ProChem EXT
15 May 2007
The lethality of a steam steilisation cycle is validated by use of a suitable biological indicator consisting of Geoacillus stearothermophilus spores of a designated control strain. The result from a biological indictor is then developed by incubating the spores with tryptone sy broth and checking for the absence of subsequent germination and growth.
Although current products (Pro Spore and Pro Spore 2 indicators) are designed to give results rapidly (within 24 hours), they do not provide an immediate indication that the sterilisation cycle has been correctly performed.
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 clearly changes colour, from green to black, upon exposure to adequate sterilization conditions for 7min at 135°C and 20 minutes at 121°C, representing an overkill or extended cycle.
Features include:
- Class 5 integrator
- Extended timing beyond biological kill
- Clear, distinct and non-reversible color change
- 510K notified as a steam integrator at 121°C and 132°C to 135°C
ProChem EXT is intended for use in steam sterilizers at 121°C or 132-135°C as an immediate indicator of cycle performance. ProCHem EXT is 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, and steam sterilization and sterility assurance. Use according to instructions on box.
