The biological indicator (BI) is known by most experts as monitoring the sterilization process. This is because BI directly evaluates the sterilization process using resistant microorganisms. The RRS packet containing a Bacillus pumilus spore strip is specially designed for the monitoring of Gamma sterilization processes. The gamma biological indicator (RRS 14-26110) is compliant with ISO 11138.
Instructions for use of the RRS gamma biological indicator
- Biological indicators spore strip have to always be placed at the worst-case location according to the validation standard which may be inside of a package with solid goods or inside of instruments.
- Select the number of BIs according to the instructions (at least two and 5 in higher capacities). But less than two is never recommended. The number of BI should be selected according to the national accreditation standards of Iranian hospitals (4th edition / 1398).
- Sterilize as usual. After the sterilization process has finished, remove the RRS spore strip envelope from the package for processing and incubation. Transfer spore strip to the laboratory for culture.
- In sterility conditions (eg. laminar flow cabinet), tear the envelope at one end very carefully and transfer the spore strip using a sterile clamp to a growth medium tube, or any other appropriate growth medium
Specific Instructions for use of the RRS gamma biological indicator
- Follow the steps in the general use instructions.
- The RRS spore strip is inside a paper cover (30 × 6 mm) that protects it from environmental pollution.
- Incubate the tube containing culture medium and spores strip at 37 ± 2 ° C for 24 hours in the RRS incubator.
The color change of biological indicator to yellow indicates a defect in the sterilization process after the mentioned period of time. The content of the vial 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 of time, the result of the test will be negative and this indicates that the sterilization process is adequate.
Important! * Check the biological indicator being incubated at appropriate intervals of 10 hours.
Use a non-sterile spore strip as a positive control. In this case, you make sure that the appropriate conditions are provided in the incubator. For results to be valid, the positive control indicator should turn to yellow and the negative control should not change its original color.
Record the positive results in the RRS CSSD Documentation NoteBookand 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.
Discard the gamma biological indicator (RRS 14-26110) after use according to your country’s healthcare and safety regulations. The positive biological indicator can be sterilized in steam sterilizers at 121 °C for at least 20 minutes or at 134 °C for at least 10 minutes.
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