– Sterilisation or bio-contamination is a process validated and used to render the environment of an isolator or any other enclosed system free of viable micro-organisms by using an antimicrobial gas (EN 13 824).
– Surfaces are bio-decontaminated by spraying a sterilising agent.
– The product used is Hydrogen Peroxide (H202 concentration 35%).
– The bio-decontamination sterilisation of a surface is certified compliant following the reduction of Geobacillus Stearothermophilus ATCC 7953 and ATCC 12980 bio-indicators to 6 log.
Characteristics
– Mobile or integrated device
– System configuration according to the volume to be decontaminated
– Automated operation
– Traceability of operating data according to GMP/GAMP/21 CFR Part 11 standards
– 304L stainless steel or anodised aluminium enclosure
– Touch-screen
– Printer + USB outlet
– Structure on self-locking wheels
– Programming of volume to be sterilised and rinse time
– Control of injected volume of sterilising agent using a mass flow meter
– Diffusion flow rate control
– Temperature control