The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.

Papers of a conference held at the University of London, April 1987. Contributors address control of microbial contamination and formulation and preservation of products to ensure microbial quality during storage and use. They also review guidelines, official and unofficial, for microbial quality. Annotation copyrighted by Book News, Inc., Portland, OR

My professional interest in antimicrobial agents and contamination control goes back 50 years to my tour as a microbiologist in a field hospital in Europe during World War II. With no experience and relying solely on a military handbook, I prepared thermometer trays with jars of blue bichloride of mercury and pink isopropyl alcohol. A preliminary typhoid diagnosis of one of our cooks resulted in the need for lab testing. His stool specimen and its subsequent disposal was my problem. My handbook said bum it. So burn it T did, in a five-gallon can with gasoline. Flames shot up almost six feet, and my next mistake was to extinguish them with carbon tetrachloride. This resulted in the production of lethal phosgene gas. The hospital had a near disaster. I could say that at that moment I vowed to write a how-to book so that such stupidities could be avoided. Nevertheless, when I was offered the opportunity to edit this book I thought back on the need for a real, practical treatment of my subject. This book, then, is a practical handbook for technical service personnel and scientists who are not necessarily specialists in microbiology. It provides information on suitable antimicrobial agents appropriate to their particular problem-solving needs and information on the microbial groups contributing to the specific problem, their ecologies, and strategies for controlling their access to the area or material of interest.

Microbiological Quality Assurance: A Guide Towards Relevance and Reproducibility of Inocula sheds light on the difficulties of obtaining results in the test tube that will be reproducible and relevant for a wide variety of tests. This book explores the current state of research in this area and troubleshoots the problems that may be encountered in setting up appropriate cultures. The text divides naturally into three sections-growth conditions, post-growth conditions, and applications. This book serves as a valuable resource for clinical microbiologists, pharmacologists, and anyone doing in vitro experiments.

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. - Contains the applications of pharmaceutical microbiology in sterile and non-sterile products - Presents the practical aspects of pharmaceutical microbiology testing - Provides contamination control risks and remediation strategies, along with rapid microbiological methods - Includes bioburden, endotoxin, and specific microbial risks - Highlights relevant case studies and risk assessment scenarios