Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Asepsis and antisepsis
Languages : en
Pages : 48
Book Description
Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Asepsis and antisepsis
Languages : en
Pages : 48
Book Description
Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Disinfection and disinfectants
Languages : en
Pages : 38
Book Description
Guidelines on Sterile Drug Products Produced by Aseptic Processing
Author: Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Center for Drugs and Biologics (É.-U.)Publisher:
ISBN:
Category :
Languages : en
Pages : 43
Book Description
Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Food and Drug Administration, Rockville/MdPublisher:
ISBN:
Category :
Languages : en
Pages : 86
Book Description
Guidance for industry
Author: Publisher:
ISBN:
Category : Asepsis and antisepsis
Languages : en
Pages : 59
Book Description
Guidelines on Sterile Drug Products Produced by Aseptic Processing
Author: United States Food and Drug AdministrationPublisher:
ISBN:
Category :
Languages : en
Pages : 43
Book Description
Advanced Aseptic Processing Technology
Author: James AgallocoPublisher: CRC Press
ISBN: 1439825440
Category : Medical
Languages : en
Pages : 495
Book Description
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
Author: Michael J. AkersPublisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 517
Book Description
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
Author: Michael J. GrovesPublisher: CRC Press
ISBN: 9780935184778
Category : Medical
Languages : en
Pages : 544
Book Description
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.