4h Rapid Self-contained Biological Indicator for EtO SKU: BT110

4h Rapid Self-contained Biological Indicator for EtO SKU: BT110 Specification

Size
Standard

Product Type
4h Rapid Self-contained Biological Indicator for EtO SKU: BT110

Use
Medical

Storage Instructions
Cool & dry place

Color
Green

Shape
Round

About 4h Rapid Self-contained Biological Indicator for EtO SKU: BT110

Bionova Rapid Self-contained Biological Indicator Specification

Brand
Bionova

Process
Ethylene Oxide

Packaging
50 indicators per pack

Microorganism
Bacillus atrophaeus ATCC 9372

Population
One million spores per carrier

Readout Time
Four hours

Regulations
IRAM 37102 Part 1, IRAM 37102 Part 2, ISO 11138 Part 1, ISO 11138 Part 2

Length
40 millimeters

Target Market
Healthcare, Pharmaceutical

Description
Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. FDA cleared. Optional visual pH color change can be checked after 48 hours. A 7-day readout is optional for validation of the four hour reading. Fluorescence results may be compared to the 7-day visual reading.

Instructions for Use

Label the SCBI with sterilizer number, load number, and processing date.
Pack SCBI with materials to be sterilized in areas least accessible to ethylene oxide.
Perform sterilization cycle.
Wait five minutes after sterilization and remove SCBI using safety glasses and gloves.
Check Process Indicator for green color to confirm exposure.
Seal tube, crush ampoule, shake to soak the spore carrier, and place in incubator.
Incubate processed and positive control indicators in Terragene Bionova Auto-Reader incubator for up to four hours at 37 degrees Celsius. Fluorescence detection indicates sterilization failure. Positive control must give positive fluorescence.

Notes

Positive control should be used at least once per day.
Holding time between sterilization and incubation should not exceed seven days.
Fluorescence detection wavelength is 340 to 380 nanometers excitation and 455 to 465 nanometers emission.
If chamber relative humidity is below 35 percent, continue incubation for pH color change as fluorescent readout may be delayed.

Reliable Sterilization Monitoring

The 4h Rapid Self-contained Biological Indicator for EtO offers dependable validation for your sterilization processes. Ensuring compliance and safety, it helps you achieve consistent outcomes by detecting even minimal sterilization failures within a short four-hour window.

User-friendly and Safe

With its round, standardized design and clear green color, the indicator is easy to handle and interpret. Simply insert it into your sterilizer load, then incubate post-sterilization for rapid results. Its self-contained format enhances safety by minimizing handling risks.

Trusted Distribution Across India

Sourced from leading distributors, suppliers, and traders in India, this indicator meets the needs of healthcare professionals nationwide. With reliable supply channels, you can be assured of product authenticity and consistent availability.

FAQ's of 4h Rapid Self-contained Biological Indicator for EtO SKU: BT110:

Q: How do I use the 4h Rapid Self-contained Biological Indicator for EtO?

A: Place the indicator in the load during the Ethylene Oxide sterilization cycle, incubate it as per instructions after sterilization, and read the results after four hours to confirm sterilization efficacy.

Q: What is the primary benefit of using this biological indicator in medical settings?

A: It provides fast and accurate confirmation of sterilization process effectiveness, which helps ensure patient safety and regulatory compliance within a short timeframe.

Q: When should the indicator be used in the sterilization process?

A: Use the indicator each time you perform an EtO sterilization cycle to routinely monitor and validate the process for consistent results.

Q: Where should I store the 4h Rapid Self-contained Biological Indicator for EtO?

A: Store the product in a cool and dry place to maintain its sensitivity and reliability over time.

Q: What makes this indicator suitable for healthcare environments in India?

A: It is distributed by trusted suppliers across India, is easy to use, and delivers quick, dependable results that align with local and international standards.

Q: What is the process to interpret the results after using the biological indicator?

A: After incubation, observe the indicator for any color change. The result indicates whether the sterilization cycle effectively eradicated biological contaminants.