Sterilization & Monitoring
Sterilization procedures should be monitored using biological and chemical indicators.
Biological indicators are test systems that contain viable microorganisms with a defined resistance to a specific sterilization process. A passing result for the BI demonstrates that the sterilizer is effective in killing many highly resistant bacterial spores, providing users with a level of assurance in their sterilization process.
Chemical indicators provide immediate verification that items have been processed as soon as they’re removed from the sterilizer, making them a key part of any sterility assurance program.
Steam Spore Strips
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Features
– Biological indicator Spore Strips for monitoring Steam processes consist of:
– An inoculated carrier, 6mm x 30mm strip of Geobacillus stearothermophilus Cell Line 7953
– Utilized to monitor Steam sterilization process efficacy at 121°C – 137°C
– Biological indicator Spore Strips for monitoring low temperature steam processes consist of:
– Inoculated carrier, 6mm x 30mm Spore Strip of Bacillus subtilis Cell Line 35021
– Utilized to monitor Steam sterilization process efficacy at low temperature steam processes of 100°C -121°C
– Available populations: 104 to 106 per Strip
Steam Self-Contained Biological Indicators
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Features
– Spore ampoules:
– Consist of a hermetically sealed glass ampule which contains modified Tryptic Soy Broth (TSB) with a pH indicator and Geobacillus stearothermophilus Cell Line 7953
– Utilized to monitor Steam sterilization processes at 121°C to 137°C and are ideal for monitoring liquid steam sterilization cycles
– Rigid Biological Indicator:
– Consist of a polycarbonate vial and a polypropylene cap
– An inoculated carrier (disc) of Geobacillus stearothermophilus Cell Line 7953
– Utilized to monitor Steam sterilization processes efficacy at 121°C to 140°C and are ideal for monitoring non-liquid steam sterilization cycles
– Available populations: 104 to 106
Steam Monitoring Chemical Indicators
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Features
Type 1 Process Dots and Autoclave Tape
– Utilized to monitor whether exposure conditions were met at the point of placement of the indicator
– The indicators are designed for use in steam sterilizers operating at 121°C to 137°C
Type 2 Bowie Dick Tests
– The Test Packs are for use in pre-vacuum steam sterilizers operating at 121°C and 134°C
– Utilized to evaluate the efficacy of air removal and steam penetration in pre-vacuum sterilizers
Type 4 Strips
– Intended for use with individual materials (i.e. pouches, pack. Tray) to demonstrate that the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods
Type 6 Emulating Indicators
– React to all critical variables (time, temperature and moisture) and reach an end point colour indicating exposure to conditions as defined by the manufacturers stated values
Bowie Dick Tests
VH2O2 Plasma Steel Spore Discs
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Features
– Steel Spore Discs for monitoring VH2O2 processes consist of
– An inoculated carrier, 6mm steel disc of Geobacillus stearothermophilus Cell Line 12980/ 7953
– Primary packaging either in Tyvek®/Mylar® pouches (SDGM-06) or Tyvek® pouches
– The Spore discs are designed to monitor VH2O2 sterilization process efficacy
– Available populations: 103 to 106
VH2O2 Plasma Self-Contained Biological Indicators
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Features
– Mini Self-Contained Biological Indicators (MSCBIs) for monitoring VH2O2 processes consist of:
– A polypropylene vial and cap
– A crushable media ampule which contains modified Tryptic Soy Broth (TSB) with a pH indicator
– The modified TSB will transition from the initial purple colour to Yellow and/or demonstrate turbidity in the presence of bacterial growth
– An inoculated carrier (disc) of Geobacillus stearothermophilus Cell Line 7953 with a population level of 10⁶
– Utilized to monitor VH2O2 efficacy in equipment and process validation and routine monitoring
VH2O2 Spore Suspensions
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Features
– Pure suspensions of spores suspended in Water for Injection consist of:
– A suspension of viable spores with a known population and resistance Packaged in a vial with screw cap and septum for access with a syringe or pipette
– Organism: Geobacillus stearothermophilus Cell Line 12980/ 7953
– Utilized for direct inoculation onto samples for sterility, bio burden and bacteriostasis testing
– Available populations: 106 to 108