ISO 11138-1 and USP Compliant (Gamma or E-beam)
True Indicating Radiation Biological Indicator are manufactured with:
• Pure high quality Bacillus pumilus spores, Cell Line 27142, within 5 passages of an original stock culture suspended only in Water For Injection (WFI)
• Spore strips are 6 x 30 mm packaged in glassine envelopes
• Spore Suspensions are packaged in pharmaceutical grade glass vials with screw cap and septum to allow for access with a pipette or syringe
The Indicators are designed to provide assurance of effective sterilization after exposure to a radiation process. The Indicators may be used to monitor radiation dose levels of 10 kGy and greater.
True Indicating offers standard configurations of Spore Strips and Spore Suspensions. In addition to standard configurations, True Indicating will manufacture custom Indicators to meet your needs.
Population: 106/Strip, DValue: 0.1 to 0.2 Mrad Or 1.0 to 2.0 kGy, Glassine dimension: 30 x 38 mm, Shelf life: 24 Months