Guide to microbiological control in pharmaceuticals
著者
書誌事項
Guide to microbiological control in pharmaceuticals
（Ellis Horwood series in pharmaceutical technology）
Ellis Horwood, 1990
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
This clear and comprehensive description of the micro-organism as a contaminant and as a potential growth medium reveals the problems of microbiological control in pharmaceutic product design and manufacture. It is a uniquely extensive and fundamental review of the problems of preserving complex formulation against the microbial stresses imposed during manufacture and afterwards, often with only a limited range of permissible preservatives and often at a stage close to licence application when formulation changes are strongly resisted. The authors, each invited for their particular expertise, underline the versatility of micro-organisms and the relative susceptibilities of product types and ingredients; the principles of factory hygiene, microbiological quality control and good manufacturing are considered as well as monitoring methods for microbiological quality. They establish the distinction between sterile and non-sterile products and the merits and demerits of available sterilization methods.
目次
- Micro-organisms: diversity, metabolism, structure
- pharmaceutical products and their formulation
- microbial contamination: spoilage and hazard
- microbiological ecology of production environment and raw materials
- good manufacturing practice
- environmental monitoring and control
- methods of monitoring product microbiological quality
- principles of sterilization
- sterilization methods
- validation of sterilization methods and sterility testing
- drug stability under sterilizing conditions
- principles of preservation
- antimicrobial properties of formulation ingredients
- properties of permitted preservatives and factors affecting efficacy
- resistance to preservatives
- preservation evaluation and testing
- preservatives toxicity
- preservation and regulatory affairs
- package design and produce integrity
- case history and examples.
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