Model: JPS-EO-BI

EO Biological Indicator

In Stock

CE / FDA / ISO 11138

Self-Contained

The JPS EO Biological Indicator provides the most rigorous test for Ethylene Oxide (EO) sterilization cycles. These self-contained BIs utilize *Bacillus atrophaeus* spores to confirm that the sterilization parameters necessary to kill highly resistant microorganisms were achieved.

High Reliability: Contains highly resistant *Bacillus atrophaeus* spores (ATCC 9372).
Self-Contained Design: Simplifies testing and minimizes contamination risks.
Clear Results: Distinct color change in the media indicates a failed cycle.
Chemical Indicator Label: Built-in process indicator for easy identification of processed vials.
Standard Compliance: Fully conforms to ISO 11138 standards for biological indicators.

Wholesale Price (FOB)

$0.60 - $1.50 / Vial

MOQ

50 Boxes

Quantity:

(Boxes)

Product Data Sheet

Download IFU & Certification (PDF)

Product Details

Technical Specs

Packaging & Shipping

Video Demo

The Ultimate Assurance for EO Sterilization

Biological Indicators offer the highest level of confidence in the lethality of an EO sterilization process. The JPS Self-Contained EO Biological Indicator uses a specific strain of bacterial spores (*Bacillus atrophaeus*) that are notoriously difficult to kill with Ethylene Oxide gas.

By surviving the cycle, these spores indicate a failure. If the cycle is successful, the spores are inactivated, and no color change occurs in the specialized growth media during the incubation period. This provides unequivocal proof of sterilization efficacy.

Key Advantages

Direct Lethality Test

Proves the cycle actually killed highly resistant spores, the ultimate test of efficacy.

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.

Incubation Options

Available in standard (typically 48 hours) or rapid readout formats.

Compliance Guarantee

Essential for load release of critical devices and routine sterilizer qualification.

Product Name	EO Biological Indicator (Self-Contained)
Test Organism	Bacillus atrophaeus (ATCC 9372)
Spore Population	≥ 1.0 x 10^6 per vial
Sterilization Method	Ethylene Oxide (EO) Gas
Incubation Time	Typically 48h (Rapid readout options may vary)
Incubation Temp	37°C ± 2°C
Result Indication	Media changes color (e.g., Green to Yellow) if spores survive (Fail)
Label Indicator	Chemical indicator changes color when processed
Compliance	ISO 11138-1, ISO 11138-2
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 (like EO) or chemical fumes.
Protect from direct sunlight.

Protective inner box packaging

How to Activate and Incubate EO 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 (e.g., 10^6) based on rigorous 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 & 2

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 EO resistometer.
3

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

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

Frequently Asked Questions

How often should I use an EO biological indicator?

Standards highly recommend using a BI in *every* Ethylene Oxide sterilization cycle. The load should generally be quarantined until the BI result is confirmed negative (pass).

What temperature is required for incubation?

EO BIs utilizing *Bacillus atrophaeus* require incubation at a specific temperature, typically 37°C ± 2°C. You will need a biological indicator incubator set to this temperature.

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. Positive BIs should be sterilized before disposal.

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Factory Direct Pricing
Free Samples Available
Low MOQ for Trial Orders