Location: Taiwan, Republic of China
Area: 30,000 m2
Project Cost: Confidential
Bio-containment level: BSL3
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The Republic of China (ROC) with the outbreak of SARS and avian flu have deemed it a national priority to become self-sufficient in terms of research during past, present and future pandemics.
PharmEng provided the GMP and design expertise to ensure that this facility will meet regulatory requirements internationally.
This facility encompasses research laboratories and pilot plants for viral vaccines, bacterial vaccines, and biological products.
The facility has been operating since 2008 when construction was finished.
Responsibilities:
- Functional Flow Specifications
- Conceptual Design
- Design Review
- Contract Documents
- Commissioning
- Validation
- Compliance with FDC – cGMPs
Validation Activities Included:
- Master Validation Plan
- Utility Validation (HVAC, Water for Injection, BMS, Standby Generator, Compressed Air, Vacuum)
- Equipment Validation (Fermentors, Lyophilizer, Filling & Packaging Equipment, Autoclave, Biosafety Cabinets, Fumehoods, Freezers, Refrigerators, Incubators)
- Process Validation & Cleaning Validation
Location:
Taiwan, Republic of China
Area:
30,000 m2
Project Cost:
Confidential
Bio-containment level:
BSL3
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