SterilAmp^® Micro/5mm

小直径，易验证。结果可靠。

简化小型液体容器的蒸汽灭菌验证

SterilAmp® Micro/5mm是一款紧凑型、自含式液体生物指示剂（BI），专为极小初级容器中液体的蒸汽灭菌验证而设计，在这些容器中无法放置标准规格的生物指示剂。

凭借其5.0 mm直径，SterilAmp® Micro/5mm能够将生物指示剂直接放置在液体产品容器内最具挑战性（最差情况）的位置，无需修改容器即可支持具有代表性、可重复且合规的验证。

索取报价

技术文档

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.

技术规格

工作原理

SterilAmp Micro5mm是一款自含式液体生物指示剂，由密封玻璃安瓿组成，内含确定的微生物菌量。

该生物指示剂被直接放置在液体容器内的“最差条件”位置（即灭菌难度最大的部位），以确保其与产品处于相同的热处理条件下。

灭菌结束后，通过培养观察颜色变化和/或浑浊现象来判断是否有微生物生长，从而直接指示在代表性产品条件下的灭菌效果。

适用场景