Self-Contained Steam Biological Indicator - Geobacillus Stearothermophilus - 24 Hour Results - 121°C-134°C Steam Sterilization

Professional Steam Sterilization Monitoring Solution

Ensure the highest standards of sterilization safety with our Self-Contained Steam Biological Indicator, the essential tool for hospitals, laboratories, dental practices, surgical centers, and sterile processing departments. This advanced biological indicator is specifically engineered to validate and monitor the effectiveness of your steam sterilization processes with unmatched reliability and precision.

Why Choose Our Steam Biological Indicator?

Inoculated with highly resistant Geobacillus stearothermophilus spores, this indicator serves as the gold standard for verifying sterilizer efficacy across all types of steam sterilization cycles. Whether you're running gravity displacement, flash sterilization, or prevacuum cycles, this biological indicator provides the confidence you need to ensure patient safety and regulatory compliance.

Key Benefits & Features:

• Comprehensive Sterilization Monitoring: Expertly designed to monitor saturated steam sterilization processes operating at temperatures between 121°C–134°C (250°F-273°F), covering gravity displacement, flash, and prevacuum cycles with exceptional accuracy
• Industry-Validated Performance: Fully compliant with current USP (United States Pharmacopeia) and AAMI/ISO 11138 performance standards for steam sterilization biological indicators, ensuring you meet all regulatory requirements
• Rapid 24-Hour Read-Out: Delivers final verification results within just 24 hours, with early growth detection possible in as little as 2.5 hours, allowing for quick sterilization confirmation and faster workflow turnaround
• Superior Growth Media: Contains pharmaceutical-grade tryptic soy broth that has been rigorously validated for growth promotion per USP guidelines, guaranteeing accurate and reliable test results every time
• Universal Compatibility: Functions effectively in both gravity and dynamic-air-removal (prevacuum) sterilization processes, with recommended protocol adjustments available for flash cycle applications
• Seamless Integration: Designed to fit existing incubators without modification, making it easy to incorporate into your current sterilization monitoring workflows and quality assurance programs
• Clear Visual Indicators: Features an integrated chemical indicator that turns brown during processing, plus a purple-to-yellow color change system that provides unmistakable visual confirmation of spore growth or sterilization success
• Self-Contained Design: All-in-one vial construction with internal glass ampule containing growth media eliminates the need for separate components and reduces handling complexity

Recommended Monitoring Frequency:

According to AAMI (Association for the Advancement of Medical Instrumentation) standards and best practices, steam sterilizers should undergo biological testing at least weekly, with daily testing strongly preferred. Every load containing an implantable device must be biologically tested to ensure patient safety and meet regulatory compliance requirements.

Complete Instructions for Use:

Pre-Processing Preparation:

1. Document the sterilizer identification number, load number, and processing date directly on the biological indicator label for complete traceability
2. Position one or more biological indicators inside an instrument tray, rigid sterilization container, peel pouch, or process challenge device (such as an AAMI challenge pack), selecting the configuration that best represents your actual load conditions
3. Place the biological indicator in the most challenging location within the sterilizer chamber as specified in your sterilizer manufacturer's instruction manual—typically the bottom shelf near the door, over the drain in large sterilizers, or on the middle shelf in compact sterilizers
4. Process the complete load according to your sterilizer manufacturer's validated instructions and cycle parameters

Post-Processing Handling:

1. Carefully remove the biological indicator after the cycle completes and verify that the chemical indicator printed on the label has changed to brown, confirming exposure to sterilization conditions
2. IMPORTANT SAFETY NOTICE: After processing, the biological indicator is extremely hot and under internal pressure. Always allow the indicator to cool for a minimum of ten (10) minutes before attempting to crush the internal ampule. Failure to observe this cooling period could cause the glass ampule to burst violently, potentially resulting in serious injury. Safety glasses must be worn at all times when handling and crushing processed biological indicators

Activation and Incubation Protocol:

1. Activate the processed biological indicator within 8 hours after sterilization cycle completion by gently crushing the inner glass media tube using an approved vial crusher device
2. Immediately place the activated indicator in a calibrated incubator set to 55–60°C (131-140°F) for a full 24-hour incubation period
3. Monitor for spore growth by checking for visual color change from purple to yellow at regular intervals throughout incubation (recommended checkpoints: 3 hours, 5 hours, and 8 hours). Note that growth of surviving spores has been documented in as little as 2.5 hours in cases of sterilization failure

Interpreting Test Results:

• Negative Result (Successful Sterilization): No color change occurs—the media remains purple throughout the full 24-hour incubation period, indicating complete spore kill and proper sterilization. Record all negative results in your Sterilizer Record Notebook with date, time, load information, and operator initials
• Positive Result (Sterilization Failure): Any color change from purple to yellow indicates spore survival and sterilization failure. This result must be reported immediately to your supervisor or infection control officer. The affected sterilizer must be taken out of service immediately and not used until the failure cause is identified and corrected. All items from the failed load must be recalled, reprocessed, and retested
• The stability of positive growth results, as indicated by yellow coloration, has been validated for up to 48 hours post-incubation

Quality Control Procedures:

As a mandatory control measure, one unprocessed biological indicator from the same lot number should be gently crushed using a vial crusher and incubated at 55-60°C each day biological testing is performed. This positive control must demonstrate spore growth (purple to yellow color change) within 24 hours to confirm the viability of the spore population and the effectiveness of the growth media. If the positive control fails to show growth, do not use indicators from that lot and contact your supplier immediately.

Applications & Ideal Use Cases:

• Hospital central sterile processing departments
• Surgical centers and operating room sterilization
• Dental office autoclave monitoring
• Veterinary clinic sterilization validation
• Laboratory equipment sterilization
• Pharmaceutical manufacturing clean rooms
• Medical device reprocessing facilities
• Ambulatory surgery centers
• Research facility sterilization compliance

Product Specifications:

• Spore Type: Geobacillus stearothermophilus (highly resistant to steam sterilization)
• Sterilization Method: Steam/Autoclave
• Temperature Range: 121°C–134°C (250°F-273°F)
• Incubation Temperature: 55-60°C (131-140°F)
• Processing Time: 24-hour final read-out (early detection possible at 2.5+ hours)
• Growth Media: USP-validated tryptic soy broth
• Design: Self-contained vial with internal glass ampule
• Compliance: Meets USP and AAMI/ISO 11138 standards
• Latex Status: Latex-free

Invest in the reliability and peace of mind that comes with professional-grade sterilization monitoring. Our Self-Contained Steam Biological Indicator is the trusted choice of healthcare professionals worldwide for ensuring patient safety and maintaining the highest standards of infection control.