EO Biological Indicator

EO Biological Indicator (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.

Key Features

• 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.

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.

Technical Specifications

Specification	Value
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

Parameter	Details
Packaging Unit	Vials/Box
Standard Box	50 or 100 Vials/Box
Boxes/Carton	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.

Quality Assurance (Biological)

1. Population Verification: Strict testing to verify the exact spore count per batch.
2. D-Value Calculation: Determining the resistance (D-value) in a certified EO resistometer.
3. Survival/Kill Testing: Verifying performance within specified EO survival and kill times.
4. Media Sterility & Growth: Ensuring culture media is sterile but highly capable of supporting growth.

OEM & Customization Options

• 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.