By Nigel Halls

ISBN-10: 0824790146

ISBN-13: 9780824790141

Detailing the clinical ideas underlying the fulfillment of sterility, this distinctive reference examines either a wide spectrum of sensible, regular sterilization techniques and the equipment to be had to substantiate sterility-assessing the strengths and obstacles of every technology.Delineates present regulatory standards for sterility-emphasizing the significance of aseptic methods 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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Sample text

In Ihose times there was considerable debate over the origins of microorganisms ("animaJcules'')by spontaneous formation (spontaneous generation) from non-living materials. on the one hand. versus formation from living "seeds" or "genns," which were supposed to be always present in the atmosphere. on the other. Sterilily and Sterility Assurance 19 Pasteur produced some pretty conclusive evidence in favor of the germ theory through his famous swan-necked flask experimenls. This experimentation was based upon detection of microorganisms by visible changes in organic infusions.

Reproducible curves. however, will nol be obtained unless cuJwres are genetically homogeneous, physiologically homogeneous. and free from clumps. Assurance of genetic homogeneily resides with sound microbiological technique. Physiological homogeneity demands thai all cells within the population are allhe same stage in their growth cycles and have been grown in me same media under the same conditions of incubalion. Microorganisms respond quite differenlly to sterilization trealments according to their physiological stale; in the grossest case abe bacterial endospore responds quile markedly differently to sterilization trealmenlS lhan Ihe vegetative cell of the same microorganism.

The test was far less a critical test for sterility, as one might suppose it was intended to be. hought to be more likely than false sterile results (the phar. macopoeia had more faith in the potential of the recommended media to recover microorganisms than it had in the ability of laboratories to perform successful aseptic manipulations). (b) The test did not address total freedom from microorganisms for preparations in 2 mL volumes or greater. For these larger volumes it was really a microbial limit lest with a lower sensitivity of detection of one microor· ganism per mL.

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Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls


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