Key Definition: Sterile Barrier System

ISO 11607-1:2006 describes a “packaging system” for a medical device as a “combination of the sterile barrier system and protective packaging.” A sterile barrier system is the “minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use,” while protective packaging is the “configuration of materials designed to prevent damage to the sterile barrier system and its content from the time of their assembly until the point of use.”

Sterile packaging manufacturers are charged with validating their processes for making preformed sterile barrier systems. Reads AMMI Technical Information Report 22: “In the case of preformed sterile barrier systems, the construction of the sterile barrier system in the specified materials and evidence for validation of the process of making preformed sterile barrier systems of those materials is the responsibility of the sterile barrier system supplier, and the medical device packager’s process validation responsibility is limited to the filling and application of a sterile barrier system closure seal.”

Jackie Daly Johnson, president of Beacon Converters (Saddlebrook, NJ), says that customers occasionally ask Beacon for “ISO 11607–compliant pouches.” In response, she explains that preformed sterile barrier systems manufactured by Beacon are made in a validated process, in accordance with ISO 11607-2, but until the final seal is made by the device manufacturer it is not considered a full sterile barrier system, and it is only after the entire packaging system is subjected to and passes a full testing protocol that it could be termed complaint by the device manufacturer. “There is still work to be done after the manufacture of a preformed sterile barrier system” she says. “There will always be tasks that a sterile packaging manufacturer cannot do. To assist our customers in demonstrating compliance we can answer questions, provide information on the preformed sterile barrier system and its components, and point them to the ISO 11607, the TIR, and other documents that will be useful to them in assessing compliance of their entire packaging system.”


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