Achieving Sterility in Medical and Pharmaceutical Products - download pdf or read online

By Nigel Halls

ISBN-10: 0824790146

ISBN-13: 9780824790141

Detailing the medical ideas underlying the success of sterility, this exact reference examines either a huge spectrum of sensible, common sterilization systems and the tools on hand to verify sterility-assessing the strengths and obstacles of every technology.Delineates present regulatory requisites for sterility-emphasizing the significance of aseptic strategies within the clinical institution and the pharmaceutical industry!Achieving 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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Extra resources for Achieving Sterility in Medical and Pharmaceutical Products

Example text

There is a panicularly striking epidemiological example of this [4] in which treatment against CampyloMeler of the water supply 10 a chicken shed resulted in the disappearance of a panicular serotype from the chicken population even though il had not at any time been recovered by culture techniques from the waler supply. Summaries of the main applicalions of newer technologies lO del'a'tion and enumeration of microoganisms merit consideration. J. Determination of Microbial ATP: ATP is presenl in all living cells.

Changes in electrical resislance (conductance. impedance. andlor capacitance) can be monitored and recorded during incubation. or alternatively inslruments can be sci to a threshold value linked to a lower sensitivity of detection. With commercially available instruments the threshold of detection has usually been quoted at around 101 microorganisms per mL. For enumeration of microorganisms. the incubation time required 10 reach the threshold "lrigger" is inversely proportional to the initial concentration of microorganisms in the sample.

The original pharmacopoeial enlries comprised a simple tesl method applicable to finding oul whelher items tested were nonsterile. K. TMrapeunc Substances Regulations in 1952, in the USP in 1955. and in the SP in 1968. The actual sample size has varied. usually related to a percenlage of lIle number of containers in the batch but limited 10 a maximum sample size (Fig. I). P NO AnON 1955 UNITS U. 1968 1970 1973 NITS U PI. 1975 1980 Fig. 1 Sampling recommendations in the phannacopoeial tests for sterility.

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Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls

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