H6301 Low-Temperature Steam Sterilization Biological Indicator

Mrogi Quality Provides H6301 Low-Temperature Steam Sterilization Biological Indicator 

Product Brand: Fukuzawa Ais

Model: H6301

Specification: 100 pieces/box

Usage: For biological validation of sterilization effectiveness at 115°C low-temperature steam sterilization

Test Tube Dimensions: Diameter 8.5mm × Height 46.5mm

Product Description:

1. Self-contained design, no need for aseptic operation, simple cultivation

2. Sterilization effectiveness can be confirmed after 24 hours, 48 hours, or 7 days of cultivation

3. Chemical indicator changes on the label allow for easy confirmation of the sterilization process

4. Stable spore count guaranteed within 24 months

5. Manufactured in accordance with the Chinese Pharmacopoeia, Japanese Pharmacopoeia, European Pharmacopoeia (EN866), ISO11138 sterilization standards, and all applicable provisions

Product Introduction:

115°C Pressure Steam Sterilization Biological Indicator: Used for biological monitoring of the effectiveness of 115°C pressure steam sterilization

The 115°C pressure steam sterilization biological indicator is a self-contained biological indicator composed of a bacterial disc with Bacillus subtilis var. niger spores (ATCC35021), culture medium (sealed in a glass tube), and a plastic outer shell. The bacterial disc contains 5×10⁵ to 5×10⁶ CFU per disc.

Usage Instructions:

1. Place the product into a standard test pack

2. According to national 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 tube and incubate it along with a control tube in an incubator at 35°C to 39°C

5. After 48 hours of incubation, determine 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.

Features: 

★ No need for aseptic operation, simple cultivation

★ Stable spore count guaranteed within 24 months

★ The external label of the indicator tube is printed with special indicator ink, making color changes before and after sterilization easily recognizable

★ The external label of the indicator tube is removable, facilitating long-term storage as sterilization records

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

★ Manufactured in accordance with the Chinese Pharmacopoeia, Japanese Pharmacopoeia, U.S. Pharmacopoeia, European Pharmacopoeia (EN866), ISO11139 sterilization standards, and all applicable provisions