Photon Instant Biological Indicator for Steam Sterilization

Packaging: Box contains 50 pieces

The Photon Instant Biological Indicator for Steam Sterilization is an ultra-rapid, self-contained biological indicator (SCBI) designed for routine monitoring and efficacy evaluation of steam sterilization processes in healthcare and industrial applications. Inoculated with a minimum of 1,000,000 (10^6) viable Geobacillus stearothermophilus spores, it pairs exclusively with the Bionova Photon Auto-reader Incubator (BPH) to deliver an automated, highly sensitive fluorescence readout in just 7 seconds.

Features:

• Ultra-Rapid Readout System: Delivers a final fluorescence result instantly (7-second readout) at 60 ± 2 °C with a diagnostic sensitivity of 97% or higher.
• Dual-Verification Mechanics: * Primary Result: Instant automated fluorescence interpretation at 7 seconds.
  • Secondary Optional Confirmation: Visual pH colorimetric transition after 48 hours of incubation. Failed cycles shift from purple to green, then yellow; successful cycles remain purple.
• Built-in Chemical Indicator: Features a chemical process indicator line on the label that shifts from pink to brown when exposed to steam, confirming immediate processing.
• Validated Sterilization Cycles: * Gravity-Displacement: 132 °C for 10, 15, or 25 minutes, and 135 °C for 10 minutes.
  • Dynamic-Air-Removal: 132 °C for 4 minutes and 135 °C for 3 minutes.
• Regulatory Compliance: Conforms to ISO 13485:2016, ISO 11138-1:2017, and ISO 11138-3:2017. FDA De Novo cleared (DEN220042) and ANMAT PM 1614-1 authorized.
• Storage : Store in a dark place in its original box at 10 to 30 °C and 30 to 80% relative humidity. 

Documents:

• Brochure
• Instructions for Use
• Product Classification Descision