Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.

By Michael K. Akers, Dan Larrimore and Dana Guazzo, this is a working reference on the tests used to show that finished injectable products are sterile, free of pyrogens and free of particles. Separate long chapters cover sterility testing, pyrogen testing and particulate matter testing, and container package integrity is treated as well. The authors set the official compendial tests beside the debate over how reliable, sensitive and applicable they are. Throughout, they stress test methods that meet both U.S. and European requirements, along with newer technologies for testing the finished product. Considerable space goes to barrier isolation systems for sterility testing. It covers how to qualify and validate them, and the regulators' worry that surface decontamination inside an isolator can produce false-negative results.