Formaldehyde Biological Indicator

Shanghai JPS Medical Co., Ltd. · #JPS-FORM-BI · source

Formaldehyde Biological Indicator

The JPS Formaldehyde Biological Indicator provides definitive lethality testing for Low-Temperature Steam and Formaldehyde (LTSF) sterilization cycles. These self-contained BIs utilize highly resistant Geobacillus stearothermophilus spores to ensure effective sterilization.

  • Optimized Resistance: Uses Geobacillus stearothermophilus (ATCC 7953) validated for LTSF processes.
  • Self-Contained Convenience: Combines spores and specialized media in a single, safe vial.
  • Clear Interpretation: Distinct color change in the growth media indicates a sterilization failure.
  • Process Indicator Label: Built-in chemical indicator on the vial label for process confirmation.
  • Standard Compliance: Fully conforms to relevant ISO 11138 standards.

Reliable Efficacy Testing for LTSF Sterilization

Low-Temperature Steam and Formaldehyde (LTSF) sterilization requires stringent monitoring due to its complex parameters. The JPS Formaldehyde Biological Indicator provides the necessary assurance that these cycles have successfully achieved sterility.

The self-contained design features a glass ampoule of specialized growth media inside a plastic vial containing the spore disc. After the sterilization cycle, the ampoule is crushed, allowing the media to contact the spores. If any spores survive, they will ferment the media during incubation, causing a distinct color change (typically Purple to Yellow).

Key Advantages

  • Direct Lethality Test: Proves the cycle actually killed highly resistant spores.
  • Self-Contained System: Includes spores and culture media in one easy-to-use vial, minimizing handling errors.
  • Clear Interpretation: A definitive color change in the media indicates a failed cycle after incubation.
  • Built-in Chemical Indicator: The label on each vial features a chemical indicator to instantly show it has been processed.
  • Optimized Incubation: Media formulated specifically for recovery of spores exposed to formaldehyde.
  • Compliance Guarantee: Essential for load release and routine LTSF sterilizer qualification.

Product Information

ManufacturerShanghai JPS Medical Co., Ltd.
ModelJPS-FORM-BI
Shelf Life18-24 Months (Store at room temp, away from sterilants)
CertificationCE (EU MDR), FDA Cleared, ISO 13485, ISO 11138-1 & 5
Storage Temperature15°C to 30°C
Sterilization MethodLow-Temperature Steam and Formaldehyde (LTSF)

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