Collagen-based products have become indispensable in regenerative medicine, offering a versatile and biocompatible solution for various clinical applications. Ensuring the sterility of these products is paramount to prevent healthcare-associated infections and promote optimal healing. Traditional sterility testing methods may have limitations, especially when dealing with complex packaging configurations. This blog explores the significance of sterility testing for collagen products and introduces Vacuum Decay Technology as a reliable and advanced approach to ensure product integrity.
What are Collagen-Based Products for Regenerative Medicine?
Despite collagen’s compatibility with the human body, these products must remain sterile to prevent infections. Even minor contamination could lead to serious health risks, compromising the healing process. For this reason, sterility testing is an essential part of the manufacturing and packaging processes.
Why is Sterility Testing Important for Collagen-Based Products?
Sterility testing is a critical step in ensuring that collagen-based products are free from microbial contamination. Since these products are often used in vulnerable medical scenarios—such as burn treatments, wound closures, and surgeries—any contamination can lead to infections, delayed healing, or other complications. Healthcare-acquired infections (HAIs) are a significant risk in these settings, and maintaining the sterility of collagen products is crucial for patient safety and recovery.
In addition to sterility, the packaging used for collagen-based products must also be sterile and maintain integrity throughout transportation and storage. Most commonly, these products are packaged in a polymer tray with a porous lidding, a format that allows for sterilization but is also prone to seal integrity issues. If the packaging is compromised, it can lead to contamination of the product inside. Ensuring package integrity, therefore, becomes a dual challenge—maintaining the sterility of the product and ensuring that the packaging is intact.
Sterility Testing Using Vacuum Decay Technology
To ensure package integrity and consistency, it is essential to accurately detect leaks and defects. While destructive Container Closure Integrity Testing ( CCIT ) methods like water bath, dye tests, and peel and burst tests can identify leaks, they are often time-consuming, unreliable, and yield subjective results. These methods also lead to significant product loss and waste. In recent years, there has been a growing demand for non-destructive package integrity testing methods, such as Vacuum Decay technology.
Vacuum Decay is a proven and widely adopted leak test method, recognized for its practicality and sensitivity over decades. This straightforward approach assesses container integrity by leveraging fundamental physical principles. Vacuum Decay technology delivers precise and reliable quantitative results, providing a clear pass or fail outcome. It has become a well-established, non-destructive, and deterministic alternative to the traditional blue dye test. The ASTM F2338 standard for vacuum decay, developed with PTI's VeriPac instruments, is endorsed by the FDA as a consensus standard for container closure integrity (CCI) testing. This method is also listed in ISO 11607 and cited in the United States Pharmacopeia (USP) Chapter 1207 on CCI.
How does Vacuum Decay Technology work?
Under this method, the leak tester instruments are connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a 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. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a return on investment in under six months for many products.
Key Benefits of Vacuum Decay technology
- Non-destructive and non-invasive
- No sample preparation
- ASTM approved test method
- FDA Recognized Consensus Standard
- Allows for increased sampling
- Quantitative results
- Repeatable
- Rapid test time
- Eliminates cost and waste of destructive testing
- Test results can be easily validated
- SPC laboratory testing or online applications