MET ONE 3400 シリーズ

MET ONE 3400シリーズは、無菌医薬品の製造区域や製造プロセスにおけるトラブルシューティングから連続モニタリング、清浄度クラスの評価およびバリデーションに至るまでの様々なクリーンルームアプリケーションに対応できる、最も簡単で最も信頼性の高いポータブル気中パーティクルカウンターソリューションです。クリーンルームでの作業を、ISO 14644、21 CFR Part 11およびEU GMP Annex1の要件に準拠して、迅速かつ確実、安全に行えます。

• 21 CFR Part 11対応の業界初のマニュアル操作を省略した安全なデータ転送
•ISO14644およびAnnex 1に対応したサンプルプランウィザード
• ユニット間の精度および再現性を確保できるISO 21501-4対応のサポート
• ワンタッチでのサンプリングおよびロケーションID
•サンプリング箇所の登録と測定サンプル設定での運用管理
• 連続稼働のためのホットスワップ可能なデュアルバッテリ
• 簡単でミスのない設定を可能にするソフトウェアとテストウィザー
• LIMSなどの情報管理ツールを用いたシームレスな設備統合とデータ管理を可能にする開かれたコミュニケーションシステム

資料とアプリケーションノート

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
無菌医薬品の製造
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

Performance	ISO 21501-4 unit-to-unit accuracy & reproducibility
Industry Standards	ISO 21501-4 , 21 CFR Part 11, ISO 14644-1:2015, FCC, CE
Light Source	Long Life Laser™ Diode
Coincidence Loss	5% at 14,126,000 particles/m³
Sample Volume	25 µm
Throughput	28.32 L per minute

Reporting	EU GMP, ISO 146441-1.2015, FS209E, BS5295, ISO 14644-1:1999
Zero Count	ISO 21501-4 & JIS B 9921 (1 count or less in 5 min; 95% UCL)
Count Alarms Display and Cycles	User-defined alarm counts, Raw counts: N/CF, N/CM, N/L in cumulative or differential mode
Item Specifications Referenced	2088900-08

資料

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Title	Description
Achieving Compliant Batch Release – Sterile Parenteral Quality Control {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.
環境モニタリング	医薬品の製造管理および品質管理に関する基準（GMP）では、バイオ医薬品製造におけるクリーンルーム内の空気清浄度に関する条件が規定されています。
Maintaining Data Integrity: Understanding FDA ALCOA Guidance	21 CFR part 11 ALCOA defines good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.
Cleanroom Routine Environmental Monitoring & Data Integrity with the MET ONE 3400+
GMPクリーンルームの清浄度クラスと日常環境モニタリング {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}
21 CFR Part 11 with the MET ONE 3400
Conducting the ISO 14644-3 Cleanroom Recovery Test with the MET ONE 3400 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This application note reviews the test method and provides guidance on selecting both the “Challenge” and the “Target Cleanliness Limit”. Attention is given to the requirement that the test concentration should not be so high that “residue contamination” becomes a risk.
Cleanroom Routine Environmental Monitoring – FDA Guidance on 21 CFR Part 11 Data Integrity {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper examines the risk of error with SOPs being implemented manually. Technology exists and is commercial available to mitigate this problem and make programs more robust, reducing the impact on data integrity and also supporting the industry's move towards environmental monitoring by production staff in the cleanroom.
Counting Efficiency: MET ONE Air Particle Counters and Compliance to ISO-21501 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	The one parameter that stands alone as the champion of confusion for defining air particle counter performance is counting efficiency. The purpose of this paper is to present counting efficiency in terms that are easy to understand.
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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).
Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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.
パーティクルカウンター資料集高圧ガス配管内の清浄度測定- MET ONE 3400ガス校正オプションで ISO 14644の計測を簡単に -	本稿は、クリーンルームのクラス規格であるISO14644-1の清浄度限界やFDA及びEUの各製造品質管理基準に定める内容に従って、クリーンルーム内で高圧ガステストを行うためのガイドラインを提供するものです。特に、このアプリケーションペーパーの内容は、製品が大気環境にさらされるようなクラス100（ISO クラス5）の空気清浄度を満足させることに関連しています。
Quality Control Electronic Records for 21 CFR part 11 Compliance {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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.
Changes to GMP Force Cleanroom Re-Classifications {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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.
MET ONE 3400 Series Portable Airborne Particle Counter {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	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 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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).
ALCOA+ Infographic	Guidance on Maintaining Data Integrity Infographic
Automating Quality Control Testing for Improved 21 CFR Part 11 and ALCOA Data Integrity {A0D0EF0B-43F2-431C-BEB0-69F98765BDC4}	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	Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
Certified Calibration Services for MET ONE {9E29D7A5-B5EC-470A-A5C1-4EF9BFAE9959}	Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences \| Published 2017
Cleanroom Routine Environmental Monitoring, 21 CFR part 11 Data Integrity FDA Guidance	Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences \| Published 2017
Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Brochure on instruments designed for Raw Materials QC, Production QC, and Final Product QC
Facility Monitoring System (FMS) Solutions Product Brochure {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	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
21 CFR Part 11 QC Instrument Suite {279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}	This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
479A MET ONE 3400 {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}

MET ONE 3400 シリーズ

見積を依頼

FAQ

特長

21 CFR Part 11

技術資料

トレーニング

標準規格への対応

Choose a MET ONE 3400 Model

特長

標準規格への対応

データ管理

操作

アプリケーション

製品仕様

資料

Technical Documents

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