Enter the first customer review for this item
e-book / PDF-Download
1st edition 2014
Delivery immediately after receipt of payment
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
Please enter these characters in the following text field.
This file is in PDF format!Filesize: 1,5 MB
To view PDF files, we recommend using the Adobe Reader.
If you choose payment by bank transfer:
If you choose payment by credit card:
The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the...
With this GMP newsletter you will be regularly informed on the latest developments in GMP.