an external vacuum source. The test chamber is monitored using single or dual vacuum transducer technology for both the level of vacuum and the change in a vacuum throughout a defined test duration. The existence of leaks and defects inside the package is indicated by variations in an absolute and differential vacuum. This inspection method is suitable for offline laboratory testing and can be customized for manual or completely automated operations. The test cycle is non-destructive to both the product and the packaging and only takes a few seconds. It saves money by not wasting products for leak tests and produces a return on investment in less than 6 months for many products.

VeriPac Vacuum Decay Technology

VeriPac Vacuum Decay technology is the optimal non-destructive solution for determining container closure integrity in a variety of package configurations. VeriPac Series will evaluate a wide range of high-risk packaging applications and ensure that the product fulfills regulatory and consumer integrity standards. The VeriPac product line systems analyze the package in a quick, repeatable, and reproducible way, providing quantitative and deterministic test results. Vacuum Decay technologies can identify package leaks and invisible defects utilizing a non-invasive, non-subjective technique that does not need sample preparation.

The VeriPac Series is a practical alternative to destructive testing methods and can detect leaks down to sub-micron levels. An appropriate VeriPac model is chosen based on the type of package and leak test sensitivity required. Configurations can be optimized and tailored to specific applications.

• Non-destructive technology
• Defect detection down to 0.05 ccm
• Accurate, reliable, and repeatable results
• Pass/fail results backed by quantitative test data
• No tools are required to evaluate alternative package formats
• Identifies which cavity is defective
• Eliminates destructive, subjective testing methods
• Supports sustainable packaging and zero waste initiatives
• FDA recognized standard for package integrity testing

Over the years, Vacuum Decay leak testing has proven to be one of the most practical and sensitive vacuum-based leak detection technologies. Vacuum Decay technology is recognized by the American Standard Testing Method ASTM F2338 and detects leaks in hermetically sealed containers, making it useful for both the pharmaceutical and medical device industries.

The pharmaceutical packaging industry is constantly developing as pharmaceutical manufacturers require reliable and efficient packaging solutions that meet a variety of requirements. Packaging is essential for the safe storage and administration of pharmaceutical products. Packaging pharmaceuticals is important not only for storing and protecting products but is also helpful in identifying, marketing, and promoting different brands, and making pharmaceutical products easier to use. Vials, blister packs, bottles, syringes, ampoules, etc are the most common pharmaceutical packages. The packages must perform correctly to ensure that the drug product remains uncompromised throughout the distribution cycle and shelf life. These packages are later tested to guarantee their quality and integrity.

Testing Package Integrity Using VeriPac 355 Series

VeriPac 355 is a non-destructive micro leak detection device for testing container closure integrity and package integrity on a variety of products and packaging types. This system is specially designed to test containers for dry product gas leaks as well as liquid leaks. Since it is non-destructive and does not need sample preparation, the VeriPac 355 can be integrated into protocols at any step in the handling process. The VeriPac 355 is the ideal non-destructive quantitative test technique for various pharmaceutical and food applications, with the capacity to detect leak rates as low as 0.2 cc/min depending on package parameters. The VeriPac 355 core technology is based on the ASTM vacuum decay leak testing method (F2338-09), which is recognized by the FDA as a consensus standard for package integrity testing. VeriPac leak test instruments were used to develop this test method.

Technology Overview

The VeriPac 355 leak tester is connected to a test chamber intended to hold the package to be tested. The package is placed inside the vacuum-sealed test chamber. High-resolution absolute transducer technology is utilized to monitor the test chamber for, both the level of vacuum and the change in vacuum during a pre-defined test duration. This is capable of detecting both gross and micro leaks. The test cycle is only a few seconds long and the results are objective. The testing is non-destructive to both the product and the package.

The sensitivity of a test is determined by the sensitivity of the transducer, the package design, the package test fixture, and the crucial test parameters of time and pressure. Test systems can be configured to operate manually or semi-automatically. This method is suitable for offline laboratory testing and QA/QC statistical process control.

Advantages of VeriPac 355

• Non-destructive, non-subjective, and no sample preparation is required
• Deterministic, quantitative test method
• Detection of defects down to 0.2 ccm (5 microns)
• High sensitivity, repeatability, and accuracy
• Operator receives a PASS/FAIL result within a short cycle time
• Portable modular design with a small footprint
• FDA standard and ASTM F2338 test method

VeriPac technology is the optimal non-destructive solution for determining container closure integrity in a variety of package configurations. The strategy for choosing the right VeriPac model is based on the package type and the required leak test sensitivity. Configurations can be optimized and customized to the needs of each application. The VeriPac Series will analyze a wide range of high-risk package applications and ensure that the product fulfills regulatory standards and customer requirements for integrity.

Testing Container Closure Integrity (CCI) is crucial for ensuring the quality of Class III medical devices. Class III medical devices are sterile components that are designed to be inserted directly into the human body. These devices often sustain or support life, are implanted or pose an unreasonably high risk of disease or damage. A compromised package can serve as a vehicle for microbial transmission and compromised sterility, leaving patient safety at risk. When bacteria or other impurities enter the container, the device ceases to be a treatment and becomes a danger to the patient. Similarly, a breach of the seal affects the sterility of the device and may present a serious quality concern at a key point of usage.

Testing Challenges in the Medical Device Industry

There are three basic approaches to package integrity testing:

• 100% in-line testing: All products in a batch are tested on a high-speed production line at an acceptable level of CCI assurance.
• Small batch testing: Testing a statistically significant batch size for certain quality parameters and extrapolating to match the quality of the manufacturing lot.
• Testing Offline: Operators test packages individually or in smaller batches.

Dye penetration is a technique for identifying defects in package body and seals that has a variable detection capacity. When carried out correctly, the approach can identify pinholes and channel defects as small as 20 microns. This method is only used to validate the packaging process and offers minimal value to in-process quality monitoring. The method is time-consuming to implement and provides limited information in the effort to ensure the quality of high-risk applications.

For CCI testing, the majority of medical device manufacturers use a 100% in-line manual visual inspection technique. Manual visual inspection has been proved to be one of the least reliable techniques for ensuring quality. The failure of manual visual inspection is caused by a number of factors. According to ASTM test method F1886, a manual visual inspection may detect 75-micron channel defects in a transparent seal 60-100% of the time. Although manual visual inspection can be applied as a 100% test method, performance on the task decreases significantly over time. This method is not applicable if the package format is not transparent or semi-transparent.

How Vacuum Decay and Airborne Ultrasound Technologies are Automated?

Vacuum Decay is a deterministic method proven to offer predictable and reliable results for CCI testing of high-risk package applications. This is an ideal solution for non-porous medical device applications. When the major focus of the inspection is the final seal of a porous package, Airborne Ultrasound is exceptionally efficient and reliable at detecting seal defects that are invisible to the manual visual inspector. Both approaches have shown to be reliable non-destructive testing methodologies, and one or the other can be used for inspection based on the unique features of the product and container.

The automation of each technology looks a little different. Vacuum Decay enables approximately 25 to 50 samples per minute, with low throughput detecting single-digit micron leak sizes. Airborne Ultrasound is a rapid-fire sensor that transmits 1000 pulses per second of sound through the seal. The final seal of Tyvek® pouches and other flexible packaging systems may be scanned at a rate of 20 inches per second (~40 cm/sec), with the capacity to detect the most frequent seal faults and seal quality concerns. Both methods enable a production line to ensure quality while reducing production throughput.

The Airborne Ultrasound technology offered by PTI can be automated in many ways. Basically, the technology can measure the quality of a quantitative seal in any way that the pouch seal can pass through the ultrasound inspection head. Ultrasound can be applied to the production flow, which captures seal quality when exiting a band-sealer or transferring pouches through a production line. Robotic handling may also be used to do a full 360-degree seal inspection on all pouch seals. Airborne Ultrasound has the flexibility to be deployed in a variety of production lines and has high reliability in detecting critical defects.

Vacuum decay is often utilized for both Tyvek® trays and non-porous container types. While a vacuum takes longer to do a test (about 5 seconds on a Tyvek tray), the sensitivity and stability of this technology make it perfect for low output applications with high sensitivity requirements. Robotic handling solutions can serve many test stations at the same time, allowing for increased product throughput without losing sensitivity.

Medical devices are packaged and delivered in a variety of ways, ranging from porous flexible packaging to non-porous rigid containers. The range of product types and packaging options create unique inspection challenges that must be overcome in order to assure seal strength, sterility, and quality. Airborne Ultrasound and Vacuum Decay offer 100% testing capabilities as well as an accurate inspection that includes quantitative test results and a pass/fail result. These new automated technologies, with more sensitive leak detection capabilities, inspect containers at a higher rate.

Pre-filled syringes are becoming more popular as a preferred container closure system for biologics. Pre-filled syringes must offer an inherent barrier that maintains drug product stability and sterility throughout its entire shelf life as a primary container closure system. The ability of the system to retain its microbial barrier integrity must be checked and demonstrated by the drug manufacturers. In 2008, the FDA endorsed CCI testing as part of the sterile product stability protocol.

The pharmaceutical industry has witnessed substantial technical developments in CCI testing in response to rising regulatory demands. MicroCurrent HVLD, Vacuum Decay Leak Testing and Helium Leak Detection are examples of new technologies that have proven enhanced detection capabilities above traditional Dye and Microbial Ingress approaches. Many of the technologies have been employed for CCI testing of drug product stability.

CCI Testing Strategy for Development

Many CCI failure modes can occur throughout the life cycle of a syringe, from component production to drug product filling and sealing, device assembly and packaging, and finally distribution and storage. It is critical to create a comprehensive plan for conducting CCI testing across the whole syringe life cycle.

The creation of the CCI testing technique begins with a detailed study of the construction, design, and manufacturing procedures used in syringes. The failure modes and impacts associated with each aspect of CCI were identified first. The next step was to evaluate whether CCI testing is required, as well as the intended uses and testing frequencies, using a risk-based approach. Knowing that the needle shield compartment seal integrity had been verified by the component supplier, apply a non-routine CCI test to validate its seal integrity during drug product loading and sealing, as well as during device assembly. To ensure CCI was achieved and successfully maintained, implement a complete set of CCI tests across the entire product development cycle for the product-containing syringe barrel compartment.

Method Development and Method Validation

Method development consists of optimizing testing parameters and determining the appropriate pass/fail threshold.

• Testing parameters optimization

Initially, several defect standards of known sizes were examined alongside undamaged samples using varied testing conditions. The relationships between key method parameters and instrument responses to intact and defect samples were comprehensively investigated, with the objective of determining a set of variables that give optimal separation between intact and defect samples. i.e. signal-to-noise ratio or SNR.

• Pass/fail threshold determination

The improved method was utilized to evaluate different lots of filled intact syringes representing relevant product variations, such as drug product batches, and packaging locations and lines, in order to define the preliminary pass/fail threshold. For intact samples, the results of the tests were statistically assessed to determine the instrument baseline and variation (σ). Typically, the pass/fail threshold should be 10 σ higher than baseline. The pass/fail threshold was then further refined and verified by testing defect standards of known sizes.

CCI testing techniques were validated for the pharmaceutical product package. Since the drug product formulation and package design may change during the early development stages, a step-by-step approach was adopted to validate the methods in line with the product development stages. Once product design and packaging design are complete, the methods are fully validated to support CCI testing for initial consistency and process evaluation. The power of the additional long-term method may be further validated before this method is implemented in QC laboratories for routine testing.

During package and pharmaceutical product development and manufacturing, properly selected and verified methodologies are critical for demonstrating container closure integrity. It should be noted that existing CCI testing methods do not provide an optimal solution for all pre-filled syringe CCI testing requirements. To maintain total container closure integrity, an integrated solution involving CCI testing as well as additional engineering and administrative controls is required.

Class III medical devices have a unique combination of criteria and package features that necessitate a comprehensive approach to determining the best inspection procedures. For medical package inspection, there are a variety of methods that require a thorough understanding to assure quality.

Manual visual inspection has been the most common form of inspection for medical device packaging. While an ASTM standard (ASTM F1886) covers this concept, it may not be applicable for all applications and has limitations. Even though a 75-micron channel defect can be detected by manual visual inspection, the ASTM method F1886 indicates that the chance of detection ranges from 60% to 100%. This vast range of uncertainty does not give the level of assurance required for the packaging of high-risk medical devices.

Although certain offline leak detection techniques can offer a quantitative evaluation of seal quality, they miss some of the most prevalent seal problems seen in Class III medical device packaging. Testing peel strength or utilizing other destructive methods will not reveal random seal problems. For class III medical devices, online non-destructive inspection procedures are excellent since they provide quality control with comprehensive manufacturing lot data.

All Class III medical devices must be sterile, however, container materials and design differ widely. A non-porous pouch or tray demands an entirely different technique than a porous pouch or tray. Tyvek® offers a sterile barrier, and the porosity of the material limits the leak test procedures that may be used on the package body. When it comes to porous packaging, the focus of online inspection moves away from leak detection and toward seal quality evaluation.

Technology Overview

Vacuum decay and Airborne ultrasound are the two main methods used by PTI/CCIT to inspect medical device packaging. Both methods are aimed at providing quantitative and deterministic test results in order to assess package quality. In terms of function and performance, the two technologies are entirely different. Package integrity and leak path detection are the main objectives of Vacuum decay. Meanwhile, Airborne ultrasound technology focuses on package seal inspection and seal quality. Both approaches aim to meet the basic requirements of being reliable and sensitive inspection procedures for Class III medical device applications.

Vacuum Decay (ASTM F2338)

Vacuum decay is the most practical and sensitive vacuum-based leak test method of CCI. When testing pouches, a versatile adjustable test chamber may be utilized to test pouches of various sizes. The package is then placed into the vacuum-sealed test chamber. The level of vacuum, as well as the change in vacuum during a pre-defined test duration, are both monitored during the short test cycle. The change in vacuum indicates the existence of leaks and defects within the package. Vacuum decay leak testing is a go-to standard for sterile products because of its sensitivity and dependability. The approach is ideal for laboratory offline testing and production applications for quality assurance process control, since test equipment may be developed for manual or automation operation.

The ASTM Vacuum decay leak test technique (F2338), which has been accepted by the FDA as a consensus standard for package integrity testing, was developed using PTI VeriPac technology. As a deterministic test technique for package integrity test solutions, Vacuum decay is mentioned in ISO 11607 and the new USP 1207 guideline document.

Airborne Ultrasound (ASTM F3004)

Airborne Ultrasound is an ASTM Test Method F3004-13 and is one of the most effective methods for non-destructive seal quality inspection of flexible packaging. It is mentioned in ISO 11607 and the new USP 1207 guidance document. Most inspection methods are challenged by the leaking nature of porous packaging, but Airborne ultrasound, with its non-destructive measure of seal quality, effectively overcomes those challenges.

The non-contact Airborne ultrasonic testing technique is used in both Seal-Scan (Offline) and Seal-Sensor (Online). Ultrasonic waves propagate through the material as a package seal passes through the sensor head, producing sound waves to be reflected. When defects are encountered, the signal intensity is reduced or eliminated. The larger the acoustic gap between mediums, the more sound is reflected and less sound is transferred through the seal.

The variety of package forms and materials makes inspecting the integrity of class III medical device packaging a challenge. CCIT's scientists and engineers have vast industry experience and can prove a complete solution, including test method development and equipment validation for Class III medical device packaging.

Testing the integrity of package seals helps ensure that nutritional packaging provides required product protection. Maintaining the reliability of package seals is critical for product quality and food safety. Airborne Ultrasound and Vacuum Decay technology can be used for testing package and seal integrity of nutritional packages. These CCI technologies produce quantitative, and repeatable results, due to their deterministic nature. The primary purpose of implementing these testing methods is to ensure the safety of consumers.

Overview of Nutritional Packaging Inspection

Nutritional packaging plays a significant role in securely delivering the product. The majority of nutritional products are shelf-stable in nature, therefore package performance is typically a concern. Chemical reactions occur naturally in all nutritional products. Any break in the nutritional packing might lead to the products deteriorating due to air, moisture, and microbial exposure. Fats and other nutrients for infants might become rancid and inactive. The quality and safety of the contents that reach the customer are determined by nutritional packaging.

Package and seal integrity techniques have great expertise in the packaging industry, which helps in inspecting nutritional packages in the most efficient method in order to preserve package and product quality. For the food and nutritional packaging industries, CCIT provides a variety of technologies and solutions. The two most common nutritional package inspection technologies are vacuum decay and airborne ultrasound. While vacuum decay is utilized for applications such as filled and sealed rigid containers, dry products in pouches, and flexible packaging. Retort pouch final seal inspection can be achieved using non-destructive with airborne ultrasound technology.

Technologies to Assure Package and Seal Integrity

Vacuum Decay Technology

Vacuum decay is a package test method for vacuum-based leak detection. It is considered one of the most practical and sensitive test methods used in nutritional package inspection. When compared to destructive test procedures, this technology not only provides for a better understanding of package quality but also minimizes waste. As a result of the waste reduction, the return on investment is higher, and the operation is closer to green initiatives.

The Vacuum Decay leak testing method operates by enclosing package samples in an evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a pre-defined test duration using single or dual vacuum transducer technology. The existence of leaks and defects within the package is indicated by variations in an absolute and differential vacuum. Test systems can be designed to be operated manually or fully automated.

Airborne Ultrasound Technology

Pouches are the common form of packaging for most nutritional products. Hence, it is necessary to ensure the package integrity of such pouches. Airborne Ultrasound is a non-destructive and non-invasive method of inspecting seal quality. In this method, ultrasound waves are permitted to pass through the package seal, causing sound waves to be reflected. The fluctuation in the reflected signal intensity is used to detect defects.

Airborne Ultrasound technology is available in both online and offline solution options. It has been proven to be one of the most successful non-destructive testing procedures for flexible package seals. According to ASTM F3004-13, this is the standard test technique for evaluating seal quality and integrity using airborne ultrasound. This method has high applicability in the food and nutrition industry.

Vacuum Decay technology and Airborne Ultrasound technology are both ASTM test methods and also FDA consensus standards for package integrity and seal quality inspection of nutritional products. An appropriate testing method for inspecting nutritional packages is selected based on the nature of the product and its package.

Pre-filled syringes have a significant role in the injectable drugs market. Because of its convenience, efficiency, and patient safety, pre-filled syringes are now widely utilized in a variety of medical areas. Pre-filled syringes, which are rapidly replacing traditional syringes are frequently used to deliver vaccinations. Defects in pre-filled syringes are mostly determined by pharmaceutical product design and syringe process design. Patient-related concerns are also a regulatory concern. As a result, it is critical for manufacturers to have a thorough understanding of the various tests involved in order to assure patient safety.

Evaluating leak test using Vacuum Decay Vs MicroCurrent HVLD Test Methods

Manufacturers perform Container Closure Integrity testing to ensure that the product maintains sterility and microbiological quality until the point of use. Container closure integrity testing evaluates a container closure system's capacity to maintain a sterile barrier against contaminants that might affect the quality of the resulting pharmaceutical and biological products. Various test techniques may be used to challenge Container Closure Integrity (CCI), however, not all of them are equally capable of finding package leaks. Vacuum Decay and High Voltage Leak Detection (HVLD) are the two deterministic test techniques for CCI mentioned in USP 1207, that are frequently used for parenteral products.

Technologies Overview

Vacuum decay leak testing is a CCI test method that has been proven over decades and improved with new technology innovations. When compared to destructive testing techniques, non-destructive testing not only provides for a better knowledge of package quality but also minimizes waste. As a result of the waste reduction, the return on investment will be higher.

Vacuum Decay method operates by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a set test duration using either single or dual vacuum transducer technology. The existence of leaks or flaws within the package is indicated by variations in an absolute and differential vacuum. The Vacuum Decay method for leak detection of pre-filled syringes have proven to be an effective method of testing.

Benefits of Vacuum Decay

• ASTM Test Method F2338 and referenced in USP 1207 Guidelines
• Deterministic, quantitative test method
• Repeatable, rapid, and reliable testing
• Non-destructive technology
• Completely tool-less with no changeover to test different packaging formats

High Voltage Leak Detection (HVLD) is a deterministic CCI test method for package inspection of non-porous pharmaceutical and parenteral goods. This technique is based on the fundamental characteristic of electricity. MicroCurrent HVLD technique, the latest evolution of HVLD developed by PTI, promises to provide a high degree of CCI assurance throughout the whole range of parenteral goods.

This method operates by scanning the container which can be done offline in the laboratory or online in an automated robotic platform. On one side of the container, a high voltage is supplied, while the other side has a ground probe. If there is no leak in the package, the two container walls (high voltage and ground) offer complete electrical resistance, and no substantial current is measured passing through the vial. The break-down resistance is achieved when there is a micro-leak or fracture in one of the container walls, and the current passes through. HVLD is the only leak detection technique that does not require mass to flow through a defect location, instead of relying on electricity to pass through a crack.

Benefits of MicroCurrent HVLD

• Non-destructive technology
• Non-invasive, no sample preparation
• High level of repeatability and accuracy
• Offline and 100% online inspection at high production speeds
• Low voltage exposure to product and environment

Pre-filled syringes have emerged as a practical and dependable source for unit dosage medication as the pharmaceutical industry continues to seek possibilities to create convenient drug delivery techniques. We, at CCIT put a lot of effort into developing customized handling solutions that guarantee that syringes are moved without touching their piston to minimize product loss.