Halbert, G.W. (2009) The weakest link is getting stronger. European Pharmaceutical Review, 14 (6). pp. 68-72. ISSN 1360-8606
Full text not available in this repository. (Request a copy from the Strathclyde author)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 |
| Subjects: | Medicine > Pharmacy and materia medica Science > Microbiology |
| Department: | Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences |
| Related URLs: | |
| Depositing user: | Strathprints Administrator |
| Date Deposited: | 31 Aug 2010 10:03 |
| Last modified: | 12 Mar 2012 11:16 |
| URI: | http://strathprints.strath.ac.uk/id/eprint/26116 |
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