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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.

Package testing is a critical aspect of product quality assurance and safety across various industries, such as food and beverage, pharmaceuticals, industrial products and consumer goods. Ensuring the integrity of packaging materials and their ability to protect contents from environmental factors like moisture, oxygen, light, and physical damage is essential to maintaining product efficacy, safety, and shelf life. One of the key parameters evaluated in package testing is Container Closure Integrity (CCI), which refers to the ability of a package to maintain its integrity and prevent the ingress of harmful substances or the egress of beneficial ones. Establishing robust test methods for assessing CCI is vital to guarantee the reliability and effectiveness of packaging solutions.

In this blog, we will delve into the development of test methods for evaluating Container Closure Integrity (CCI) in package testing.

Overview of Test Method Development

Test method development in package quality testing serves as the cornerstone for assessing and guaranteeing the robustness of packaging materials and systems. The need for rigorous testing methodologies is paramount to meet regulatory requirements, industry standards, and consumer expectations. Package Testing Method Development at PTI’s CCIT Center of Excellence focuses on package/product characteristics and the extent to which the package characteristics need to be challenged to ensure closure integrity. Test method development includes the optimization of test parameter settings, including the level of vacuum or high voltage (depending on the technology), test cycle times, and pass/fail criteria for a particular test method. The detailed report will include test protocols and criteria, test results, and expected leak rates for the client with recommendations and conclusions. Before being included in the final report, each test method developed in Test Method Development is validated to make sure it is repeatable, accurate, precise and appropriate for the intended use. Developing the most accurate and appropriate test methods for package quality testing involves identifying the relevant data for testing.

Relevance of Test Method Development in Package Quality Testing

Test method development is essential for ensuring high-quality packaging. Here's a breakdown of why it's so crucial:

Reliable and Accurate Results:

• Standardized Approach: Testing can be subjective and inconsistent without a defined method, leading to unreliable data. Test method development creates a standardized process with clear procedures, equipment requirements, and data analysis methods. This consistency guarantees accurate and repeatable results that you can trust.

Optimizing Package Performance:

• Identifying Weaknesses: A well-designed test method can pinpoint weak spots in the packaging design or material selection. This valuable information allows manufacturers to identify areas for improvement and create a more robust and reliable package.
• Setting Benchmarks: Test method development establishes clear pass/fail criteria for package performance. This sets a benchmark for quality and helps manufacturers ensure their packaging consistently meets the required standards.

Cost Savings and Risk Reduction:

• Preventing Product Damage: By identifying potential package failures before products reach consumers, test methods help prevent costly product recalls and replacements. This creates significant cost savings for manufacturers.
• Optimizing Resource Allocation: A well-developed test method focuses resources on the most critical aspects of package performance, leading to a more efficient testing process. This saves time and money compared to generic or poorly designed testing procedures.

How can PTI's Consultative Services Help Accelerate the Process?

PTI's consultative services can expedite the package testing process through various means:

• Expertise in Testing Methods: PTI's team possesses in-depth knowledge of package testing methods, including advanced technologies and industry best practices. They can advise on the most appropriate testing methods for your specific packaging needs, ensuring efficient and accurate testing.
• Customized Testing Protocols: PTI can develop customized testing protocols tailored to your unique packaging requirements. By optimizing test parameters and procedures, PTI helps streamline and accellerate the testing process, saving time and resources.
• Equipment Selection and Optimization: PTI can assist in selecting the right testing equipment for your needs and optimizing its performance. This ensures that testing is conducted effectively and efficiently, without unnecessary delays or errors.
• Regulatory Compliance: PTI's experts are well-versed in regulatory requirements for package testing, including FDA and international standards organizations. They can ensure that your testing protocols meet regulatory standards, helping you navigate the regulatory process more smoothly.
• Troubleshooting and Problem-solving: If issues arise during the testing process, PTI can provide expert troubleshooting and problem-solving support. Their experienced team can quickly identify and address any issues, minimizing delays and ensuring testing progresses smoothly.

The development of robust test methods for assessing Container Closure Integrity (CCI) is essential for ensuring the safety, efficacy, and quality of packaged products across various industries. By employing appropriate methodologies and considering key factors in method development, manufacturers can uphold product integrity, comply with regulatory requirements, and safeguard consumer health and trust. Continuous innovation and refinement in CCI testing methodologies will contribute to advancements in packaging technology and product quality assurance in the future.

Nutraceuticals are products that are derived from food sources with extra health benefits, in addition to the basic nutritional value found in foods. They encompass a wide range of products including dietary supplements, functional foods, and beverages fortified with vitamins, minerals, herbs, or other bioactive compounds. The global nutraceutical market has been experiencing rapid growth, driven by factors such as increasing health consciousness among consumers, aging populations, and a growing emphasis on preventive healthcare.

Nutraceuticals are distinguished from traditional pharmaceuticals in that they are not strictly regulated as drugs but are instead classified as dietary supplements or functional foods. This classification allows nutraceutical manufacturers more flexibility in product development and marketing. However, it also places a greater responsibility on manufacturers to ensure the safety, efficacy, and quality of their products.

Package integrity testing plays a crucial role in ensuring the quality and safety of nutraceutical products. It involves the assessment of packaging materials and techniques to prevent contamination, spoilage, and degradation of the product during storage and transportation. The integrity of the packaging directly impacts the shelf-life, potency, and efficacy of the enclosed product.

Techniques to Evaluate Integrity of Nutraceuticals

1. VeriPac Series

The VeriPac series by PTI offers cutting-edge inspection systems designed for leak detection and package integrity testing. These systems employ a non-destructive and non-invasive approach, contributing to waste reduction while delivering real-time and quantitative results. The technology is based on the ASTM-approved Vacuum Decay leak test method F2338, a methodology recognized by the FDA for its reliability and accuracy.

The VeriPac testers seamlessly connect to specially designed test chambers, creating a controlled environment for the inspection process. During testing, a vacuum is applied to the package, and absolute transducer technology is employed to monitor changes in vacuum levels over a predefined test duration. This meticulous monitoring allows the system to swiftly identify leaks and defects within the package.

Given the adherence to the ASTM-approved Vacuum Decay leak test method F2338, these inspection systems not only meet industry standards but also comply with FDA regulations. This recognition further underscores the reliability and precision of the VeriPac series in ensuring the integrity of packages.

2. Seal-Sensor PQX Technology

The Seal-Sensor PQX is an advanced automated pouch seal quality inspection system designed for seamless integration into production lines. Leveraging Seal-Sensor Airborne Ultrasonic technology, this cutting-edge system conducts swift online scans of final pouch seals, aligning with ASTM Test Method F3004 and FDA consensus standards. Its deterministic and quantitative approach enables the rapid identification of defects, including incomplete seals, weak areas, and concealed issues that could compromise product quality.

The system operates with remarkable efficiency, delivering pass/fail results and generating traceable data in less than a second, even at speeds of up to 350 mm/sec. This ensures a quick and reliable assessment of seal quality, contributing to enhanced overall production efficiency.

The Seal-Sensor PQX is characterized by its user-friendly design and plug-and-play functionality, making it easy to integrate into existing manufacturing setups. Its modest footprint ensures that it can be seamlessly incorporated into various production environments without occupying excessive space. In the event of a defective pouch seal, the system features a built-in reject chute that promptly removes defective pouches from the production line. This not only prevents substandard products from progressing further in the manufacturing process but also helps maintain the integrity of the overall production flow.

Incorporating advanced technologies like the VeriPac series and Seal-Sensor PQX, package integrity testing revolutionizes nutraceutical quality control, ensuring products meet rigorous standards for safety and efficacy. By swiftly detecting defects and maintaining packaging integrity, these systems play a vital role in safeguarding the quality and reliability of nutraceuticals in an evolving market landscape.

Package integrity testing plays a crucial role in ensuring that products are delivered to consumers in optimal condition. A package is not merely a container; it serves as a protective barrier against various external factors that could compromise the product's quality and safety.

Package integrity testing involves assessing the ability of packaging materials to maintain product quality and safety throughout the distribution chain. It encompasses various techniques and methods aimed at detecting any defects or vulnerabilities in packaging that could lead to product contamination, spoilage, or damage. It typically includes evaluating factors such as seal strength, leak detection, burst strength, and microbial barrier properties. These tests are essential for ensuring compliance with regulatory standards, meeting consumer expectations, and safeguarding brand reputation.

Why Consider Feasibility Studies for Package Quality Testing?

CCIT offers specialized expertise in the application of deterministic inspection technologies and test methods to assess the integrity of various packaging formats. An initial step in this process involves conducting either an experimental or a more comprehensive feasibility study to evaluate and determine the most suitable Container Closure Integrity (CCI) technology and test method for a specific application. The primary objective of such feasibility studies is to assess the efficacy of a recommended CCI solution and establish optimal test parameters, including the Limit of Detection (LoD). These studies are conducted in accordance with established standards such as USP 1207, ASTM, and ISO to ensure compliance with regulatory requirements, notably those set forth by agencies like the FDA.

The results obtained from these studies can be seamlessly integrated into production environments for rapid validation and deployment. Various test methods are available to assess and ensure package quality and performance, with the primary goal of identifying the most optimal inspection technology that yields accurate, sensitive, and reliable data for comprehensive package integrity verification.

Upon completion of a feasibility study, clients receive a detailed report outlining a quantitative test method tailored to their specific package format. This report encompasses the validation of the recommended approach, leveraging known good test samples and positive controls with predefined defects to establish the test method and confirm the Limit of Detection.

PTI is committed to delivering deterministic package integrity testing solutions to its customers, guiding them through the implementation of comprehensive CCI systems, and providing ongoing after-sales support and periodic certification mandated by regulatory bodies.

In conclusion, feasibility studies by PTI-CCIT are crucial for determining the most effective container closure integrity (CCI) solutions. Through meticulous assessment of inspection technologies and adherence to standards like USP 1207 and ASTM, PTI ensures clients receive compliant and tailored package integrity testing solutions. The detailed reports empower informed decision-making, enhancing product quality and regulatory compliance.

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 Container Closure Integrity Testing (CCIT) is a specialized form of testing that focuses on verifying the integrity of the container closure systems of several types of containers used to store and transport products. This can include vials, pre-filled syringes, bottles, pouches, and other types of containers. The container closure system includes the closure device (such as a stopper or cap) and the container or package itself (such as a glass or plastic vial or bottle), and it is essential to ensure that it is properly sealed so that it does not allow any leaks or contaminants to enter the container.

Automated CCI testing of pre-filled syringes involve using specialized testing equipment and techniques to simulate real-world conditions and test the container closure system's integrity. This testing process can be done in the laboratory by an operator or fully automated to increase efficiency and accuracy.

Testing Pre-filled Syringes Using E-Scan RTX

The E-Scan RTX platform is a modular, fully automated container closure integrity solution for pre-filled syringes. The RTX is a practical and dependable CCI solution with a dynamic robotic design that is adjusted to meet your production needs. This robust, flexible platform uses MicroCurrent HVLD technology, a revolutionary form of HVLD that is the optimal CCI solution for fragile, high-risk biologic liquids. It is appropriate for batch release testing at the production line, in the lab, and provides a quick PASS/FAIL result with a test cycle of only seconds.

A robotic arm will track and pick up nested syringe trays from a standard single lane conveyor. The robot removes the syringes from the nested tray and rotates the syringes through two test stations, one to detect needle shield defects and the other to inspect the rest of the syringe body. The test starts automatically and gives a fixed PASS/FAIL signal on completion of the test. An adjustable failure reference can be set to allow PASS/FAIL based on a predetermined LOD (limit of detection) setting in the initial recipe. After testing, syringes are automatically loaded back into the syringe tray, defective syringes are collected in the reject tray.

Benefits of E-Scan 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 a recommended method for parenteral liquid package inspection.
• Robust method and good Signal-Noise-Ratio between good and defective products.
• Low voltage exposure reduces the production of ozone.

Automated pre-filled syringe testing is critical to ensuring the safety and efficacy of pre-filled syringes used in the pharmaceutical industry. By using automated testing techniques, manufacturers can ensure that the container closure system is reliable and free from defects, reducing the risk of contamination or other safety concerns.

Tyvek is a highly durable and lightweight material that is commonly used in the medical industry for the packaging and sterilization of medical devices and equipment. It is a non-woven material made from high-density polyethylene fibers that are bonded together using heat and pressure. Medical device manufacturers and packaging professionals prefer Tyvek packaging because it is a sterile barrier that protects against bacteria and other contaminants. Tyvek is also breathable, allowing for sterilization methods such as ethylene oxide and gamma irradiation to be used effectively.

Tyvek packaging is used in a variety of medical applications, including surgical gowns, drapes, and covers, as well as in medical device packaging such as catheters, implants, and instruments. Its use in the medical industry is regulated by government agencies such as the FDA to ensure that it meets the necessary standards for safety, sterility and efficacy.

What are the Challenges Associated with Tyvek Package Testing?

Leak testing of Tyvek packages is a critical step in ensuring the integrity of the package and the safety of its contents. However, there are several challenges associated with leak testing Tyvek packages, including:

• Sensitivity of the test method: The sensitivity of the leak testing method can impact the ability to detect leaks in Tyvek packages. For example, some testing methods may not be able to detect very small leaks or may be impacted by the size or shape of the package.
• Environmental conditions: Environmental factors, such as temperature, humidity, and pressure, can impact the results of the leak test. For example, changes in temperature can cause the package to expand or contract, which can impact the tightness of the seal and the results of the test.
• Interference with product properties: Some leak testing methods may use test gases or liquids that can interact with the product inside the package. For example, the test gas may cause the product to degrade or impact its efficacy, which can affect the overall performance of the package.

In summary, leak testing of Tyvek packages requires careful consideration of the test method, the packaging process, and the environmental conditions to ensure accurate and reliable results.

Testing Tyvek Packages Using Airborne Ultrasound Technology

With today’s sensory technology advancements, Tyvek packages can be tested using Airborne Ultrasound technology. Airborne Ultrasound technology is a seal quality testing method that uses airborne ultrasound to evaluate seals for flaws and defects non-destructively. It is an ASTM Test Method F3004 for testing the seal quality and a recognized FDA standard for seal quality inspection. These tests are mostly carried out to improve seal quality inspection of pouches, flexible packaging, and tray seals. Tyvek, paper, foil, film, aluminum, plastic, and poly are just a few of the packaging materials that may be used with Airborne Ultrasound technology to enable thorough seal quality evaluations.

In this method, sound waves are reflected as ultrasonic waves are transmitted through the packaging seal. If there is a leak or flaw, the signal intensity is decreased or lost. To find the leak, these differences are closely monitored. Most leak test techniques encounter the problem of being unable to identify non-leaking defects. By using Airborne Ultrasound technology, users may recognize a variety of seal faults, including visible and invisible, leaking and non-leaking, process-related and random. Airborne ultrasound can be applied in the laboratory for offline in-depth seal quality analysis as well as for 100% online seal quality inspection on the production line.

Benefits of Airborne Ultrasound Technology

• Non-destructive, non-subjective, no sample preparation.
• Deterministic inspection method producing quantitative results.
• Can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable and reliable results.
• Eliminates subjective manual vision inspection methods.
• Characterizes overall quality and uniformity of the seal.
• Economical cost-effective solution for seal integrity testing the final pouch seal.

The method used for leak testing Tyvek packages will depend on the specific requirements of the medical device or equipment being packaged and the regulations set forth by regulatory agencies such as the FDA. It is important to use a validated and appropriate method for leak testing to ensure the safety and effectiveness of the packaged medical devices or equipment. Airborne Ultrasound is one such technique.

Container Closure Integrity (CCI) refers to whether a container keeps the sterile barrier intact. Environmental pollutants can quickly turn a life-saving therapy into a microbial soup if there is a leak or breach of the sterile barrier. The CCIT of blister packages is a critical process in ensuring the quality and safety of pharmaceutical products. Blister packages are commonly used to package solid-dose medications such as tablet and capsules.

The CCI testing of blister packages is performed to ensure that the package is properly sealed and that there are no leaks or defects that could compromise the quality of the medication inside. This testing is important because if the package is not properly sealed, moisture and oxygen can enter, potentially degrading the medication and reducing its effectiveness.

Overview of OptiPac Technology

OptiPac One-Touch Tool-less Leak Detection Technology is a non-destructive method for testing the integrity of blister packaging that is designed to detect any leaks or defects in the package's seal. OptiPac uses volumetric imaging technology to measure the blister cavities under vacuum and identify leaks. The OptiPac applies controlled inputs and measurable outputs without the inconvenience and reliability concerns of the dye ingress approach. It is designed with One-Touch Technology to accomplish a quick test cycle needing no changeover or tools for various blister formats. Unlike other non-destructive blister package inspection systems that demand complicated parameter modifications, OptiPac requires no tooling replacement with new blister package forms.

The test begins by placing the sample on the testing area for vacuum-based measurement. Vacuum is pulled to a definite vacuum after pushing the start button. Under vacuum, blisters expand and push air out of the blister through any leaks that may be present. If there is a leak in the blister, air leaks into the chamber and collapses the blister package. The defective blister cavities are identified using a volumetric measurement reading during the dynamic vacuum test cycle. Along with the quantitative measurement related to each package test, a clear pass/fail result is displayed.

Functions Offered by OptiPac's Insightful Technology

• Auto configuration for easy recipe setup and validation of new blister formats.
• Auto orientation of blister packs (test blister packs in any position –no specific orientation).
• Auto calibration is an integrated one-touch function.
• Advanced batch reporting with audit trail including image of blister pack and defect results.

OptiPac Benefits

• Non-destructive technology - Pass/Fail results backed by quantitative test data.
• Completely tool-less.
• No changeover to test different blister formats.
• Identifies defective cavity.
• Pre-loaded recipe library with easy recipe setup and validation of new blister formats.

In addition to selecting the appropriate method for leak testing, other factors to consider when performing blister package leak testing include the type of material used for the package, the seal strength of the package, the packaging process, and the potential for environmental factors to affect the package's integrity. By carefully considering these factors and implementing an effective leak testing (pharmaceutical package testing) process, pharmaceutical companies can ensure that their products are of the highest quality and meet regulatory requirements.

We all know that the primary function of any package is storing, handling & protecting the product. So, what is package integrity? Package integrity is defined as a package’s ability to protect its contents from potential hazards that include various physical, microbial & chemical factors. Its usefulness may have many nuances depending on the products & content. But industries like pharmaceutical, nutrition & medical device, deal with lifesaving & sustaining products that are shipped across the globe. Any discontinuity in the package can result in the contamination of the product making a life-saving product into a life-threatening one. Therefore, package integrity is imperative to ensure the safety of the products at the time of use.

The selection of the appropriate package inspection method is essential to maintain the quality standards that the regulatory bodies stand by today. Since 2016, the United States Pharmacopeia (USP) released guidance encouraging the use of deterministic, reliable test methods. Package leak test methods offered by CCIT s.a. are all deterministic, non-destructive, quantitative test methods with a specific on the reliability of the test result to assure integrity at the highest level.

VeriPac Vacuum Decay Technology

Vacuum decay is validated as one of the most reliable & sensitive vacuum-based leak detection methods that give quantitative & reproducible results with a pass or fail determination. PTI’s VeriPac inspection method is based on vacuum decay technology. It is one of the most ideal non-destructive container closure integrity testing solutions for different types of package formats that include parenteral packaging and other types of flexible and semi-flexible package formats. This method is non-invasive, non-subjective & requires no sample preparation. VeriPac 400 series can be used in various applications like stability studies, clinical trials, quality assurance testing and production statistical process control.

With PERMA-VAC, PTI redefined the vacuum-based leak detection method and addresses vacuum decay leak detection at the very core of physical test measurement & maximizing the SNR between good and defective samples.

Microcurrent HVLD

PTI has revolutionized the conventional HVLD method with the new HVLDmc – MicroCurrent HVLD, a highly sensitive leak detection method for all Parenteral and Biologic Products. The new E-scan 655 Microcurrent HVLD system exposes the product and environment to less than 5% of the voltage than conventional HVLD solutions. Referenced in USP <1207>, PTI’s HVLDmc has proven to be a highly sensitive leak detection method for applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, pouches.

Airborne Ultrasound

PTI’s proprietary Airborne Ultrasound technology is one of the most reliable seal quality inspection methods that characterize the overall quality and uniformity of the seal. This technology can be integrated for 100% online leak detection of pouch seals. Airborne ultrasound can be used for many material types such as Tyvek ®, paper, foil, film, aluminum, plastic & poly. This technology is referenced in the new USP <1207> Chapter guidance as a deterministic test method for seal quality testing. It is also an ASTM Test Method and FDA-recognized standard for seal quality testing.

Automated Inline Solutions

CCIT provides automated package inspection solutions across all PTI technology platforms – Vacuum Decay, Airborne Ultrasound and MicroCurrent HVLD. The Automated Systems are designed using PTI’s VeriPac, MicroCurrent HVLD and Airborne Ultrasound technologies for applications that include automated statistical process control (SPC) testing and 100% inline testing. The configurations are equipped with the capability of fully automated inspection with robotic pick and place. HVLDmc and Vacuum Decay overlap in capabilities, but more importantly encompass the full parenteral market range. The Airborne Ultrasound Technology for the 100% inline inspection of pouch seals has been an efficacious solution to verify final pouch seal quality.

Helium Leak Testing

Helium leak testing can be used for packaging tests quantitatively using helium as a tracer gas. Helium-based leak testing systems allow comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle. This method is also effective for various package types including cold form blister cards, foil pouches, parenteral vials, syringes, pre-filled syringes and unique medical devices.

The package systems of complex drug and biologic required to be stored at below -20°C, and needs storage and distribution environment that include dry ice (~-78.5°C), or even liquid nitrogen (~-200°C) can be quantitively and accurately tested using helium leak detection technology. This one technology has many applications for container closure integrity testing of pharmaceutical and medical device products.

In today's world, with the popularity of health products continuing to rise, manufacturers must ensure products are packed properly. Because of this reason, the universal health-wise regulation has set a fixed standard for nutritional products packaging process. This is for the elimination of defects happening due to innate chemical reactions within the nutritional products. Such defects can expose products to oxygen, moisture or bacteria- compromising its quality and reducing shelf life.

Nutritional products including dairy products and protein powders are mostly shelf stable in nature. The high fat content in dairy products including cream, butter and ghee is prone to deterioration in its storage process, causing auto-oxidative reactions. The defects in the dairy products can be eliminated through proper nutritional packaging inspection only. Similarly, protein-based powders including soy and casein are extensively used as energy sources. Inefficiencies in packaging of such products can have an adverse effect on consumer’s health. Therefore, conducting package integrity testing of nutritional products are vital to eliminate defects in packaging as well as possibility of product contamination.

Vacuum Decay Technology – The Ideal Nutritional Packaging Inspection Solution

Vacuum Decay technology is a deterministic Container Closure Integrity test method for evaluating quality of nutritional product packaging. The non-destructive testing method improves quality of packaging and reduces wastage compared to destructive test methods. Cost-effective non-destructive testing results in higher return on investments and ensures quality of products.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, with an external vacuum source. A single or dual vacuum transducer technology monitors the test chamber over a predetermined test period. The changes occurring in vacuum levels are analyzed to identify leaks and defects within the package. CCIT’s VeriPac series helps in detecting small leaks before it becomes critical in quality abbreviations.

Benefits of Vacuum Decay technology

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

Medical device quality control inspection is considered to be highly significant in ensuring safe delivery of medical devices from their place of origin to the market. However, tremendous development in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging

Adding to that, drug contamination is a serious concern in any medical industry- specifically for Class III medical devices. Class III medical devices are understood as devices that sustain or support life and are implanted, or present potential unreasonable risk of illness or injury. Since these devices are directly placed into human bodies, proper packaging is required to ensure quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, causing major health risks. Hence, appropriate package integrity testing and seal quality inspection of Class III medical devices are required so as to ensure seal quality and sterile barrier integrity are maintained.

Initially, manufacturers heavily relied on visual inspection or other probabilistic test methods to inspect seal quality and integrity. However, such methods lacked accuracy and reliability in terms of test results. Hence, manufacturers are now shifting towards non-destructive method for evaluating seal quality and inspecting physical properties of a seal. One such technique that is increasingly becoming popular among medical device manufacturers is Airborne Ultrasound technology. It is an ASTM test method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. The test is conducted by transmitting high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can also be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced

Airborne Ultrasound technology variants, namely Seal-Scan® and Seal-Sensor provide both, offline and online inspection of packages and accommodate various package specifications, test sensitivity and package handling requirements. Seal-Scan® offline systems offer in-depth seal quality analysis and seal characterization. Seal-Sensor online inspection systems for automated 100% inline scanning of pouch seals can be integrated into pouch production or pouch handling line. They provide a quick analysis of the seal area without tampering with the packaging to identify defects, such as incomplete or missing seals, wrinkles, channel defects and so on.

Advantages of Seal Scan and Seal Sensor method

• Deterministic seal quality inspection method that produces quantitative results.
• This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.
• Non-destructive and non-subjective test method that requires no sample preparation.
• Technology can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable, reproducible and reliable results for seal quality inspection.
• Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal.