Document Detail

Validation of sterilization procedures and usage of biological indicators in the manufacture of healthcare products.
MedLine Citation:
PMID:  21946318     Owner:  NLM     Status:  In-Data-Review    
Healthcare product manufacturers strive to provide safe, sterile products by validating and controlling manufacturing procedures. Validation study is the result of a multidisciplinary team effort. This successful effort relies on each discipline understanding the fundamentals of each technical disciplines and applying those fundamentals in terms of their own technical background. This paper is to introduce the basic concepts of sterilization methodology which are involved in validating various technical methods of sterilization and biological indicators (BIs). These will mainly address sterilization procedures in general terms and highlight on their microbiological aspects. The proper starting point is defining what sterility is and how it can be achieved through the validation studies by using BI.
Hideharu Shintani
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Biocontrol science     Volume:  16     ISSN:  1342-4815     ISO Abbreviation:  Biocontrol Sci     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-09-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9712121     Medline TA:  Biocontrol Sci     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  85-94     Citation Subset:  IM    
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