By Nigel Halls
Detailing the medical ideas underlying the fulfillment of sterility, this precise reference examines either a large spectrum of functional, ordinary sterilization tactics and the tools to be had to verify sterility-assessing the strengths and boundaries of every know-how. Delineates present regulatory requisites for sterility-emphasizing the significance of aseptic techniques within the clinical institution and the pharmaceutical undefined! reaching Sterility in clinical 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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Extra info for Achieving Sterility in Medical and Pharmaceutical Products (Drugs and the Pharmaceutical Sciences)
The former is not required to be pyrogen free, and only the latter is to be recommended for use in preparations intended for parenteral administration. Sterile ophthalmic products have no requirement to be pyrogen free. II. STERILE MEDICAL DEVICES The term medical device includes instruments, apparatus, implements, contrivances, implants, or other similar or related articles used in medical treatment. A medical device does not achieve its principal intended purpose through chemical or pharmacological action within or on the body.
Biodegradable Polymers as Drug Delivery Systems, edited by Mark Chasin and Robert Langer Page d 46. Preclinical Drug Disposition: A Laboratory Handbook, Francis L. S. Tse and James J. Jaffe 47. HPLC in the Pharmaceutical Industry, edited by Godwin W. Fong and Stanley K. Lam 48. Pharmaceutical Bioequivalence, edited by Peter G. Welling, Francis L. S. Tse, and Shrikant V. Dinghe 49. Pharmaceutical Dissolution Testing, Umesh V. Banakar 50. Novel Drug Delivery Systems: Second Edition, Revised and Expanded, Yie W.
In BP 1963 there were two important innovations: incubation changed from 37°C for 5 days to 30–32°C for 7 days, and a membrane filtration technique was introduced for certain antibiotics. The membrane filtration technique, now almost universally used for pharmaceutical preparations but not for devices, was an advance of major significance. BP 1963 advised dissolution of the antibiotic in saline, followed by passage through a sterile membrane filter. The principle is that soluble substances pass through the membrane in solution and any microbial contaminants are retained.
Achieving Sterility in Medical and Pharmaceutical Products (Drugs and the Pharmaceutical Sciences) by Nigel Halls