Photon Instant Process Challenge Kit

Packaging: Box contains 25 pieces

The Photon Instant Process Challenge Kit is a compact Process Challenge Device (PCD) designed for routine monitoring, load release, and periodic validation of 132 °C to 135 °C steam sterilizers. Using a porous card challenge system, it detects poor air removal or inadequate steam penetration. The kit features a dual-verification system combining a Type 5 chemical integrator and an ultra-rapid self-contained biological indicator (SCBI) for automated, definitive results in 7 seconds.

Features:

• Integrated Components: Each test pack holds an ultra-rapid SCBI (Bionova BT225), a Type 5 moving-front chemical integrator (Integron IT26-C), and a self-adhesive record card. Separate SCBIs are included to serve as positive controls.
• External Process Indicators (Type 1): The outer box features a Type 1 chemical indicator that turns from blue to dark gray/black to distinguish processed from unprocessed packs. 
• Regulatory Compliance: Manufactured under ISO 13485:2016. Fully complies with ISO 11140-1:2014, ISO 11138-1:2017, ISO 11138-3:2017, and ANSI/AAMI ST79. Authorized under ANMAT PM 1614-4 (Class 1 Risk).
• Storage & Transport: Store in a dark place at 10 to 30 °C and 30 to 80% relative humidity. 
• Shelf Life: Features an 18-month shelf life. 
• Usage Restrictions: Strictly limited to steam sterilization monitoring. Do not expose to or store near Ethylene Oxide (EO), dry heat, radiation, or other chemical/physical sterilization methods.

Documents:

• Brochure
• Instructions for Use