SterilAmp® Micro/5mm 

 Small diameter. Simple validation. Confident results. 

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    SterilAmp Micro/5mm

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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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技术文档
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主要优势

  • Ultra-Small Diameter: SterilAmp Micro/5mm features a 5.0 mm diameter, allowing direct placement inside very small containers such as 1 mL syringes, cartridges, narrow-neck ampoules, small vials, and IV fluid bag ports.

     

  • In-Container BI Placement: Enables placement of the BI at the most challenging (worst-case) thermal location within the liquid product container without modifying the container, supporting robust, repeatable, and compliant sterilization validation.

     

  • Simplified and Controlled Validation Process: 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.

     

  • Clear, Reliable Results: Provides a clear, reliable visual readout through color change after incubation

     

技术规格

技术规格

SterilAmp® Micro/5mm

  • Spore: Geobacillus stearothermophilus 7953

  • Population: 10⁶

  • Incubation: 48 h at 55–60 °C

  • Storage: Refrigerate at 2-8°C

  • 有效期：自生产日期起18个月

  • Certification: SterilAmp biological indicators are traceable to a recognized culture collection and certified for population, D-value, z-value, F0 value, and performance.

  • Dimensions: 5.0 mm Ø × 25 m

工作原理

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.

适用场景

  • Terminal steam sterilization of liquid products in formats such as prefilled syringes, cartridges, small vials, and IV bag ports. 

  • Applications with limited internal access where standard BI placement is not feasible. 

  • QA and validation teams currently using direct product inoculation with a spore suspension or surrogate configurations. 

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