Validation Studies for Microbial Contamination and Control of Contaminants

Microbiological control is a regulatory　requirement and one that can be defined as the continued interaction of science and applied technology with products, processes, materials, equipment, and personnel entering the manufacturing areas. In the ISO 14644-1, control of microbial contamination is add...

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Bibliographic Details
Published inBiocontrol Science Vol. 20; no. 3; pp. 161 - 170
Main Author SHINTANI, HIDEHARU
Format Journal Article
LanguageEnglish
Published Japan The Society for Antibacterial and Antifungal Agents, Japan 2015
Japan Science and Technology Agency
Subjects
Biotechnology - methods
Contaminant
Disinfectant
Drug Contamination - prevention & control
Environmental Microbiology
Humans
Infection Control - methods
Microbial contamination
Technology, Pharmaceutical - methods
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Summary:Microbiological control is a regulatory　requirement and one that can be defined as the continued interaction of science and applied technology with products, processes, materials, equipment, and personnel entering the manufacturing areas. In the ISO 14644-1, control of microbial contamination is addressed. 　A good microbiological control program starts with understanding the risks for microbial contamination in the manufacturing process and identification of possible types of contaminants. The results obtained from such risk assessment can be used in the design of facilities and equipment as well as when establishing protocols regarding equipment and personnel. Once possible sources of contamination have been identified, control and preventative measures can be implemented and qualified/validated.
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ISSN:1342-4815
1884-0205
DOI:10.4265/bio.20.161