MET ONE 3400 便携式空气颗粒计数器

MET ONE 3400 系列空气颗粒计数器是最简单、最可靠的便携式空气颗粒计数解决方案，适用于各种洁净室应用—从无菌生产和过程故障排除到持续监测、分类和验证。按照 ISO 14644、21 CFR 第 11 部分和欧盟 GMP 附件 1 的要求，快速、自信、安全地完成洁净室的工作。

• 具备先进的嵌入式安全数据传输，符合 21 CFR 第 11 部分的要求
• 14644 和 Annex 1 合格标准的样品规划向导
• 支持符合 ISO 21501-4 标准点对点的准确性和重现性
• 一键采样和定位 ID
• 嵌入式位置和样品配方管理
• 双热插拔电池，持续工作
• 软件和测试向导，方便无误的配置
• 开放的通讯架构，用于无缝化设备集成和数据管理 

*本产品仅供工业与科研使用，不用于临床诊断 

 

资源 + 工具
21 CFR Part 11 常见问题解答 产品特点 请求报价 合规标准 技術文件

选择 MET ONE 3400 Series 型号

功能特点

合规标准

  • 启用了 ISO 14644-1 标准抽样和报告功能
  • 符合 ISO 21501-4 标准保证仪器之间的准确性和重现性
  • 使 21 CFR 第 11 部分和欧盟附件 1 符合规定

数据管理

  • 与数据管理软件的行业标准连接
  • 无线、以太网、串行和 USB 通讯
  • 打印或无纸化数据输出

仪器操作

  • 操作参数的基于区域、组和位置的配置
  • 密码保护的多级访问 21-CFR 第 11 部分兼容的数据安全

应用程序

  • 洁净室日常环境监测
  • 无菌药品生产
  • 持续的环境监测
  • 无尘室分类和验证
  • 故障诊断过程
  • 有效过滤器泄漏检测

Content and Resources

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Resource Type
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.
符合《联邦法规 21 章》第 11 部分规定的质量控制电子记录 本文介绍了如何针对制药用途优化质量控制仪器，从而帮助提高最终电子记录中数据的完整性。
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring This paper examines a thoughtfully designed and well-executed environmental monitoring program that tests the controls put in place to maintain the cleanroom to the required Good Manufacturing Practices standards (e.g., CGMP, EU-GMP, and PIC/S).

技术文件

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