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 precise reference examines either a huge spectrum of useful, accepted sterilization approaches and the equipment to be had to substantiate sterility-assessing the strengths and obstacles of every technology.Delineates present regulatory specifications for sterility-emphasizing the significance of aseptic procedures within the clinical institution and the pharmaceutical industry!Achieving Sterility in clinical and Pharmaceutical items discusses sterilization ways that make the most of saturated steam dry warmth ethylene oxide gamma radiation·sterile filtration·and extra!

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Sample text

Let us suppose that the inimical process can be applied 10 a population of bacleria in an incremenlal manner. Initially and after various periods of expo. sure we can withdraw samples from the population and count the number of viable bacteria preient. When we plot these data as a survival curve on arith· metic axes we get me fonn of Fig. 23. The relationship of survivors to lime of exposure shows an initial rapid decline and then levels oul and becomes asymptotic to the time axis. IJ we were to cooven Ihe urvivor data to logarithms and then plot Ihese logarithmic data against time of exposure we would oblain a straight-line relationship (Fig.

Versus the other standards for sterility. it places rar greater demands on sound knowledge of the product's bioburden (numbers and types of microorganisms conUlminating the proouct prior to sterilization), its response to the sterilization treatment, and the uniformity of the pankuw sterilization processes. Ultimalely it relies on the confidence in Ihe extrapolation required to demonstrate that lhe process is capable of achieving what it is supposed 1'O achieve. V. DETERMINANTS OF STERILITY ASSURANCE When validation depends on eXlrapohuion, it is of utmost importance 10 have confidence in the base data from which the extrapolation is to be made.

Es the idea of confidence. How confidenl should we be that an item is Slerile? 000 lhal viable microorganisms are presenr in a sterilized anicle or dosage form (JO-6 probability of nonsterilily). To obIain this assurance we must have good knowledge of the effects of sterilization processes on microbial populations. Microbial inactivation has been well researched. This is panicularly lrue for populalions of bacleria. Although each Iype of microorganism responds differenlly to the various available sierilization processes.

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Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls


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