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如何应用现代化生物制药技术快速实现GMP认证设施的升级
蒲公英制药论坛首发
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tt Upgrading of Biopharma Facilities
h for GMP Compliance,
by Implementation of Advanced Technologies
Wilfried Kappel, Sartorius Stedim Biotech
2013 ISPE-CCPIE China Conference 蒲公英制药论坛首发
Topics
Introduction
Hybrid Systems
Case Study Fermentation Expansion Project
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Automation of Hybrid Systems
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Case Study Buffer Storage and Distribution
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Engineering for Hybrid Systems
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Conclusion
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Upgrading of Biopharmaceutical Facilities for GMP Compliance by Implementation of Advanced Technologies
Slide 2
Upgrading of Process Equipment for GMP Compliance
蒲公英制药论坛首发
Extension of plants with new process systems
CIP upgrades for existing plants without CIP capabilities
Higher automation level, e.g SIP temperature monitoring
CFR 21 Part 11 compliant Batch Reports
Added functionality resulting from process optimization com
- e.g. additional feedings ao.
Convert open systems to closed sys
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