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.
Table of Contents
Effects and Causes of Contamination in Sterile Manufacturing, N. Halls
Microbiological Environmental Monitoring, N. Halls
Media Fills and Their Applications, N. Halls
Contamination of Aqueous-Based Nonsterile Pharmaceuticals, N. Halls
Bioburden Determinations, N. Hodges
Materials of Construction and Finishes for Safe Pharmaceutical Manufacturing, D. Fortune
Rapid Microbiological Methods Explained, S. Green and C. Randell
"…Throughout the book one finds concise, practical and helpful chapters and sections. Everything within the book avoids unnecessary descriptions, but comes to the point underlined by years of experience….
"…an excellent practical reference….An enjoyment to read and learn."
-European Journal of Parenteral and Pharmaceutial Sciences