Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s, 1st Edition (Hardback) book cover

Aseptic Pharmaceutical Manufacturing II

Applications for the 1990s, 1st Edition

Edited by Michael J. Groves, Ram Murty

CRC Press

520 pages

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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.

Table of Contents

Chapters include:

Controlled Environments in the Pharmaceutical & Medical Products Industry: A Global View, R. Dabbah

Quality Systems & Total Quality, K. Stephens

Aseptic Processing of Healthcare Products, M. Korczynski & J. Lyda

Validation of Aseptic Processes, V. Kumar & R. Murty

Laboratory Techniques, R. Mehta & R. Murty

Aseptic Production: Radiopharmaceuticals, P. Bremer

Education & Training of Personnel, M. Akers

Predictive Sterility Assurance for Aseptic Processing, C. Sinclair & A. Tallentire

Aseptic Processing of Biopharmaceuticals, N. Lugo

Lyophilization, E. Trappler

Lyophilization Under Barrier Technology, J. Snowman

Aseptic Packaging and Labeling, R. Murty

Barrier Isolation Technology: A Systems Approach, J. Lysfjord, P. Haas, H. Melgaard & I. Pflug

Hydrogen Peroxide Vapor Sterilization: Applications in the Production Environment, L. Edwards & R. Childers

Appendix: USP 23 Chapter 1116: Microbiological Evaluation of Clean Rooms and Other Controlled Environments, United States Pharmacopoeial Convention, Inc.

About the Editors

Michael J. Groves, Ram Murty

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General