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The weakest link is getting stronger

Halbert, G.W. (2009) The weakest link is getting stronger. European Pharmaceutical Review, 14 (6). pp. 68-72. ISSN 1360-8606

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Abstract

The manufacture of sterile products attracts the greatest regulatory scrutiny of all product types, since manufacturing failures can be fatal and manufacturers are required to utilise the most robust sterilisation method possible to limit the probability of this occurring. However, aseptic preparation, which is the last resort manufacturing method, continues to be employed since for sensitive products this is the only feasible route. Aseptic preparation has always suffered from the potential for undetected, or undetectable, microbial ingress occurring during the manipulation of sterile components. The implementation of isolator systems have provided an advance over standard clean rooms technologies and the weakest link of aseptic preparation is getting stronger.

Item type: Article
ID code: 26116
Keywords: sterile products, sterilisation, aseptic preparation, microbial ingress, Pharmacy and materia medica, Microbiology, Biophysics, Biotechnology, Biochemistry, Molecular Medicine, Pharmacology, Toxicology and Pharmaceutics(all)
Subjects: Medicine > Pharmacy and materia medica
Science > Microbiology
Department: Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences
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Depositing user: Strathprints Administrator
Date Deposited: 31 Aug 2010 10:03
Last modified: 05 Sep 2014 05:16
URI: http://strathprints.strath.ac.uk/id/eprint/26116

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