MET ONE 3400 シリーズ

業界初の Simply Paperless（21CFR Part11 対応）

MET ONE 3400（メットワン 3400）シリーズは、吸引量28.3 L／分と大吸引量50 L／分,100 L／分の3タイプを用意しており、軽量にして、コンパクトで持ち運びやすく簡単な使い勝手を実現し、微粒子測定・管理に係わる時間を大幅に短縮しました。ホットスワップ可能なバッテリ駆動です。操作はカラータッチパネルを採用し、USBメモリでのダウンロードが可能です。
保証期間3年の長寿命半導体レーザーを光源としており、長期間にわたって安定した性能を提供します。 

MET ONE 3400 Air Particle Counter

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FAQ
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技術資料
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特長
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トレーニング
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標準規格への対応

Choose a MET ONE 3400 Model

特長

標準規格への対応

  • ISO 14644-1 Class 5 のサンプリングに対応
  • ISO 21501-4 で要求されるユニット間の精度および再現性に対応
  • 21CFR Part 11 と EU Annex 1 準拠

データ管理

  • データ管理ソフトウェアに業界標準のフォーマットで接続可能
  • ワイヤレス、Ethernet、シリアル、USBでのデータ通信
  • 印刷またはペーパーレスのデータ出力

操作

  • 設置区域・場所を選ばないコンパクト設計
  • 21CFR Part 11対応のデータセキュリティ

アプリケーション

  • クリーンルームの環境モニタリング
  • 無菌医薬品の生産
  • 継続的な環境モニタリング
  • トラブルシューティング・プロセス
  • HEPAフィルターのリーク検出

製品仕様

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資料

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Title Description
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring
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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).
Automating Quality Control Testing for Improved 21 CFR Part 11 and ALCOA Data Integrity
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Infographic showing manual to automated - how our QC Suite instruments help you comply with 21CFR part 11 ALCOA
Manufacturing Processes for Engineered T-Cell Therapy – CAR-T
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Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
Manufacturing Processes for Engineered T-Cell Therapy – CAR-T
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Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
21 CFR Part 11 QC Instrument Suite
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This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
Certified Calibration Services for MET ONE
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Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter
Quality Control Testing Instrumentation Solutions for GMP Manufacturing
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Raw Materials QC, Production QC, and Final Product QC product solutions
Facility Monitoring System (FMS) Solutions Product Brochure
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Brochure: With new innovative designs specifically tailored to address the requirements of the Pharmaceutical industry, MET ONE particle counters feature full ISO 21501 compliance in advance of ISO 14644 standard adoption for all calibration parameters
MET ONE 3400 Series Portable Airborne Particle Counter
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Product brochure for the enhanced MET ONE 3400 Series, which is the easiest-to-use and easiest-to-integrate portable particle counter for any facility or environmental monitoring program
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring with Beckman Coulter Life Sciences MET ONE 3400 Portable Air Particle Counters
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Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017
Quality Control Electronic Records for 21 CFR part 11 Compliance
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}|{E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}
This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.
Automating Biopharma Quality Control to Reduce Costs and Improve Data Integrity
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}|{E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}
This whitepaper takes a look at four common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst also saving time and reducing operating costs. The four quality control procedures discussed in this paper form a common thread in the biopharmaceutical manufacturing industry and are water quality testing, cleanroom routine environmental monitoring, biological cell counting and viability testing and final injectable drug particulate testing.
Cleanroom Routine Environmental Monitoring, 21 CFR part 11 Data Integrity FDA Guidance
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Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017
Changes to GMP Force Cleanroom Re-Classifications
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Whitepaper by author Tony Harrison, Senior Marketing Manager, Particle Counting & Characterization Business Unit


Technical Documents