Guidance for industry

Guidance for industry
Author:
Publisher:
Total Pages: 59
Release: 2004
Genre: Asepsis and antisepsis
ISBN:

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Advanced Aseptic Processing Technology

Advanced Aseptic Processing Technology
Author: James Agalloco
Publisher: CRC Press
Total Pages: 495
Release: 2016-04-19
Genre: Medical
ISBN: 1439825440

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The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies

Sterile Drug Products

Sterile Drug Products
Author: Michael J. Akers
Publisher: CRC Press
Total Pages: 517
Release: 2016-04-19
Genre: Medical
ISBN: 1420020560

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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Aseptic Pharmaceutical Manufacturing II

Aseptic Pharmaceutical Manufacturing II
Author: Michael J. Groves
Publisher: CRC Press
Total Pages: 544
Release: 1995-05-31
Genre: Medical
ISBN: 9780935184778

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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.