Important Considerations in Sterile Packaging Design, Development and Validation
As described in ISO 11607-1:2019(E): The goals of a terminally sterilized medical device packaging system were to allow sterilization, provide physical protection, maintain sterility up to the point of use and allow aseptic presentation. The specific nature of the medical device, the intended sterilization method(s), the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials.
Medical devices need to be packaged in a steady, secured, and sterile environment to deliver optimal results when used by the medical practitioners. The packaging must come with a sterile barrier system (SBS) which is required to prevent the ingress of microorganisms (contamination) and ensure aseptic removal of the product at the point of use. Another important requirement for the SBS is the ability to enable and maintain sterility of the product.
The Design, Development and Validation of a Sterile Barrier System is of great importance to the Medical Device Manufacture. Join our panellists of experts in medical product packaging on 8 September 2021, 4pm SGT to learn more about Important Considerations in Sterile Packaging Design, Development and Validation.
The slides presented are available here