Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.Applications for the 1990s Michael J. Groves, Ram Murty ... Pharmaceutical manufacturing began with open-manual production (Figure 14.1) and progressed to glove boxes. ... Sandia Laboratories (Albuquerque, NM) originated the clean room concept, which became common practice for atomic energy applications; microelectronic applications; and ... of barrier isolators have not been very user- friendly.
|Title||:||Aseptic Pharmaceutical Manufacturing II|
|Author||:||Michael J. Groves, Ram Murty|
|Publisher||:||CRC Press - 1995-05-31|