– 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 Peracetic Acid (PPA concentration 4.5%).
– The bio-decontamination sterilisation of a surface is certified compliant following the reduction of Bacillus Atropheus ATCC 9372 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 enclosure
– Touch-screen
– USB outlet
– Manual programming of volume to be sterilised and rinse time
– Visual check of volume of sterilising agent and residual volume of sterilising agent
– Electronic control of evaporation temperature
– Control of compressed air flow
– Pressure of clean and dry compressed air system 3.5 to 6 bars
– Sterilising agent consumption: 60 to 80 ml/hr
– Recommended usage flow and pressure: 50 to 70 l/min at 1 bar
– Decontamination temperature: Ambient +/- 1°C