- Compliant with USP, ISO 11138-1 and 11138-4
- Suitable for High Temperature Dry Heat Sterilization Processes
- Minimum Incubation Period of 72 Hours
- Consistent Population, Purity and Resistance Ampule to Ampule
Process: Dry Heat or Depyrogenation
Dimensions Ampule: 47 mm x 10.6 mm
Packaging: 50 Ampules + 50 Tubes of Growth Medium
Volume of Growth Medium 4.5 mL
24 months shelf life
- Snap top glass ampule containing silica material inoculated with Bacillus atrophaeus Cell Line 9372 Spores with a known population and resistance.
- Tubes of growth medium specially formulated for Bacillus atrophaeus modified with a pH indicator that transitions from Green to Yellow and offers a reduced incubation time of 72 hours.
- All materials are compatible with extremely high temperatures such as those in dry heat tunnels or ovens used for sterilization or depyrogenation in manufacturing of aseptically filled pharmaceutical liquids.