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ISO 11607 Section 6.4

Q.

Trying to best interpret ISO 11607 section 6.4 – Stability Testing. The question we are trying to resolve is if multiple product families use the same pouch material (Tyvek & film structure) will doing a real time shelf life study on that material cover the shelf life (expiry dating) of all the other product families since they use the same pouch material? Shelf Testing
typically consists of samples that have been sterilized to our worse case, and after 3 years of real time aging the pouches would be subject to a seal strength test (per ASTM F88) and would have to meet our internal standard of a minimum peel.

A.

The same type of rationale that you used to group your individual products into product families can probably be used to justify grouping these into a larger product family for the purposes of stability testing. The important thing is to make sure your rationale covers all the attributes of the items. For instance, is there likely to be a difference in product/package interaction? If the difference (in any situation or package material) is the product rather than bulk or size of same product, then the rationale would have to include a risk management assessment by the company. The only other caveat is that this would only apply to the stability of the seals, if you are looking to limit performance testing of the sterile barrier or packaging system a rationale will need to be developed separately.

Last updated on 2008-04-28 12:23:15 UTC
Keywords: product family, aging, shelf life, seal, stability, expiry dating, product families

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