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1st edition 2014
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Excerpt from the GMP Compliance Adviser Whereas in Europe aseptic processing is regarded as last option for the manufacturing of sterile medicinal products when all sterilisation methods in the final container have been excluded, the FDA regards aseptic processing as a freely selectable alternative to terminal sterilisation. In this e-book you will find answers to the following questions:
1 Introduction 2 Room requirements 3 Monitoring 4 Personnel 5 Sterile filtration 5.1 Mode of operation of sterile filters 5.2 Materials, designs and use of filters 5.3 Filter integrity test 5.4 Executing sterile filtration 5.5 Validating sterile filtration 6 Validating aseptic processing (media fill) 6.1 Documentation 6.2 Preparing the culture medium 6.3 Filling the culture media 6.4 Qualification of personnel 6.5 Environmental controls for media fill 6.6 Incubation of containers 6.7 Optical check of the containers 6.8 Growth promotion test 6.9 Reconciliation and evaluation of the media fill 7 Author
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The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the...
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