SterilAmp® Micro/5mm
Small diameter. Simple validation. Confident results.
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SterilAmp Micro/5mm
Simplifying Steam Sterilization Validation for Small Liquid Containers
SterilAmp® Micro/5mm is a compact, self-contained liquid biological indicator (BI) designed for steam sterilization validation of liquids in very small primary containers where standard BI formats cannot be placed.
With its 5.0 mm diameter, SterilAmp® Micro/5mm enables BI placement directly at the most challenging (worst-case) location within the liquid product container, supporting representative, repeatable, and compliant validation without container modification.
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Key Benefits
- 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.
Technical Specifications
SterilAmp® Micro/5mm
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Spore: Geobacillus stearothermophilus 7953
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Population: 10⁶
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Incubation: 48 h at 55–60 °C
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Storage: Refrigerate at 2-8°C
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Expiration: 18 months from date of manufacture
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Certification: SterilAmp biological indicators are traceable to a recognized culture collection and certified for population, D-value, z-value, F0 value, and performance.
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Dimensions: 5.0 mm Ø × 25 m
How It Works
SterilAmp Micro/5mm is a self-contained liquid biological indicator comprising a sealed glass ampoule with a defined microbial population.
The BI is placed directly inside the liquid container at the worst-case location, ensuring exposure under the same thermal conditions as the product.
After sterilization, incubation reveals growth through color change and/or turbidity, providing a direct indication of sterilization efficacy under representative product conditions.
Ideal For
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Terminal steam sterilization of liquid products in formats such as prefilled syringes, cartridges, small vials, and IV bag ports.
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Applications with limited internal access where standard BI placement is not feasible.
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QA and validation teams currently using direct product inoculation with a spore suspension or surrogate configurations.
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