SterilAmp^® Micro/5 mm 

Beneficios clave

• Ultra-Small Diameter: SterilAmp Micro/5mm features a 5.0 mm diameter, enabling placement inside small volume prefilled syringes, cartridges, narrow-neck ampoules, small vials, and IV fluid bag ports.
• Direct Placement at the Worst-Case Location: Enables the biological indicator to be positioned directly within the liquid product container at the most challenging thermal location, supporting representative and repeatable validation without container modification.
• Simplified and Controlled Validation: Reduces reliance on variable and difficult-to-control approaches such as direct product inoculation using a spore suspension, use of inoculated spore strips immersed in the product, surrogate containers, or container modification. Fewer handling steps reduce variability, test complexity, and operational risk.
• Clear Results. No Negative Controls Required: Provides a clear visual readout after incubation. The optimized growth medium prevents heat-induced color change during sterilization, eliminating the need for negative controls and simplifying result interpretation.