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Environmental and Microbiological Monitoring at Drug Manufacturing Sites

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This e-book 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.


99 Seiten

ISBN: 978-3-95807-032-5

Lieferung sofort nach Zahlungseingang

345,00 € netto


Excerpt from the GMP Compliance Adviser

This just-released report provides you with the essential in-depth knowledge you need to correctly monitor the hygienic status of your sterile drug sites and evaluate your cleaning and disinfecting measures.

Step by step, you'll go through the 4 key monitoring processes

  • risk analysis and defining contamination limits
  • planning and conducting sampling
  • evaluating your findings and
  • making modifications.

And you'll get a detailed look at monitoring and testing 3 critical areas: surfaces, personnel and air. The report also covers monitoring and testing utilities, cleansing agents and disinfectants.

Specifically, you'll learn how to set alert and action limits and the measures to take if those limits are exceeded. And you'll get in-depth coverage of:

  • Sampling plans
  • U.S. and EU requirements for contamination limits and monitoring frequency
  • Pharma monitoring of HVAC systems
  • Data management
  • Physical and microbiological monitoring of clean rooms
  • Operation and maintenance of HVAC systems
  • Microbial contamination risks and how to investigate and manage them

It's all here in the most thorough report available: everything you need to know to successfully monitor, investigate and mitigate contamination risks at drug manufacturing plants and stay in compliance with FDA and EU regulations.

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Filesize: 1,92 MB

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