- 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.
- 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 (Data available upon customer
request) Use according to instructions.
ProChem SSIs
are packaged 250 per box, with 16 boxes per case.
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.
Ethylene Oxide Integrator- Complete color change after sufficient exposure
to four critical parameters: EO concentration, RH, Time, and Temperature.
Acceptable for use in 100% EO or one of the HCFC blends.
- Shows Fail at 15 Minutes (600mg/L, 40-60% RH, 54°C)
- Shows Pass at 45 Minutes (600mg/L, 40-60% RH, 54°C)
- Reference standard printed on each integrator.
- Easy to interpret, distinct, non-reversible color change.
- 510K notification and meets AAMI, EN 867-1*, EN 867-2 Class D
and ISO 11140-1 Class 5 Integrator.
| Catalog # CI-EOINT |
250/box |
16 boxes/case |
Expires 2 years from date of manufacture
*Contact Raven for specifications sheet
|
|
