Biotech, pharmaceutical, and medical device 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. PSC’s core competencies are in the validation of 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 validation consultants are experts in commissioning and qualification of facilities and utilities to bring a facility on line. Our facility experience includes but is not limited to the following:
Facility Systems:

• HVAC systems
• Airflow Studies
• Clean Rooms
• Class 100
• Class 10K
• Class 100K
• Building Management System (BMS) and Process Monitoring
• Emergency Generator and Uninterruptible Power Supply (UPS)

If you have a need for Facility Qualification, please Contact Us.