Radiation Chemical Process Indicators (CPIs) are manufactured to meet performance specifications described in ANSI/AAMI/ISO 11140-1 “Sterilization of health care products - Chemical indicators - Part 1: General Requirements,” for Class 1 Process Indicators. The color transitions are dose dependent. Radiation CPIs are not intended for use as dosimeters, but rather as throughput process indicators used to monitor exposure to radiation processes. Radiation CPIs are intended for use in gamma or e-beam radiation sterilization processes.
Radiation CPIs are labeled with 24 months of shelf life and room temperature storage (23 ± 7°C). The shelf life is based on the date the indicating ink is applied to the substrate. Product may have a shelf life of less than 24 months at the time of purchase. Moderate heat (up to 35°C) will not adversely affect indicators performance. Labeled storage conditions should be observed at all times to maintain optimum sensitivity. Avoid contact or storage of indicators near flourescent lighting and direct sunlight which are forms of radiation.
Exposed indicators are stable and remain the signal color when stored under labeled conditions. Each roll is individually packaged with a certificate of conformance to ensure the products’ quality and consistency.
Radiation CPIs are non-odorous and non-hazardous to use. The printed labels are safe to dispose in general waste receptacles. No MSDS required per CFR.1910.1200.