By R Baird; N Hodges
This booklet is a pragmatic consultant to suggestions utilized in microbial caliber coverage within the pharmaceutical undefined. It goals to fill the distance within the literature among foodstuff and clinical microbiology suggestions books.
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Such information, combined with the design specifications of manufacturing environment and processing equipment has enabled the microbiologist to predict the probable hazards associated with the product and to identify the likely points for microbial contamination or growth. Once these critical control points have been identified and estimated at each step in the manufacturing process, they should be monitored regularly and intensively; if necessary, appropriate corrective steps should also be taken to ensure that control is maintained at all times.
Coli and by the limited number of samples which may contain Enterobacteriaceae. In pharmaceutical terms this scheme is suitable where positive results are unacceptable. For example, a raw material of natural origin, such as thyroid powder, may have a specification requiring the absence of salmonellae in 25 g (where n is 5×5 g and c is 0). Three-class attribute scheme In this scheme three quality levels are defined: the fully acceptable, often known as the acceptable quality level or AQL; the marginally acceptable; and the unacceptable.
P. (1998) Chemical disinfectants, antiseptics and preservatives. B. D. (eds), Pharmaceutical Microbiology, 6th edn. Blackwell Scientific Publications, Oxford, pp. 201–28. G. (1992) Containment in the development and manufacture of recombinant DNA-derived products. H. J. (eds), Safety in Industrial Microbiology and Biotechnology. Butterworth-Heinemann, Oxford, pp. 201–28. United States Pharmacopoeia XXIII (1995) United States Pharmacopoeial Convention, Rockville, MD. 1 Introduction Microbiologists working today have considerable choice in the range and type of culture media available to them.
Handbook of Microbiological Quality Control Pharmaceuticals by R Baird; N Hodges