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.

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 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. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.

The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.

Until now, information on cosmetic microbiology was scattered and mostly consisted of oral tradition passed on from mentors to apprentices. Finally, here is an understandable and easy-to-read guide documenting cosmetic microbiology practices. Cosmetic Microbiology: A Practical Handbook contains technical information on sanitation and the preservation of cosmetics for microbiologists as well as for process engineers, plant managers, and workers. The book provides the knowledge needed to create safe and usable cosmetic products. All aspects of cosmetic microbiology are covered, including testing methods, preservation, toxicology, and regulatory concerns.

This updated edition provides research scientists, microbiologists, process engineers, and plant managers with an authoritative resource on basic microbiology, manufacturing hygiene, and product preservation. It offers a contemporary global perspective on the dynamics affecting the industry, including concerns about preservatives, natural ingredients, small manufacturing, resistant microbes, and susceptible populations. Professional researchers in the cosmetic as well as the pharmaceutical industry will find this an indispensable textbook for in-house training that improves the delivery of information essential to the development and manufacturing of safe high-quality products

Balanced coverage of natural cosmetics, and what it really means to be "green" The use of natural ingredients and functional botanical compounds in cosmetic products is on the rise. According to industry estimates, sales of natural personal care products have exceeded $7 billion in recent years. Nonetheless, many misconceptions about natural products for instance, what "green" and "organic" really mean continue to exist within the industry. Formulating, Packaging, and Marketing of Natural Cosmetic Products addresses this confusion head-on, exploring and detailing the sources, processing, safety, efficacy, stability, and formulation aspects of natural compounds in cosmetic and personal care products. Designed to provide industry professionals and natural product development experts with the essential perspective and market information needed to develop truly "green" cosmetics, the book covers timely issues like biodegradable packaging and the potential microbial risks they present, the use of Nuclear Magnetic Resonance (NMR) to identify biomarkers, and chromatographic methods of analyzing natural products. A must-read for industry insiders, Formulating, Packaging, and Marketing of Natural Cosmetic Products provides the reader with basic tools and concepts to develop naturally derived formulas.