Environmental Monitoring Handbook
for Pharmaceutical Manufacturers

The Environmental Monitoring Handbook for Pharmaceutical Manufacturers 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. This Handbook helps readers understand the topic of Environmental Monitoring (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 this free handbook now.

The Environmental Monitoring Handbook for Pharmaceutical Manufacturers is split into three sections:

Environmental monitoring handbook

Chapters in the Environmental Monitoring Environmental monitoring handbookHandbook are:

  • Fundamentals of cleanrooms and design
  • 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

The first section of the handbook covers the fundamentals of particle counting and cleanroom design, which helps establish a baseline for the technology used to manufacture pharmaceutical and life science products in controlled areas. It also explains how to demonstrate and confirm that control.

The second section looks at the environmental monitoring standards applicable to production areas and the expectations of regulatory bodies governing the release of aseptic drugs, advanced therapies, medical devices, and non-sterile products.

Finally, once the fundamental principles point the way, the standards and requirements define what is necessary to …

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