Can you please give some more examples for worst case sterile barrier systems?
As each of the three clauses in ISO 11607 that references worst-case mean something slightly different, there are three different types of “worst-case systems” that have to be considered. We will attempt to provide more examples of each:
Clause 6.1.6 of ISO 11607-1 applies to worst-case configuration of devices using a common sterile barrier system. In general, the device(s) that apply the most stress to the packaging system would be considered the “worst case”. Examples of what may represent the worst case device configurations follow:
Clause 5.1.5 of ISO 11607-2 applies to the worst-case configuration of the sterile barrier system family that is being validated. In general, the sterile barrier system family will be made with common materials using a common process but be of different sizes. Examples of worst-case sterile barrier system configurations include:
Clause 6.3.4 of ISO 11607 -1 refers to the sterile barrier system itself. The goal is to ensure the performance testing has been conducted on sterile barrier systems that represent the range of variation that will be seen in the sterile barrier system. There are two common approaches to creating worst-case sterile barrier systems to be used for performance testing: