Microbiological Contamination Control in Pharmaceutical Clean Rooms

Features

Discusses measurement and control of contamination for safe drug manufacturing

Offers logical approaches to problems associated with oral and nasal preparations

Reviews the most common commercial rapid microbiological test methods

Features a chapter on clean room finishes and construction materials - information available nowhere else

Highlights microbial focus of clean room control and the importance of knowledgeable laboratory practices

Summary

Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisciplinary approach, Microbiological Contamination Control for Pharmaceutical Clean Rooms neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms.

The book helps you satisfy domestic and international regulations and prevent your organization from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This valuable guide brings you up to date on the types of techniques available, the scientific principles that underpin them, and the practicalities and limitations of each.