Model: JPS-FORM-BI

Formaldehyde Biological Indicator

In Stock

CE / FDA / ISO 11138

Self-Contained

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.

Wholesale Price (FOB)

$0.60 - $1.60 / Vial

MOQ

50 Boxes

Quantity:

(Boxes)

Product Data Sheet

Download IFU & Certification (PDF)

Product Details

Technical Specs

Packaging & Shipping

Video Demo

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 Name	Formaldehyde Biological Indicator (Self-Contained)
Test Organism	Geobacillus stearothermophilus (ATCC 7953)
Spore Population	≥ 1.0 x 10^5 or ≥ 1.0 x 10^6 per vial
Sterilization Method	Low-Temperature Steam and Formaldehyde (LTSF)
Incubation Time	Typically 48h (Verify specific IFU)
Incubation Temp	55°C - 60°C
Result Indication	Media changes color (e.g., Purple to Yellow) if spores survive (Fail)
Label Indicator	Chemical indicator changes color when processed
Compliance	ISO 11138-1, ISO 11138-5
Shelf Life	18-24 Months (Store at room temp, away from sterilants)

Packing Configuration

Packaging Unit	Vials/Box	Boxes/Carton
Standard Box	50 or 100	20 or 40

Storage Instructions

Store between 15°C and 30°C.
Do NOT store near sterilants or chemical fumes.
Protect from direct sunlight.

Protective inner box packaging

How to Activate and Incubate Formaldehyde BIs

Watch on YouTube

OEM & Customization Options

We provide contract manufacturing services for biological indicators to meet your brand's specific requirements.

Custom Population

Specific spore populations based on testing needs.

Custom Vial Labels

Your logo, lot numbers, and branding printed directly on the BI vial label.

Custom Packaging

Bespoke box design and instructions for use (IFU) in your required languages.

Incubation Times

Development of media for specific standard or rapid readout incubation times.

International Certifications

CE (EU MDR)

FDA Cleared

ISO 13485

ISO 11138-1 & 5

Advanced Biological Manufacturing

Our biological indicators are manufactured in high-level cleanrooms under strict aseptic conditions. We maintain our own culture collection to ensure the highest traceability and consistency of the spore crops.

ISO

Class 7 Cleanroom

100%

Batch Testing

Quality Assurance (Biological)

1

Population VerificationStrict testing to verify the exact spore count per batch.
2

D-Value CalculationDetermining the resistance (D-value) in a certified resistometer.
3

Survival/Kill TestingVerifying performance within specified LTSF survival and kill times.
4

Media Sterility & GrowthEnsuring culture media is sterile but highly capable of supporting growth.

Frequently Asked Questions

What temperature is required for incubation?

BIs utilizing *Geobacillus stearothermophilus* require incubation at temperatures between 55°C and 60°C. You will need a specific biological indicator incubator for this purpose.

How often should I use a biological indicator?

Standards typically recommend using a BI during sterilizer qualification and routinely based on facility protocols and local regulations (often weekly or daily).

What do I do with a positive (failed) BI result?

A positive result signifies a sterilization failure. The entire load must be recalled and reprocessed. The sterilizer must be taken out of service, inspected, repaired, and re-qualified with multiple consecutive successful BI tests before returning to use.

Get a Wholesale Quote Today

Partner with JPS Medical for your sterilization consumable needs. Our export team typically responds within 12 hours.

Factory Direct Pricing
Free Samples Available
Low MOQ for Trial Orders