In the first part of selecting a sterile barrier system, we delved into various considerations such as the packaging method and the selection criteria for the packaging materials. It follows that choosing the right medical package depends on understanding the effect that materials and sterilization processes have on one another.
As described in ISO 11607:2019 (Annex A), the selection of sterile packaging materials in packaging system design for a medical device must consider the relationship between the device’s features and the sealing and sterilization processes. A sterile barrier system and the protective packaging should maintain sterility while exposed to expected conditions and hazards during specific processing, storage, and distribution up to the point of use. At the same time, it must allow for aseptic presentation.
In this article, we focus on how the sterilization process and toxicological properties affect the choice of packaging materials.
Taking into account compatibility with a sterilization method, it is necessary to clearly understand the different aspects of the sterilization process before choosing the right packaging material for a medical device. ISO 11607 covers the packaging requirements. One of the key properties to be evaluated for all packaging materials is that it should not release toxic substances sufficient to be hazardous to health whether before, during or after sterilization.
In selecting the materials for a sterile barrier system, the general performance requirements should be that the:
As microbial barrier properties are important for packaging integrity and product safety, they are assessed according to methods applicable to nonporous materials and methods applicable to porous materials*.
(* More testing methods for microbial barrier systems can be found in ISO/TS 17665)
Regarding materials compatibility with the sterilization process, there are several aspects that need to be considered, including:
(* CI printing should follow the requirements of EN/ISO 11140-1)
Ensuring compliance with performance testing as per ISO 11607 Annex D — that the sealing strength should not be less than 1.5N/15mm either before or after the sterilization process. Moreover, that the wet strength of sealing should not be less than 1.2N/15mm either before or after steam or EO sterilization.
According to the biocompatibility evaluation of ISO 1093-1, packaging materials and their components should not react with a medical device to cause pollution, or transfer any substance that would have an adverse effect on the medical device. As for what is required of the material, it must be free of taste and not affect the performance and safety of the medical device that it will pack.
All in all, choosing the appropriate packaging method and materials for the sterilization type are key elements in developing an effective sterile barrier system. However, the sealing process also directly affects the sterility of the sterile barrier system and the packaging validation test. Therefore, it is important to understand how these individual requirements affect each other and to maintain clear communications between medical device manufacturers, packaging materials suppliers, and sterilization providers.
Understandably, compliance with ISO 11607 and keeping pace with changes in the medical packaging industry is fraught with challenges. At SIGMA, we are committed to partnering with our customers to produce ever-improving medical sterile barrier systems that meet evolving regulatory requirements.