Biological Indicators

We offer ETO Self Contained Biological Indicators (BI) - which assist in monitoring ETO Machines for proper ETO Sterilization in CSSD.

These are Class 5 Indicators also called Integrating Indicators designed to react to all critical variables like ETO Gas, Temperature, Time which eventually lead to killing of the bacterial spores.

Construction

• ETO Biological indicators contain bacterial spores (Bacillus atrophaeus ATCC 9372) on a small paper carrier packaged with a special plastic tube
• Population of Geobacillus Spore is 1x10 ^{6  or 1x10} 5
• Inside the Tube, a sealed-glass ampoule with a culture medium contains a color indicator which turns dramatically to yellow when spores grow
• Accurate indicator color chance
• A Class 1 Process Indicator on the label of the BI which changes color from Pink to Brown

Steps for Use

• Write the ETO Machine Number, Load number and processing date on the ETO BI label
• For Usage, place the BI in the ETO machine (Preferably Centre of the Load) and run the full cycle for the ETO Machine (8 hours - 12 Hours as per Hospital Protocol)
• On completion of aeration cycle remove the BI from Machine
• The Class 1 Process Indicator on the BI Label will change color to Green which shows successful completion of the ETO Sterilization Process
• Crush the Glass Ampoule which mixes the Paper Carrier with the Culture medium
• Incubate the BI at 37°C in a Incubator for 48 Hours
• If the color changes from Blue to Yellow, it means that Sterilization Failure has occurred and there is growth of Spores in the BI
• This would entail checking the machine and getting it repaired for proper parameters
• If there is no color change, the ETO Sterilization is a pass and the ETO Machine is ok for use

Features

• Process Indicator conform to ISO 11138 for BI's
• A Specially formulated Synthetic Medium allows to get result in short times
• Best and most stringent Indicator to show the performance of an ETO Machine i.e. Killing of Bacterial spores
• With a BI test pass, you can be assured of your ETO Machine to be working perfectly
• Each BI offered by PSI comes with a Lot/ Bacth Number, Expiry date
• Helps in NABH/QCI Documentation for CSSD

Biological Indicators (BI)

We offer Steam Self Contained Biological Indicators (BI) - which assist in monitoring Autoclaves for proper Steam Sterilization process in CSSD.

These are Class 5 Indicators also called Integrating Indicators designed to react to all critical variables like Steam, Temperature, Time which eventually lead to killing of the bacterial spores.

Construction

• Steam Biological indicators contain bacterial spores (Geobacillus stearothermophilus ATCC 7953) on a small paper carrier packaged with a
  special plastic tube
• Population of Geobacillus Spore is 1x10 ^{6  or 1x10 5}
• Inside the Tube, a sealed-glass ampoule with a culture medium contains a color indicator which turns dramatically to yellow when spores grow
• A Class 1 Process Indicator on the label of the BI which changes color from Pink to Brown

Steps for Use

• Write the Autoclave Number, Load number and processing date on the BI label
• For Usage, place the BI in the Autoclave machine within a pack/tray and run the full cycle at 121°C - 134°C for Pre vacuum Autoclave and 121°C for Gravity Displacement
• On completion of cycle remove the BI from the Tray/ Pack and let it cool for 5-10 min
• The Class 1 Process Indicator on the BI Label will change color to brown which shows successful completion of the Steam Sterilization Process
• Crush the Glass Ampoule which mixes the Paper Carrier with the Culture medium
• Incubate the BI at 58°C in a Laboratory Incubator for 24 Hours
• If the color changes from Purple to Yellow, it means that Sterilization Failure has occurred and there is growth of Spores in the BI
• This would entail checking the machine and getting it repaired for proper parameters
• If there is no color change, the Sterilization is a pass and Autoclave is ok

Features

• Process Indicator conform to ISO 11138 for BI's
• A Specially formulated Synthetic Medium allows to get result in short times
• Best and most stringent Indicator to show the performance of an Autoclave Machine i.e. Killing of Bacteria spores
• With a BI test pass, you can be assured of your Machine to be working perfectly
• Each BI offered by PSI comes with a Lot/ Bacth Number, Expiry date
• Helps in NABH/QCI Documentation for CSSD