Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals || Copyrights
โ Scribed by ,
- Book ID
- 121809594
- Publisher
- Elsevier
- Year
- 2013
- Weight
- 38 KB
- Category
- Article
- ISBN
- 1907568387
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๐ SIMILAR VOLUMES
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices
Medical products sterilized in a gamma processing facility are given an absorbed dose greater than or equal to a specified minimum dose chosen to achieve a required sterility assurance level. Because of the dose variation in the product volume, most of the product receives a dose greater than the mi