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Sterile Production

Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the pharmaceutical industry busy. Are you already prepared for the possible changes?
Based on a comparison with the currently valid version this download demonstrates where action is needed.

NEW ++ NEW ++ NEW

 
 
Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets
What safety features for product and personnel protection do isolators provide? What regulatory requirements must be met?

With this clear and concise guide you will get answered to these and other frequently asked questions!

 
 
 
Microbiological Monitoring in Pharmaceutical Manufacturing
A Guide to Control Microbial Risks in Sterile and Aseptic Drug Manufacturing

 
 
Environmental and Microbiological Monitoring at Drug Manufacturing Sites
This pdf download leads you step by step through the 4 key processes in microbiological monitoring.
Additionally you will get a detailed look at monitoring and testing in 3 critical areas: surfaces, personnel and air.

 
 
Classes and Grades for Air Cleanliness
This pdf download provides you with the tools you need to achieve compliance with the limits for airborne particles and microorganisms. Learn all you need to know about GMP requirements for cleanroom premises!

 
 
 
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