In the healthcare industry, packaging is not just a protective layer—it is a critical barrier that ensures sterility and safety until the point of use. Porous flexible pouches, commonly made from materials like Tyvek® or medical-grade paper, are widely used to package sterilized medical devices. Their ability to allow gas sterilants like ethylene oxide (EO) or steam to permeate while keeping contaminants out makes them indispensable. However, these same features make package integrity testing particularly challenging.
Porous Packaging: Trends and Challenges
With the increasing demand for sterile, ready-to-use medical devices, porous materials have become a staple in packaging. They support sterilization, are lightweight, and are often designed to meet sustainability goals. However, as package designs become more complex, the risks associated with undetected leaks or seal failures grow.
One of the major challenges is that porous materials do not behave the same way as non-porous films during integrity testing. Their ability to "breathe" makes it difficult for conventional methods like dye ingress or bubble emission to detect micro-leaks reliably. Moreover, visual inspection methods are subjective and may fail to identify defects that can lead to contamination. This calls for advanced testing systems that are both accurate and non-destructive.
Why Package Integrity Testing Matters?
In the context of medical device packaging, integrity testing is not optional—it’s a regulatory requirement and a patient safety imperative. Even a microscopic breach in the packaging can compromise sterility, which may lead to product recalls, regulatory penalties, or worse, patient harm.
Regulatory standards like ISO 11607 and guidance from the FDA emphasize the need for deterministic, validated testing methods over traditional, probabilistic techniques. The goal is to ensure that each package provides a robust sterile barrier throughout its shelf life.
Testing the Integrity of Flexible Porous Pouches with VeriPac Flex
VeriPac FLEX Systems offer a powerful, non-destructive solution for leak testing of pouches and other flexible packaging. Utilizing Vacuum Decay technology, these systems comply with ASTM F2338, a standard recognized by ISO 11607 and the FDA. They deliver exceptional sensitivity, capable of detecting defects as small as 10 to 20 microns, while providing accurate PASS/FAIL results along with quantitative leak rate data.
What makes VeriPac FLEX truly stand out is its unmatched versatility. Designed with multiple configurations, it easily adapts to a wide range of package formats and sizes—from small sachets to large bulk bags—without the need for changeovers. This flexibility significantly streamlines the testing process.
Unlike traditional destructive methods such as water bath or dye testing, Vacuum Decay eliminates subjectivity, reduces waste, and offers deeper insights into the overall packaging process. It also ensures a faster return on investment, making it a superior choice for container closure integrity testing (CCIT) in flexible packaging applications.
Benefits of VeriPac Flex
- 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
- Accurate and repeatable results
- ASTM test method and FDA standard
- USP < 1207> compliant
Testing the integrity of porous flexible pouches is one of the more complex tasks in medical device packaging. With the stakes so high, relying on outdated or inadequate methods is no longer an option. VeriPac Flex offers a modern, compliant, and efficient solution to this challenge. It brings together the precision of vacuum decay technology with the flexibility needed for diverse packaging formats, enabling manufacturers to meet both regulatory expectations and internal quality goals with confidence.