Microbial testing in support of aseptic processing

Microbial testing is conducted in the sterile pharmaceutical industry in support of sterile product development; for in-process monitoring during aseptic processing and filling operations; and for testing finished products. Microbial considerations play a key role in the successful development of ne...

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Bibliographic Details
Published in:Pharmaceutical Technology 2004-06, Vol.28 (6), p.56-66
Main Author: CUNDELL, Anthony M
Format: Magazinearticle
Language:English
Subjects:
Batch processing
Biological and medical sciences
General pharmacology
Ingredients
Manufacturing
Medical sciences
Microorganisms
Pharmaceutical industry
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Product development
Product life cycle
Product testing
R&D
Research & development
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Summary:Microbial testing is conducted in the sterile pharmaceutical industry in support of sterile product development; for in-process monitoring during aseptic processing and filling operations; and for testing finished products. Microbial considerations play a key role in the successful development of new sterile drug products. During formulation development, the potential microbial and endotoxin content of the active pharmaceutical ingredients and excipients should be considered. The development of a sterile product requires initial and ongoing consultation with an experienced pharmaceutical microbiologist. The application of the sterility test is one indicator of the presence or absence of conlaminating microorganisms in a sterile batch, but the sterility assurance is established by process design and validation, not simply finished product testing. An unfortunate trend in the pharmaceutical industry is the compliance-inspired drive to take recommended target microbial levels for cleanrooms and other controlled areas and use them for the evaluation of microbial monitoring to detect adverse trends and make product release specifications.
ISSN:1543-2521
2150-7376