Tuttnauer Process Challenge Device (PCD)

Hardware kit for validation and daily testing of VHP H₂O₂ plasma sterilizer penetration. Designed to simulate worst-case sterilization scenarios with lumens up to 4 meters in bidirectional configuration and 1.4 meters one-sided. Includes 1 mm diameter lumens and cavity for chemical indicator placement. Used to verify effective H₂O₂ vapor penetration into complex device geometries during daily confidence testing and formal validation (IQ/OQ/PQ). Compliant with ISO 11140, ISO 14937, and AAMI ST58 standards. Kit has no predefined shelf life when used according to operation manual and undamaged.