Navigating through the jungle of ISO 11607

Validation of packaging for terminally sterilised medical devices is carried out in accordance with ISO 11607-1 and ISO 11607-2. The requirements of ISO 11607-1 should already be taken into account during the development phase of such packaging. Important requirements for the packaging material include compatibility with the sterilisation process, biocompatibility, shelf-life studies, and the handling process (aseptically presentation). In addition to ISO 11607, DIN CEN ISO TS 16775 can be used as a supporting guideline for the validation of sterile barrier systems.

Packaging validation is always machine- and tool-specific. In line with the standard ISO 11607, an IQ, OQ and PQ are required for packaging validation as a minimum. The OQ is used to determine the parameter limits and the worst-case cavity. The worst-case seal can also be determined within the OQ. During the PQ, the performance and process capability of the sterile barrier system is verified, by various tests on the nominal parameters. Tests can include (but are not limited to) seal strength measurement, dye penetration test, visual and manual test, and burst pressure test. The number of samples for the individual tests should be selected and evaluated based on a statistical approach.

In addition to the packaging validation, it’s also essential to verify that the sterile barrier system retains its integrity after sterilisation process. Full integrity tests should be carried out for this purpose. Full integrity can be tested by assessing microbiological barrier properties (DIN 58953-6) or conducting a bubble test (ASTM F2096), for example. Furthermore, a transport simulation should be carried out for the final packaging system, covering the worst-case distribution route and factoring in all necessary climatic conditions. Finally, the safe storage of the packaging system over a specified period of time must be confirmed. For this purpose, the sterile barrier system should be stored under real-time conditions and then evaluated. To generate initial ageing data, the ageing process of the packaging can be accelerated in accordance with ASTM F1980.