Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls

By Nigel Halls

Detailing the clinical rules underlying the success of sterility, this detailed reference examines either a huge spectrum of functional, prevalent sterilization methods and the tools to be had to substantiate sterility-assessing the strengths and barriers of every expertise. Delineates present regulatory specifications for sterility-emphasizing the significance of aseptic approaches within the scientific institution and the pharmaceutical undefined! reaching Sterility in clinical and Pharmaceutical items discusses sterilization ways that make the most of ·saturated steam ·dry warmth ·ethylene oxide ·gamma radiation ·sterile filtration ·and extra!

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Extra info for Achieving Sterility in Medical and Pharmaceutical Products (Drugs and the Pharmaceutical Sciences)

Example text

Official report on this incident [7] concluded that the contaminating microorganisms were of low pathogenicity. They also commented that the types of first aid dressings involved were most commonly applied to wounds that were already contaminated. They evaluated the risk to health arising from use of these contaminated dressings to be small. Nonetheless they severely criticized the manufacturers for labelling these products as “sterile” and judged the risk to be unacceptable. F. Incidents Originating from Other Sources It should not be assumed that all serious consequences arising from the use of nonsterile products are of industrial origin.

3. Felts, S. , and Koenig, M. G. (1972). Sepsis caused by contaminated intravenous fluids—Epidemiological, clinical and laboratory investigation of an outbreak in one hospital. Annals of Internal Medicine 77 (6): 881–890. 4. Maki, D. , Rhame, F. , Mackel, D. , and Bennet, J. V. (1976). Nationwide epidemic of septicemia caused by contaminated intravenous products. American Journal of Medicine 60: 471–485. 5. Center for Disease Control (1973). Follow-up on septicemias associated with contaminated intravenous fluids.

Confirmed cases were mainly drawn from large hospitals, often university teaching hospitals, using significantly large volumes of infusion fluids. It is possible that many more patients in small hospitals were implicated, but the cases were not diagnosed or reported. The microorganisms associated with the epidemic were identified with Enterobacter cloacae, Enterobacter agglomerans, and other Enterobacter species. The precise cause of the incident was traced to a program of gradual replacement of Gilsonite cap liners for the infusion fluid bottles with an elastomer cap liner (Fig.

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