Chemical Indicators for Steam Sterilization

6 ISO Types for Typical Life Science Applications

TYPES WHAT THEY INDICATE APPLICATION EXAMPLE STERIS LIFE SCIENCES PRODUCTS

TYPE 1: One or more critical
Process variables in the
sterilization process
The unit has been Autoclave tape or chemical indicator VERIFY™ Valueline Class 1 Steam Chemical
directly exposed to the strips Indicator
sterilization process (PCC009)
Located inside or attached to the
outside of packs Steam Indicator Tape
(260010)
Provide visual confirmation of
exposure to
sterilization process

TYPE 2: Defined in relevant sterilization standards for specific Bowie-Dick test packs Steraffirm® Bowie-Dick Test Pack
Specific-Use test procedures (EQC003)
Test air removal in a prevacuum
steam sterilization cycle VERIFY™ Bowie-Dick Test Packs
(EQC009, EQC010)

Daily Air Removal Test–DART®

(NB113, NB215)

VERIFY™ Bowie-Dick Test Card

(S3095)

TYPE 3: One critical variable in Exposure to a Chemical pellet Not currently available
Single-Variable the sterilization sterilization process
process at a stated value Melts at a specified temperature
(SV) of the variable
Demonstrates the steam sterilization
process has achieved a specified
temperature

TYPE 4: Two or more critical
Multi-Variable variables in the
sterilization process
Exposure to a Chemical indicator tubes Steraffirm™ Sterilizer Control Tube
sterilization cycle at Steam at 121°C/250°F for:
stated values (SVs) Change color only when exposed to a -15 minutes
of the variables given temperature for a specified (PCC024)
time in a steam sterilization -12 minutes
(PCC025)

TYPE 5: All critical variables in Stated values (SVs) Moving front indicators VERIFY™ Steam Integrating Indicator
Integrating the sterilization meet or exceed (PCC065B, PCC065, PCC064)
process performance Respond to all critical process
(Integrators)
requirements in the parameters
ISO 11138 series for
biological indicators

TYPE 6: All critical variables for Stated values (SVs) Cycle-specific indicators Steraffirm™ Steam Class 6 Emulating Indicators
Emulating specified sterilization are generated from -121°C/250°F for 15 minutes
cycles the critical variables Typically placed in the pack, pouch or (PCC012)
(Cycle Verification)
of the specified container
sterilization process
Respond to all critical process
parameters for a specified
sterilization cycle

Critical Variables in Steam Sterilization TIME TEMPERATURE STEAM

Mentor, OH | sterislifesciences.com | Phone 1-440-354-2600 | lifesciences@steris.com LSFC-BR4166.F-IT-E 09/2018