The world’s most extensive GMP knowledge portal.
Enter the first customer review for this item
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
Reading Sample "Aseptic Processing of Sterile Medicinal Products"
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.
The e-book is password protected to prevent copying and modification of content.
Please note the following procedure guidelines:
For payment by invoice:
When paying by credit card:
The Newsletter of GMP-Verlag
News and upcoming trends: Stay up-to-date on the latest developments in GMP!
Please select your currency