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

Vacuum Decay Technology

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

Applications of Vacuum Decay Technology in Various Industries

• Pharmaceutical

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

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

• Medical Device

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

Vacuum Decay Technology Benefits

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

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

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.

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

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

VeriPac Vacuum Decay Series for Snack Food Package Integrity Testing

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

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

Working Principle

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

VeriPac Inspection System Benefits

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

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

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

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

Technology Overview

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

VeriPac Vacuum Decay Technology

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

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

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

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

Pharmaceutical vials are small bottles or containers designed for parenteral administration (injection or infusion) in a single patient for a single case, procedure, or injection. They offer the highest Container Closure Integrity (CCI), which is a measure of how well a container protects the pharmaceutical ingredient against contamination by a variety of factors such as moisture, air, and chemicals.

In pharmaceutical manufacturing, the leak test is a critical parameter for vials. A visual inspection process may not detect defects that cause a sterile vial to leak. Thus, the pharma companies move toward CCI test methods. Many manufacturers are not sure how to conduct a container closure integrity test, but parenteral product leak testing is very important to assure that the product remains sterile in the packaging configuration throughout the duration of the product's shelf life.

What is CCIT?

Container Closure Integrity Testing (CCIT) is an important quality control technique for pharmaceuticals. It is an assay that evaluates the container closure and its capacity to keep possible contaminants out. Microorganisms, reactive gases, and other chemicals are examples of potential contaminants. This test is necessary for parenteral products since the seal quality is crucial to the drug product's sterility and quality throughout its shelf life. Inadequate sealing can accelerate the expiration of a drug product and cause significant risk to the patient's health if the product loses its sterility.

Previously, sterility testing was used to demonstrate container integrity. However, due to the insensitivity and other challenges associated with sterility tests, a variety of container closure integrity tests were developed. MicroCurrent HVLD, Vacuum Decay, and Helium Leak Detection are some of them. We give a brief overview of the above pharmaceutical package testing methods that can be used for testing pharmaceutical vials.

Leak Testing Vials Using Various CCI Techniques

• MicroCurrent HVLD Technology

High Voltage Leak Detection (HVLD) is a non-destructive Container Closure Integrity technology that is used to evaluate the closure integrity of parenteral product packaging. HVLD technology makes use of quantitative electrical conductivity and resistance principles. The technology works by transmitting high voltage microcurrent impulses through sample packages. The electrical resistance of the sample lowers in the presence of a leak, resulting in an increase in current. HVLD technology relies on the “flow” of current, while other leak detection methods rely on the flow of gas or liquid. The MicroCurrent HVLD lowers product voltage exposure to less than 5% of that experienced while testing with similar HVLD technologies. When compared to conventional HVLD systems, reducing exposure voltage not only eliminates any risk that the voltage provides to the product, but also significantly reduces Ozone formation during operation. MicroCurrent HVLD can be used to test for leaks in nonporous, rigid or flexible packages, as well as packages containing liquid or semi-liquid products.

• Helium Leak Testing

Helium leak testing is the method of locating leaks in enclosed or sealed systems by utilizing helium as a “tracer” gas and measuring the concentration as it exits owing to leakage. The package is filled with helium and vacuumed in this method. A helium leak detector is used to determine how much helium leaks from the container. The outcome is expressed as a leak rate. Helium leak testing is used in product design, product quality studies, failure analyses, and validation, in addition to being an effective container closure integrity test technique. Helium leak testing ensures high sensitivity leak detection, which is not achieved by many other leak test methods.

• Vacuum Decay Technology

Vacuum Decay is a deterministic Container Closure Integrity testing methodology that relies on package integrity and leak path detection. Unlike human inspection and other non-deterministic testing techniques, Vacuum Decay provides quantitative and reliable test results to assure package integrity. Vacuum Decay technique can handle a wide range of package types, including filled and sealed rigid, semi-rigid, and flexible packaging comprised of nonporous or porous materials. This test involves placing packages in an evacuation test chamber with an external vacuum source. Vacuum levels are regularly monitored to detect deviations from a predetermined intended vacuum level. A defect in the packaging will allow air to escape into the test chamber. Packages with no defects, on the other hand, maintain a steady chamber vacuum level. Over the years, Vacuum Decay technology has proven to be one of the most practical and sensitive vacuum-based leak detection technologies.

Historically, dye immersion and microbiological immersion were the two most popular methods for leak testing vials. Recently, the USP has issued guidelines requiring the use of deterministic methods in order to produce more consistent and predictable results. USP<1207> recommends that dye immersion tests are avoided and HVLD or Vacuum Decay tests are used instead.