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Cerilliant's operations are located in Round Rock, Texas, just north of Austin,
in a light industrial park. Its current operations are housed in approximately 44,000
square feet of leased space, of which approximately 60% is dedicated to its production
operations. The remainder of the space is dedicated to sales and administrative
functions.
The production area includes segregated suites for organic synthesis work (bench
scale to multi-kg); isolation suites for synthesis of toxic, hazardous, or light
sensitive materials; cGMP synthesis suites; reference standard manufacturing; ampoule
filling, powder filling, packaging; analytical testing; shipping; receiving; and
material storage areas for bulk and finished products. Cerilliant’s facility is
designed to meet the specifications outlined in cGMP 21CFR211.
Cerilliant's synthesis suites are negative pressure, controlled environments with
sophisticated air handling and ventilation systems. Isolation suites and controlled
environment chambers are available for the production and handling of toxic and
sensitive materials. The cGMP areas are isolated, positive pressure, controlled
environments with dedicated and sophisticated air handling, ventilation, and environmental
monitoring systems. All production areas are equipped with UV light filters and
environmental conditions are continuously electronically monitored. Material storage
areas include 4300cf of cold storage, including subfreezer, ambient storage and
DEA approved vault storage for controlled substances. All material storage units/areas
are mapped and continuously monitored through the use of a validated electronic
monitoring system.
The facility is controlled access and is monitored through the use of video surveillance
and various electronic alarm components as well as third party monitoring and after-hours
security. Critical systems are supported by an uninterrupted power supply and a
back-up generator.
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