MET ONE 3400+ 系列空氣粒子計數器

我們新型的MET ONE 3400+系列手攜式粒子計數器,採用自動化的SOP控制和採樣圖層點位功能,可加載到計數器中標記採樣位置,並為每個位置定義SOP要求。通過10’’觸碰螢幕輕鬆獲取SOP和採樣點位置圖,採樣後位置圖標呈綠色,使進度一目瞭然,將操作誤差降至最低。

通過web瀏覽器可遠程監控計數器,諸如審核、批准、SOP版本控制和電子記錄導出等功能都可以直接在計數器中獲取,無需額外的軟體。內建安全的搜索/篩選審查追蹤功能可在審核過程中提供快速報告,MET ONE 3400+ 使用微軟活動目錄來控制登錄和電子簽名的用戶名和密碼,支持21 CFR Part 11 合規性和 ALCOA原則。

*本產品僅供工業與科研使用,不用於臨床診斷  

 

功能特點

定制的交互式電子SOP地圖

使用Web瀏覽器界面,將SOP加載到計數器中,標記採樣位置,並為每個位置定義SOP採樣需求。

互動追蹤

根據大螢幕操作說明,操作員可快速導航採樣地圖,並根據SOP執行採樣。 採樣後位置圖標呈綠色,進度一目瞭然

直接獲取電子記錄( Excel 或 PDF )

MET ONE 3400+ 可通過USB、網路或WiFi直接獲取安全的電子記錄( Excel 或 PDF )

Web瀏覽器SOP版本控制以及審核和批准工作流程

主管可以通過網路瀏覽器遠程查看日常監控進度及所有採樣結果,管理員可以通過Web瀏覽器進行遠程SOP配置和版本控制,以及進行遠程審核採樣結果、警報和評論,批准最終電子記錄並附上電子簽名

Explore MET ONE 3400 Plus Models

產品規格明細

Industry Standards ISO 21501-4 , 21 CFR Part 11, ISO 14644-1, EU GMP (2015), CE, FCC, 802.11, 802.1x
Light Source Long Life laser diode with 10 year mean-time-to-failure
Coincidence Loss 10% at 36,000,000 particles/m³
Reporting EU GMP Annex 1, CGMP, ISO 146441-1.2015
Zero Count 1 count or less in 5 minutes, 95% confidence level
Counting Efficiency 50% ±20% for 0.3 μm (100% ±10% for 0.45 μm)
Count Alarms Display and Cycles Multiple user-defined alert and/or alarm levels for counts, concentration, or environmental sensors
Item Specifications Referenced C38675

Content and Resources

Filter by:
Resource Type
Automating Quality Control Testing for Improved 21 CFR Part 11 and ALCOA Data Integrity Infographic showing manual to automated - how our QC Suite instruments help you comply with 21CFR part 11 ALCOA
ALCOA+ Infographic Guidance on Maintaining Data Integrity Infographic
Certified Calibration Services for MET ONE Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter
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).
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017

Technical Documents

Didn't find what you are looking for? For more results click here.