Rapid Self-Contained Biological Indicator for EO, 4h Results, 50/box
BT110
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$238.00
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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
FDA, Rapid Fluorescence
Product code: BI-BEO-4
OEM: BT110
Features
Sold separately:
Bionova Incubator
Bionova MiniBio Auto-Reader Incubator
FDA, Rapid Fluorescence
Product code: BI-BEO-4
OEM: BT110
Features
- Rapid 4-Hour Readout: fluorescence-based readout.
- UV Light Stimulation: detects Bacillus atrophaeus spore viability post-sterilization.
- Single-Use SCBI: 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: each tube contains a population of Bacillus atrophaeus ATCC® 9372 spores inoculated on a spore carrier.
- Ethylene Oxide Process Indicator: a Process Indicator on the label 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, allowing 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: 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.
Sold separately:
Bionova Incubator
Bionova MiniBio Auto-Reader Incubator
Technical Specifications
| Process | Ethylene Oxide (EtO) |
|---|---|
| Packaging | 50 Biological Indicators per box |
| Microorganism | Bacillus atrophaeus (ATCC® 9372) |
| Population | 10^6 spores per vial |
| Readout | 4 hours fluorescence readout |
| Optional Visual Confirmation | 48 hours (color change) |
| Process Indicator | Brown/bordeaux to green when exposed to Ethylene Oxide |
| Shelf Life | 2-year shelf life from manufacture under recommended storage |
| OEM | BT110 |
Storage Note: 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.
- Positive Control and Incubation: Use a non-sterilized SCBI as a positive control daily during sterilization cycles. Ensure both controls are from the same batch. 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.
FAQ
Scroll down for frequently asked questions
Scroll down for frequently asked questions
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Explore Our FAQs for Helpful Answers
Find answers to common questions about this product, including features, specifications, and operation. Need more help? Our team is here to assist.
How often should I spore test my sterilizer?
How often should I spore test my sterilizer?
The CDC recommends biological monitoring (spore testing) of each sterilizer at least weekly, and with every load that contains an implantable device. Your state or local regulations may require more frequent testing.
What should I do if a spore test fails (positive result)?
What should I do if a spore test fails (positive result)?
Take the sterilizer out of service and repeat the spore test right away using the same cycle. If the mechanical and chemical indicators show the sterilizer is working properly, a single positive result often points to operator error, such as loading or packaging. If the repeat test is also positive, do not use the sterilizer until it has been inspected or repaired and passes spore tests in three consecutive cycles.
Isn't the color change on the pouch or tape enough?
Isn't the color change on the pouch or tape enough?
No. Chemical indicators show that the sterilizing agent reached the item, but they do not prove sterilization was achieved. Only a biological indicator (spore test) confirms that highly resistant spores were killed.
What sterilization process is this for?
What sterilization process is this for?
Ethylene oxide (EtO) sterilization. It uses Bacillus atrophaeus (ATCC® 9372) spores, 10^6 per vial.
How long until I get results?
How long until I get results?
Up to 4 hours with fluorescence readout in a Bionova auto-reader incubator. An optional visual color-change confirmation can be done at 48 hours: green to yellow means living spores, blue confirms successful sterilization.
What does the label color change mean?
What does the label color change mean?
The Process Indicator on the label changes from brown/bordeaux to green when exposed to ethylene oxide. This confirms exposure only, not sterility.
Do I need a positive control?
Do I need a positive control?
Yes. Use a non-sterilized indicator from the same batch as a positive control daily. It must give a positive fluorescence readout.
What if humidity is low?
What if humidity is low?
If humidity is low (under 35%), incubate for the pH color change, since fluorescent readout times may be extended.
How should I store them?
How should I store them?
In a dark place at 10-30 °C and 30-80% relative humidity, away from sterilizing agents and chemicals. Do not freeze. Shelf life is 2 years from manufacture.