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Microbiological Monitoring in Pharmaceutical Manufacturing

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

e-book

43 Seiten

ISBN: 978-3-943267-90-7

1st edition 2014

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117,00 € netto

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Excerpt from the GMP Compliance Adviser

When manufacturing and filling sterile drug products, all possible sources of microbial contamination must be controlled. This primarily concerns air, surfaces and personnel. Microbiological monitoring is therefore indispensable. The aim of the monitoring is to detect deviations from the validated state. Monitoring is designed to demonstrate that the process is under control.

A monitoring program must be established which defines levels, sampling points, frequencies, methods/equipment and measures in the event of deviations.

In this e-book you will find answers to the following questions:

  • Which microbial contamination risks must be anticipated during the manufacture of sterile preparations?
  • What level should be set for individual clean areas?
  • Which methods should be used for the environmental monitoring?
  • At what frequencies should the investigations be carried out?
  • Which points should be investigated?
  • How should one proceed if the level is exceeded?
  • How can isolates be identified?

Table of Contents

1 Introduction
2 Sources of contamination
3 Room classification
4 Monitoring program
5 Level
5.1 Air
5.2 Surfaces (rooms/technical equipment)
5.3 Personnel
6 Methods and equipment
6.1 Microbiological testing of air
6.2 Microbiological testing of surfaces and personnel
6.3 Culture media
6.4 Incubation
6.5 Method validation
7 Sampling
7.1 Sampling Frequencies
7.2 Sampling points
8 Measures if levels are exceeded
8.1 Investigation plan
8.2 Investigation report
9 Organism identification
10 Author


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