Chemical Process Indicator Label, Indicator Turns Orange to

Dry Heat Chemical Process Indicators (CPIs) are designed to signal, through a transition in color, when exposed to high temperatures such as dry heat and steam sterilization or depyrogenation processes. The CPIs will transition from the initial to the signal color depending on the temperature and length of exposure (see chart to the right). The CPIs are manufactured to meet the requirements of Crosstex’s Quality System and where applicable have been validated per the standard depyrogenation cycles outlined in USP. NAMSA is an ISO 13485 certified and ISO 17025 accredited facility. Depyrogenation CPIs are not intended to verify sterility or endotoxin levels, but rather to indicate exposure to high temperature processes. CPIs are labeled with 24 months of shelf life at 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. Exposed indicators are stable and will remain the signal color when stored under labeled conditions. Each roll is packaged individually and is accompanied by a certificate of conformance. Each lot of CPIs is tested to ensure the products’ quality, consistency and compliance to NAMSA’s label claims. Crosstex high temperature 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.