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Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments /

Bibliographic Details
Main Author: Hout, Sam (Author)
Corporate Author: Knovel (Firm)
Format: eBook
Language:English
Published: Hoboken, NJ : Wiley, 2022.
Subjects:
Drugs > Sterilization.
Drug factories.
Pharmaceutical industry.
Drug Industry
Laboratoires pharmaceutiques.
Industrie pharmaceutique.
Médicaments > Stérilisation.
Drug factories
Drugs > Sterilization
Pharmaceutical industry
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Sterilization
  • Sterile Manufacturing Facilities
  • Sanitary Process Piping and Equipment
  • Passivation
  • Chilled Water System
  • Clean-In-Place (CIP) Systems
  • Computerized Automated Systems
  • Personal Protective Equipment (PPE) and Process Flow
  • Sterile Aseptic Processing
  • Integrated Facility Design
  • Barriers and Isolators
  • Guidelines for Statistical Procedure
  • Calibration
  • Cleaning Validation
  • Validation of Filling Equipment
  • Manufacturing Process Validation
  • Appendix A: Installation Test Plans
  • Appendix B: Operational Tests Plans
  • Appendix C: WFI Turbulence Flow Requirements
  • Appendix D: Water For Injection (WFI) - Design Requirements
  • Appendix E: Solution Transfer System (STS) - Design Requirements
  • Glossary
  • Nomenclature.