H3723A Biological Indicator

Mrogi Quality Provides H3723A Pressure Steam Sterilization Biological Indicator

Product Brand: ACE

Model: H3723A

Specifications: 25 pieces/box, 100 pieces/box

D-value: 1.3～1.9 minutes

Product Description:

H3723A Pressure Steam Sterilization Biological Indicator is 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 centers, clinics, as well as health material production facilities and medical device manufacturers. 

H3723A Pressure Steam Sterilization Biological Indicator is a self-contained biological indicator consisting of a bacterial carrier with Geobacillus stearothermophilus spores (ATCC7953), a culture medium (sealed in a glass ampoule), and a plastic vial. The bacterial count per carrier is 5×10⁵～5×10⁶ cfu/carrier. The D-value is 1.3～1.9 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 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～58°C.

5. After 48 hours of incubation, interpret the results. If the culture medium changes from purple-red 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.

Brief Introduction to the Function of Pressure Steam Sterilization Biological Indicator 

Product Features:

★ No need for aseptic operation; simple incubation.

★ Guaranteed stable spore count within 24 months.

★ Confirmation of complete sterilization based on the color change of the chemical indicator on the label.

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

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

★ Manufactured in accordance with the Chinese Pharmacopoeia, Japanese Pharmacopoeia, United States Pharmacopeia, European Pharmacopoeia (EN866), ISO11139 sterilization standards, and all applicable regulations.