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Halls, Nigel A., 1945-

Achieving sterility in medical and pharmaceutical products / Nigel A. Halls. - iv, 281 pages : illustrations ; 23 cm. - Drugs and the pharmaceutical sciences ; volume 64 .

Includes bibliographical references and index.

The Need for SterilitySterility and Sterility AssuranceSterilization by Gamma RadiationSterilization by Saturated SteamDry Heat Sterilization and DepyrogenationSterilization by Ethylene OxideSterilization by FiltrationAseptic ManufactureMaintenance of SterilityParametric Release and Other Regulatory Issues


Details the scientific principles underlying the achievement of sterility; examines practical, commonly-used sterilization procedures and the methods available to confirm sterility; and assesses the strengths and limitations of each technology. Regulatory requirements for sterility are defined.

ISBN: 0824790146 (alk. paper)

LCCN: 94006372

Subjects--Topical Terms:
Sterilization.
Drugs--Sterilization.
Sterilization--methods.
Drug Contamination--prevention & control.
Equipment and Supplies.

LC Class. No.: RA761 / .H29 1994

Dewey Class. No.: 614.48 / H.N.A

National Library of Medicine Call No.: W1 DR893B v. 64 1994 WA 240 H193a 1994