By Nigel Halls
Detailing the medical rules underlying the fulfillment of sterility, this exact reference examines either a large spectrum of useful, conventional sterilization methods and the equipment to be had to verify sterility-assessing the strengths and obstacles of every expertise. Delineates present regulatory specifications for sterility-emphasizing the significance of aseptic methods within the scientific institution and the pharmaceutical undefined! reaching Sterility in scientific and Pharmaceutical items discusses sterilization methods that make the most of ·saturated steam ·dry warmth ·ethylene oxide ·gamma radiation ·sterile filtration ·and extra!
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Detailing the medical ideas underlying the fulfillment of sterility, this specific reference examines either a extensive spectrum of useful, established sterilization strategies and the tools on hand to verify sterility-assessing the strengths and obstacles of every expertise. Delineates present regulatory specifications for sterility-emphasizing the significance of aseptic techniques within the clinical institution and the pharmaceutical undefined!
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Extra resources for Achieving Sterility in Medical and Pharmaceutical Products (Drugs and the Pharmaceutical Sciences)
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. Journal of Medical Microbiology 3: 99–102.
Although all the incidents described below occurred quite a long time ago and technology has changed and improved, and regulatory control has become more demanding and explicit, we believe that because sterility can only be achieved consistently by constant vigilance there are important lessons to be learned from reviewing them again. A. K. K. Some postoperative patients who had been given supposedly sterile but actually contaminated infusion fluids died; others made unnecessarily long recoveries.
The 1932 BP method recommended that the complete contents of a container should be tested only when the volume was less than 2 mL (two equal parts, one part for each medium). For volumes of 2 mL and greater, 1 mL was to be tested in each medium. If there was no growth under these conditions, the preparation was confirmed as sterile (passed the Test for Sterility) If growth was detected, retests Page 21 and second retests were allowed on fresh samples. The preparation could only be failed if growth was seen in all three tests, or if the same microorganisms were found in two of the tests.