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In the rapidly growing nutraceutical industry, ensuring the longevity and quality of products is crucial for maintaining consumer trust and market competitiveness. One of the essential factors in preserving product integrity is effective packaging, which protects contents from environmental factors that can lead to spoilage and degradation. Advanced packaging technologies and rigorous testing methods are essential for enhancing the shelf life of these products, ensuring they remain fresh, safe, and effective for consumers over extended periods. The Seal-Sensor technology offers a revolutionary solution for enhancing the shelf life of nutraceutical products through advanced seal inspection capabilities.

Importance of Package Testing in Extending Product Shelf Life

In today's competitive market, ensuring the longevity and quality of products is paramount. One of the critical aspects of maintaining product integrity and extending shelf life is packaging. Packaging not only serves as a container for products but also acts as a barrier against environmental factors that can degrade product quality. This makes package testing a vital process in product development and distribution phases.

Package testing involves a series of assessments designed to evaluate the durability, integrity, and effectiveness of packaging materials under various conditions. These tests simulate real-world scenarios, such as transportation stresses, temperature fluctuations, and exposure to moisture and oxygen, to ensure that the packaging can protect the product throughout its intended shelf life.

The significance of package testing in extending product shelf life cannot be overstated. It helps manufacturers identify potential weaknesses in packaging materials and design, allowing for improvements that can prevent spoilage, contamination, and degradation. This not only enhances the consumer experience by ensuring that products remain fresh and safe for longer periods but also reduces waste and increases cost-efficiency for producers.

How Does Seal-Sensor PQX Ensure Packaging Effectiveness?

Seal-Sensor PQX is a cutting-edge automated handling system and pouch seal inspection solution. Engineered for easy integration into production lines, it boasts a variety of advanced features. This technology employs Seal-Sensor airborne ultrasound, which the FDA has recognized as a consensus standard for seal quality inspection according to ASTM Test Method F3004. One of the key advantages of the Seal-Sensor PQX is its capability to perform high-speed online scanning of the final pouch seal. Utilizing rapid linear scans, the system can quickly and effectively verify seal quality, delivering immediate feedback and test results within seconds. This inline inspection feature is especially beneficial for industries where seal integrity is critical, such as food packaging and pharmaceutical manufacturing.

The Seal-Sensor PQX is designed for easy installation with its plug-and-play setup. Its compact size allows it to fit seamlessly into existing production lines without significant modifications. The full-screen Human-Machine Interface (HMI) enables operators to monitor and analyze test results in real time as pouches are scanned, providing instant feedback on seal quality. With inspection rates of up to 350 mm/sec, the Seal-Sensor PQX delivers exceptional throughput, allowing production lines to maintain high output levels without sacrificing seal inspection quality. When defects are detected, the system's built-in reject chute promptly removes faulty pouches from the line, minimizing production disruptions. Additionally, the integrated stack light system makes it easy to identify pass and fail results, enhancing quality control and overall efficiency.

Seal-Sensor PQX technology represents a significant advancement in packaging inspection for the nutraceutical industry. By ensuring the integrity of pouch seals, this innovative solution helps manufacturers extend product shelf life, reduce waste, and maintain the highest standards of quality and safety. Investing in such cutting-edge technology is a strategic move for nutraceutical manufacturers aiming to enhance product longevity, comply with regulatory standards, and meet consumer demands for fresh and reliable health supplements.

Airborne Ultrasound technology is a seal integrity test method for analyzing seal quality, offering non-destructive inspection of seals for potential defects. It adheres to ASTM Test Method F3004 and is recognized by the FDA as a standard for seal quality testing. Primarily utilized for pouches and flexible packages, this technology provides comprehensive analyses of seal quality across various materials such as Tyvek, paper, foil, film, aluminum, plastic, and poly.

In this technology, ultrasound waves pass through the package seal, generating reflections of sound waves. The presence of a leak or defect reduces or eliminates the signal strength. These fluctuations are meticulously monitored to pinpoint any leaks. The inability to detect non-leak defects is a common challenge many leak test methodologies face. However, Airborne Ultrasound technology empowers users to detect diverse types of seal defects, whether visible or invisible, leaking or non-leaking, process-related or random.

By employing Airborne Ultrasound technology, industries can ensure thorough seal quality assessments, enhancing product safety and reliability.

Industrial Applications:

Pharmaceutical: Airborne ultrasound technology represents a crucial advancement in the pharmaceutical industry, offering versatile and effective solutions for quality assurance and safety throughout the manufacturing and packaging processes. By enabling precise seal quality inspection, and quality control during manufacturing, Airborne Ultrasound technology helps pharmaceutical companies maintain compliance with regulatory standards and ensure the integrity of their products. The non-destructive nature, sensitivity, and versatility of Airborne ultrasound technology makes it an indispensable tool for pharmaceutical and medical device manufacturers striving to deliver safe and effective medications to patients worldwide. As the industry continues to evolve, the application of Airborne ultrasound technology will remain instrumental in upholding the highest standards of product quality and patient safety.

Medical Device: In the Class III medical device industry, where products carry the highest risk and require the most stringent regulatory oversight, Airborne ultrasound technology emerges as an indispensable asset. This technology, leveraging high-frequency sound waves, plays a pivotal role in ensuring the uncompromised integrity, reliability, and safety of these critical devices. From implantable devices to life-sustaining equipment, the applications of Airborne ultrasound are extensive and indispensable.

In this industry, where precision and accuracy are paramount, Airborne Ultrasound technology offers unparalleled non-destructive testing capabilities. By detecting even the minutest defects, leaks, or structural inconsistencies, it empowers manufacturers to uphold the highest standards of quality control and regulatory compliance. The versatility of Airborne Ultrasound technology is particularly advantageous in the Class III medical device sector. Whether inspecting complex device components, verifying the integrity of seals in sterile packaging, or monitoring critical manufacturing processes, its applications are wide-ranging and vital.

Airborne Ultrasound Technology Benefits

• Deterministic inspection method producing quantitative results
• Non-destructive, non-subjective, no sample preparation
• 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.

In conclusion, Airborne Ultrasound technology represents a significant advancement in seal quality inspection, promising improved reliability, efficiency, and confidence in product integrity. Its adoption heralds a new era of quality assurance, ensuring the highest standards of safety and satisfaction for consumers worldwide.

In the pharmaceutical industry, the integrity of packaging plays a pivotal role in ensuring the safety, efficacy, and quality of medications. Packaging serves as a barrier that protects pharmaceutical products from external factors, such as moisture, air, light, and contaminants, which could compromise their stability and effectiveness. Ensuring the integrity of pharmaceutical packaging is not only crucial for regulatory compliance but also for maintaining patient safety and confidence in the products.

Traditional methods of package testing often involve destructive techniques, where samples are opened, punctured, or otherwise altered for assessment. However, these methods come with inherent drawbacks, including product wastage, the need for additional samples, and prolonged testing times. To address these challenges, the pharmaceutical industry has increasingly turned to non-destructive methods for package integrity testing.

What are the Non-destructive Methods Used for Pharmaceutical Package Testing?

Vacuum Decay Technology

Vacuum decay is a non-destructive Container Closure Integrity Test (CCIT) that provides reliable, repeatable, reproducible, and accurate results along with clear pass/fail quantitative data. The basic idea of Vacuum decay technology is to question the integrity of containers based on their fundamental physical properties. Sample packages are initially placed within a tightly sealed evacuation test room with an external vacuum source. Based on the test sample and the needed level of sensitivity, a predetermined vacuum level is selected. The test chamber and test system dead space must be evacuated after that for a certain period of time. To monitor variations in vacuum level over time, differential pressure transducers are utilized. The container is leaking if the pressure rises over the designated pass/fail limit.

Volumetric Imaging Technology

Non-destructive leak detection of blister packages is done using OptiPac One-Touch Tool-less technology. The OptiPac uses volumetric imaging technology to monitor the movements of a blister package while it is under vacuum in order to identify leaks. The interface is practical and simple to set up with new blister package forms, necessitating no tooling changeover or significant parameter revisions as with previous non-destructive blister package inspection systems. In response to different cavity shapes, sizes, and combinations of various blister pack types, the system gathers volumetric data from each cavity.

Airborne Ultrasound Technology

Airborne ultrasound is a deterministic test technique for seal quality inspection in materials including aluminum, foil, paper, plastic, poly, film, and Tyvek. It has been proven to be one of the most effective non-destructive testing techniques for flexible package seals. According to studies, conventional seal inspection methods are ineffective because they miss undetectable defects and incorrectly reject pouches that are tightly sealed. On the other hand, Airborne ultrasound technology has been successful in both online and offline solution options. Airborne ultrasound is a typical test method for evaluating seal quality and integrity in accordance with ASTM F3004-13.

Microcurrent HVLD technology

High Voltage Leak Detection, often known as HVLD, is a deterministic, non-destructive leak detection technique used to evaluate the Container Closure Integrity of vials, cartridges, and other liquid-filled parenteral products. It is one of the most efficient approaches for online container closure testing. MicroCurrent HVLD uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to standard HVLD systems. This technique doesn't require sample preparation and is non-invasive. Pre-filled syringe testing is one of the main uses of MicroCurrent HVLD, along with vial leak testing.

Non-destructive Package Integrity Testing Method Benefits

Non-destructive package integrity testing holds significant importance in the pharmaceutical industry due to the critical nature of pharmaceutical products and the strict regulatory requirements in place. Here are some key benefits of using non-destructive package integrity testing in the pharmaceutical industry:

• Product Safety: Ensuring the integrity of pharmaceutical packaging is paramount for product safety. Non-destructive testing methods can identify leaks, defects, or breaches in packaging that could lead to contamination, spoilage, or compromised efficacy of the medication.
• Regulatory Compliance: The pharmaceutical industry is heavily regulated to ensure patient safety and product quality. Non-destructive package integrity testing helps companies meet regulatory requirements outlined by agencies such as the FDA (U.S. Food and Drug Administration) and other international regulatory bodies.
• Reduced Risk of Contamination: Non-destructive testing methods can detect micro-leaks or breaches in packaging that may not be immediately visible to the naked eye. This reduces the risk of contamination from external factors like air, moisture, or pathogens.
• Preservation of Sterility: Many pharmaceutical products require a sterile environment to maintain their efficacy and safety. Non-destructive testing ensures that the packaging's sterile barrier is intact, preventing any potential breach of sterility.
• Enhanced Product Quality: Maintaining package integrity helps prevent degradation of pharmaceutical products caused by exposure to light, moisture, or air. This ensures that medications maintain their intended potency and effectiveness.
• Cost Efficiency: Non-destructive testing methods save costs by preventing the need for destructive testing, which would require additional samples for analysis. This also reduces the need for retesting, minimizing waste and resource consumption.

As the demand for stringent quality control and regulatory adherence in the pharmaceutical sector continues to grow, understanding the nuances of non-destructive package testing methods becomes essential. By adopting these innovative techniques, pharmaceutical manufacturers can uphold their commitment to patient safety, product efficacy, and overall excellence in the field.

Leak testing is an essential process in the pharmaceutical industry to ensure the safety and quality of the products. The purpose of leak testing is to detect any leaks or defects in the packaging, that could compromise the integrity of the product.

There are different methods of leak testing available, and the choice of method depends on various factors, including the type of packaging, the product being packaged, and the desired sensitivity of the test. Some of the commonly used methods for leak testing in the pharmaceutical industry are:

Vacuum Decay Technology

Vacuum Decay is a non-destructive container closure integrity test (CCIT) method that focuses on package integrity and detecting leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay measurements offer deterministic and reliable test results to ensure package integrity. Vacuum Decay technology can accommodate a wide variety of packaging formats, including filled and sealed rigid, semi-rigid, flexible, non-porous or non-porous materials. This test works by placing packages in a well-equipped evacuation test chamber with an external vacuum source. Vacuum levels are continuously monitored to detect any deviations from predetermined targeted vacuum levels. A defect in the package can cause air to escape from the package into the test chamber. On the other hand, defect-free packages hold in air by maintaining a constant chamber vacuum level. Vacuum Decay technology has proven over the years to be one of the most practical and sensitive vacuum-based leak detection solutions.

MicroCurrent HVLD Technology

High Voltage Leak Detection (HVLD) is a non-destructive container closure integrity test (CCIT) for evaluating parenteral product packaging integrity. The concepts of quantitative electrical conductivity measurement are used in HVLD technology. HVLD is based on the fundamental nature of electric current. The package barrier must be non-conductive and prevent the flow of electricity, while the package contents must generally be able to carry voltage. The container is placed horizontally on the rotating stage. As the container rotates, a high voltage is applied to one side, and a ground probe is attached to the opposite side. If the package does not leak, the two container walls (high voltage and ground) offer complete electrical resistance and will not record significant current as it travels through the bottle. Breakdown resistance is encountered if there is a micro-leak or crack in one of the container walls and the current passes through. Examples of high-voltage leak detection technology applications include pre-filled syringes, ampoules, drug product cartridges, liquid-filled vials, and blow-fill-seal (BFS) containers.

Force Decay Technology

Force Decay is a quantitative leak detection method that works particularly well with low-headspace packaging. Non-porous materials such as foils, laminates, and films can be used for packaging types. Since it is a non-destructive test procedure, the sample packets are not harmed or changed. Packages do not need to be discarded away when the test is over; they can be added back to the batch. The test system use nested tooling to place the package in the same place and to prevent unmeasured extension of the package under test. Once the test is started, a vacuum is drawn onto the test chamber, which causes the package to expand inside the chamber. The ASTM F2338 vacuum decay leak test technique monitors vacuum levels during the test cycle to evaluate the package. The expansion of the package being tested applies force to the VeriPac force measurement system.

Volumetric Imaging Technology

OptiPac Leak Detection System is one of the deterministic non-destructive package integrity test solutions made especially for blister packs. The One-Touch Technology used in the design and engineering of OptiPac allows for a quick test cycle without the need for sample preparation or changeover. Depending on the size of the blister cavity, this unique technique can quickly identify defects less than 5 microns. Although the OptiPac system employs similar concepts to those used in a vacuum-based blue dye test, it uses controlled inputs and monitored outputs without the hassle and reliability issues of the dye ingress technique. To identify leaks, OptiPac use volumetric imaging technology to measure the motion of a blister package while it being vacuumed.

It is important to note that leak testing should be done at various stages of the packaging process, including before and after filling, and during storage and transport. Proper leak testing can help ensure that the pharmaceutical product is safe and of high quality, which is crucial for patient safety.

Since many years ago, manufacturers have tested the quality of container closures, and their perceived value has constantly grown. Companies that once relied on probabilistic techniques like the blue dye test are now aiming to use a more reliable and predictable procedure for integrity testing of various package formats. The pharmaceutical industry is getting ready to adapt to the deterministic testing world in order to enhance quality, increase efficiency, and comply with changing regulatory standards.

Overview of Airborne Ultrasound Technology

Airborne ultrasound technology is a seal quality inspection technique. It is an ASTM test method F3004, the FDA approved standard for seal quality testing. Such tests are mainly performed to provide enhanced seal quality testing of pouches, flexible packages and tray seals. Airborne ultrasound technology ensures in-depth seal quality analysis and applies to multiple packaging materials including Tyvek, paper, foil, film, aluminum, plastic and poly.

In this technique, sound waves are reflected when ultrasound waves pass through the package seal. Signal strength is reduced or eliminated in the presence of leakage / fault. Such deviations are closely monitored to detect leakage. The inability to detect non-leak defects is a common challenge faced by most leak test methods. However, with Airborne ultrasound technology, users can identify various types of seal defects; visible and invisible, leaky and non-leaky, process-related and random.

Seal-Scan and Seal-Sensor Technology

Seal-Scan and Seal-Sensor are the two variants of Airborne ultrasound technology that utilizes non-contact airborne ultrasonic testing technology. With advancements in the form of seal-scans and seal-sensors, Airborne ultrasound technology has proven to be the most effective method for non-destructive seal integrity testing in both offline laboratory testing for seal quality analysis and 100% inline testing on the production line.

Seal-Scan® is a non-destructive offline technology that is highly effective in inspecting and analyzing pouch seal defects. It is a deterministic, quantitative, high-resolution package integrity testing method for identifying defects and sealing integrity for consistency. What makes this technique unique is that it is a non-invasive technique and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control, offering in-depth seal quality analysis. This technology is capable of producing opto-acoustic images and detailed statistical analysis using L-scan and C-scan modes. An L-scan is a single linear scan along the x-axis of the seal that provides a line graph of seal integrity and simulates an online inspection. A C-scan produces multiple scans (in the X and Y-axis of the seal area) that provide a high-resolution ultrasonic image of the seal structure.

Seal-Sensor™ is an Airborne ultrasonic technology (ABUS) that non-destructively inspects the final pouch seal 100% online. The seal sensor detects incomplete seals, partial or weak areas of the seal, and many other common defects in a seal that are visually acceptable, but have that affect product quality, value, and shelf life. A pass/fail result and quantitative, traceable data are produced in less than a second by a single linear scan (L-scan) of the pouch seal. The Seal-Sensor is a definitive, quantitative, rapid and reliable approach to inspecting pouch seals for defects.

Benefits of Airborne Ultrasound Technology

• Non-destructive, non-subjective, no sample preparation.
• Accurate and reliable results.
• Can accommodate a number of packaging formats and materials.
• Eliminates subjective manual inspection methods.
• Deterministic inspection method producing quantitative results.
• ASTM Test Method F3004 and FDA Standard for seal quality inspection.

Today, package integrity test solutions continue to evolve, driven by industry demands, regulatory requirements, and advancements in technology. The focus remains on improving sensitivity, accuracy, and efficiency to ensure the integrity and safety of packaged products.

For packaging sterile devices in the medical industry, porous packaging materials are widely used. The sterile products are frequently packaged, shipped, and distributed to multiple places, where they may be exposed to a range of humidity conditions during the course of the distribution cycle. The leaks in the porous packaging materials can contaminate medical devices as well as products. These leaks are frequently observed at tiny pinholes or breaches in the seals between packing components. Hence, maintaining the microbial barrier of sterile medical devices is of grave importance. In order to maintain the sterility and microbial barrier, various package integrity test solutions can be used. Airborne Ultrasound technology is one such method.

Airborne Ultrasound Technology Overview

Airborne ultrasound is an inspection method for testing seal quality that is able to evaluate seals for defects without causing any damage. It is an FDA recognized standard and ASTM Test Method F3004 for testing seal quality. Such tests are mostly carried out to provide enhanced tray seals, flexible packages, and pouch seal quality inspection. 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 ensure in-depth seal quality analyses.

Integrity Testing of Porous Packages using Airborne Ultrasound Technology

Airborne Ultrasound technology is one of the commonly used methods for testing the seal quality of porous packages. In this technique, sound waves are reflected when ultrasound waves pass through the packaging seal. The signal intensity is reduced or destroyed when there is a leak or defect. These variations are meticulously monitored to identify defects. With airborne ultrasound technology, it’s now possible to identify a variety of seal defects, including visible and invisible, leaking and non-leaking, process-related and random both offline in the lab and in automated production environment.

Airborne Ultrasound technology has been proven in the field with both online (Seal-Sensor) and offline (Seal-Scan) solution options. Both of these technologies make use of non-contact airborne ultrasonic testing. It is known to be among the best techniques for non-destructive testing of flexible packaging seals in both offline laboratory testing for seal quality analysis and 100% inline testing on the production line. According to ASTM F3004-13, this is the standard test procedure for the airborne ultrasound evaluation of seal quality and integrity.

Benefits of Seal-Scan and Seal-Sensor Methods

• Deterministic seal quality inspection method that produces quantitative outcomes.
• Regardless of color, transparency, print, surface polish, or porosity, this method works for all material types and combinations.
• Non-destructive and non-subjective test technique that does not require any sample preparation.
• Technology may be used for 100% online final pouch seal defect detection.
• Seal quality inspection results are repeatable, reproducible and reliable.
• Cost-effective solution for testing seal integrity and seal analysis that characterizes the overall quality and uniformity of the seal.

According to studies, the conventional seal inspection techniques are ineffective because they miss undetectable flaws and wrongly reject pouches that are tightly sealed. Airborne Ultrasound is a deterministic seal quality testing method. The technology has established itself as a highly practical solution for non-destructive testing of porous packages. The integrity of porous packages can be tested efficiently using Airborne Ultrasound technology.

The integrity of container closure systems can be interpreted as their capacity to maintain a sterile barrier against potential contaminants that could compromise the quality of the end product. The sterile barrier can be damaged by even the smallest leak, which might affect the product's healing properties. Over the years, dye ingress and microbial ingress are common leak testing methods. It has been proven that they provide inaccurate and subjective results. As a result, regulatory organizations have mandated a shift towards more deterministic test procedures that can be controlled, calibrated, and provide a definite determination of CCI. Airborne Ultrasound technology is a deterministic test method mentioned in the revised USP< 1207> Chapter Guidance for seal quality testing.

Explain Airborne Ultrasound Technology

Airborne Ultrasound Technology is a technique for testing the seal quality. It is an ASTM test method F3004 and the Food and Drug Administration (FDA) approved standard for seal quality testing. Such inspections are mainly done to provide improved seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analysis and is applicable to multiple packaging materials such as Tyvek, paper, foil, film, aluminum, plastic and poly.

In this technique, sound waves are reflected when ultrasound waves travel through the packaging seal. In the presence of a leak or fault, the signal intensity is diminished or removed. To find the leak, these fluctuations are carefully monitored. More sound is reflected, and less sound is transferred through the seal as the acoustic difference between the medium increases (most evident at the transition from a gas to solid state). The inability to detect non-leak defects is a common challenge faced by most leak test methods. However, users may recognize a variety of seal defects, including visible and invisible, leaky and non-leaking, process-related and random, using airborne ultrasound technology.

Seal-Scan and Seal-Sensor

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 Seal-Scan® and Seal-Sensor™ are the two configurations of Airborne Ultrasound technology. Seal-Scan® technology inspects and analyzes pouch seals non-destructively offline. This deterministic, quantitative, high resolution method inspects pouch seals for defects and seal integrity for consistency. Testing does not involve sample preparation, and is non-invasive as well. The technique includes advanced digital imaging software tools for process control that allow in-depth seal quality analysis. Utilizing Airborne Ultrasound technology, Seal-Scan® systems evaluate seal quality and integrity in accordance with ASTM Test Method F3004-13. Seal-Scan® is a semi-automatic inspection system with an x-y drive for the detection of seal defects, seal characterization, and material analysis.

Seal-Sensor™ is an Airborne Ultrasonic technology that inspects the final pouch seal 100% online in a non-destructive manner. Seal-Sensor™ is a deterministic, quantitative, fast, and reliable way to test for defects in pouch seals. The Seal-Sensor™ technology detects defective seals, seals with partial or weak areas, and several other typical seal defects that may not be physically visible but have an impact on the quality, and life span of the product. A pass/fail result and quantitative, traceable data are generated by a single linear scan (L-Scan) of the pouch seal in less than one second.

Why Use Airborne Ultrasound Technology?

• Deterministic inspection technique yielding quantifiable results.
• Non-destructive, non-subjective, and does not need sample preparation.
• Independent of color, transparency, print, surface polish, or porosity, it is applicable to all materials and combinations.
• Can be integrated completely online to identify defects in the final pouch seal.
• Consistent and dependable results.
• Referenced in USP Chapter 1207.Inexpensive method for evaluating the seal integrity of the final pouch seal.
• Describes the overall quality and uniformity of the seal.

Both Seal-Scan® and Seal-Sensor™ technologies utilize non-contact airborne ultrasonic testing technology. With the innovation of Seal Scan and Seal-Sensor, Airborne Ultrasound technology has emerged as the most reliable technique for non-destructive seal integrity testing, both in offline laboratory testing for seal quality analysis and 100% inline testing on the production line.

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.

Package integrity leak test methods offered by CCIT such as Seal-Scan utilize non-contact Airborne Ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging. The method is applicable to pharmaceutical as well as medical device packaging.

Seal Quality Testing and Seal Analysis using Seal-Scan Technology

Seal-Scan® is a non-destructive offline inspection and analysis technique for pouch seals using Airborne Ultrasonic technology (ABUS). Seal-Scan® offers advanced digital imaging software tools for process control, including in-depth seal quality inspection. Seal-Scan system uses the non-destructive ASTM Test Method F3004-13 for "Evaluation of Seal Quality and Integrity Using Airborne Ultrasound Technology." This test method was approved using PTI's ABUS technology. Seal-Scan® is a deterministic, quantitative, high-resolution technology for inspecting pouch seals for defects and ensuring seal integrity.

Seal-Scan has two scanning modes:

• Linear Scan (L-Scan) to simulate online defect identification (line graph)
• C-Scan for detailed seal analysis, resulting in pixel-by-pixel seal evaluation (Opto-Acoustic image)

Technology Overview

The pouch seal or packaging material is scanned between two focused ultrasonic sensors. Ultrasonic waves travel through single or several layers of bonded materials. The reflection of sound waves caused by ultrasonic transmission via different materials reduces/eliminates signal intensity. The signal level that passes through the seal is a function of the seal's quality. Defects of various forms, such as leaking and non-leaking, process-related and random, can be detected. Seal-Scan® can provide Opto-Acoustic images as well as thorough statistical analysis using one of two scan modes (L-Scan and C-Scan).

An L-Scan is a single linear scan along the seal's X-axis that generates a line graph of seal integrity and replicates real-time inspection. C-Scan generates a series of scans (along the X and Y-axis of the seal region), that offers a high-resolution ultrasonic image of the seal structure. This technology, via the Seal-Sensor, can be integrated into a pouch production process for 100% online seal defect detection.

Benefits of Seal-Scan Technology

• Deterministic inspection approach yielding quantitative results.
• Works with any material and combination, independent of color, transparency, print, surface polish, or porosity.
• Produces a high-resolution Opto-Acoustic seal image.
• Characterizes the overall quality and consistency of the seal.

Seal-Scan® is a semi-automatic inspection system with an x-y drive that is used to identify seal defects, characterize seals, and analyze materials. This approach is non-invasive, non-destructive, and does not need any sample preparation. The ability of PTI to adapt this technology to diverse production restrictions and conditions makes it an effective solution for flexible packaging systems.

Airborne Ultrasound is a deterministic test method for seal quality inspection and analysis of material types such as aluminum, foil, paper, plastic, poly, film & Tyvek. In accordance with ASTM F3004-13, airborne ultrasound is a standard test technique for evaluating seal quality and integrity. It has been proven to be one of the most successful non-destructive testing methods for flexible package seals. As per research the standard seal inspection methods are inaccurate because they fail to detect invisible defects and mistakenly reject well sealed pouches. Airborne Ultrasound technology, on the other hand, has been proven in the field of both online and offline solution options

How does Airborne Ultrasound Technology mitigate the risk of food and nutrition packaging?

Packaging has been an integral part of food and nutrition preservation in recent decades. Food is packaged with the intention of being transported and stored. Quality, brand, safety, and value of a product are all affected by packaging. To ensure the safety of their products, food producers pack their products in a way that ensures they are correctly constructed, tamper-proof, defect-free, and complete.

In Airborne Ultrasound technology, sound waves are reflected when ultrasound waves are allowed to travel through the packaging seal. Change in the intensity of the reflected signal is used to identify defects. The seal is positioned in a straight line between a pair of transducers, then moves them along the seal. Transmission and reflection of the ultrasound occur at the transition from one medium to another. When the difference in acoustic properties between two materials is greater, only less sound is transmitted, and more sound is reflected. Thickness variations have a minor impact. It is possible to identify a wide range of defects, including those that are visible and invisible, leaking and non-leaking, process-related and random.

As one of the most successful methods for non-destructive testing of flexible packaging, Airborne Ultrasound technology was awarded the ASTM Test Method F3004-13 in 2013. The flow of gas or liquid through the seal is an example of seal defect. Inability to discover non-leak defects is a basic problem with leak testing methods. However, Airborne Ultrasound technology gives a complete way to evaluating seal quality, even when a seal has a defect but may not leak.

Key benefits of Airborne Ultrasound Technology

• Deterministic inspection technique resulting in quantitative results
• Non-destructive, non-subjective, zero sample preparations
• Detects defects in the final pouch seal in real time
• This method works with any material and combination, regardless of color, porosity, surface finish, transparency, and print
• The subjective manual vision inspection procedures are no longer necessary
• Results are repeatable and reliable
• Testing the final pouch seal integrity at a low cost
• Characterizes the seal's overall quality and consistency