MET ONE 3400 Portable Air Particle Counter

The MET ONE 3400 Series is the easiest and most reliable portable air particle counting solution for a wide variety of cleanroom applications—from aseptic production and process troubleshooting to continuous monitoring, classification and validation. Complete your cleanroom work quickly, confidently, and securely in compliance with ISO 14644, 21 CFR Part 11, and EU GMP Annex 1 requirements.

• Industry’s first embedded secure data transfer for 21 CFR Part 11 compliance
• Sample plan wizard for 14644 & Annex 1 compliance
• Supports ISO 21501-4 compliance for unit-to-unit accuracy & reproducibility
• One-touch sampling & location ID
• Embedded location & sample recipe management
• Dual hot-swappable batteries for continuous operation
• Software & test wizards for easy error-free configuration
• Open communications architecture for seamless facility integration & data management

Documentation and Application Notes

MET ONE 3400 Features

Standards

ISO 14644-1 enabled sampling and reporting
ISO 21501-4 unit-to-unit accuracy & reproducibility
Enables 21 CFR Part 11 and EU Annex 1 compliance

Data Management

Industry standard connectivity to data management software
Wireless, Ethernet, serial, and USB communication
Printed or paperless data output

Operation

Easy area, group, and location based configuration of operating parameters
Password protected multi-level access for 21-CFR Part 11-compliant data security

Applications

Cleanroom routine environmental monitoring
Aseptic pharmaceutical production
Continuous environmental monitoring
Cleanroom classification and validation
Process troubleshooting
HEPA filter leak detection

MET ONE 3400 Specifications

Industry Standards

21 CFR Part 11

Item Specifications Referenced

2089494-01

Documentation

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Title	Description
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
Automating Biopharma Quality Control to Reduce Costs and Improve Data Integrity	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.
Quality Control Electronic Records for 21 CFR part 11 Compliance	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.
Cleanroom Routine Environmental Monitoring, 21 CFR part 11 Data Integrity FDA Guidance {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences \| Published 2017
Changes to GMP Force Cleanroom Re-Classifications {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	Whitepaper by author Tony Harrison, Senior Marketing Manager, Particle Counting & Characterization Business Unit
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
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
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
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 {749D68FB-4893-4B2D-BD6C-C662F0520F64}	Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
Manufacturing Processes for Engineered T-Cell Therapy – CAR-T	Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
Achieving Compliant Batch Release – Sterile Parenteral Quality Control {442DF88C-CA7F-4B78-AF75-9D2B985534C0}
Environmental Monitoring
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.
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.
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.
Automating Biopharma Quality Control to Reduce Costs and Improve Data Integrity {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper 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.
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.
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.
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).
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.
Changes to GMP Force Cleanroom Re-Classifications {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper explains the new 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.

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MET ONE 3400 Portable Air Particle Counter