Bio-decontamination systems
JCE Biotechnology designs and manufactures a wide range of surface bio-decontamination systems for all types of equipment, including isolators, controlled-environment zones, containers, transfer airlocks, and all types of hermetic systems and equipment requiring the reduction of Geobacillus Stearothermophilus or Bacillus Atropheus spores to 6 log.
STELEC® PAA
Principle
– 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
STELEC® H202
Principle
– 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