Sterilization biological indicator DriAmp®

temperaturefor the pharmaceutical industry

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 1ml 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. Set includes small, conveniently-shaped BI ampoule (49mm x 11 mm) and Releasat® Culture Media tube (16mm x 100 mm) Incubation: 72 Hours at 36-38 °C 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. Each set includes DriAmp BI and Releasat media.