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Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (Pharmaceutical Science Series) de Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer

DescripciĆ³n - ReseƱa del editor 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. BiografĆ­a del autor Rosamund M. Baird, Norman A. Hodges, Stephen P. Denyer

Detalles del Libro

  • Name: Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (Pharmaceutical Science Series)
  • Autor: Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
  • Categoria: Libros,Libros universitarios y de estudios superiores,Medicina y ciencias de la salud
  • TamaƱo del archivo: 16 MB
  • Tipos de archivo: PDF Document
  • Descargada: 435 times
  • Idioma: EspaƱol
  • Archivos de estado: AVAILABLE


[Download] Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (Pharmaceutical Science Series) de Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer Ebooks, PDF, ePub

Guide to Microbiological Control in Pharmaceuticals and ~ Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity.

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Handbook of Microbiological Quality Control ~ Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices Edited by ROSAMUND M. BAIRD Department of Pharmacy and Pharmacology, University of Bath, UK NORMAN A. HODGES School of Pharmacy and Biomolecular Sciences, University of Brighton, UK STEPHEN P. DENVER School of Pharmacy and Biomolecular Sciences, University of .

Handbook of Microbiological Quality Control in ~ 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 provi

Guide to Microbiological Control in Pharmaceuticals and ~ Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological .

Handbook of Microbiological Quality Control in ~ DOI: 10.1201/9780203305195 Corpus ID: 139082378. Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices @inproceedings{Baird2000HandbookOM, title={Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices}, author={Rosamund M. Baird and Norman A. Hodges and Stephen Paul Denyer}, year={2000} }

Guide to Microbiological Control in Pharmaceuticals and ~ Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices.

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PHARMACEUTICAL MANUFACTURING HANDBOOK ~ Medical University of Graz, Graz, Austria, GMP - Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells. James M. Barquest, Ground Zero Pharmaceuticals, Inc., Irvine, California, Role of Quality Systems and Audits in Pharmaceutical Manufacturing Environment. Denise Bohrer, Chemistry Department, Universidade Federal de Santa Maria,

The importance of microbiological quality control in the ~ Microbial contamination in pharmaceutical products has massive consequences. Karla Fjeld explains what we can do to optimise our QC and help prevent contamination. In recent years, the number of .

Microbiological quality of non-sterile pharmaceutical ~ One of control stages is the assessment of microbiological quality of medicinal products (Tyski, 2011, Guide to good manufacturing practice for medicinal products, 2013). Consecutive editions of the European Pharmacopoeia (EP) are useful tools in the quality assessment, as they set out the microbiological specifications, criteria and the methods for microbial examination of non-sterile products.

Handbook of microbiological quality control ~ Get this from a library! Handbook of microbiological quality control : pharmaceuticals and medical devices. [S P Denyer; R M Baird; Norman A Hodges;] -- This is a practical guide to techniques used in microbial quality assurance in the pharmaceutical industry. It aims to fill the gap in the literature between food and medical microbiology techniques .

Pharmaceutical Microbiology Manual ~ A. Microbiological Issues for Inspection of Pharmaceutical . product testing of pharmaceuticals and medical devices. . Office of Regulatory Science Medical Products and Tobacco Scientific .

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Guide to Microbiological Control in Pharmaceuticals and ~ Engineering, Medicine; Published 2006; DOI: 10.1201/9781420021622 Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition @inproceedings{Denyer2006GuideTM, title={Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition}, author={Stephen Paul Denyer and Rosamund M. Baird}, year={2006} }

Microbiological quality of non-sterile pharmaceutical products ~ One of control stages is the assessment of microbiological quality of medicinal products (Tyski, 2011; Guide to good manufacturing practice for medicinal products, 2013). Consecutive editions of the European Pharmacopoeia (EP) are useful tools in the quality assessment, as they set out the microbiological specifications, criteria and the methods for microbial examination of non-sterile products.

Microbiological quality of pharmaceutical products in ~ Microbial quality assurance in cosmetics, toiletries and non-sterile pharmaceuticals. London: Taylor & Francis; S [38] Hodges NA. Pharmacopoeial methods for the detection of specified micro-organisms. In: Baird RM, Hodges NA, Denyer SP, editors. Handbook of microbiological quality control: pharmaceuticals and medical devices.

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Guide to microbiological control in pharmaceuticals and ~ Introduction to microbiology --Microbial contamination --Microbial ecology of the production process --The design of controlled environments --Microbiological considerations for biotechnological products --Microbiological considerations in the production of medical devices --Good manufacturing practice in the control of contamination --Dispersion of airborne contaminants and contamination .

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