3M™ Comply™ (SteriGage™) Steam and EO Chemical Integrators

The steam chemical integrators are Class 5 integrating indicators which are designed to react to all critical variables. These chemical integrators are used for pack control as a method for monitoring sterilization process conditions inside each pack. The 3M™ Comply™ Steam Chemical Integrators can also be used inside a process challenge device (PCD) to release processed items, excluding implants (load control). Use for this purpose does not replace the use of biological indicators.

3M™ ComplyTM) Steam Chemical Integrators consist of a paper wick and steam and temperature sensitive chemical pellet contained in a paper/film and foil laminate envelope. Steam enters the permeable topside of the device - the chemical pellet melts and migrates as a color along the paper wick; the distance or extent of migration depends on exposure to steam, time, and temperature. The migration is visible through a window marked Accept or Reject. The color should enter the Accept window for an Accept result. If the color has not entered the Accept window, a reject result is indicated.

Used in all 245-280°F/118-138°C steam sterilization cycles.

3M™ Comply™ EO Chemical Integrators consist of color chemistry on an absorptive strip contained in an envelope of paper/film/foil sealed on all but one side. Ethylene oxide (EO) and moisture enter the unsealed side of the integrator and turn the strip at that point from yellow to blue. The distance or rate of migration of the blue color is influenced by all the critical parameters of EO sterilization (i.e., EO concentration, relative humidity, time and temperature). The blue color migration is visible through windows marked Accept or Reject. For an Accept result, the strip inside the integrator will turn blue and enter the Accept window. If the blue color has not migrated into the Accept window or any yellow color remains in the Reject window, a Reject result is indicated.

This chemical indicator can only be used in warm 120-145°F/49-63°C and cool 85-100°F/29-38°C cycles in EO/HCFC gas mixture sterilization processes.

3M™ Comply™ Chemical Integrator Extendors - A paper extension that can be attached to an integrator using the adhesive strip attached to the extendor.