SterilAmp® Micro/5mm
Small diameter. Simple validation. Confident results.
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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Vantaggi principali
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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.
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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.
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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.
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Clear, Reliable Results: Provides a clear, reliable visual readout through color change after incubation
Specifiche tecniche
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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Scadenza: 18 mesi dalla data di produzione
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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
Come funziona
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.
Ideale per
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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.
Prodotti correlati
Servizi correlati
Laboratorio di ricerca esterno
Il laboratorio indipendente di studi di contratto di Mesa esegue la verifica certificata e conforme del certificato di analisi dei bioindicatori di terze parti.
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Sviluppo del ciclo di sterilizzazione
Chiedi aiuto a un esperto per il tuo bioburden. Mesa Labs fornisce assistenza per lo sviluppo del ciclo di sterilizzazione, la qualificazione e la convalida del bioindicatore e il supporto per il monitoraggio di routine.
Ulteriori informazioni