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Material and Sterile Barrier Systems

"Choosing Sterilizable Materials"

How do you choose materials that are 'sterilizable'? Do certain components of laminations (i.e. Tyvek, PET films, LDPE, Papers, Adhesives, Inks, et al) carry a certification stating that they are sterilizable? Radiation and/or EtOH?

Last Updated On July 31, 2009

Sterilization packaging manufacturers are material suppliers of rollstock or converted packaging such as cut lid stock or preformed sterile barrier systems. They are a key source of information regarding material for sterilization and can provide guidance throughout the selection process whether it is for a new product in developmental or an existing product where packaging needs or design are changing. Working together with your supplier you can discuss the sterilization process type and exposure levels and the shelf life and storage conditions expected after sterilization. They are likely to have information about a history of successful use in typical sterilization processes but generic certifications would not exist as each device manufacturers process and sterilization procedures are unique. As you take any recommended materials through your processing steps to qualify and to validate, your supplier can continue to provide solutions or answers to questions. There are also established guidance documents available to guide your decision-making. AAMI Technical Information Report TIR-17: Compatibility of materials to sterilization is a resource that can help in understanding what types of materials can be successful in different sterilization processes.