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Project Name: Scios
Location: Sunnyvale, CA
Architect: Triad Technologies Inc., Life Sciences.
Project
Synopsis
This
design-build project consisted in the complete architectural, process
piping, electrical system and mechanical system remodel of a 5,000 sq.
ft. cGMP Pharmaceutical plant used for the production of clinical trial
materials for Natrecor.
Natrecor was approved by FDA in 2001 for the treatment of patients with
acutely decompensated congestive heart failure who have dyspnea (shortness
of breath) at rest or with minimal activity.
Upgraded systems include: WFI, RO/DI, plant and clean steam, HVAC system
with humidification, standby power, glycol cooling system for process,
steam system, cold rooms, rare gases, fermentor piping and installation,
pharmaceutical quality air, depyrogenation system, stainless steel industrial
sewer system with kill system.
All of the
facility is classified as Class 100000 clean rooms. The fermentation room
and adjacent rooms are class 1000 clean rooms.
The original plant had been built with major deficiencies by a major general
contractor.
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