HUMAN MEDITEK CO., LTD.
Q : Please give us the detailed explanation about the the BI or SCBI.
A : 1) What is the SCBI?
: It is short for Self-contained Biological Indicator. It is a plastic crushable vial consisting of a spore-coated fiber disc and media.
2) What is the storage condition of the SCBI?
: It should be stored at 2 - 25 ℃ under dry conditions. Do not store it near any sterilizers or sterilization agent like EtO, steam, hydrogen peroxide, acids, alkalis, volatile antimicrobials or other oxidizers.
3) What is the shelf-life of the SCBI?
: It is 18 months from the date of manufacture.
4) What is the recommended temperature to incubate the SCBI?
: It is 58 ℃ ±2 ℃.
5) How often do we have to do the SCBI test?
: It is recommended to do it for every cycle.
6) How long do we have to incubate the SCBI?
: It is 48 hours.
7) What is the strain of the SCBI of HMTS?
: It is Geobacillus stearothermophilus which is proven as a most resistant to hydrogen peroxide.
8) Why do we have to do the SCBI test?
: BI should be used to finally guarantee the strilization result by HMTS.
9) What are SAL and CFU?
- SAL is short for Sterility Assurance Level; probability of a viable microorganism remaining alive after sterilization. An SAL is normally expressed as 10-6 which means that there is less than or equal to one chance in a million that a single viable microorganism remains alive on a sterilized item.
- CFU is short for Colony Formation Unit.
10) How can we test the SCBI?
1. After finishing the sterilization by HMTS, take out the SCBI from the pouches.
2. Press the SCBI cap until the vial is crushed until you hear of a second click and
make it sure the cap is obviously put into the white disc.
3. Record the date, time, cycle number and name of the operator on the SCBI.
4. Incubate the processed SCBI in the incubator for 48 hours.
11) What is the purpose of testing the Control SCBI?
: It is to confirm the condition of the SCBI.
- Positive Control: Crush an unprocessed SCBI and place in the same incubator used for the processed SCBI. It is recommended that a positive control be used with processed biological test.
- Negative Control: An unprocessed and uncrushed SCBI is used. Place Negative Control in the same incubator used for the processed SCBIs and Positive Control.
12) What do we do with the used SCBI?
: Discard it immediately including the Positive Control after sterilizing in steam sterilizer at 132℃ for over 15 minutes.
13) Is Geobacillus stearothermophilus dangerous bacterial strain to people?
: No. It is not dangerous.