By Nigel Halls

ISBN-10: 0824790146

ISBN-13: 9780824790141

Detailing the clinical rules underlying the fulfillment of sterility, this distinctive reference examines either a wide spectrum of sensible, ordinary sterilization methods and the tools to be had to substantiate sterility-assessing the strengths and boundaries of every technology.Delineates present regulatory standards for sterility-emphasizing the significance of aseptic procedures within the scientific 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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Additional info for Achieving Sterility in Medical and Pharmaceutical Products

Example text

The Canadian Standard for Industrial Sterilization of Medical Devices by the Steam Process. 1979 (II) differentiates between prodUClS intended to come into contact with compromized tissue. 9999%) and products not intended to come inlO contact with compromised tissue. 9%). No other formally acknowledged exceptions to the general rule of sterility being defined as a 10--6 SAL are known. SALs are not dircclly measureable. A supposedly sterile item can only be sterile or nonsterile. as indicated by testing or usage.

01 %. Media were to be incubated at 37·C for 5 days. The 1932 OP method recommended that the complete contents of a container should be tested only when the volume was less than 2 mL (two equal pans. one part for each medium). For volumes of 2 mL and greater, I mL was to be tested in each medium. If there was no growth under these conditions. the preparation was con· finned as sterile (passed the Test for Sterility). [f growth was delected, retests Sterility and Sterility Assurance 21 and second retests were allowed on fresh samples.

4). J. Technical Considerations: Survival curves cannot be derived theoretically for panicuJar microorganisms versus particular sterilization treatments; they can only be determined through laboratory studies. If it is assumed that the technology of the sterilization treatment in question can be controlled sufficiently well to deliver reasonably precise incremental treatment levels. then the procedures and precautions required to derive reproducible survival curves are quite similar. Most survival curves have been construcled for pure cultures of microor· ganisms.

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Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls


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