Handbook of microbiological quality control pharmaceuticals and medical devices.
Handbook of microbiological quality control pharmaceuticals and medical devices. Handbook of microbiological quality control. - London | Taylor & Francis | 2000. - 293 Pages Includes bibliographical references and index. - Taylor & Francis series in pharmaceutical sciences. .
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.
0-748-40614-X (Print Edition) 0-203-35192-4 (Adobe eReader Format) 0-203-30519-1 Master e-book = Handbook of microbiological quality control: pharmaceuticals and medical devices acid activity agar agents antibiotic antimicrobial aseptic assay assessment ATCC audit auditor autoclave Bacillus bacteria batch bioburden biological bioluminescence British Standards broth cells cetrimide chemical chromogenic CIP clean room coagulase coli colonies colour contamination cosmetic culture media DENYER detection dilution disinfection edn end-point endotoxin Enterobacteriaceae environment environmental EP equipment European Pharmacopoeia fermentation filter filtration gel-clot Gram-negative growth identification inactivation incubation inhibition inoculated inoculum isolates kinetic chromogenic kinetic turbidimetric laboratory LAL levels limit lysate manufacturing medical devices medium membrane methods micro micro-organisms microbial microbiological ml ml¹ monitoring moulds non-sterile operator pathogens pH pharmaceutical pharmaceutical microbiology plates polysorbate 80 preparation preservative efficacy tests procedures Pseudomonas aeruginosa raw materials reagent recommended risk Salmonella sample selective sensitivity species spores Staphylococcus aureus sterility sterility test storage suitable surface techniques temperature test organisms tubes United United States Pharmacopoeia USP validation viable count
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