Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls

By Nigel Halls

Detailing the medical rules underlying the fulfillment of sterility, this special reference examines either a wide spectrum of sensible, commonplace sterilization techniques and the tools on hand to substantiate sterility-assessing the strengths and boundaries of every expertise. Delineates present regulatory necessities for sterility-emphasizing the significance of aseptic procedures within the clinical institution and the pharmaceutical undefined! attaining 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)

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Halls Page v Contents Preface iii 1. The Need for Sterility 1 2. Sterility and Sterility Assurance 17 3. Sterilization by Gamma Radiation 53 4. Sterilization by Saturated Steam 81 5. Dry Heat Sterilization and Depyrogenation 109 6. Sterilization by Ethylene Oxide 123 7. Sterilization by Filtration 153 8. Aseptic Manufacture 179 9. Maintenance of Sterility 241 10. Parametric Release and Other Regulatory Issues 259 Index 275 Page vi This page intentionally left blank. Page vii Achieving Sterility in Medical and Pharmaceutical Products Page viii This page intentionally left blank.

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.

The clinical features seen with patients who received these contaminated fluids included extreme fever, shaking chills, systemic toxicity, abdominal cramps, nausea, vomiting, diarrhea, delirium, and seizures. With hindsight these are the symptoms of gram-negative septicemia, but with sudden onset they were sometimes misdiagnosed [3]. 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.

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