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Autoclaves Qualification & Validation

Autoclaves Qualification & Validation

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sterilisation methods) • Description of the sterilisation process (e.g. standard sterilisation, F0-sterilisation) on basis of the product properties • Definition of all (as possible) relevant GMP-critical points (e.g. sterility of cooling media, coldest spots) • Definition of the user needs for documentation and operation (e.g.

  Process, Sterilisation, Sterilisation process

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