Glossary Term
Sterility Barrier Systems
Definition
Sterility barrier systems are packaging systems designed to maintain the sterility of medical devices from the point of sterilization through to the point of use. These systems are critical in ensuring that medical devices, especially those that are implantable or used in sterile environments, remain free from contamination until they are used in clinical procedures. Sterility barrier systems are typically composed of materials such as plastic films, foils, and nonwoven fabrics that form sealed enclosures around medical devices. These materials must be both resistant to microbial penetration and provide a physical barrier to protect the device from environmental factors, such as moisture, dust, and physical damage.
Relevance to the MedTech Industry
Sterility barrier systems are crucial for ensuring patient safety. The effectiveness of a sterilization process is contingent upon the device being protected from contamination until it is used in a clinical setting. These systems play a central role in meeting regulatory requirements (such as ISO 11607, which sets the standards for packaging for terminally sterilized medical devices) and maintaining the integrity of sterile products during transportation, storage, and handling. Failure to maintain sterility during storage and transport can result in compromised patient outcomes and lead to recalls or legal liabilities. As such, ensuring the proper design, material selection, and validation of sterility barrier systems is an integral part of the product lifecycle in MedTech.
Additional Information & Related Terms
Related Terms
ISO 11607: An international standard for packaging for terminally sterilized medical devices, ensuring that packaging systems maintain device sterility until use.
Sterilization Validation: The process of confirming that sterilization methods and packaging systems effectively destroy pathogens without compromising the device’s integrity.
Tamper-Evident Packaging: Packaging that includes features to indicate if the package has been opened or compromised, ensuring that the sterility of the device is maintained.
Biological Indicator: A device used to verify the effectiveness of a sterilization process, often used to ensure that sterility barrier systems are properly validated.