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Published in:
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2013 | OriginalPaper | Chapter

8. Decontamination of Aseptically Operated Isolators

Authors : Hans-Jürgen Bässler, Frank Lehmann

Published in: Containment Technology

Publisher: Springer Berlin Heidelberg

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Abstract

The FDA “Guidance for Industry” requires that all product contact surfaces inside the isolator before the start of each aseptic process are sterilized. Here is the method of choice the heat sterilization with steam (SIP). All plant parts or accessories which do not withstand the temperatures to be achieved for successful steam sterilisation, must be fumigated with a decontamination procedure, which makes the surfaces in the work area free of living organisms. It must be demonstrated a germ reduction of 6 log-levels with a suitable biological indicator.

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Literature
1.
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. U.S. Department of Health and Human Services, Food and Drug Administration (FDA), 09-2004 (2004)
2.
Sigwarth, V., Moirandat, C.: Development and quantification of H2O2 decontamination cycles. PDA J. Pharm. Sci. Technol. 54(4), 286–304 (2000)
3.
Technische Regeln für Gefahrstoffe, Gemeinsames Ministerialblatt für Arbeit und Soziales, GMBI, Nr. 28, S. 605
4.
Vanhecke, V., Sigwarth, V., Moirandat, C.: A Potent and Safe H2O2 Fumigation Approach. PDA J. Pharm. Sci. Technol. 66(4) 354–370 (2012)
Metadata
Title
Decontamination of Aseptically Operated Isolators
Authors
Hans-Jürgen Bässler
Frank Lehmann
Copyright Year
2013
Publisher
Springer Berlin Heidelberg
Book
Containment Technology

Print ISBN: 978-3-642-39291-7

Electronic ISBN: 978-3-642-39292-4

Copyright Year: 2013

DOI
https://doi.org/10.1007/978-3-642-39292-4_8