Project Description
Chemical Process Indicators (CPIs)
For Monitoring Radiation (Gamma or E-beam)
ISO 11140-1 Type 1
Product Description
Goldcrest Radiation Chemical Process Indicator labels contain no lead or other toxic heavy metals. The Indicators are manufactured to monitor whether radiation conditions were met at the point of application using latex-free pressure sensitive adhesive, The Indicators are designed for use with irradiation doses as low as 10 kGy.
Physical Properties
| Process | Radiation (Gamma or Ebeam) |
| Dimensions | 12.5 mm Standard or Bespoke to order |
| Packaging | 5,000 Standard Indicators/Roll |
| Chemical Indicator | Initial Colour: Yellow
Signal Colour: Red |
Indications for Use
Type 1 Process Indicator
- 10 kGy
Instructions for Use
Use an Indicator on each item, pack, peel pouch or tray intended for irradiation exposure. Process packages/items as required. Upon exposure to irradiation, the Indicator will transition from Yellow to Red. The transition colour may vary depending on the load configuration, length and conditions of the dose. A colour transition from Yellow to a shade of Dark Orange/Red provides indication to exposure to radiation. The longer the dose the deeper the signal colour will become. If signal colour is not achieved, this suggests ideal conditions were not met. If the load was not successfully processed, re-process the load using a new Indicator.
The chemical reaction which causes the colour transition is a radiation specific reaction and is irreversible under most conditions. Post exposure storage near pH basic environments such as reagents or cleaning product fumes may cause involuntary reversion from Red back to Yellow/Orange.
Performance Characteristics
Colours shown are representations of printed ink initial and signal colours but may vary from actual use.
The signal colour from exposure to irradiation may vary from the example above due to differences in processing parameters (i.e. load content, cycle time, dose, etc.). For a Type 1 Process Indicator, a colour change to a shade of Orange/Red produced during exposure to irradiation which is difference from the initial colour is considered acceptable.
Compliance
ISO 11140-1:2014 Sterilization of health care products – Chemical Indicators – Part 1: General requirements for Type 1 Chemical Process Indicators
Storage and Shelf Life
Disposal
Discard as general waste.