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]
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.