MET ONE FMS 設備監控系統

設備監控系統（FMS）可以配置迎合各種產業（包括製藥生產）需求的涉及面廣泛的無塵室管理。FMS 系統可以監測不可存活的空氣粒子數、空氣溫度和相對濕度。我們的 FMS 系統解決方案基於一個開放體系結構平台，該平台旨在與現有客戶系統（SCADA）輕鬆、精簡地整合。每台儀器都是圍繞著經過驗證的 MET ONE 技術構建的，包括用於常規監測和無塵室分類的便攜式MET ONE 3400 系列，以及 6000和 7000系列固定的、無活性的空氣顆粒計數器。MET ONE 軟體平台具有直觀的界面，使其易於操作，從而減少了人工 SOP 監視可能發生的人為錯誤。此外，為了幫助集中報告和簡化 EUGMP/FDA 合規性（例如 ISO 14644 和 21 CFR Part 11 的法律條款），貝克曼 FMS 數據可以整合到一個一鍵生成的電子簽名無紙化報告中。

  • 優化的工作流程，全面的解決方案從而監控您的無塵室
  • CFR 21 Part 11 條款允許軟體的工作流程以 確保安全的數據管理
  • 整合攜帶型及遠端空氣粒子計數器

 

*本產品僅供工業與科學研究使用，不用於臨床診斷  

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MET ONE Facility Monitoring System產品特性

數據管理

  • 將多個監視系統分解為單個集成系統，以便更容易地進行驗證、維護和數據管理
  • 冗餘數據管理消除了單點故障

軟體特點

  • 用於空氣粒子計數監測和報告的簡單界面
  • 基於向導的計數器安裝和配置
  • 一鍵式報告生成操作
  • IQ/OQ 的文檔模板

  • 區域服務提供專業人員現場進行 ISO 2150-1-4 校準和服務
  • 預定的現場校準和維修服務協議選項（包括維修折扣）

合規標準

  • ISO 14644 標準無塵室管理
  • ISO 21501-4 標準空氣粒子計數器校準，用於測量傳感器之間的準確度和重復性
  • 符合 CFR 21 Part 11 的要求關於電子數據記錄的管理
  • 遵從歐盟 GMP《無菌藥品生產規範》附件一條款

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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.
Specifying Non-Viable Particle Monitoring for Aseptic Processing This paper details key considerations when implementing a continuous non-viable particle monitoring (NVP) system.
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).

Technical Documents

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