Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices 1st Edition 2011 by Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell
Injectable product manufacturing is booming because of the growth of new biopharmaceuticals and small molecule anticancer drugs. The requirements for contamination control will become even more stringent than today. Isolators or blow-fill-seal equipment have already replaced the conventional clean rooms and LAF-hoods in many production facilitities. Conventional microbiological monitoring methods, requiring 3 to 5 days of incubation will become inappropriate. Equipment is already available allowing real time, simultaneous viable and non-viable counting.
- Author:Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell
- Binding Type:Hard Bound
- ISBN:9788190646741
- Total Pages:996
- Publishing Year:2011
- Language:English
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