Download Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls PDF

By Nigel Halls

Detailing the medical ideas underlying the success of sterility, this certain reference examines either a vast spectrum of functional, widely used sterilization approaches and the equipment to be had to substantiate sterility-assessing the strengths and barriers of every know-how. Delineates present regulatory standards for sterility-emphasizing the significance of aseptic approaches within the clinical institution and the pharmaceutical undefined! reaching Sterility in scientific 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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Additional info for Achieving Sterility in Medical and Pharmaceutical Products (Drugs and the Pharmaceutical Sciences)

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In the years since, the methods have changed in detail and in application, and have differed between the two major pharmacopoeias. Page 20 Table 2 Evolution of the Test for Sterility in the British Pharmacopoeia 1932 Media and methods specified, direct inoculation, incubation at 37°C for 5 days 1948 Thioglycollate medium included as an alternative recovery medium for anaerobes 1953 No change from 1948 1958 Accommodation made for solid dosage forms, ‘‘neutralizers” allowed, and specified for certain antibiotics 1963 Incubation conditions changed to 30–32°C for 7 days, membrane filtration allowed for certain antibiotics 1968 Sample sizes included to allow certification of batches as sterile 1973 Inclusion of European Pharmacopoeia 1971, recommended that the membrane filtration technique be used wherever possible, inclusion of media control tests; incubation conditions changed to 30–35°C for bacteria and 20–25°C for fungi over 7 days 1980 General expansion of the detail 1988 No significant change from 1980 Therefore, although the concept of sterility is absolute and unchanging, the standard required to confirm its achievement has never been consistent.

In March 1973, Cutter Laboratories withdrew from the market all 1,000-mL bottles of 5% Dextrose in Lactated Ringers Injection produced at its Chattanooga, Tennessee, plant since September 1972. Five cases of clinical septicemia had been associated with administration of these fluids; three of the five patients died [5]. The microorganisms implicated in the clinical cases were Enterobacter agglomerans, Enterobacter cloacae, and Citrobacter freundii. Unopened bottles from the same plant were found to be contaminated with the same and similar microorganisms, in some instances to the point of visible turbidity.

Nunn 56. New Drug Approval Process: Second Edition, Revised and Expanded, edited by Richard A. Guarino 57. Pharmaceutical Process Validation: Second Edition, Revised and Expanded, edited by Ira R. Berry and Robert A. Nash 58. Ophthalmic Drug Delivery Systems, edited by Ashim K. Mitra 59. Pharmaceutical Skin Penetration Enhancement, edited by Kenneth A. Walters and Jonathan Hadgraft 60. Colonic Drug Absorption and Metabolism, edited by Peter R. Bieck 61. Pharmaceutical Particulate Carriers: Therapeutic Applications, edited by Alain Rolland 62.

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