Rapid Microbiological Methods in the Pharmaceutical Industry

Martin C. Easter1574911414, 9781574911411, 9780203010877

This collection presents newly developed alternative and rapid methods that offer enhanced capabilities for detecting microbial contamination in pharmaceutical products. The 14 papers describe labor-saving devices, automation of traditional methods, adenosine triphosphate (ATP) bioluminescence, electrical impedance, species identification and typing, sterility testing, DNA-based technologies for detecting specific organisms, and the limulus endotoxin test. The contributors overview the techniques and systems available from specific companies, sometimes even listing their cost, note their potential and established applications for testing pharmaceutical articles, and address the issues of validation and regulatory acceptance.