Biotechnological, pharmaceutical, and medical device facilities must comply with the FDA’s current Good Manufacturing Practices (cGMPs). The validation process 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 the commissioning and qualification of facilities and of utilities necessary to bring a facility on-line. Our facility experience includes, but is not limited to, the following:
- HVAC systems
- Airflow Studies
- Clean Rooms
- Class 100-100k
- EU Grade A-D
- Building Management System (BMS) and Process Monitoring
- Emergency Generator and Uninterruptible Power Supply (UPS)
If you would like more information, get in contact with us directly here.