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Rapid Self-Contained Biological Indicator for EO, 4h Results, 50/box

Rapid Self-contained Biological Indicator for Ethylene Oxide, 4H

BT110

Price: $238.00

Product Code: BI-BEO-4

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Description

Technical Specs

Literature

Bionova Rapid Self-Contained Biological Indicator for Ethylene Oxide sterilization processes, with Bacillus atrophaeus 10^6 spores per vial, with completed results in 4 hours, 50/box
A Self-Contained Biological Indicator inoculated with viable 106 Bacillus atrophaeus bacterial spores
FDA, Rapid Fluorescence

Product code: BI-BEO-4
Mfr: BT110

Features:

Rapid 4-Hour Readout, Fluorescence-based readout
UV light stimulation detects Bacillus atrophaeus spore viability post-sterilization.
Single-use Self-Contained Biological Indicators (SCBI) comprising a polypropylene tube, a spore carrier, and a glass ampoule with culture medium.
Components enclosed with a colored cap, emphasizing the design for one-time use.
Spore Population and Ethylene Oxide Indicator:
- Each tube contains a population of Bacillus atrophaeus ATCC® 9372 spores inoculated on a spore carrier.
- Features a Process Indicator on the label that changes color (brown/bordeaux to green) when exposed to Ethylene Oxide, serving as a visual confirmation of sterilization exposure.
Barrier Permeable to Ethylene Oxide:
- The plastic cap with holes and a barrier is permeable to Ethylene Oxide.
- Highlights the device's ability to allow the penetration of Ethylene Oxide, a crucial aspect for effective sterilization.
Visual Confirmation at 48 Hours:
- Optional 48-hour visual color-change confirmation.
- Green to yellow indicates living spores, while blue confirms successful sterilization.

Optional 7-Day Readout:
- Optional 7-day readout for initial validation, comparing results with 4-hour fluorescence data.
- Humidified environment needed to prevent medium drying if 7-day readout performed.
Monitoring Frequency:
- Adheres to professional standards for monitoring sterilization loads.
- Emphasizes the use of appropriate biological indicators for optimal patient safety.
Shelf Life and Expiration:
- 2-year shelf life from manufacture under recommended storage.
Endpoint Stability Reaction:
- Chemical indicator endpoint remains stable for a minimum of 6 months under recommended conditions.
- SCBI (BT110) serves as a self-contained Biological Indicator with 10^6 Bacillus atrophaeus spores, monitoring ethylene oxide sterilization processes.

Sold Separately:
Bionova Incubator
Bionova MiniBio Auto-Reader Incubator

50 Biological Indicators per box

Storage Recommendations:

- Store in a dark place at 10-30 °C and 30-80% relative humidity.

- Strict warnings against freezing and proximity to sterilizing agents or chemicals.

Instructions for Use:

Labeling SCBI
- Identify SCBI with sterilizer number, load number, and processing date.
Packaging and Placement
- Pack SCBI with materials for sterilization, placing it in less exposed areas.
Sterilization Process
- Carry out standard sterilization procedures.
Post-Sterilization Steps
- After sterilization, open the door, wait five minutes, and carefully remove SCBI.
- Caution: Wear safety glasses and gloves.
- Warning: Avoid excessive handling to prevent glass ampoule bursting. Let SCBI cool to room temperature.
Process Indicator Check
- Check the Process Indicator on the SCBI label. A color change to green indicates exposure to Ethylene Oxide.
- Note: Color change doesn't confirm sterility; further checks on the sterilization process are necessary if no change occurs.
Sealing and Ampoule Crushing:
- Press the lid to seal the tube and crush the ampoule using an individual ampoule crusher or one within the incubator.
- Vigorously shake the tube to ensure the medium fully soaks the spore carrier.

Important: Use a non-sterilized SCBI as a positive control daily. Ensure both controls are from the same batch.

Positive Control and Incubation:
- Use a non-sterilized SCBI as a positive control daily during sterilization cycles.
- Incubate both the processed and positive control indicators in Terragene® Bionova® Auto-reader incubators for a maximum of 4 hours.
- Fluorescence detection within 4 hours indicates sterilization failure; positive control should give a positive fluorescence readout.
Incubation and Results Recording:
- Incubate SCBIs for a pH color change if humidity is low (<35%) for potential extended fluorescent readout times.
- Record positive results promptly and discard SCBIs as indicated.

Precautions:

WARNING: Do not use SCBI to control sterilization processes other than those specified.

WARNING: Place one or more SCBI in hard-to-reach areas to ensure complete chamber sterilization. Evaluate load configurations to identify and place SCBI in all such locations.

WARNING: Do not reuse SCBI.

WARNING: Do not reuse the sterilizer until the SCBI test result is negative.