Servicor Completes cGMP Cleanroom for FDA Clinical Trials

<%=company1%> Inc. (San Carlos, CA) has recently completed and fully commissioned a clinical trials facility which meets FDA cGMP's for human drug production. The new cleanroom, located in Northern California, consists of two fully populated suites with dedicated airlock/gown-up entry rooms, and two completely separate and isolated HVAC systems, providing independent control of each suite with no cross-contamination.

According to Servicor, it delivered the facility, which had to certify as Class 10,000 operational (ISO Grade 7, M5.5), under very tight time constraints. The cleanroom suites were retrofitted into an existing light industrial building space that had formerly housed commercial businesses.

One of the two cleanroom suites recently completed by Servicor for a Silicon Valley client.

The Servicor Ultra Style seismically-rated framing system, load-bearing
Unigrid brand ceilings, baked-on powder coated finishes, and innovative new rounded corner detailing are all combined to provide the owner with a flexible and easily cleanable cGMP envelope. Cleanroom Consulting (Syracuse, NY) provided the conceptual (Basis of Design) design package for the project and ICOM Mechanical (San Jose, CA) provided the neutral plenum design HVAC system, which delivers validatable pressure, temperature, and humidity control. ICOM also supplied a process support services package including CO₂ and CDA.

Founded in 1984, Servicor provides clean enclosures for all industries requiring ultraclean environments, including semiconductor, microelectronics, aerospace, pharmaceutical, biotechnology, medical, and food processing industries. Servicor was acquired by Veloz Holdings in February 2000, and is rapidly expanding nationally and internationally to meet customer demand for its flexible, rugged, pre-engineered cleanrooms.

For more information: Reza Kazemi, VP of Sales and Marketing, Servicor, 830 Bransten Rd., San Carlos, CA 94070. Tel: 650-591-0900. Fax: 650-591-3121.

Edited by Angelo DePalma