By Rosamund M. Baird, Norman A. Hodges, Stephen P. Denyer
Microbiologists operating in either the pharmaceutical and clinical equipment industries, face substantial demanding situations in preserving abreast of the myriad microbiological references on hand to them, and the regularly evolving regulatory specifications. The guide of Microbiological quality controls presents a special distillation of such fabric, by way of supplying a wealth of microbiological details not just at the useful concerns dealing with the corporate microbiologist this present day, but in addition the underlying rules of microbiological caliber coverage. the entire chapters were written via top specialists during this box. The instruction manual of Microbiological qc presents tips on secure microbiological practices, together with laboratory layout and sampling recommendations. The layout garage, use and qc of microbiological tradition is taken into account intensive. ideas of enumeration and id of micro-organisms, utilizing either conventional and quick equipment in addition to the pharmacopoeial tools for the detection of precise organisms, are elaborated intimately. assistance is given on laboratory equipment assisting the sterility insurance approach: sterility checking out, bioburden trying out, using organic signs and environmental tracking equipment, in addition to equipment for detecting and quantifying endotoxins. Pharmacopoeial tools for microbiological assay and preservative efficacy checking out are reviewed. difficulties for these inquisitive about disinfection and detoxing strategies and microbiological audit are mentioned from a pragmatic point of view. ultimately, a couple of pertinent case experiences and labored examples illustrate difficulties highlighted within the textual content. The instruction manual of Microbiological quality controls is the basic reference resource for the pro microbiologist
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Extra resources for Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
5 Control of ready-to-use agar plates Recent years have witnessed a considerable growth in the commercial supply of ready-touse agar plates across the various microbiology disciplines, and specifically in pharmaceutical microbiology. There are several reasons for this, but among them the lack of skilled staff and adequate facilities, coupled with the requirement for cost containment, have driven microbiologists to seek alternative suppliers. Furthermore, the ability to cope with surges in demand has favoured the purchase of ready-to-use media.
4 Local safety rules should be drafted, including the names and contact addresses of persons with overall responsibility for safety. In an industrial setting, these will have been written at the company level, but it may be necessary to make additional comments, for example on routes of evacuation from clean room facilities. 5 Notification to HSE of intention to propagate Category 2 organisms. 6 If genetically modified micro-organisms are to be used, then a Genetic Modification Safety Committee will have to be established and a Biological Safety Officer appointed.
Alimenta (Sonderausgabe), 19–34. T. B. (1983) Quality assurance of selective culture media for bacteria, moulds and yeasts: an attempt at standardisation on the international level. Journal of Applied Bacteriology, 54, 313–27. , STRUIJK, C. M. (eds) (1995) Essentials of the Microbiology of Foods. John Wiley, Chichester, pp. 63–83. A. L. (1991) Guidelines for the preparation, storage and handling of microbiological media. Campden Food and Drink Research Association. Technical manual no. 33. P. A.