Ultra-Rapid Biological Indicators for Steam Sterilizers, 20 Minute Results, Tuttnauer WTL198-0072 50/box
WTL198-0072
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THIS ITEM HAS BEEN DISCONTINUED AND REPLACED WITH Bionova Ultra Rapid Self-Contained Biological Indicator for Steam (BI-BS-20)
Tuttnauer Ultra-Rapid, Biological Indicators for Steam Sterilizers, 20 Minute Results, 50/box
Product code: BI-TUR
OEM: Tuttnauer WTL198-0072
Important: 20-min Tuttnauer BI’s can ONLY be used for 132C-135C (or 270F-275F)
Be compliant. Avoid long turn-around times on spore tests. Tuttnauer's new biological indicators prove sterilizer performance in just 20 minutes! Recommended for use with Tuttnauer MiniBio Auto-Reader.
Compatible with Class S Gravity and Class B Pre-Post Vacuum autoclaves.
Features
Sold separately:
Tuttnauer MiniBio Auto-Reader, for both 1-hour results and 20-min results
Tuttnauer Ultra-Rapid, Biological Indicators for Steam Sterilizers, 20 Minute Results, 50/box
Product code: BI-TUR
OEM: Tuttnauer WTL198-0072
Important: 20-min Tuttnauer BI’s can ONLY be used for 132C-135C (or 270F-275F)
Be compliant. Avoid long turn-around times on spore tests. Tuttnauer's new biological indicators prove sterilizer performance in just 20 minutes! Recommended for use with Tuttnauer MiniBio Auto-Reader.
Compatible with Class S Gravity and Class B Pre-Post Vacuum autoclaves.
Features
- Self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores
- Spore Tests Results in 20 minutes!
- On each BI is a chemical process indicator that changes color from pink to brown when exposed to steam
- Easy to use and 100% accurate
- 50 biological indicators per pack
Sold separately:
Tuttnauer MiniBio Auto-Reader, for both 1-hour results and 20-min results
Technical Specifications
| Process | Steam, 132°C-135°C (270°F-275°F) only |
|---|---|
| Compatible Sterilizers | Class S Gravity and Class B Pre-Post Vacuum autoclaves |
| Packaging | 50 biological indicators per box |
| Microorganism | Geobacillus stearothermophilus ATCC 7953 |
| Population | 10^6 spores |
| Readout | 20 minutes fluorescence readout at (60 ± 2) °C |
| Optional Visual Confirmation | 48 hours (color change) |
| Process Indicator | Pink to brown when exposed to steam |
| Incubator | Tuttnauer MiniBio Auto-Reader |
| OEM | Tuttnauer WTL198-0072 |
Composition
WTL198-0072 Self-contained Biological Indicator: plastic tube and lid with hermetic seal containing nonpathogenic spores of Geobacillus stearothermophilus ATCC 7953 embedded in carriers, and indicator culture medium contained within a glass ampoule.
Instructions for Use
- Identify the WTL198-0072 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label.
- Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door).
- Sterilize as usual.
- After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package.
CAUTION: Wear safety glasses and gloves when removing the WTL198-0072 SCBI from the sterilized package. WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature. - Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam.
IMPORTANT: this color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process. - Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. IMPORTANT: Use a non-sterilized SCBI as a positive control in order to ensure that correct incubation conditions were met; capability of medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch.
- Incubate the processed indicator and the positive control indicator in Auto-Reader Incubators for a maximum of 20 minutes at (60 ± 2) °C for ultra rapid readout.
Readout Times
- Ultra Rapid readout: 20 minutes. The Ultra Rapid Readout must be carried out in the Auto-Reader Incubators. Fluorescence is emitted after the reader stimulates the spore carrier with UV light. Final readout of negative results is readily available after 20 minutes of incubation. Fluorescence readout is an indirect measure of the germination and growth of Geobacillus stearothermophilus spores, which have survived the sterilization process (positive result). Furthermore, a failure in the sterilization process can also become evident by culture medium color change. Due to the high sensitivity of the fluorescence results at 20 minutes, conventional incubation for color change of WTL198-0072 is not an advantage.
- Visual Confirmation: 48 hours. Optionally, you can perform a visual color-change confirmation after a 48-hour incubation. If the sterilization process has not been successful, culture medium will turn yellow during incubation at 60 ºC, indicating the presence of living spores. If sterilization was successful, culture medium will remain purple after incubation. The positive control must show a color change from purple to yellow for results to be valid.
- Readout time: 7 days. A 7-day readout is optional and may be routinely performed. This is an initial validation of the 20-minute readout. Fluorescence results are compared to the 7-day visual readouts. NOTE: If 7-day readout is performed, a humidified environment will be required to prevent medium from drying out.
Learn More
Read the BI-TUR Instructional Manual before use. See also How to Spore Test Your Autoclave in our Learning Lab.
Ultra-Rapid Biological Indicators for Steam Sterilizers, 20 Minute Results, Tuttnauer WTL198-0072 - Brochure
Ultra-Rapid Biological Indicators for Steam Sterilizers, 20 Minute Results, Tuttnauer WTL198-0072 - Safety Data Sheet
Ultra-Rapid Biological Indicators for Steam Sterilizers, 20 Minute Results, Tuttnauer WTL198-0072 - Quality of Certification
Tuttnauer Biological Indicator What to Know Brochure
Ultra-Rapid Biological Indicators for Steam Sterilizers, 20 Minute Results, Tuttnauer WTL198-0072 - Safety Data Sheet
Ultra-Rapid Biological Indicators for Steam Sterilizers, 20 Minute Results, Tuttnauer WTL198-0072 - Quality of Certification
Tuttnauer Biological Indicator What to Know Brochure
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.
Is this product still available?
Is this product still available?
No. The Tuttnauer WTL198-0072 (BI-TUR) has been discontinued and replaced by the Bionova Ultra Rapid Self-Contained Biological Indicator for Steam (BI-BS-20), which also gives results in 20 minutes.
Which sterilization temperatures was it for?
Which sterilization temperatures was it for?
20-minute Tuttnauer BIs can ONLY be used for 132°C-135°C (or 270°F-275°F) steam cycles, in Class S gravity and Class B pre-post vacuum autoclaves.
Which incubator does it use?
Which incubator does it use?
The 20-minute readout must be carried out in an Auto-Reader incubator at (60 ± 2) °C, such as the Tuttnauer MiniBio Auto-Reader.
What does fluorescence mean?
What does fluorescence mean?
Fluorescence detected by the Auto-Reader means spores survived and the sterilization process failed. If no fluorescence is detected at 20 minutes, the result is negative.
What does the brown label mean?
What does the brown label mean?
A color change to brown on the Process Indicator shows the indicator was exposed to steam. It does not prove sterility.
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.
Is a rapid-readout result as reliable as a 24- or 48-hour test?
Is a rapid-readout result as reliable as a 24- or 48-hour test?
Yes. Independent studies published in Infection Control & Hospital Epidemiology found rapid-readout biological indicators to be as sensitive as conventional 24- and 48-hour indicators, and the fluorescence results correlate with the 7-day visual readout.