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Facility Commissioning,
Qualification, and Validation
U.S. biotech and pharmaceutical facilities must comply with the FDA's current Good Manufacturing Practices (cGMPs). The validation effort documents that a facility's design meets the intent of the cGMP's. We can help you design your facility from the ground up. Our key competencies lie in state-of-the-art laboratories, cGMP areas, pilot plants, facility automation and advanced process controls and specialized utility systems e.g. for sterile manufacture.
PSC consultants are experts at Commissioning new facilities, performing HVAC Validation, and validating other systems as part of a facility qualification/validation
Utilities/Facility Systems:
- Water Systems
- USP Purified
- Water-for-Injection (WFI)
- Reverse Osmosis
- Deionized
- Ozonation
- Clean Steam
- Clean-in-Place/Steam-in-Place
- Compressed Gases
- Air
- Carbon Dioxide
- Oxygen
- Nitrogen
- Helium
- Ethanol Supply Systems
- Process Glycol Systems
- HVAC
- Chilled Water Systems
- Airflow Studies
- Clean Room
- Class 100
- Class 10K
- Class 100K
- Building Management System (BMS) and Process Monitoring
- Emergency Generator and Uninterruptible Power Supply
- Manufacturing Requirements Planning (MRP)
- Adverse Event tracking and Reporting Systems
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