Mrogi Quality Provides H3723T Pressure Steam Sterilization Biological Indicator

Brand: Fuzi Ais

Model: H3723T

Specification: 100 pieces/box

Strain: Geobacillus stearothermophilus spores ATCC7953

Product Description: 

Pressure steam sterilization biological indicator, used for biological monitoring of sterilization effectiveness in gravity displacement steam sterilizers at 121°C, pre-vacuum steam sterilizers at 132°C, and pulsed vacuum steam sterilizers. The bacterial load on the carrier is suitable for medical institutions such as hospitals, health stations, clinics, as well as health material production facilities and medical device manufacturers.

The pressure steam sterilization biological indicator is a self-contained biological indicator composed of a carrier with Geobacillus stearothermophilus spores (ATCC7953), a culture medium (sealed in a glass ampoule), and a plastic vial. The bacterial load per carrier is 10^6 CFU or higher. The D-value ranges from 1.3 to 1.9 minutes. Under saturated steam conditions at 121°C ± 0.5°C, the survival time is ≥ 3.9 minutes, and the kill time is ≤ 19 minutes.

Usage Instructions:

1. Place the pressure steam sterilization biological indicator into a standard test pack.

2. According to relevant regulations, place the test pack in different locations within the pressure steam sterilizer.

3. After sterilization, remove the biological indicator.

4. Crush the enclosed glass ampoule and incubate it along with a control vial in an incubator at 56°C to 58°C.

5. After 48 hours of incubation, interpret the results. If the culture medium changes from its original purple-red color to yellow, it indicates incomplete sterilization. If the color remains unchanged, continue incubation for another 2 days. If no color change occurs, sterilization is considered complete.

Product Features:

★ No aseptic technique required, simple incubation

★ Guaranteed stable spore count for 24 months

★ Chemical indicator change on the label confirms complete sterilization

★ Sterilization effectiveness can be confirmed after 24 hours, 48 hours, or 4 days of incubation

★ Compatible with American-made incubators (ACEtest size: diameter 8.5mm × height 46.5mm)

★ Manufactured in accordance with the Chinese Pharmacopoeia, Japanese Pharmacopoeia, United States Pharmacopeia, European Pharmacopoeia (EN866), ISO 11139 sterilization standards, and all applicable regulations

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