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Seal Area Validation

Q.

When you refer to validating the seal area, do you mean manufacturer or end-user made seals?

A.

ISO 11607 requires that you validate the sealing process on the seals that you produce. In the case of packages made in a form fill and seal process or a tray and lid system, the medical device manufacturer is responsible for validating all of the seals. In the case of pre-made sterile barrier packages, the sterile packaging manufacturer is responsible for validating the seals that they make and the medical device manufacturer would be responsible for validating the final seal.

Last updated on 2008-05-15 21:43:40 UTC
Keywords: validation, seal, seal area

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