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Beschreibung
All-in-one guide to monitoring and maintaining microbiological safety in the manufacturing of pharmaceuticals, diagnostics, and cosmetics

Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, Pharmaceutical Microbiology covers methods and technologies required by regulatory authorities throughout the world, with all methods and protocols rated in terms of their compliance with current (2023) EU legislation.

Written by the former head of biological quality assurance for one of Europe?s biggest pharmaceutical and diagnostics companies, Pharmaceutical Microbiology covers sample topics including:

* General conditions for the operation of microbiological laboratories, calibration and qualification of devices, and type culture maintenance
* Industrial hygiene, ambient monitoring, quality control, process validation, microbiological water examination, and rapid microbiological methods
* Automation in the microbiology laboratory, quality assurance, identification of microorganisms, cleaning, sterilization, decontamination, and disposal, and contract testing
* Pharmacopoeial and non-pharmacopoeial methods for the identification and quantification of microorganisms, including cell culture and selected animal tests

Pharmaceutical Microbiology is an essential practice-oriented all-in-one reference for engineers, researchers, and professionals involved in setting up and running a microbiological quality control unit in the pharmaceuticals, diagnostics, and cosmetics industries.
All-in-one guide to monitoring and maintaining microbiological safety in the manufacturing of pharmaceuticals, diagnostics, and cosmetics

Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, Pharmaceutical Microbiology covers methods and technologies required by regulatory authorities throughout the world, with all methods and protocols rated in terms of their compliance with current (2023) EU legislation.

Written by the former head of biological quality assurance for one of Europe?s biggest pharmaceutical and diagnostics companies, Pharmaceutical Microbiology covers sample topics including:

* General conditions for the operation of microbiological laboratories, calibration and qualification of devices, and type culture maintenance
* Industrial hygiene, ambient monitoring, quality control, process validation, microbiological water examination, and rapid microbiological methods
* Automation in the microbiology laboratory, quality assurance, identification of microorganisms, cleaning, sterilization, decontamination, and disposal, and contract testing
* Pharmacopoeial and non-pharmacopoeial methods for the identification and quantification of microorganisms, including cell culture and selected animal tests

Pharmaceutical Microbiology is an essential practice-oriented all-in-one reference for engineers, researchers, and professionals involved in setting up and running a microbiological quality control unit in the pharmaceuticals, diagnostics, and cosmetics industries.
Über den Autor
Michael Rieth studied biology with main focus on microbiology and biochemistry at the University of Göttingen, obtaining a doctorate at the Institute of Microbiology. In 1988 he entered into the pharmaceutical world: initially at biosyn Arzneimittel GmbH, Stuttgart, then Nordmark Arzneimittel GmbH, Uetersen and Schering AG, Berlin. From 1999 to 2014 he was Head of Biological Quality Testing at Merck KGaA, Darmstadt, then worked in the field of "Global Regulatory Affairs" until his retirement in 2020.
In 2012, he published the book "Pharmaceutical Microbiology" in German language, for which the Wallhäusser Prize was awarded the following year. In 2016, his book "Hygiene in Pharmaceutical Production" was published. The second edition of "Pharmaceutical Microbiology" followed in 2017 and his book "Endotoxins and Pyrogens" was published in 2021.
Inhaltsverzeichnis
1 Introduction to microbiology
2 General conditions for the operation of microbiological laboratories
3 Calibration and qualification of devices
4 Type culture maintenance
5 Industrial Hygiene
6 Ambient monitoring
7 Quality control
8 Process validation
9 Microbiological water examination
10 Rapid microbiological methods
11 Automation in the microbiology laboratory
12 Quality assurance
13 Identification of Microorganisms
14 Cleaning, sterilization, decontamination, disposal
15 Contract testing
Appendix
Networks and associations
Recommended reading
Glossary
Details
Erscheinungsjahr: 2025
Fachbereich: Populäre Darstellungen
Genre: Chemie, Mathematik, Medizin, Naturwissenschaften, Technik
Rubrik: Naturwissenschaften & Technik
Medium: Buch
Inhalt: 432 S.
59 s/w Illustr.
59 Illustr.
ISBN-13: 9783527354252
ISBN-10: 3527354255
Sprache: Englisch
Herstellernummer: 1135425 000
Einband: Gebunden
Autor: Rieth, Michael
Hersteller: Wiley-VCH GmbH
Verantwortliche Person für die EU: Wiley-VCH GmbH, Boschstr. 12, D-69469 Weinheim, product-safety@wiley.com
Maße: 244 x 175 x 27 mm
Von/Mit: Michael Rieth
Erscheinungsdatum: 15.12.2025
Gewicht: 0,958 kg
Artikel-ID: 129339713