5min Biological Indicator for Hydrogen Peroxide – Hyper

Introducing the Terragene Bionova BT98 Hyper Rapid Self-contained Biological Indicator—a cutting-edge solution engineered for the swift and reliable monitoring of vaporized hydrogen peroxide (VH₂O₂) sterilization processes. With an impressive final readout time of just 5 minutes, this advanced biological indicator (BI) significantly enhances efficiency and ensures the highest standards of sterility assurance in healthcare settings.

Key Features:

Ultra-Fast Readout: Achieve conclusive results in a mere 5 minutes, allowing for prompt validation of sterilization cycles and minimizing downtime.

Self-Contained Design: The BT98 is a single-use, self-contained biological indicator (SCBI) comprising a polypropylene tube, a spore carrier inoculated with Geobacillus stearothermophilus ATCC 7953 spores, and a glass ampoule containing a specialised culture medium. This integrated design reduces the risk of contamination and false positives, ensuring accurate results.

Process Indicator: Each BT98 features a process indicator on the label that transitions from purple to green upon exposure to hydrogen peroxide, providing immediate visual confirmation of processing. It’s important to note that this colour change indicates exposure but does not confirm the effectiveness of the sterilization process.

High Sensitivity and Reliability: With a standardized spore population of 10⁶ per carrier, the BT98 offers consistent and dependable performance, meeting stringent international standards such as ISO 11138-1:2017 and ISO 13485:2016.

Applications:

The BT98 is meticulously designed for rapid and straightforward monitoring of plasma or vaporized hydrogen peroxide sterilization cycles. It is particularly suitable for use in healthcare facilities where VH₂O₂ sterilization is employed, ensuring that medical instruments and devices are free from viable microorganisms.

Instructions for Use:

Identification: Clearly label the BT98 SCBI with pertinent information, including the sterilizer number (if multiple units are in use), load number, and processing date.

Placement: Package the SCBI alongside the materials intended for sterilization, ensuring adherence to recommended sterilization practices. Position the package in areas considered most challenging for the sterilizing agent to penetrate, such as the center of the load or near the door.

Sterilisation: Proceed with the standard sterilization cycle as per facility protocols.

Post-Sterilization Handling: Upon completion of the sterilization process, open the sterilizer door, allow a 5-minute cooling period, and carefully remove the SCBI from the package. It is advisable to wear safety glasses and gloves during this step to prevent injury. Avoid excessive handling or crushing of the SCBI to prevent accidental breakage of the glass ampoule. Allow the SCBI to cool to room temperature before further handling.

Process Indicator Verification: Examine the process indicator on the SCBI label. A colour change to green confirms exposure to hydrogen peroxide. If no colour change is observed, reassess the sterilization process for potential issues.

Activation and Incubation: Seal the tube by pressing the lid firmly. Utilise an ampoule crusher to break the internal glass ampoule, releasing the culture medium. Vigorously shake the tube to ensure the medium fully saturates the spore carrier. Place the activated SCBI into the appropriate Terragene Bionova auto-reader incubator, specifically designed for hyper-rapid readout, and incubate at 60 ± 2 °C.

Positive Control: Incorporate a non-sterilized SCBI as a positive control at least once daily when a sterilization cycle is performed. This control verifies the incubation conditions, medium efficacy, and spore viability, ensuring the reliability of the sterilization process.

Result Interpretation: The auto-reader incubator will detect fluorescence emission, indicating the presence of viable spores. Detection of fluorescence signifies a failed sterilization process, while the absence of fluorescence after 5 minutes indicates a successful sterilization. The positive control should exhibit fluorescence to validate the test results.

Storage and Shelf Life:

Storage Conditions: Store the BT98 SCBIs in a dark environment at temperatures between 10–30 °C and relative humidity levels of 30–80%. Avoid freezing and keep the indicators away from sterilizing agents or other chemical products to maintain integrity.

Shelf Life: The BT98 has an expiration period of 2 years from the date of manufacture when stored under recommended conditions. Do not use the indicators beyond their expiration date to ensure accurate performance.

Disposal:

After use, dispose of the biological indicators in accordance with local healthcare and safety regulations. Positive biological indicators can be decontaminated by autoclaving in a gravity air displacement steam sterilizer at 121 °C for 5 minutes, 132 °C for 15 minutes, or 134 °C for 10 minutes; or in a dynamic air removal steam sterilizer at 132 °C for 4 minutes or 135 °C for 3 minutes.

Regulatory Compliance:

The BT98 complies with international standards, including IRAM 37102-1:1999, ISO 11138-1:2017, and ISO 13485:2016 / NS-EN ISO 13485:2016, ensuring it meets global quality and safety requirements.

Conclusion:

The Terragene Bionova BT98 Hyper Rapid Self-contained Biological Indicator represents a significant advancement in sterilization monitoring technology. Its ultra-fast 5-minute readout time, combined with a user-friendly self-contained design, offers healthcare professionals a reliable and efficient tool for ensuring the effectiveness of vaporized hydrogen peroxide sterilization processes. By incorporating the BT98 into your sterilization protocol, you can enhance operational efficiency, reduce instrument turnaround times, and maintain the highest standards of patient safety.