MET ONE 3400

Der transportable Luftpartikelzähler MET ONE 3400 wurde speziell für Reinraumanwendungen nach ISO 14644 und 21501-4 entwickelt. Organisieren Sie Ihre tägliche Reinraumüberwachung mit individuell programmierbaren Standorten und Testverfahren. Bei der Reinraumqualifizierung unterstützt der integrierte Assistent eine regelkonforme Durchführung.

Messbereich: 0.3 µm - 25 µm
ISO 14644 und 21501-4 konform
Durchflussrate: bis zu 50 LPM
Datenspeicherung: bis zu 5.000 Messungen
Akkuladedauer: min. 6,75 Stunden - max. 10 Stunden

MET ONE 3400 Eigenschaften

Flexible Kommunikation – einfache Konfiguration und problemloser Datentransfer

Reduzieren Sie Papier-, Kopier- und Schreibarbeit. Nutzen Sie WIFI, Ethernet oder serielle Kommunikation für Ihr MET ONE Datenmanagement oder Ihre eigenen Softwarelösungen

Passwortgeschützte Benutzeranmeldung für 21 CFR Part 11 Konformität

Passwortschutz in unterschiedlichen Zugangsebenen gewährleistet die Datensicherheit zur Einhaltung von 21 CFR Part 11

Intuitive Benutzeroberfläche

Einfache Programmierung Ihrer Probennahmepläne über Bereich, Standort und sonstiger Parameter spart Zeit und verhindert Bedienungsfehler
Durch Replikation Ihrer Einstellungen auf einen USB-Stick übertragen Sie Ihre Konfigurationen ganz einfach auf Ihren gesamten Partikelzählerbestand

Anwendungen

Reinraumüberwachung
Reinraum Qualifizierung
ISO 14644 Reinraumüberprüfung
Reinraumvalidierung
Aseptische pharmazeutische Produktion
HEPA Filterleckermittlung
Hochdruckgasüberwachung mit einfachem Gasauswahlmenü und automatischer Probenflusseinstellung

MET ONE 3400 Spezifikationen

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 4,000,000 particles/m³
Sample Volume	25 µm
Throughput	50 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	2088900-13

Dokumentation zum MET ONE 3400 Luftpartikelzähler

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Title	Description
Cleanroom Routine Environmental Monitoring & Data Integrity 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.
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.
Environmental Monitoring	Good Manufacturing Procedure (GMP) mandates the air quality conditions for biopharmaceutical production in cleanrooms.
GMP-Reinraumklassifizierung und Routine-Umgebungsüberwachung {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	Die verschiedenen GMP-Richtlinien und internationalen ISO-Normen rund um GMP-Reinräume sind komplex und scheinen oft widersprüchliche Ratschläge zu geben, was zu Verwirrung und manchmal falscher Interpretation führt.
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.
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.
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.
Particle testing in cleanroom high-pressure gas lines to ISO 14644 made easy with the MET ONE 3400 gas calibrations	This paper provides guidelines for the testing of high pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines and the EU GMP Guidelines. Specifically, this applications paper relates to satisfying the air particle concentration limits of Class 100 (ISO 5) where product is exposed to the air environment.
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).
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.
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.
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.
Manufacturing Processes for Engineered T-Cell Therapy – CAR-T	Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
【カタログ】MET ONE 3400+ {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	GMPに準拠したクリーンルームの環境モニタリングを簡便にし、向上したデータインテグリティ機能を搭載した気中パーティクルカウンター
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
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 {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
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
21 CFR Part 11 QC Instrument Suite {279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}	This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
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
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
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
479A MET ONE 3400 {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}

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MET ONE 3400