Product catalogue
Tests for sterilisation control- formaldehyde sterilisation |
biological control
DS-100 - a biological indicator of monitoring the steam-formaldehyde sterilization process - SPORAL Atrophaeus, SPORAL Stearothemophilus
An indicator looks like a strip of tissue-paper saturated with spore suspension of Bacillus stearothemophilus ATCC 7953 (for Forms) type and Bacillus Atrophaeus ATCC 9372 type in a single special paper wrapping protecting against contamination. Each indicator contains no less than 2.3 x 10 units capable of passing to the vegetative form (CFU).
In case of formaldehyde sterilization the test should undergo exposure in minimum 1-2% formalin within 60-90 minutes
Directions for use
- Control indicators should be placed in at least two biggest representative packs for a particular load and put in places difficult for a sterilization agent to access.
- An established sterilization programme in minimum 1-2% formalin should be performed within 60-90 minutes.
- After sterilization process test indicators should be removed from the load and inoculation performed within up to 5 hours after exposure. If indicators cannot undergo incubation in a particular time they should be placed in room temperature and stay there up to 24 hours.
- Food microorganisms control constitutes an indicator which does not undergo sterilization process.
- Tests after use and out of date should be sterelized in an autoclave or burnt.
- For formaldehyde sterilization a biological test for each batch is conducted.
Culture
- Maintaining aseptic conditions a tissue-paper strip should be removed from a paper-foil bags and every strip should be placed in a separate bacteriological test-tube with TSB base (Soy Broth mode – casein – ion broth bouillon) – a bag can be cut in any place.
- A tissue-paper strip should be fully dipped in the bouillon
- Incubtion should last 5 days in temerature of 37 +/- 2°C.
- In test-tubes containing tissue-paper strips there should be no growth from the indicators which underwent sterilization. When growth appears the sterilization process was not correct.
- Test-tubes should be observed daily to state probable growth. In case of inefficient sterilization in 90% of cases the growth will appear within 48 hours. Test-tubes must be observed for 5 days.
- In a test-tube containing an indicator which has not undergone sterilization growth should appear within 48 hours.
Standards
A product meets EN 866 standard for bilological control ISO 11138
Manufacturer
SPS Medical NY USA, Henrietta Road
