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Examples of Worst Case Sterile Barrier Systems

Q.

Can you please give some more examples for worst case sterile barrier systems?

A.

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:

  • For IV sets, the worst case configuration may be the set with the most fitments.
  • For implantable joints, the worst case configuration may be the heaviest joint.
  • For bulk or kit packaging, the configuration with the most individual pieces may be the worst case.

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:

  • For a chevron pouch family, the worst case may be the largest and smallest pouch.
  • For rigid trays with a flexible lidding material, the worst could be the largest and smallest seal perimeters.
  • For a form-fill-seal application using a sealing platen, the worst case may be the configuration (array) with the greatest and least sealing area.

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:

  • The first and most common approach is to source from a fully validated process selecting an appropriate sample size from multiple lots to represent the range of package characteristics. For further assurance, the final closure seal can be made at the specified process limits of sealing.
  • The second approach is to utilize sterile barrier systems where all seals are made at the worst-case conditions of manufacture within the validated window.

Last updated on 2008-05-15 21:44:38 UTC
Keywords: validation, worst case, product family, process limit

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