H630K Dry Heat Sterilization Biological Indicator

Mrogi Quality Provides H6302K Dry Heat Sterilization Biological Indicator 

Brand: ACE test Fukuzawa Ace

Model: H6302K

Specification: 100 sets/box

Product Features:

◆ No sterile operation required, simple cultivation

◆ Sterilization effect can be confirmed after 24 hours, 48 hours, or 7 days of cultivation

◆ Based on the color change of the chemical indicator on the label, it can distinguish whether sterilization has been performed

◆ Guaranteed stable spore count within 24 months

◆ Manufactured in accordance with the Chinese Pharmacopoeia, Japanese Pharmacopoeia, United States Pharmacopeia, European Pharmacopoeia (EN866), ISO11138 sterilization standards, and all applicable provisions

Technical Parameters:

Purpose: Monitoring sterilization effectiveness at 160–350°C dry heat

Indicator Bacteria: Bacillus atrophaeus 

Spore Count: 1×10⁶ or more 

Cap Color: － 

Packaging: 100 tubes/box

H6302K Dry Heat Sterilization Biological Indicator Product Description:

Dry Heat Sterilization Biological Indicator: Used to determine the ability of a dry heat sterilizer to kill bacterial spores, verifying whether its sterilization performance meets the original design specifications and for biological monitoring of dry heat sterilization effectiveness.

The dry heat sterilization biological indicator consists of Bacillus subtilis var. niger spores (ATCC9372) on a carrier (high-temperature resistant glass fiber) sealed in a glass tube. The spore count per carrier is 1×10⁶ to 5×10⁶ cfu/carrier. The D-value is 1.3–1.9 minutes. Under conditions of 160°C ± 2°C, the survival time is ≥3.9 minutes, and the kill time is ≤19 minutes.

Usage Method:

1. Place the spore ampoule into the dry heat sterilization equipment along with the items to be sterilized, following your sterilization protocol. (Sterilization temperature: 160–350°C)

2. After sterilization, under aseptic conditions, remove the spore carrier from the ampoule and place it into a phenol red culture medium tube.

3. Incubate the dry heat sterilization biological indicator upright at 37°C. Use an unused dry heat sterilization biological indicator from the same batch as a control for incubation.

Result Interpretation:

1. After 24 or 48 hours of incubation, if the culture medium changes from red to yellow, it indicates incomplete sterilization. Please re-sterilize.

2. If the culture medium remains red, it indicates complete sterilization.

3. The biological test result is valid only if the culture medium of the control ACE test tube changes from red to yellow, showing a positive result.

Product Storage:

Store away from light at 2–10°C

Precautions:

1. Before use, confirm the product's integrity and use within the validity period. The shelf life is 24 months.

2. Biological indicators should be kept away from sterilizers and chemical disinfectants.

3. Dispose of biological indicators that are judged as incompletely sterilized or expired after sterilization treatment.