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ENVIRONMENTAL MONITORING HANDBOOK
FOR PHARMACEUTICAL MANUFACTURERS
Home » Application Notes » Environmental Monitoring Handbook for Pharmaceutical
Manufacturers
The Environmental Monitoring Handbook is a practical guide that covers
everything from the technology of particle counting, to the regulatory standards
that apply to the pharmaceutical manufacturing industry, to the instrumentation
and techniques needed to meet them. The Environmental Monitoring Handbook for
Pharmaceutical Manufacturers helps readers understand the topic of EM more
holistically and more extensively. With the release of the EU GMP Annex 1 2022
standard, the pharmaceutical manufacturing industry is entering a new era of
regulatory requirements. Discover how the new Annex 1 standards, and the
adoption of a Contamination Control Strategy (CCS), fit into the larger picture
of the industry by downloading the handbook now!
THE ENVIRONMENTAL MONITORING HANDBOOK FOR PHARMACEUTICAL MANUFACTURERS IS SPLIT
INTO THREE SECTIONS:
CHAPTERS IN THE ENVIRONMENTAL MONITORING HANDBOOK ARE:
* Fundamentals of cleanrooms
* Fundamentals of particle counters
* How ISO and EU GMP Annex 1 regulations apply to cleanrooms
* How to classify a cleanroom
* How to monitor a cleanroom
* Risk assessment: definition and uses
* Portable monitoring best practices
* Microbial monitoring best practices
* Designing an environmental monitoring solution for GMP applications
* Alarm rationale
* Compressed gas applications
This Environmental Monitoring handbook for pharmaceutical manufacturers covers
the fundamentals of particle counting and cleanroom designs, which will help
establish the baseline of the technology being used to manufacture
pharmaceutical and life science products in controlled areas. It will also
explain how to demonstrate that control.
The second section looks at the environmental monitoring standards applicable to
production areas and the expectation of regulatory bodies governing release to
market of aseptic drugs, advanced therapies, medical devices, and non-sterile
products.
And finally, once the fundamental principles point the way, the standards and
requirements define what is necessary to …
LEARN MORE…COMPLETE THE FORM TO GET THE COMPLETE HANDBOOK.
GET THIS PAPER
--------------------------------------------------------------------------------
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