North Bay/Bioscience, LLC - Chemical Indicators/Integrators

Raven ProChem SSI (box of 250)

Easy to Interpret
Measures time, temperature and presence of steam
Instant visual verification of adequate steam penetration into the pack/pouch
510K Notified as a Steam Integrator at 132°C to 135°C
Behaves as a Process Indicator at 121°C
White to Black color change is not reversible
An integral part of a comprehensive sterility assurance program

Use ProChem SSIs to verify adequate steam penetration into every pack/pouch. The indicator ink changes from white to black during steam sterilization. Tests have shown that ProChem SSIs complete their color change at a time equivalent to or beyond the time needed to kill Biological Indicators. Use according to instructions. ProChem SSIs are packaged 250 per box.

This product has received 510K notification for use as a steam integrator at 132°C to 135°C, and is manufactured in an FDA registered facility pursuant to FDA Quality System Regulations (QSRs). Use ProChem SSIs in conjunction with BIs as described in current AAMI Standards and Recommended Practices: Good Hospital Practice: Steam Sterilization and Sterility Assurance.

Chemical Indicators/Integrators

Chemical indicators show that the package has been exposed to the physical conditions within a sterilizer; they do not prove that sterilization has taken place.
There are several types of chemical indicators available. Each type is meant to monitor specific parameters such as time, temperature, and/or the presence of steam or gas.
External chemical indicators which are placed on the outside of the package and should be checked after the sterilization process.
Internal chemical indicators which are placed within the package in an area that is least accessible to the sterilant and should be checked at point-of-use. If parameters are not met, the product should NOT be considered sterile and should be reprocessed before use.
A special type of chemical indicator, called a chemical integrator measures time, steam, and temperature.
Chemical indicators are best when used with every load or at least once daily. Follow the chemical indicator manufacturer's instructions for interpretation of results.

Centers for Disease Control and Prevention (CDC)
Guidelines for Infection Control in Dental Health-Care Settings --- 2003

MMWR December 19, 2003 / 52(RR17); 1-61.

F. Sterilization Monitoring

1. Use mechanical, chemical, and biological monitors according to the manufacturer's instructions to ensure the effectiveness of the sterilization process (IB) (248,278,279).

6. Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number) (IB) (2,9,243,247,278,279).

7. Use a biological indicator for every sterilizer load that contains an implantable device. Verify results before using the implantable device, whenever possible (IB) (243,248).

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