Most experts know the biological indicator (BI) as monitoring the sterilization process. This is because BI directly evaluates the sterilization process using resistant microorganisms. The RRS steam spore ampoule consists of a glass body containing Geobacillus stearothermophilus (ATCC 7953) spores for the steam sterilizer. The Geobacillus stearothermophilus Spore Ampoules 10^6 (RRS 14-21310) is compliant with ISO 11138.
General Use Instructions for Geobacillus stearothermophilus Spore Ampoules
- Record the number of the sterilizer and the date of the process on the BI.
- Place the spore ampoules 10^6 (RRS 14-21310) inside a container with the liquid being sterilized or inside a similar container with liquid. This container should be the same size and have the same volume as the one containing the liquid being sterilized. The number of BI should be selected according to the national accreditation standards of Iranian hospitals (4th edition / 1398).
- Once the sterilization process has finished, open the sterilizer door, wait five minutes, and remove the spore ampoule from the container.
Specific instructions for RRS spore ampoule
- Follow the steps in the General Use Instructions.
- Incubate the processed spore ampoule, negative control, and a non-sterilized BI as a positive control, at 56 ± 2 ºC. The positive control ensures that the incubation conditions were met.
The color change of BI to yellow indicates a defect in the sterilization process after the mentioned period. The content of the ampoule can become turbid, or the appearance of a precipitate can be observed due to bacterial growth. If there is no color change in the indicator after the specified period, the test result will be negative, indicating that the sterilization process is adequate.
Important! * Check the incubated biological indicator at appropriate intervals of 10 hours.
Use a non-sterile spore ampoule as a positive control. In this case, make sure that the appropriate conditions are provided in the incubator. For results to be valid, the positive control indicator should turn yellow, and the negative control should not change its original color.
Record the positive results in the RRS CSSD Documentation NoteBook and -discard them immediately.
- The BI should be stored away from light, at temperatures between 10-30 ºC and 30-80% Relative Humidity.
- Do not freeze and store close to other sterilization agents or chemical products.
- The RRS biological indicator has a certain shelf-life that marked on it.
Each indicator is intended for a single-use and must be discarded after use. The ampoule is fragile, protect it from shocks, falls, and sudden temperature changes.
Geobacillus stearothermophilus Spore Ampoules 10^6 (RRS 14-21310) after use according to your country’s healthcare and safety regulations. The positive biological indicator can be sterilized in gravity air displacement steam sterilizers at 121 °C for at least 20 minutes or at 134 °C for at least 10 minutes in vacuum-assisted steam sterilizers.
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