Dry Heat Biological Indicator
The biological indicator (BI) is known by most experts as monitoring the sterilization process. This is because BI directly monitoring the sterilization process using resistant microorganisms. The snap-top glass ampoule containing silica material inoculated with 106 Bacillus atrophaeus (ATCC 9372) spores. The Dry Heat Biological Indicator (ampoule) (RRS 14-25110) is compliant with ISO 11138.
General Use Instructions for Dry Heat Biological Indicator
- Record the number of the sterilizer and the date of the process on the BI.
- Biological indicators 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. 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 a few minutes, and remove the spore ampoule from the container.
- Transfer biological indicator to laboratory for culture.
Specific instructions for RRS dry heat biological indicator
- Disinfect the ampoule with 70% alcohol before placing it under laminar hood.
- In aseptic conditions and under the laminar hood, separate the ampoules by applying pressure to the marking line on the ampoule.
- Transfer the silica material of each ampoule to culture medium.
- Incubate the tube containing culture medium and spores at 37 ± 2 ° C for 48 hours in the RRS incubator.
Result
The color change of BI to yellow indicates a defect in the sterilization process after the mentioned period of time. The content of the tube 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.
Record the positive results in the RRS CSSD Documentation NoteBookand and discard them immediately.
Positive control
At least one positive control must be placed in each test series. Use a non-sterile spore ampoule as a positive control. For results to be valid, the positive control indicator should turn to yellow or indicates turbid color of the culture medium and the negative control should not change its original color.
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Geobacillus stearothermophilus Spore Ampoules 10^6 (RRS 14-21310)
Dry Heat Chemical Indicator Type 6 (RRS 14-15610)
Bacillus atrophaeus Spore Strip (Dry Heat) (RRS 14-22110)
