North Bay/Bioscience, LLC - Chemical Indicators/Integrators

Raven ProChem EXT (box of 250)

Class 5 Integrator
Extended Timing Beyond Biological Kill
Clear, distinct, non-reversible color change
510K Notified as a Steam Integrator at 121°C and 132°C to 135°C

ProChem EXT is a Class 5 Integrating Indicator (Integrator) that is designed to accurately depict the lethality of steam sterilization cycles at 121°C (250°F) and 135°C (275°F). ProChem EXT changes from its green color to black upon exposure to adequate sterilization conditions for 7 minutes at 135°C and 20 minutes at 121°C representing an overkill or extended cycle.

Intended for use in steam sterilizers 121°C or 132-135°C. Not intended to replace regular BI testing. When used as directed, ProChem EXT integrator strips provide immediate visual confirmation of adequate steam penetration into packs. During exposure to steam, the indicator strip turns from green to black. If the strip becomes as dark or darker than the color standard, sterilization conditions were met at point of placement.

ProChem EXT is packaged with 250 integrators per box. Use ProChem EXT in conjunction with BIs as described in current AAMI Standards and Recommended Practices: Good Hospital Practice: Steam Sterilization and Sterility Assurance. Use according to instructions on box.

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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