H6304 Irradiation Sterilization Biological Indicator

Mrogi Quality Provides H6304 Radiation Sterilization Biological Indicator

Model: H6304

Strain: Bacillus pumilus NBRC 14367 (ATCC27142)

Use: Radiation sterilization biological monitoring

Spore Count: 1×10^6 or more 

Packaging: 100 pieces/box

Culture Medium Composition:

Culture Medium: Soy peptone culture medium

Indicator: Phenol red indicator

Application: Used to monitor the sterilization effect of gamma radiation.

Dimensions (mm): Φ8.5×H46.5

Incubation Temperature: 30-35°C

Shelf Life: 2 years

Usage Instructions:

1. Place the bacterial strip bag in positions that are difficult to sterilize, such as around the space and corners, and perform radiation sterilization.

2. After sterilization is completed, under aseptic conditions, place the bacterial strip into the culture solution in the indicator tube.

3. Tighten the cap of the culture medium bottle and place it in a constant temperature incubator. Set the temperature to 30-35°C for incubation, with an incubation time of 48 hours.

4. Take another bag of non-sterilized bacterial strips from the same batch and place them in the culture medium for incubation as a control. A control tube must be used for each incubation.

Product Precautions:

Before use, confirm whether the indicator is within its validity period.

Before use, confirm whether the product is intact.

Disposal Method:

H6304 radiation sterilization biological indicators that have failed sterilization and expired indicators must be disposed of after radiation sterilization (121°C, 30 minutes).

Product Storage:

Store away from light at 2～25°C, 20%～80% RH. (The culture medium should be stored at 2～10°C.) Store away from sterilizers and disinfectants.

Fuzesis Brand Introduction:

Fuzesis specializes in the research, development, and production of sterilization biological indicators. It is one of the early enterprises in China to produce self-contained sterilization biological indicators. In 1997, it obtained a license issued by Shanghai and began sales nationwide, as well as exporting to Japan and Taiwan, China. In May 2005, it passed ISO9001 and ISO13485 certifications, and in the same year, its products obtained the health permit approval issued by the Ministry of Health. Currently, the products are widely used in hospitals, pharmaceutical factories, and disposable medical device manufacturers for sterilization monitoring and validation.
The company provides technical consultations on quality indicators for sterilization biological indicators and assists customers in establishing sterilization management documents during GMP and ISO certification processes.
The company strictly implements ISO management systems, and all employees work together with a persistent and meticulous attitude to continuously improve product quality and provide customers with excellent service.

Shanghai Mrogi, as the authorized Chinese agent of Fuzesis, is committed to serving both new and existing customers. It provides technical support and assurance for the daily production and operation of enterprises, helps reasonably reduce related production costs, and enhances competitiveness in the market!

Main products include: pressure steam sterilization biological indicators, ethylene oxide sterilization biological indicators, H2O2 sterilization biological indicators, spore strip space sterilization biological indicators, suspension biological indicators, dry heat sterilization biological indicators, biological indicator incubators, rapid biological readers, and other products.