Model: JPS-STEAM-BI

Steam Biological Indicator

In Stock

CE / FDA / ISO 11138

Self-Contained

The JPS Steam Biological Indicator (BI) provides the highest level of sterility assurance. These self-contained BIs contain *Geobacillus stearothermophilus* spores and are designed for routine monitoring, load releasing, and validating steam sterilization cycles.

High Reliability: Utilizes *Geobacillus stearothermophilus* spores (ATCC 7953).
Self-Contained Design: Reduces the risk of post-sterilization contamination.
Clear Results: Easy-to-read color change in the media indicates spore growth (failure).
Fast Readout Options: Standard (24/48 hr) and rapid readout versions available.
Standard Compliance: Strictly meets ISO 11138 standards for biological indicators.

Wholesale Price (FOB)

$0.50 - $1.20 / Vial

MOQ

50 Boxes

Quantity:

(Boxes)

Product Data Sheet

Download IFU & Certification (PDF)

Product Details

Technical Specs

Packaging & Shipping

Video Demo

The Gold Standard for Sterility Assurance

Biological indicators (BIs) provide the only direct measure of the lethality of a sterilization cycle. The JPS Self-Contained Steam Biological Indicator contains a standardized, viable population of bacterial spores known to be highly resistant to steam.

If the sterilization cycle is effective, the spores are killed, and the subsequent incubation will show no color change. If the cycle fails, surviving spores will grow during incubation, causing the media to change color (usually from purple to yellow), clearly indicating a failure.

Key Advantages

Direct Lethality Test

Proves the cycle actually killed highly resistant spores, not just reached a temperature.

Self-Contained System

Includes spores and culture media in one vial, minimizing handling errors.

Easy Interpretation

A clear color change in the media indicates a failed cycle after incubation.

Built-in Chemical Indicator

The label on each vial has a chemical indicator to show it has been processed.

Incubation Options

Available in standard (24-48 hours) or rapid readout formats depending on your incubator.

Compliance Guarantee

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

Product Name	Steam 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	Steam / Autoclave (121°C - 134°C)
Incubation Time	24h, 48h, or Rapid Readout (e.g., 1h, 3h) depending on model
Incubation Temp	55°C - 60°C
Result Indication	Media changes from Purple to Yellow if spores survive (Fail)
Label Indicator	Chemical indicator changes from Blue to Brown/Black when processed
Compliance	ISO 11138-1, ISO 11138-3
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 Steam BIs

Watch on YouTube

OEM & Customization Options

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

Custom Population

Specific spore populations (e.g., 10^5, 10^6) based on requirements.

Custom Vial Labels

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

Custom Packaging

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

Incubation Times

Development of media for standard or rapid readout incubation times.

International Certifications

CE (EU MDR)

FDA Cleared

ISO 13485

ISO 11138-1 & 3

Advanced Biological Manufacturing

Our biological indicators are manufactured in high-level cleanrooms under strict aseptic conditions. We maintain our own culture collection to ensure 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 survival and kill times.
4

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

Frequently Asked Questions

How often should I use a biological indicator?

Standards typically recommend using a BI at least weekly, but preferably daily. A BI must be used in every load containing implantable devices, and the load must be quarantined until the BI result is negative (pass).

What temperature is required for incubation?

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

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

A positive result means the sterilization process failed. The entire load must be recalled and reprocessed. The sterilizer should be taken out of service, inspected, repaired if necessary, and re-qualified with consecutive BI tests before being used again. Positive BIs should be sterilized before disposal.

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Factory Direct Pricing
Free Samples Available
Low MOQ for Trial Orders