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Min and max loads in oven (Dry heat) Depyrogenation / sterilization

Hello,

I have a question concerning min / max loads in depyrogenation ovens.

Is it acceptable to validate a min / max loads and than to allow using the whole range in production process?

Does the standards discuss or recommend how to validate loads
(fixed load / variable)?

[quote=ysabov]Hello,

I have a question concerning min / max loads in depyrogenation ovens.

Is it acceptable to validate a min / max loads and than to allow using the whole range in production process?

Does the standards discuss or recommend how to validate loads
(fixed load / variable)?[/quote]

Dear Ysabov,

Yes, Validation / qualification must be performed on worst case , you may use min and max loads pattern for depyrogentor qualification but load pattern should be considered and define and use the same load pattern as use in qualification studies.