GMP Compliant Cleanroom for STERIS
We delivered a fully-flush cleanroom, with EU GMP compliant pressure cascades and air handling to deliver the high air change rate and low particulate concentration levels required for STERIS.
Key facts
6 zones
For medical device and biological indicator testing
EU GMP cleanroom qualification
Covering DQ, IQ, OQ and PQ
GMP compliant features
Pressure cascades, in-duct UV disinfection, interlocks, coved floor and control system
Temperature and humidity control
21±2ºC and 40-60%RH
What did our client need?
STERIS is a leading provider of infection prevention and other procedural products and services. They required a GMP cleanroom suite comprising of 6 zones for medical device and biological indicator testing, as well as pharmaceutical testing.
How did we help our client?
We delivered a fully-flush cleanroom, with EU GMP compliant pressure cascades and air handling to deliver the high air change rate and low particulate concentration levels required. HVAC delivers a temperature of 21±2ºC and 40-60% Relative Humidity. Safe-step walkable lighting supports maintenance requirements and provides the correct lux levels for task work.
How did our client benefit?
The cleanroom was designed with EU GMP compliant features such as in-duct UV disinfection, interlocks on both materials and people transfer, an antibacterial coved vinyl floor and an ECO control system with alarm function and batch control.
C2C also provided EU GMP cleanroom qualification, covering DQ, IQ, OQ and PQ.
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