DURALINE SYSTEMS STERI-DOT Process Indicators for Ethylene Oxide (EO) Sterilization Instruction Manual
- June 9, 2024
- DURALINE SYSTEMS
Table of Contents
DURALINE SYSTEMS STERI-DOT Process Indicators for Ethylene Oxide (EO)
Sterilization
INSTRUCTION FOR USE
Steri-Dot process indicator is an Ethylene Oxide indicator, designed to
display a distinct color change after exposure to EO sterilization. The
indicator consists of EO-sensitive chemical ink printed on one surface of a
circular-shaped adhesive paper (“Dot”). The chemical ink will change color
from purple-red to green during EO sterilization exposure. The endpoint color
is stable and will not revert under specified conditions of storage, although
some minor fading may occur over time.
Sterilization parameters necessary to change color of the indicator are the
following:
- The concentration of Ethylene Oxide
- The relative humidity level
- Exposure temperature
- Time of exposure
The Steri-Dot process indicator is certified by Propper to perform in accordance with the requirements of ISO 11140:2014-1, Type 1 with the following stated values:
- 54oC, 600mg EO, 20 min, 60%RH
- 37oC, 600mg EO, 25 min, 60%RH
The indicator is suitable for the following typical cycles used in healthcare:
| TEMPERATURE | ETHYLENE OXIDE | RH% | EXPOSURE TIME |
|---|---|---|---|
| 37°C | 736 mg/l | ≥35% | 3 hours |
| 37°C | 759 mg/l | ≥35% | 3 hours |
| 54°C | 600 mg/l | 40-60% | 45 min or longer |
| 54°C | 736 mg/l | ≥35% | 1 hour |
| 55°C | 759 mg/l | ≥35% | 1 hour |
| 55°C | 600 mg/l | 40-60% | 4 hours |
HOW TO USE STERI-DOT® PROCESS INDICATOR AND INTERPRET THE RESULTS:
One or more Steri-Dot process indicators should be placed on the external (exposed) surfaces of each package in a load. Each indicator on each package should be positioned to allow sufficient contact of the indicator with the processing environment. An indicator color change from purple-red to any shade of green indicates exposure to EO process, but not necessarily an adequate sterilizing exposure. Failure of the indicator to achieve the green color indicates:
- The package or load was not processed at all
- The package was sterilized in a wrong process (Steam, VHP, Dry heat)
- Substantially inadequate exposure to one or more of the critical process variables
Process failure must be reported to the supervisor. Hospital protocol for
reprocessing loads must be observed.
Indicator disposal should be in accordance with existing laws and regulations
for disposal of non-hazardous
chemical waste.
Unprocessed Steri-Dot indicators should be stored below 32oC and 70% relative
humidity. When stored as indicated, this product has 42 months shelf life from
the date of manufacture. For record keeping purposes, use the same storage
conditions and protect from light.
Duraline BioSystems, Inc – 39 Western Hwy, West Nyack, NY 10994
877-561-0500
[email protected] –
www.duralinesystems.com