by Charlie A. Webb, CPP, CMC
“Validation,” is an often misused and misunderstood term in the medical packaging industry. There are many definitions for the term that are specific in relation to its usage. The author of the recently added ISO 11607 parts 1 and 2 revision defines validation as “the culmination of numerous tests, processes and events which demonstrate the ability of the sterile barrier system to ensure sterility maintenance and device effectiveness throughout the package lifecycle.”
In the revised documents, new terminology was introduced that should help medical device manufacturers communicate more clearly and effectively. Adding better-defined terminology helps increase product efficacy and ultimately, patient safety. Here are the new terms:
Sterile Barrier System (SBS) – Minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at point of use;
Preformed Sterile Barrier System (PSBS) – Sterile barrier system that is supplied partially assembled, for filling and final closure or sealing;
Protective Packaging – Configuration of materials designed to prevent damage to the sterile barrier system (SBS) and its contents from the time of assembly to the point of use;
Packaging System – Combination of the sterile barrier system (SBS) and protective packaging
The reasoning behind medical package validation is simple. Validation proves the device packing and shipping containers are constructed in a way that protects the device from alteration or damage during processing, storage, handling and distribution.
Medical device manufacturers can find compliance guidelines within ISO 11607 parts 1 and 2. These guidelines include design requirements analysis, material attributes, design of a sterile barrier system, risk analysis and package capabilities, pass/fail testing, validated manufacturing processes, functionality testing, and re-evaluation of validation.
Each of these steps include a great deal of detail. For instance, the design requirements analysis includes collecting data to adequately understand the lifecycle of the packaged device. Analysis should include sterilization processes, mode of distribution and more. When looking at material attributes, safety barrier properties, durability and heat sealability are just a few design inputs that should be considered.
Design of a sterile barrier system is a process that needs to be well-documented and follow an established procedure. Pass/fail testing exposes the product packaging to tests to verify whether it is capable of withstanding potential environmental hazards. Sterile packaging manufacturers must verify the consistent reliability of the product time and again. Validating manufacturing processes should be done in accordance with ISO guidelines.
Testing seal strength and seal integrity after exposure to distribution aging and the sterilization process should be conducted following worst-case scenarios to assure the maintenance of packaging integrity no matter the situation. Sterile packaging manufacturers should then take the time to re-evaluate the entire process to assure no steps/scenarios have been missed.