Extrait
Contents
Abstract
1.0 Introduction
1.1 Aims/objective
2.0 Detail of the process
2.1 Process description
2.2 Raw material required
2.3 Equipment required
2.4 Staff Involved
3.0 Design of Manufacturing facility
3.1 Plant location
3.2 Plant layout
3.21 Layout of the Plant site appendix 1
3.22 Layout of the Production House appendix 2
3.3 Manufacturing Flow.
3.4 Room Specification data sheets appendix 3
4.0 Plant Services, Systems and Utilities
4.1 Heating, ventilation and air-conditioning (HVAC) system
4.2 Water
4.3 Clean steam.
4.4 Heat and power
4.5 Cleaning Systems
4.51 Clean in Plane (CIP)
4.52 Sterilise in Place (SIP)
4.6 Cleanrooms
4.7 Process control & instrumentation Instrumentation
5.0 Process Validation and cGMP
5.1 Process Validation
6.0 Gannt Chart
7.0 Costing
8.0 Conclusion
9.0 References
Appendix
Appendix 1 Layout of the Plant site
Layout of the Production House Appendix 2
Gantt Chart Appendix 4
Costing Appendix 5
- Citation du texte
- Sharyar Ahmed (Auteur), 2017, Plant Design and Manufacturing Principles in DNA Vaccine Production, Munich, GRIN Verlag, https://www.grin.com/document/903166
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