Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments
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| Main Author | |
|---|---|
| Format | Electronic eBook |
| Language | English |
| Published |
Hoboken, NJ :
Wiley,
2022.
|
| Subjects | |
| Online Access | Full text |
| ISBN | 9781119802358 1119802350 9781119802334 1119802334 9781119802341 1119802342 9781119802327 1119802326 |
| Physical Description | 1 online resource. |
Cover
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.