Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls

By Nigel Halls

Detailing the medical ideas underlying the fulfillment of sterility, this distinctive reference examines either a extensive spectrum of functional, ordinary sterilization methods and the equipment on hand to substantiate sterility-assessing the strengths and obstacles of every expertise. Delineates present regulatory standards for sterility-emphasizing the significance of aseptic tactics within the scientific institution and the pharmaceutical undefined! attaining Sterility in clinical and Pharmaceutical items discusses sterilization techniques that make the most of ·saturated steam ·dry warmth ·ethylene oxide ·gamma radiation ·sterile filtration ·and extra!

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

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Microbial contamination of medical preparations. Acta Pharm. Suecica 3: 219–228. 7. Marples, R. R. (1983). Contaminated first-aid dressings: Report of a working party of the PHLS. Journal of Hygiene (Cambridge) 90: 241–252. 8. , Dawes, C. , and Hay, N. P. (1981). Microbiological contamination of imported wound dressings. Pharmaceutical Journal 1981: 783. 9. Michaels, L. and Ruebner, B. (1953). Growth of bacteria in intravenous infusion fluids. Lancet 1953: 772–774. 10. Robertson, M. H. (1970). Fungi in fluids—A hazard of intravenous therapy.

Real expertise in sterilization, particularly in sterilization science, is often concentrated among a limited number of microbiologically qualified staff who have gained their knowledge through hands-on experience of specific technologies. This book attempts to cover a wider spectrum of sterilization technologies than most practitioners might ever encounter in a working lifetime with one company or organization. It is intended to increase the breadth of knowledge of the sterilization specialist beyond the boundaries of his or her hands-on experience and to assist in communicating the fundamentals of the main sterilization technologies to interested personnel who work in this area but do not have a strong microbiological background.

In 1969, cracks in bottles led to inadvertent infusion of fungal-contaminated glucose-saline solution to two patients [10]. Fungal microcolonies were visible in the fluids. Both patients recovered satisfactorily after prompt treatment with ampicillin and amphotericin B. K. hospital acquired bacteremia, urinary tract infections, or respiratory infections from in-house manufactured sterile parenteral solutions. The infective agent, Pseudomonas thomasii, was traced to water used for cooling sterilized parenteral solutions in a rapid-cooling autoclave.

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