GMP Compliant Cleanroom 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

Cleanroom suite for medical device and biological indicator testing, and pharmaceutical testing

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.

GMP Compliant Cleanroom Features - magnehelic gauges to verify pressure cascades, plus an EMS and door interlocking system

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.

LED lighting and HEPA filtration with in-duct UV disinfection

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.