The unique DriAmp® biological indicator (BI) is appropriate for either high temperature direct air exposure or submersion in oils and other non-water based solutions where traditional paper strip indicators are difficult to use.
The DriAmp BI is a 1 mL snap-top glass ampoule containing silica material inoculated with 106 Bacillus atrophaeus (#9372) spores. All materials are compatible with extremely high temperatures such as those delivered by dry heat tunnels or ovens used for the sterilization of instruments and depyrogenation in the manufacture of aseptically filled pharmaceutical liquids.
The Releasat culture medium is specially formulated for rapid outgrowth of B. atrophaeus, and is supplied in individual tubes for easy aseptic transfer and culturing. This medium offers the advantage of a 72 hour reduced incubation time compared to 7 days with competing products. Test results are obtained during incubation by observing the medium which changes color from red-orange to yellow if any spores have survived the process.
Availability
| DriAmp Culturing Set with Releasat Medium |
| Spore |
Incubation |
Sets |
Population |
Reorder # |
| B. atrophaeus |
72 Hours at
36-38 °C |
50 |
106 |
DH/50 |
Use
Please follow instructions provided with each DriAmp Culturing Set box.
Sterilization
- Place ampoule(s) with representative materials to be sterilized. Package as usual.
- Locate test packages in areas of sterilizer most difficult to sterilize. Identify test packages as to location in the dry heat sterilizer.
- After sterilizing, forward ampoule(s) and media to test laboratory along with at least one non-sterilized ampoule marked POSITIVE CONTROL.
Test Laboratory
- All testing should be performed within confines of a laminar flow hood. All transfers and manipulations must be done with rigid aseptic techniques to avoid "false positive" samples.
- Procedure:
- Let the ampoules cool for at least ten minutes before culturing.
- Before the ampoule is placed in the workstation, the ampoule should be sprayed with 70% IPA.
- Remove the caps of the ampoules as follows:
Hold the top of the ampoule with one hand and the body of the ampoule with the other hand.
Place thumbs tip-to-tip over the scored glass line at the neck of the ampoule.
Snap the top off of the ampoule by using the thumb tips as a hinge and applying pressure at the scored glass line.
- Slowly pour the contents from the ampoule into a test tube of Releasat medium, one tube for each ampoule.
- Incubate at 36-38°C.
- Results are read at NLT 72 hours.
- Observe tubes daily for growth.
Yellow = growth = non-sterile
Red = no growth = sterile
Test cultures should show no growth if sterilization has been achieved. A yellow color and/or turbidity indicates bacterial growth occured in culture tubes. Tubes can be sub-cultured if identification of positive growth is desired. Recommended sub-culturing procedure techniques are available from SGM Biotech.
- Controls
Positive: One or more positive controls should be included in each test series. Transfer a non-sterilized ampoule to Releasat culture medium and incubate with test series. Yellow color and turbidity inicates that the medium possesses suitable growth promoting qualities and that the carrier contains viable spores. If positive control does not grow, do not use the lot.
Storage
Room temperature.
Expiration
12 months from date of manufacture.
Certification
DriAmp biological indicators are traceable to a recognized culture collection, and certified for population, D-value, Z-value, and performance.
