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Class III medical devices are the highest risk medical devices, as they support or sustain life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III medical devices include:

• Pacemakers
• Defibrillators
• High-frequency ventilators
• Cochlear implants
• Fetal blood sampling monitors
• Implanted prosthetics

Because of the high risk associated with Class III medical devices, it is essential to ensure that their packaging is intact and that the devices are sterile. Class III medical devices are the most strictly regulated medical devices by the US Food and Drug Administration (FDA).

There are several challenges associated with Class III medical device package integrity testing . One challenge is that the devices themselves are often complex and delicate, making them difficult to test without damaging them. Another challenge is that the packaging for Class III medical devices must be very effective in protecting the devices, maintain the sterile barrier and protect from contamination and damage during product lifecycle until point of use. To ensure the integrity of Class III medical devices, it is important to implement a comprehensive quality control program that includes the following measures:

• Design and testing: Medical device manufacturers must design and test their devices to ensure that they meet all applicable safety and performance standards.
• Manufacturing and assembly: Medical device manufacturers must implement strict quality control measures during the manufacturing and assembly process to ensure that devices are produced consistently and to a high standard of quality.
• Packaging: Medical device manufacturers must design and test their packaging to ensure that it can protect the devices from contamination and damage during shipping and handling.
• Testing: Medical device manufacturers must test a sample of each batch of devices to ensure that they meet all applicable safety and performance standards.

Package integrity testing and seal integrity testing are crucial for medical device packages to ensure the protection of the enclosed products from external contaminants and environmental factors. Maintaining package integrity is essential to prevent the compromise of sterile barriers, safeguarding the sterility of medical devices and ensuring their efficacy in clinical applications. Additionally, these tests help meet regulatory requirements, promoting patient safety and ensuring the reliability of medical devices throughout their lifecycle

1. Vacuum Decay technology

PTI's VeriPac Vacuum Decay technology is a non-destructive, online inspection system that can be used to test the integrity of Class III medical device packaging. The VeriPac system uses a vacuum chamber to create a differential pressure between the inside and outside of the packaging. This differential pressure is then used to detect any leaks in the packaging. PTI's VeriPac system is particularly well-suited for testing Class III medical device packaging because it is able to test a wide variety of packaging materials and designs. Additionally, the VeriPac system is able to test the integrity of the packaging without damaging the packaging or the product inside.

2. Airborne Ultrasound technology

PTI's Airborne Ultrasound technology is another non-destructive, online inspection system that can be used to test the integrity of Class III medical device packaging. The Airborne Ultrasound system uses ultrasonic waves to inspect the packaging for any defects. The Airborne Ultrasound system is particularly well-suited for testing Class III medical device packaging because it is able to detect a wide variety of defects, including small holes, tears, and wrinkles. Additionally, the Airborne Ultrasound system is able to test the integrity of the packaging without damaging the packaging or the product inside.

Package integrity testing is an essential part of the quality control process for Class III medical devices. By implementing CCI testing, medical device manufacturers can help to ensure the safety and efficacy of their devices.

Food packaging is essential for protecting food from contamination, spoilage, and damage. It also plays an important role in maintaining food quality and shelf life. Package integrity is a critical factor in ensuring the safety and quality of food products. Food packaging can be made from a variety of materials, including plastic, metal, glass, and paper. The type of packaging used depends on the type of food being packaged and its intended use. For example, perishable foods, such as meat and dairy products, require packaging that can provide a barrier to moisture and oxygen to prevent spoilage. Non-perishable foods, such as canned goods and dried goods, may require less stringent packaging requirements. Packaging that goes through a processing or retort system presents yet another set of challenges to insure integrity of the package and protection of product quality.

Package integrity testing is the process of evaluating the ability of a package to protect its contents from contamination and spoilage. It is an important quality control measure that can help to ensure food safety and quality. There are a variety of different package integrity testing methods available. Some methods are destructive, while others are non-destructive. Destructive methods, such as water bath testing, involve damaging the package to test for leaks. Non-destructive methods, such as Vacuum Decay testing, do not damage the package.

The VeriPac technology is a non-destructive Container Closure Integrity Test (CCIT) system that uses Vacuum Decay technology to detect leaks in food packaging. Vacuum decay is an ASTM-approved test method (F2338) that is recognized by the FDA as a consensus standard for package integrity testing.

To test a package using VeriPac technology, the package is placed in a vacuum chamber and the pressure is applied. The system then measures the rate at which the pressure in the chamber changes. If there is a leak in the package, the pressure in the chamber will increase more quickly. Vacuum Decay technology is a highly sensitive and accurate test method that can detect leaks as small as 20 microns. It is also a very versatile test method that can be used to test a wide variety of food packaging types and sizes.

• Non-destructive, non-subjective, 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 operator with PASS/FAIL result.
• Small footprint and modular portable design.
• ASTM test method and FDA standard.
• Referenced in USP 1207 guidance.

Overall, the VeriPac Vacuum Decay is a valuable tool for food manufacturers and processors who are looking to improve their quality control processes and ensure the safety and quality of their products.

Medical device package inspection is the process of evaluating the quality and integrity of the packaging of medical devices to ensure that they are safe for use. The packaging of medical devices is critical, as it protects the device from damage during shipping and handling, prevents contamination from external sources, and maintains the sterility of the device until it is used.

The package inspection process involves examining the packaging for any defects or damage that could compromise the integrity of the device. This includes checking for punctures, tears, or holes in the packaging material, as well as inspecting the seals and closures to ensure that they are secure and intact.

Medical device manufacturers are required to adhere to strict regulations and standards to certify that their packaging meets the necessary quality and safety requirements. Package integrity testing is an essential part of this process, as it helps identify any potential defects or issues with the packaging before the device reaches the end user.

Destructive package integrity testing involves damaging the package in some way to evaluate its integrity. This type of testing is typically more invasive and may not be suitable for products that need to be sold intact. An example of destructive package integrity testing is burst testing, where the package is subjected to internal pressure until it ruptures.

Non-destructive package integrity testing, on the other hand, involves evaluating the package's integrity without damaging it. This type of testing is typically less invasive and is more suitable for products that need to be sold intact. An example of non-destructive package integrity testing includes pressure decay testing, where a package is subjected to a pressure change and any leaks are detected by measuring the change in pressure.

Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) that provides a definite pass/fail quantitative data along with dependable, reproducible, repeatable, and accurate results. The basic idea underlying Vacuum Decay technology is to question the integrity of containers based on their basic physical characteristics. Sample packages are first put into an evacuation test chamber that is tightly fitted and has an external vacuum source. A predetermined vacuum level is selected for the test based on the test sample and required level of sensitivity. The next step is to evacuate the test chamber and test system dead space for a certain amount of time. Differential pressure transducers are used to track changes in vacuum level over time. A pressure increase above the specified pass/fail limit indicates that the container is leaking.

• Non-destructive, non-subjective, no sample preparation.
• Accurate, reliable, repeatable results.
• Definite pass/fail result based on quantitative test data.
• Accommodates multiple packaging formats.
• Eliminates destructive, subjective testing methods.
• Effective in detecting even minute leaks.

Packaging is an essential aspect of the meat snack product industry. Proper packaging helps maintain the quality, safety, and freshness of meat snack products, which is important for both consumer satisfaction and safety.

Modified Atmosphere Packaging (MAP) Tray Packs are a popular packaging method for fresh beef, pork, and poultry products, as well as for many other processed meats. Modified Atmosphere Packaging is a packaging technique that involves altering the composition of the atmosphere inside a package to extend the shelf life of the product. The goal of MAP is to slow down the natural degradation process of food by reducing the amount of oxygen inside the packaging and increasing the number of other gases, such as nitrogen or carbon dioxide. MAP has been widely used in the food industry for many years and is particularly useful for fresh fruits, vegetables, and meats. By reducing the amount of oxygen in the package, the growth of bacteria and fungi is slowed down, which helps to preserve the quality of the product for a longer period of time.

1. Extended shelf life: MAP can significantly increase the shelf life of perishable foods, reducing the risk of spoilage and food waste.

2. Improved food safety: By creating an environment that inhibits the growth of microorganisms, MAP can reduce the risk of foodborne illnesses.

3. Reduced need for preservatives: With a longer shelf life, there is less need for the addition of chemical preservatives, which can be harmful to health.

4. Maintained food quality: MAP can help maintain the color, texture, and flavor of the food, which improves customer satisfaction.

The integrity of meat snack products can be tested using various methods including visual inspection, microbiological testing, or other non-destructive Container Closure Integrity Test (CCIT) methods. In this blog we will discuss how Vacuum Decay technology can be used to test the integrity of meat products

Vacuum Decay is a test method that has been proven over decades and further improved with new technological innovations. It involves drawing vacuum on a package within a test chamber and monitoring the vacuum level for decay, which would indicate a leak. The method established itself as a non-destructive replacement to the water bath leak test. It provides significant savings by not wasting product on a leak test and generates a return on investment in under six months for many products.

Vacuum Decay's acceptance as a regulatory tool is evident, and continued development optimizes the technology so that it can do more, perform better, and perform faster. PTI’s next generation of improvements are not incremental improvements, but rather foundational shifts in how the technology will serve the food, pharmaceutical, and medical device industries.

The next generation of VeriPac test systems has undergone a technology overhaul across the product line, improving each model to better perform for their respective applications. Innovation in the field of vacuum decay has often been focused on improving the practicality and sensitivity of the test method. The next generation of VeriPac systems combine both technological innovation and practical adjustments to current technology to make it the most sensitive and versatile vacuum-based leak detection technology to date. Through the introduction of unique test cycles, pneumatic controls, and processing algorithms, the VeriPac Vacuum Decay Technology is establishing itself as the foremost vacuum-based leak detection 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 .
• Accurate, reliable, repeatable results.
• ASTM test method F2338

PTI is a group of researchers, engineers, and professionals who are dedicated to enhancing the overall package quality experience over the course of the packaging lifecycle. To ensure container closure integrity, PTI has created and developed a number of inspection technology platforms. Each technology is based on the principle that there cannot be a test method without a valid test method. The technology solutions provided by PTI are centred on container closure integrity and give a deterministic measurement of package performance needed by critical applications. By delivering package performance data from the development stage to in-production online package inspection, the solutions are widely utilized to address a variety of packaging design and material difficulties.

Vacuum Decay is one of the most practical and sensitive vacuum-based leak detection techniques. This test provides the most accurate, repeatable, and reliable quantitative results, along with a pass/fail determination. The ASTM F2338 standard vacuum decay test method was developed using PTI’s VeriPac instruments. Additionally, it is recognized in the United States Pharmacopeia Chapter on CCI and classified in ISO 11607. The non-destructive container closure integrity testing (CCIT) method from VeriPac can use a differential pressure or absolute pressure transducer leak test device to find package leaks and undetectable defects.

PTI packaging and inspection systems transformed the traditional HVLD method and offered a new technology for assessing the integrity of all parenteral and biological products, including low conductivity liquids such as sterile water for injection (WFI). When compared to standard HVLD solutions, this innovative technology, known as Microcurrent HVLD, uses approximately 50% less voltage and exposes the product and environment to less than 5% of that voltage. The Microcurrent HVLD test method may detect and locate pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and a variety of other defects.

Helium leak testing is the process of identifying leaks in various enclosed or sealed systems by utilizing helium as a "tracer" gas and measuring the concentration of the gas as it escapes as a result of a leak. Because it is non-toxic, non-flammable, non-condensable, and its atmospheric concentration is less than 5 ppm, helium is utilized as a tracer gas. Helium can pass through almost any cracks or openings since it is the second-smallest molecule in the periodic table. Additionally, helium is relatively safe to use because it does not react with other substances. This method uses a mass spectrometer leak detector (MSLD), also known as a helium leak detector, to locate and measure the leak.

PTI's proprietary Airborne Ultrasound technique is a non-destructive, non-invasive seal quality inspection method. Airborne Ultrasound technology offers thorough seal quality studies and is applicable to a wide range of packaging materials, including: Tyvek, paper, foil, film, aluminium, plastic, and poly. Defects of many forms, visible and invisible, leaking and non-leaking, process-related and random, can be detected. Airborne Ultrasound technology is an ASTM Test Method F3004 and an FDA-approved standard for testing seal quality.

The OptiPac One-Touch Tool-less technology is intended for non-destructive leak detection of blister packages. To identify leaks, the OptiPac uses volumetric imaging technology to measure the motion of a blister package under vacuum. With new blister package formats, the interface is practical and straightforward to set up, requiring no tooling changeover or extensive parameter modifications as seen with previous non-destructive blister package inspection systems. The system collects volumetric data from each cavity, responding to variable cavity shapes, sizes, and configurations of various blister pack forms.

Force Decay is a quantitative package integrity testing approach that is well-suited for low-headspace packaging. Non-porous materials, such as films, laminates, or foils, can be used in packaging formats. It does not harm or modify the sample packages because it is a non-destructive test method. When the test is finished, the packages can be returned to the batch without being discarded. The 410's force decay technology can measure force from a package's surface deflection during a conventional vacuum-based test cycle. VeriPac 410 force decay technology has been validated on a variety of package types, including: blister packs, transdermal patch sachets, and low headspace suture packs.

PTI’s continuous technology development has brought more technology and measurement solutions to market under one brand. Whether it be helium leak detection, high voltage leak detection, airborne ultrasound, or a vacuum-based solution, PTI - Science of Quality is the think tank you can rely on to provide the highest level of technology solutions for package quality. PTI continues to build on our journey, and we look forward to supporting you on yours.

The ability to evaluate the possibility of the container closure system to maintain a sterile barrier or to prevent leakage is a vital step in determining the safety and suitability of primary packaging. The United States Pharmacopeia (USP) and Food and Drug Administration (FDA) implement strict guidelines for container closure integrity testing (CCIT) as the driving factors behind safety examination of materials and closure systems in the US.

Historically, the two most common procedures for testing container closure integrity were dye immersion and microbial immersion (both probabilistic tests). In 2016, USP provided recommendations stating that deterministic methods are favored over probabilistic methods for CCIT because they produce reliable and predictable findings at low detection limits.

Non-Destructive CCI Test Methods Offered by PTI

1. Vacuum Decay Technology

Vacuum Decay has been substantiated as one of the most practical and sensitive vacuum-based leak detection methods. This test provides a quantitative result that is reliable, reproducible, and accurate, as well as a pass or fail judgement. PTI's VeriPac equipment was used to produce the ASTM F2338 standard vacuum decay test procedure. It is also recognized in the United States Pharmacopeia Chapter on CCI and is classified in ISO 11607. Using an absolute pressure or differential pressure transducer leak test device, VeriPac's non-destructive technology can detect package leaks and unseen defects.

2. Volumetric Imaging Technology

The OptiPac One-Touch Tool-less technology is intended for non-destructive leak detection in blister packages. To identify leaks, the OptiPac employs volumetric imaging technology to measure the motion of a blister package under vacuum. With new blister package formats, the interface is practical and straightforward to set up, requiring no tooling changeover or extensive parameter modifications as seen with previous non-destructive blister package inspection systems. The system collects volumetric data from each cavity, responding to variable cavity shapes, sizes, and configurations of various blister pack forms.

2. MicroCurrent HVLD Technology

PTI packaging and inspection systems transformed the traditional HVLD method and offered a game-changing new technology for assessing the integrity of all parenteral and biological products, including low conductivity liquids such as sterile water for injection (WFI). When compared to standard HVLD solutions, this innovative technology known as MicroCurrent HVLD uses approximately 50% less voltage and exposes the product and environment to less than 5% of the voltage. The Microcurrent HVLD test method may detect and locate pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and a variety of other faults.

PTI provides package leak testing, seal integrity testing, and container closure integrity testing systems (CCIT). Our technologies eliminate subjectivity from package testing and employ ASTM-compliant test methodologies. The inspection technologies developed by PTI are deterministic test procedures that generate quantitative test result data.

The role of packaging in the secure delivery of nutritional products to the end-user can never be overlooked. Packaging determines the quality and safety of the contents that reach the customer. Most nutritional products are oxygen-sensitive in nature, therefore package performance is a common cause of concern. Defects in packaging can allow air, moisture, and microorganisms to enter the products, making it unfit for consumption. This is why manufacturers stress package integrity testing of nutritional products before they are dispatched. For testing the integrity of nutritional packages, PTI has developed two technologies: Vacuum Decay and Airborne Ultrasound.

Package Inspection Techniques Offered by PTI

1. Airborne Ultrasound Technology

Airborne Ultrasound is a non-destructive seal quality inspection test method used primarily for evaluating seal quality. Such tests offer enhanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology has proven capability of providing deterministic, reliable and accurate test results across a wide range of packaging materials including Tyvek, paper, foil, film, aluminum, plastic and poly. It is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality testing.

Airborne Ultrasound technology utilizes ultrasound waves to detect defects in package seals. As the package seal moves along the sensor head, ultrasound waves are passed through the package seal, causing reflections of sound wave. If there is any defect in the package, the signal strength is reduced or even eliminated. Such variations are closely observed to identify defects in the seal.

Benefits of Airborne Ultrasound Technology:

• Deterministic seal quality inspection technique that assures quantitative and reliable results.
• Creates a visual image of seal quality.
• Applicable for multiple material types and combinations regardless of color, transparency, print, surface finish or porosity.
• Eliminates subjective manual inspection methods.
• Non-destructive, non-subjective, no sample preparation
• Technology can be integrated for 100% online defect detection of the final pouch seal.

2. Vacuum Deacy Technology

Vacuum Decay is a Container Closure Integrity test (CCIT) method, proven over decades to ensure package integrity at the production line with unmatched reliability and sensitivity. Being a non-destructive test method, it allows a greater understanding of package quality and reduces waste compared to destructive test methods. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

With the next generation of VeriPac test systems, PTI brings a tradition of excellence and performance reliability to its line of non-destructive package testing equipment. VeriPac test systems have undergone technological advancements across the product line, improving each model to better perform for their respective applications.

Primary areas of focus in terms of innovations in the field of vacuum decay have been improving the practicality and sensitivity of the test method. PTI's VeriPac test systems combine both technological innovation and practical adjustments to current technology to make it the most sensitive and versatile vacuum-based leak detection technology to date. Features like unique test cycles, pneumatic controls and processing algorithms make VeriPac technology the foremost vacuum-based leak detection technology.

Benefits of Vacuum Decay Technology:

• Non-destructive technology.
• ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines.
• Accurate, repeatable results.
• Eliminates destructive, subjective testing methods.
• Pass/fail results backed by quantitative test data.

The novel coronavirus emerged late December 2019 and spread rapidly globally. It is a notifiable communicable disease of the fifth category and is also known as Severe Pneumonia with Novel Pathogens. The incubation period of coronavirus ranges between 2-14 days and is considered to be highly contagious.

As of now, most of us have either had COVID-19 ourselves or known someone close to us who has had it. Studies show that nearly 80 million U.S. residents have had confirmed COVID-19 infections since March 2019. And many more likely have been infected but without reported tests to confirm. In fact we’re still witnessing variants and mutations of the virus.

One of the smartest and safest measures to know your status and avoid infections is regular testing. With the outbreak of a more contagious Omicron variant of COVID-19, testing remains a critical tool to suppress the spread of the virus. Luckily, COVID-19 tests are getting easier to find. And now, there are different types of home tests that, when used together, paint an accurate picture of your COVID-19 status.

With the rising demand for test kits, ensuring the integrity of testing activities is also critical to fighting the virus. COVID 19 test kits are extremely moisture sensitive as the absorption pad and other critical components are made of filter paper and other absorbent materials. Compromised test cassettes can lead to incorrect results or unusable test kits. False-negative results lead to the further spread of the virus, while false positives can induce fear and unnecessary quarantine.

Common issues in flexible packaging are leaks, poor sealing within the fin seal, cuts in the package, channel leaks, wrinkles, and completely open seals. Low humidity production environments and desiccant packaging materials do not suffice if a leak is present in the package.

PTI has developed a solution for container integrity testing of diagnostic test cassettes in flexible packaging. Utilizing PTI’s VeriPac vacuum decay technology in accordance with ASTM F2338 and USP 1207, leaks in flexible packaging can be detected down to 5 microns. With PTI’s Hand Flex Chamber (HFC), multiple samples can be tested in a single test cycle. The HFC membranes engulf the package to avoid any additional stress to the package seals and remain a non-destructive test method. ?The test cycle is rapid and provides pass/fail results and supporting quantitative result data.

Benefits of Vacuum Decay Technology

• Non-destructive, non-subjective, no sample preparation.
• Deterministic, quantitative test method.
• Repeatable, rapid and reliable testing.
• Cost effective and economical.
• Simplifies the inspection and validation process.
• ASTM test method and FDA standard

Medical devices and pharmaceuticals products are manufactured with zero tolerance to defects. For this reason, manufacturers give top priority to quality control procedures and regulatory standards. This is to make sure that products maintain the quality standards required for their intended use.

Packaging plays an important role in maintaining product quality and ensuring the product reaches consumers defect-free. While selecting the right packaging material is important, testing integrity of packages also holds high relevance. Traditionally, destructive testing methods like Dye Ingress and Water Bath were popular Container Closure Integrity Testing (CCIT) techniques. However, in recent years, the industry has moved towards deterministic methods to achieve more precise, reliable results.

How PTI's VeriPac Series ensure package integrity?

PTI 's VeriPac series are non-destructive, non-subjective test systems ideal for leak testing high-risk applications that require extreme levels of test reliability and accuracy. This technology uses an ASTM approved vacuum decay leak test method F2338, which is listed in ISO 11607, USP <1207>. It is an FDA recognized consensus standard for package integrity testing. Using cutting-edge innovation, VeriPac inspection systems provide repeatable, sensitive, and more robust detection of defects. VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats including flexible, rigid and semi-rigid packaging. Apart from package integrity testing, VeriPac technology can also be used for stability studies, clinical trials, quality assurance testing and statistical process control (SPC).

Technology Overview

The test method is initiated by connecting VeriPac leak testers to a test chamber that is specially designed to contain the package being tested. The package is placed inside the test chamber to which a vacuum is applied. Using a single or dual vacuum transducer technology, the level of vacuum as well as the change in vacuum over a predetermined test time are monitored. The variations in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.

Benefits of VeriPac series

• Deterministic, quantitative test method.
• Defect detection down to 0.034 cc/min.
• Highest level of repeatability and accuracy.
• Cost-effective with rapid return on investment.
• Simplifies the inspection and validation process
• Results proven superior to dye ingress.
• ASTM test method and FDA standard
• USP <1207> Compliant.

Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile products intended to be administrated directly into human bodies. Parenteral drug products are expected to be free from microorganisms, pyrogenic substances as well as other visible particles. Contaminated parenteral drug products can cause serious health concerns to the patient. Hence, sterility assurance and package integrity testing are of paramount importance in parenteral drug manufacturing. Read on to know more about parenteral products package testing methods offered by PTI.

Parenteral products package testing methods:

1. Vacuum Decay technology

Vacuum Decay technology is a non-destructive Container Closure Integrity test method primarily used to detect leaks in package seals. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is capable of identifying leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection. Vacuum Decay technology has established itself as a non-destructive alternative to traditional test methods like Water Bath and Dye Ingress, making it a practical solution for leak detection in the Pharmaceutical and Medical Device industry.

How does Vacuum Decay technology work?

The principle behind Vacuum Decay technology is simple and it challenges container integrity based on fundamental physical properties. The test begins by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Based on the test sample and level of sensitivity required, a pre-determined vacuum level is chosen for the test. The next step involves evaluating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor changes in vacuum levels for a specified period. A pressure increase beyond the predetermined pass/fail limit indicates container leakage.

Benefits of Vacuum Decay technology

• Non-destructive package inspection system
• Accurate and reliable results
• Definite pass/fail result based on quantitative test data 
• Accommodates multiple packaging formats
• Eliminates destructive, subjective testing methods
• Effective in detecting even minute leaks
• ASTM Test Method F2338, FDA Consensus Standard and USP 1207 compliant
 

2. MicroCurrent HVLD Technology

PTI’s Microcurrent is patent-pending unique CCI technology that has revolutionized the conventional high voltage leak detection method. It is a non-invasive and deterministic container closure integrity testing method that is effective across all parenteral and biologic products including low conductivity liquids such as sterile water for injection. The Microcurrent HVLD test method is highly effective in detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects across applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. A unique mode of Microcurrent HVLD uses about 50% less voltage and reduces the exposure of product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. The E-scan HVLD series is a leading solution of sturdy container closure integrity test equipment.

Benefits of MicroCurrent HVLD technology

• Non-destructive & requires no sample preparation
• Deterministic & non-invasive
• Highly effective across all parenteral products
• High levels of sensitivity, accuracy and reliability in results
• Offline and 100% online inspection at high production speeds
• Simplifies the inspection and validation process
• Referenced in Chapter USP 1207 Guidance for CCIT

Maintaining quality requirements and ensuring package integrity are important criteria for pharmaceutical product manufacturers. As such, the shift to more automated processes and digital measurement systems have systematically become a greater part of pharmaceutical manufacturing. In this blog, we will discuss automated package inspection techniques offered by PTI.

1. Vacuum Decay technology

Vacuum Decay technology is a non-destructive Container Closure Integrity Test (CCIT) used for leak detection in nonporous, rigid, or flexible packages. It is an ASTM-approved, FDA-recognized test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. This method involves drawing vacuum on the sample package kept in the test chamber and analyzing the vacuum level for any defect, indicating a leak.

Vacuum Decay technology is applicable across a wide range of pharmaceutical and medical devices with the capability of detecting leaks in single digit micron range while accommodating multiple packaging types. PTI has made further advancements in Vacuum Decay technology with its PERMA-VAC technology and VeriPac FLEX Series.

PERMA-VAC technology that addresses vacuum decay detection at the very core of physical test measurement, controlling the test system volume and maximizing the SNR between good and defective samples. It is a a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results.

The VeriPac FLEX series, designed specifically for dry filled pouches and flexible packaging are available in several configurations with the ability to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. The VeriPac FLEX series offer defect detection to the 10 to 20 micron range.

2. MicroCurrent HVLD Technology

PTI's MicroCurrent HVLD technology is a unique High Voltage Leak Detection Technology for container closure integrity testing. It is found to be highly effective across a wide range of high-risk pharmaceutical products and medical devices. When compared to traditional HVLD solutions, this method uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. Being a non-invasive technique it requires no sample preparation and has a high degree of reproducibility and accuracy throughout.

The Microcurrent HVLD test method can detect the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. It assures product CCI by scanning a non-conductive sealed container with electrode probes. Any defect in the packaging results in resistance differential and change in current flow in the container as well as the approximate defect location.

Such automated platforms would provide the same 100% testing capability with an accurate inspection that includes quantitative test data and a pass/fail result. Proper sensory measurement requires time to capture a result. However, these new automated technologies can still reliably inspect containers at a much higher rate than was possible before, with a more sensitive leak detection capability.

Packaging has always been an indispensable factor in the pharmaceutical manufacturing process. Since most pharmaceutical products come under high-risk category, appropriate packaging is vital to prevent product deterioration. Faulty or damaged packaging can cause oxygen, moisture, microorganisms or other harmful substances to enter the product- making it unfit for use. Given the sensitive nature of pharmaceutical products, package inspection testing holds high relevance. Let us now understand what CCI techniques are being offered by PTI for pharmaceutical package testing.

Techniques to ensure CCI

1. Vacuum Decay technology

Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) method that is highly effective in detecting leaks in nonporous, rigid and flexible packages. It is a simple test method that challenges container integrity based on fundamental physical properties. As the name suggests, this test is conducted by drawing vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207). PTI has revolutionized Vacuum Decay technology with its s next generation of improvements in the form of PERMA-VAC technology and VeriPac FLEX Series.

PERMA-VAC Technology is a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results. This method can be applied to flexible and semi-flexible packages alike.

The VeriPac FLEX series are innovative packaging inspection systems specifically for flexible packages. These are available in different configurations to accommodate various package specifications, capable of detecting leaks down to the 10 to 20 micron range.

Benefits of Vacuum Decay technology

2. MicroCurrent HVLD Technology

High Voltage Leak Detection (HDLV) is a Container Closure Integrity test method that utilizes high voltage leak detector system for evaluating integrity of nonporous packages. The latest evolution in the HVLD technology, PTI’s MicroCurrent HVLD is revolutionary technology, a non-destructive, non-invasive CCI technique which can precisely detect any leak in a wide range of liquid filled products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

This method operates by scanning a sealed container using electrode probes to detect the presence of any leak. By analyzing a change in the current flow, the test operator can detect Defect in the container as well as its approximate location. PTI's MicroCurrent HVLD uses about 50% less voltage and exposes the product and environment to less than 5% of the voltage compared to conventional HVLD technologies. This technology can be easily shifted from offline to 100% inline testing application, thereby simplifying the inspection and validation process.

Benefits of MicroCurrent HVLD technology

• Non-destructive, non-invasive, no sample preparation
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Low voltage exposure to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package inspection
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
• Simplifies the inspection and validation process
• Offline and 100% online inspection at high production speeds

Package integrity is of paramount importance in ensuring that sterility is maintained over a product’s entire shelf life. It is also a critical factor in preventing penetration of microorganisms throughout the distribution process. International Organization for Standardization defines package integrity as "the unimpaired physical condition of the final package."

Flexible pouches are extensively being used in the pharmaceutical and food industry as a primary packaging component. Even a minute breach in the sterile condition of the product is often considered a serious risk, resulting in the disposal of valuable products. Therefore, manufacturers give utmost importance for package integrity testing. Today, the market offers a host of techniques that can evaluate packages both destructively and non-destructively. In this blog we will discuss how VeriPac Flex system effectively evaluates integrity of a wide range of flexible packages.

Flexible package inspection using VeriPac Flex Series

Designed specifically for pouches and other flexible packaging with dry-filled products, VeriPac FLEX series are innovative non-destructive container closure integrity testing (CCIT) systems. Applicable across a wide range of flexible packaging formats, this technology provides unparalleled sensitivity, reliability and practicality in testing without requiring change-over of settings or tooling.

Utilizing the ASTM method for Vacuum decay leak testing (F2338), VeriPac inspection systems provide quantitative data and definitive PASS or FAIL results. PTI offers VeriPac FLEX Systems in several configurations to accommodate various package specifications and test sensitivity requirements. Such configurators for both the leak test instrument and the test chamber capacity enable evaluation of small format sachets and stick packs, up to large bulk size pouches and bags.

Because it eliminates subjectivity, reduces the waste and cost associated with traditional test methods, they are perfect alternatives to destructive package inspection techniques. Infact Vacuum decay leak testing technology has proven to provide a short return on investment when compared to destructive methods, such as the water bath or blue dye leak test. Listed in ISO 11607 and recognized by the FDA as a consensus standard for package integrity testing, VeriPac test systems detect critical packaging failures reliably and reveal valuable information on the packaging process.

Understanding the working of VeriPac FLEX systems

Depending on the size of the package, the test operator first connects VeriPac tester to the appropriate FLEX chamber. There are two VeriPac systems namely, integrated flexible test chamber (IFC) and drawer Style test chamber (D-Series) that can be paired with the FLEX chamber to provide different leak detection capability depending on the application. While the integrated flexible test chamber is for sachets or stick packs with low headspace, drawer style test chamber features two standard sizes, the Small (D) or Large (DXL) depending upon the package size and specifications. Customs designs can be manufactured for large package formats and bulk products. The unique difference with VeriPac FLEX systems is how the package is tested. PTI utilizes its flexible membrane that conforms to the package shape and size, eliminating any stress and damage to the film materials.

Benefits of VeriPac FLEX systems

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

Container closure integrity testing (CCIT) or leak testing is an important process in the manufacturing phase of a pharmaceutical drug product in particular parenteral products. CCIT is performed to evaluate and maintain sterility over the shelf life of a product as well as to prevent contamination of the product from moisture, reactive gases, or micro-organisms. In earlier times, dye ingress, microbiological ingress and other probabilistic test methods were being used in the industry. However, the results produced by such methods lacked accuracy, reliability and were highly subjective. Therefore, manufacturers are now replacing probabilistic test methods with deterministic methods, which reduce the needs for sample preparation and validation and provide more accurate detection of leaks and defects.

Why is VeriPac 465 effective in highly sensitive micro leak testing?

PTI's VeriPac 465 is a deterministic, quantitative inspection technology that is non-destructive and non-invasive to the package being tested. This technology requires no sample preparation and performs leak detection based on the basic principles of physics. The VeriPac 465 is an ASTM approved, FDA recognized package integrity testing method which is based on vacuum decay leak test method (F2338). This test method was developed using VeriPac leak test instruments. Unique test cycles, pneumatic controls and processing algorithms are certain features of VeriPac 465 system that make it the foremost vacuum-based leak test for parenteral products.

This inspection method is suitable for laboratory offline testing and QA/QC statistical process control. The test cycle takes only a few seconds, results are non-subjective and testing is non-destructive to both product and package.

Technology overview

The test begins by connecting VeriPac 465 leak tester to a chamber that is specially designed to contain the package to be tested. Vacuum is then applied to the test chamber in which the package is placed. Using dual transducer technology, the test chamber is monitored for both- level of vacuum and 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 sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. VeriPac 465 technology reduces the baseline measurement for good samples and amplifies the test result for defective samples. This technology is geared towards detecting leaks in the MALL range for parenteral packaging and can also be applied to flexible and semi flexible package formats

Inspection Criteria

• Measures seal integrity of entire container or package
• Measures and verifies container closure system integrity
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, pre-filled syringes)

Benefits of VeriPac 465

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.002 cc/min
• Highest level of sensitivity, repeatability and accuracy
• Results proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method and FDA standard

Package validations for medical devices play a significant role in ensuring safe and effective use of products when they reach the patient. Packaging for these safety-critical products must withstand the rigors of the manufacturing process, storage, and the distribution cycle. Package integrity is crucial to maintaining sterility for medical devices, especially those that are to be used during medical procedures or implanted into patients. This is because even a minute defect in the package can affect sterility of the device and cause health risk to the patient. Given below is a list of non-destructive package inspection techniques that help maintain highest quality standards.

CCI techniques offered by PTI

Vacuum Decay technology

Vacuum Decay is a non-destructive package inspection technique that offers the ability to inspect both the entire body of the package and seals for micro leaks and defects. The technology proven to provide reliable, reproducible, repeatable, and accurate quantitative results, is recognized by the FDA as a consensus standard for container closure integrity testing (CCIT). Vacuum Decay leak test method is an ASTM Test method (ASTM F2338) that was developed using PTI instruments, it is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

Technology overview

Vacuum Decay test method is simple in practice and challenges container integrity based on fundamental physical properties. The samples are placed in a closely fitting test chamber, equipped with external vacuum source. A pre-determined vacuum level is selected depending on test sample and level of sensitivity required. The next step involves evacuating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor change in vacuum level for a specified period. A pressure increase beyond predetermined pass/fail limit indicates container leakage.

Advantages of Vacuum Decay technology:

• Non-destructive package inspection system
• Accurate and reliable results
• Definite pass/fail result based on quantitative test data 
• Accommodates multiple packaging formats
• Eliminates destructive, subjective testing methods 
• Effective in detecting even minute leaks 

Airborne Ultrasound technology

Airborne Ultrasound technology is a non-destructive Container Closure Integrity test used to examine seal quality for defects. 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. Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection technique suitable for many materials including Tyvek, paper, foil, film, aluminum and plastic. Airborne Ultrasound technology offers a comprehensive approach to evaluate seal quality even in conditions where a seal has a defect but may not leak.

Technology overview

Under this method, ultrasonic waves are propagated through the package seals as they move along the sensor head. This causes reflections of sound waves. The signal strength is either eliminated or reduced in the presence of any defect/leak. Such variations in signal strength are closely monitored to identify the defects.

Benefits of Airborne Ultrasound technology

• Non-destructive, non-subjective, no sample preparation
• Accurate and reliable results
• Deterministic package inspection technique 
• Works on multiple packaging formats and materials 
• Economical cost-effective solution for seal integrity testing
• Can be applied to 100% inline seal quality testing

Package integrity testing may be understood as a set of techniques used to protect the contents of a package from potential physical, chemical and microbial threats. It plays a crucial role in determining and maintaining sterility and shelf life of pharmaceutical products, medical devices, and food and nutrition products. Since such products are extremely sensitive to external environmental conditions, even a minute breach in the package can cause micro-organisms, reactive gases or other harmful substances to enter the product. This can result in serious health issues to the end user and affect brand loyalty of manufacturing companies. As such, testing for leaks is an important aspect of the manufacturing process.

Historically, manufacturers relied on destructive testing methods like Water Bath or Dye Ingress as well as other unreliable methods such as Visual Inspection to test integrity of packages. However, such tests lacked accuracy and reliability in test results. Moreover, being destructive testing methods, it caused damages to the package being tested making it unfit for use. These limitations of destructive techniques prompted manufacturers to opt for non-destructive testing methods that do not harm the product and provide reliable, repeatable and quantitative rest results. Reduction in waste coupled with material cost advantage gives non-destructive methods an practical edge over destructive test methods. Examples of non-destructive testing methods include Vacuum Decay technology, Airborne Ultrasound technology and Microcurrent HVLD technology.

VeriPac test systems for precise and reliable package integrity testing

PTI’s VeriPac series are non-destructive, non-invasive inspection systems for leak detection and package integrity testing. These systems reduce waste and provide operators with a clear understanding of package quality. The VeriPac test system produces real time results from precise quantitative measurements that identify packaging defects before critical process issues get out of control. Tests can be performed in any sequence and even repeatedly on a single sample. Good packages can be returned undamaged to the packaging line. Testing is more reliable, sensitive and efficient than destructive methods. VeriPac series utilizes the ASTM approved patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

Technology Overview

PTI’s 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. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or fully automated operation. This inspection method is suitable for laboratory offline testing, QA/QC statistical process control, automated batch or 100% inline testing.

Benefits of VeriPac series

• Non-destructive, non-subjective, 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 operator with PASS/FAIL result
• Small footprint and modular portable design
• ASTM test method and FDA standard
• Referenced in USP 1207 guidance

The pharmaceutical industry is crucial to the health care system as they assure treatments that were unimaginable a few years ago. As the industry grows in importance, the techniques of primary packaging for pharmaceutical products, especially high-risk medicines have taken on new prominence.

Since many high-risk pharmaceutical products are filled and sealed in combination devices, it’s critical for manufacturers to ensure that the components function well together. Hence, design and distribution considerations are critical to both the drug and the container. Manufacturing inconsistencies and tolerance differences in packages containing multiple components are primary contributors to distribution issues. Often, such inconsistencies result in container closure failure, causing serious implications down the supply chain. For instance, glass vials and pre-filled syringes may not seal properly at critical fill-finish closure points. Such a failure can cause oxygen or other environmental contaminants to enter the product and compromise the efficacy of the drug in the barrel. At this point, it is critical to use the most precise leak testing method possible.

Why Container Closure Integrity testing is important?

As per the FDA- Food and Drug Administration, A container and closure system refers to "the entirety of packaging components that together contain and protect the product". In simple words, Container Closure Integrity testing can be understood as a leak detection test. CCI solutions include non-destructive package inspection technologies to ensure product sterility throughout the product’s lifecycle. CCIT plays a vital role in ensuring that the products are free from any possible contamination. Conventionally, probabilistic test methods like bubble tests, dye ingress and microbial challenge were extensively used in pharmaceutical package testing. Since it was found that such test results lacked accuracy and reliability, the United States Pharmacopeia (USP) released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. With this new USP <1207> chapter guidance, manufacturers today rely on non-destructive alternatives like Vacuum Decay technology and Micro Current HVLD technology that ensure highly sensitive package integrity solutions.

1. Vacuum Decay technology: Vacuum Decay technology is a non-destructive container closure integrity solution capable of detecting leaks in nonporous, rigid or flexible packages. Vacuum Decay leak testing is conducted by placing a sample package in a well-fitting evacuation chamber, which is provided with an external vacuum source. The vacuum levels as well as the change in vacuum over a fixed test time are closely observed using single or dual vacuum transducer technology. Changes in vacuum level beyond a predetermined pass/fail limit indicate defects within the package. VeriPac Vacuum Decay series can non-destructively test packaging down to sub-micron leak rates - making it an excellent alternative to destructive testing methods.

PTI’s VeriPac 465, the latest addition to the vacuum decay series is a robust and reliable solution for testing pharmaceutical containers and parenteral products, achieving highly sensitive sub-micron leak detection. The VeriPac 465 is the most sensitive vacuum based technology on the market to-date.

Benefits of Vacuum Decay Technology:

• Non-destructive, non-subjective, no sample preparation
• Deterministic test method that provides quantitative results
• Multiple package testing in a single test cycle
• Economical with rapid return on investment
• ASTM Test Method, FDA standard and USP 1207 Guidance

2. Microcurrent HVLD technology: Microcurrent HVLD is a unique High Voltage Leak Detection technology, highly effective across all liquid filled parenteral products. Its applications include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to large molecule-based proteinaceous products with suspensions. Its ability to detect small pinholes, micro cracks and seal defects makes it an ideal choice for testing high risk pharmaceutical and parenteral products.

Benefits of PTI’s MicroCurrent HVLD technology:

• Non-destructive, non-invasive, no sample preparation
• Highly effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Ensure higher levels of accuracy and reliability in test results
• Simplifies the inspection and validation process
• Offline and 100% online inspection
• Referenced in USP 1207 Guidelines

Ophthalmic preparations majorly consist of sterile liquid, semi-solid or solid preparations with active pharmaceutical ingredients. More than 70% of ophthalmic drug products are supplied in plastic container closure systems, which generally contain a month or longer supply of the drug. The liquid filled package formats are often soft containers with snap on or torque screw caps, but also include foil lidded blister packs for single use contacts. Any breach, channel, or micro leak in the container closure systems can greatly increase the risk of contamination of the ophthalmic solution. Therefore, in terms of product performance and safety, ophthalmic drug product packaging is considered to be more crucial than the packaging used for solid oral drug dosage forms.

Packaging defects are the key factors contributing to contaminated eye care solutions. For instance, the soft plastic containers and snap caps are typically blow molded plastics. The area for primary concern with both torque and snap on caps is the flange area of the bottle. Although traditional methods like visual inspection can detect many container failure modes of an uncapped container, inaccuracies or marks in the flange area can go unnoticed. However, such a defect can provide a clear path for bacteria and fungi to transfer into the product. This is both the most common and most difficult container defect to detect and remains hidden beneath the cap once it is applied. Hence, manufacturers require leak detection techniques capable of detecting even minute leaks for ensuring highly sensitive leak testing solutions.

PTI’s Vacuum Decay technology is a non-destructive leak testing method, capable of evaluating both liquid and air-filled containers and detecting defects as small as below 1 micron. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is an ASTM test method, FDA consensus standard, eliminating false positives and subjective results associated with manual visual inspection. Vacuum Decay technology is capable of identifying leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection.

PTI’s VeriPac 455 is a deterministic and quantitative package inspection solution for highly sensitive liquid filled containers making it ideal for ophthalmic package leak testing needs. This test method was developed using VeriPac leak test instruments. The VeriPac 455 features patented dual vacuum transducer technology, PERMA-Vac, which offers increased test sensitivity and produces repeatable, reliable results. Under this technique, the VeriPac 455 leak tester is connected to a test chamber that contains sample packages. Vacuum is applied to these packages and a dual 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.

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

Fresh coffee is the best coffee. The quality of coffee is directly linked to freshness, and maintaining freshness requires adequate packaging. In simple words, packaging is what holds coffee products and maintains its quality. However, maintaining freshness and shelf life of packaged coffee is often a challenge for manufacturers. The flavors and oils in coffee are oxygen sensitive, while flavor profile being the key differentiator for consumers. External conditions like high temperature, light, or high humidity can increase the rate of staling. Under such conditions, whole beans will lose significant amounts of flavor and develop stale fragrance in 1-2 weeks, while in case of ground coffee the process takes 1-2 days. Compromised package integrity can result in oxidation, flavor degradation, and spoilage. Leaks as small as 10 microns can draw oxygen into the package over its shelf life. If a consumer encounters a product that exhibits oxidation, the bitterness and stale flavor will likely affect the consumer’s decision to repurchase. This explains why manufacturers give prime importance to evaluating integrity of coffee packaging.

Conventionally, water bath was the most popular technique for leak testing coffee products. Although water bath is a simple and effective leak testing method for rigid containers, it fails to meet critical needs associated with flexible coffee packages. Additionally, the cost associated with maintaining standard destructive methods is high. Subjective test results, variable test standards, and higher risks associated with the use of other methods emphasize the need for better alternatives. Hence manufacturers today opt for non-destructive testing methods that eliminate the cost associated with wasted product, and ultimately facilitate better quality control.

Package integrity testing using Vacuum Decay technology

PTI’s Vacuum Decay technology is an ASTM-approved, FDA recognized non-destructive Container Closure Integrity test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. It can detect oxygen critical leaks, providing a more reliable and sensitive solution for a range of packaging formats that is designed to protect oxygen sensitive products. This method involves drawing vacuum on the sample package kept in the test chamber, and analyzing the vacuum level for any defect-indicating a leak. VeriPac systems reliably detect leaks as small as 10 microns, identifying process issues before they become critical, avoiding costly quality deviations.

For coffee sachets, stick packs or pouches, PTI’s VeriPac FLEX series offer the highest level test sensitivity, detecting micro leaks into the single digit micron range. These are versatile non-destructive package inspection systems designed specifically for flexible packages. To accommodate various package specifications, the VeriPac FLEX is available in several configurations. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. Hence, VeriPac vacuum decay is a practical alternative and significant improvement to the destructive test methods commonly used for flexible packaging.

Benefits of Vacuum Decay technology:

• Reliable and sensitive leak detection of quality critical defects
• Cost savings
• Using a non-destructive leak test method allows an increase in the number of product samples tested
• Rapid test cycle and minimal training required to operate tester
• Rapid ROI due to substantial cost savings and elimination of product loss

Nutritional products are expected to be manufactured with zero tolerance to defects and should reach the consumers in the best and safest possible state. This is a criterion that cannot be ignored due to health and safety regulations. This is because most nutritional products are subject to innate chemical reactions. Defects in the nutritional packaging can cause the products to deteriorate with exposure to oxygen, moisture and bacteria. Fats and other infant nutrients can go rancid and inert.

Among other nutritional products, the standard of quality within dehydrated dairy industry is most critical. Even a minute defect in the package can deteriorate product quality, making it unfit for consumption. This is especially true for protein-based powders which are manufactured under controlled conditions to prevent spoilage and retain its nutritional purpose throughout its shelf life.

The protein content in most dairy products allows bacteria to consume majority of oxygen content before an increase in oxygen is detected by gas testing equipment. Leaks as small as 10-20 microns will only increase the oxygen content to levels below 3%, which cannot be detected using conventional testing methods. However, such leaks can dramatically decrease the typical 12 to 24 months shelf life of protein-based products. Oxygen and moisture ingress into the package will rapidly degrade the product prior to use, changing flavor, texture, and ultimately turning any valuable product into a liability.

Since conventional testing methods like water bath or dye ingress fall short of detecting such defects, it is important to apply techniques that offer high sensitivity leak testing and quality assurance.

Ensuring package integrity with Vacuum Decay technology

Vacuum Decay technology is a Container Closure Integrity test (CCIT) method with 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 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. PTI’s VeriPac Series a practical alternative and significant improvement 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 technology:

• 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

Seal integrity plays a vital role in ensuring the quality of packaging products. Even a minute defect in the seal can initiate a leak, which can compromise the quality of the product and directly affect its shelf life. It can also result in huge financial losses to the manufacturer. That being said, manufacturers give considerable importance to conducting appropriate seal integrity tests to ensure package integrity at every stage of its lifecycle.

Seal integrity testing methods can be classified into two- Destructive testing methods and Non-Destructive testing methods. Since under Destructive methods, the packages may get destroyed, its popularity has steadily declined over the past few decades due to this waste and high cost. “There is a huge shift in the industry towards deterministic and quantitative test methods,” says Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes vacuum decay and airborne ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Seal quality inspection techniques offered by PTI:

Vacuum Decay technology is a non-destructive Container Closure Integrity test (CCIT) method, used for seal quality inspection in nonporous, rigid or flexible packages. With the ability to detect leaks down to the sub-micron level, , Vacuum Decay technology is identified as one of the most practical vacuum-based leak detection methods. Its ability to provide quantitative, reliable and repetitive test results make it ideal solution for seal quality inspection in Pharmaceutical, Medical Device and Food and Nutrition industries.

Under this method, the sample packages are first placed in a close fitting evacuation test chamber that contains an external vacuum source. The vacuum levels and changes in vacuum over a pre-determined time are closely monitored. The 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 the absolute and differential vacuum indicate the presence of leaks and defects within the package.Over the past few years, Vacuum Decay technology has seen great advancements in the form of PTI’s PERMA-VAC technology and VeriPac FLEX Series.

The next generation PERMA-VAC technology is a single or dual vacuum transducer technology that has made the VeriPac line of test systems the most sensitive vacuum-based leak tests available in the market. It has higher test sensitivity for providing accurate and reliable results and can be applied to rigid and semi-flexible packages alike. PTI’s PERMA-VAC technology ensures the most stable test measurement ever achieved through vacuum decay.

Airborne Ultrasound technology is yet another seal quality inspection technique, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

As the name suggests, this method utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

Apart from validating the functionality and design of medical devices, ensuring package integrity is crucial to make sure that the product reaches the end-user intact. Packaging and delivery formats available for medical devices range from porous flexible packaging to non-porous rigid containers. Each packaging format has a unique set of characteristics and requirements, which necessitates a comprehensive approach while selecting an appropriate inspection technique.

With increasing innovations in packaging formats and materials, packaging challenges have also increased. Among other medical devices, Class III medical devices pose the highest level of risk associated with ensuring package integrity. Such devices sustain or support life and are implanted. Examples of Class III devices include pacemakers, cardiovascular stents, respiratory ventilators and breast implants. Since these devices are directly placed into human bodies, even a minute breach in the packaging can pose significant risk to patient safety. Hence testing container closure integrity (CCI) of medical devices is crucial.

Vacuum Decay is a non-destructive Container Closure Integrity test (CCIT) method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating wide range of high-risk package applications. It can be efficiently incorporated into the packaging process to ensure quality, reduce waste and allow operators to have a proper understanding of package integrity. Multiple vacuum supply types along with single or dual high-resolution transducers configuration enables the VeriPac series to provide fast and reliable test results that are quantitative and deterministic. It is an ideal solution for medical device manufacturers to ensure that the product meets regulatory standards. Based on packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

PTI has revolutionized Vacuum Decay technology with the development of next generation PERMA-VAC technology, that offers increased test sensitivity and repeatable results. The technology is capable of detecting leaks in the MALL range for parenteral packaging and can accommodate a variety of flexible and semi-flexible package formats. The advancements in PERMA-VAC technology has made the VeriPac series the most reliable and practical vacuum-based leak test method available today.

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
• ASTM test method F2338

Medical device industry is crucial to health care system as they play a vital role in the delivery of many health care services. Over the past few decades, tremendous developments in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging. Although testing package quality of all medical devices is critical, in case of Class III medical devices it amplifies several folds. Class III medical devices are understood as devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and respiratory ventilators. Since these devices are directly placed into human bodies, proper packaging is required to ensure the quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, thereby making it more of a threat to the patient than a treatment. Hence appropriate CCI technologies are needed to ensure standardized packaging quality.

Container Closure Integrity Testing(CCIT) is a leak detection test conducted using a non-destructive package inspection system to ensure sterility and product quality throughout its shelf life. Earlier, probabilistic test methods such as bubble test, dye ingress and manual visual inspection were used to test package quality of medical devices. However, these traditional methods lacked accuracy and provided uncertain and subjective results. In order to overcome the shortcomings of probabilistic methods, industries are now moving towards deterministic methods that assures a higher level of accuracy with quantitative results. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “ There is a huge shift in the industry toward deterministic and quantitative test method. This includes Vacuum Decay and Airborne Ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Packaging Technologies & Inspection-PTI’s VeriPac Vacuum Decay Technology and Airborne Ultrasound Technology have revolutionized automated CCI Technologies.

Vacuum Decay Technology is a CCI testing method that detects leaks in nonporous, rigid or flexible packages. Such tests are conducted by placing a sample in an evacuation test chamber, drawing vacuum and monitoring vacuum level for any decay, indicating a leak. Such tests are known to provide reliable and quick results. PTI’s VeriPac Vacuum Decay Technology is a non-destructive package inspection system based on the ASTM vacuum decay leak test method (F2338-09) and accredited by the FDA for package integrity testing. Its applications include empty and pre-filled syringes, liquid-filled and lyophilized vials and other flexible and rigid liquid-filled packaging. PTI’s PERMA- VAC technology, known to provide consistent and reliable results is the latest development in the VeriPac line of test systems. The VeriPac Universal Blister Verification (UBV) system designed for non-destructive blister package leak detection uses a volumetric imaging technology to measure the motion of a blister package under vacuum to detect leaks.

PTI’s Airborne Ultrasound Technology is a non-destructive Seal Integrity Test used to examine seal quality for defects. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. Under this method, high-frequency sound waves are passed through the pouch seal area, causing the reflection of sound waves. Variations of the reflected signal strength are used to reflect defects if any. PTI’s Airborne Ultrasound Technology for 100% Inline inspection of pouch seals has been extremely helpful in verifying final pouch seal quality. Any defect in the pouch seal including voids and delamination, foreign materials and inclusions, incomplete seals and misaligned seals can be detected using a Seal-Sensor scan and are automatically rejected from the production line.

Vacuum Decay Method (VDM) is used by manufacturers of packages for the food, beverage, industrial and pharmaceutical industries in order to detect leaks in rigid or flexible packages.

Both methods are established ASTM test methods: Vacuum Decay ASTM F2338 and Airborne Ultrasound ASTM F3004.These technologies are non-destructive methods and can be chosen depending on the characteristics of the product to be tested.