Description
PSI Biological Indicators (BIs) ? TYPE 5
Trusted Assurance for Sterilization Process Validation
PSI offers a full range of Biological Indicators (BIs) designed in accordance with ANSI/AAMI and ISO standards. These indicators are essential tools for validating the effectiveness of sterilization processes, using viable microorganisms with a defined resistance to specific sterilization methods. These are gold standards in Sterilization.
Biological indicators provide the highest level of assurance by verifying whether the sterilization process conditions were sufficient to inactivate a known population of microorganisms. The most commonly used organisms are bacterial spores, chosen for their exceptional resistance to sterilization methods?making them ideal for challenging the process.
For example:
- ? Geobacillus stearothermophilus spores are highly resistant to steam and vaporized hydrogen peroxide (VH2O2), and are the preferred choice for monitoring these processes.
- By incorporating BIs into your sterilization routine, you gain a critical layer of safety and compliance, ensuring confidence in your infection control protocols.
- • Regulatory Compliance ? Meets ANSI/AAMI and ISO requirements for biological indicators. .
- • High Resistance Spores ? Uses highly resistant spores like Geobacillus stearothermophilus/ Bacillus Atropheus for reliable performance monitoring.
- • Process-Specific Selection ? Tailored for specific sterilization methods such as steam, ETO or VH2O2.
- • Enhanced Safety Assurance ? Offers the highest level of sterilization validation and risk management.
Key Benefits.
Features:
- • Self-Contained Design ? Combines the carrier, spore, and growth medium in a single vial, eliminating the need for aseptic transfer and reducing contamination risk.
- • Simple Activation ? After sterilization, the vial is easily activated to mix spores with the growth medium, allowing for straightforward incubation and monitoring.
- • Rapid Results ? Some SCBI models feature enzyme-based detection for faster spore growth detection, offering shorter incubation times compared to traditional systems.
- • Standards-Compliant ? Manufactured under a certified Quality Management System according to.
- • ISO 13485:2003 / NS-EN ISO 13485:2012, ensuring product reliability and regulatory compliance.
BT10 Biological Indicator – ETO Usage Instructions:
- 1.???? Identification: Label the BT10 indicator with sterilizer number, load number, and processing date.
- 2.???? Placement: Position the indicator in areas considered most inaccessible to the sterilizing agent, such as the center of the load.
- 3.???? Sterilization: Subject the indicator to the ethylene oxide sterilization process as per standard operating procedures.
- 4.???? Activation: Crush the glass ampoule inside the indicator to release the growth medium. .
- 5.???? Incubation: Place the indicator in an incubator at 37 ? 2?C for a maximum of 48 hours. .
- 6.???? Result Interpretation:
- o?? Negative Result: No color change indicates successful sterilization.
- o?? Positive Result: Color change from blue to yellow indicates the presence of viable spores, suggesting a failure in the sterilization process.
BI20 Biological Indicator – Steam Usage Instructions:
- 1.???? Identification: Label the BT20 indicator with sterilizer number, load number, and processing date.
- 2.???? Placement: Position the indicator in areas considered most inaccessible to the sterilizing agent, such as the center of the load.
- 3.???? Sterilization: Subject the indicator to the steam sterilization process as per standard operating procedures.
- 4.???? Activation: Crush the glass ampoule inside the indicator to release the growth medium.
- 5.???? Incubation: Place the indicator in an incubator at 55?C to 62?C for a maximum of 24 hours.
- 6.???? Result Interpretation:
- o??? Negative Result: No color change indicates successful sterilization.
- o??? Positive Result: Color change from purple to yellow indicates the presence of viable spores, suggesting a failure in the sterilization process.
Biological Indicator – Plasma Usage Instructions:
- 1.???? Placement: Position the indicator in areas considered most inaccessible to the sterilizing agent, such as the center of the load.
- 2.???? Sterilization: Subject the indicator to the plasma or VH2O2 sterilization process as per standard operating procedures.
- 3.???? Activation: Crush the glass ampoule inside the indicator to release the growth medium.
- 4.???? Incubation: Place the indicator in an incubator at 55?62?C for a maximum of 24 hours.
- 5.???? Result Interpretation:
- o??? Negative Result: No color change indicates successful sterilization.
- o??? Positive Result: Color change from purple to yellow indicates the presence of viable spores, suggesting a failure in the sterilization process.
| Biological Indicator ETO ? BT10 | The Bionova? BT10 is a self-contained biological indicator (SCBI) designed for monitoring the efficacy of ethylene oxide (EO) sterilization processes. Manufactured by Terragene, this indicator utilizes Bacillus atrophaeus spores to assess sterilization effectiveness. | Purple to Yellow ? Positive Result | Box of 100 Nos |
| Biological Indicator Steam ? BT20 | The Bionova? BT20 is a self-contained biological indicator (SCBI) designed for monitoring the efficacy of steam sterilization processes. Manufactured by Terragene, this indicator utilizes Geobacillus stearothermophilus spores to assess sterilization effectiveness. | Blue to Yellow ? Positive Result | Box of 100 Nos |
| Biological Indicator Plasma VH2O2 ? BT91 | The Bionova? BT91 is a self-contained biological indicator (SCBI) designed for monitoring the efficacy of plasma or vaporized hydrogen peroxide (VH2O2) sterilization processes. Manufactured by Terragene, this indicator utilizes Geobacillus stearothermophilus spores to assess sterilization effectiveness. | Purple to Yellow ? Positive Result | Box of 100 Nos |
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