MET ONE 3400+ 系列空气颗粒计数器

我们新型的MET ONE 3400+系列便携式颗粒计数器，采用自动化的SOP控制和采样图层点位功能，可加载到计数器中标记采样位置，并为每个位置定义SOP要求。通过10’’触摸屏轻松获取SOP和采样点位图，采样后位置图标呈绿色，使进度一目了然，将操作误差降低。

通过web浏览器可远程访问计数器，诸如审核、批准、SOP版本控制和电子记录导出等功能都可以直接在计数器中获取，无需额外的软件。 内置安全的搜索/筛选审计追踪功能可在审核过程中提供快速报告，MET ONE 3400+ 使用微软活动目录来控制登录和电子签名的用户名和密码，支持21 CFR Part 11合规性和 ALCOA原则。

*本产品仅供工业与科研使用，不用于临床诊断 

 

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MET ONE 3400 Air Particle Counter

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使用MET ONE 3400+ 进行 ISO 14644-3 洁净室自净时间测试 本应用指南将带您回顾标准检测方法，并就“检测浓度（Challenge）”和“目标洁净度等级（Target Cleanliness Level）”的选择提供指导。
GMP Cleanrooms Classification and Routine Environmental Monitoring The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.
Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing This paper describes changes and improvements to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which is a regulatory requirement during aseptic processing. Aseptic processing is becoming more automated and increasingly important to future products of the biopharmaceutical industry. In the same manner, NVP monitoring is also becoming more automated and increasingly important for contamination risk management during aseptic processing.
Changes to GMP Force Cleanroom Re-Classifications This paper explains the rules of ISO 14644-1:2015, which has substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
Achieving Compliant Batch Release – Sterile Parenteral Quality Control This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.

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