MET ONE 3400

El contador portátil de partículas del aire MET ONE 3400 está diseñado específicamente para aplicaciones de sala limpia según ISO14644. Organice su control periódico de sala limpia con gestión de fórmula de muestra y ubicación integrada. El asistente de clasificación del contador portátil de partículas del aire MET ONE 3400 garantiza el cumplimiento durante la certificación periódica de sala limpia.

MET ONE 3400 Air Particle Counter

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Tech Docs

Features

Training

Standards

Choose a MET ONE 3400 Series Model

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

Product Specifications

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Documentation

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Title Description
Quality Control Electronic Records for 21 CFR part 11 Compliance
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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
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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.
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).
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
Certified Calibration Services for MET ONE
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Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter
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
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
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
Changes to GMP Force Cleanroom Re-Classifications
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Whitepaper by author Tony Harrison, Senior Marketing Manager, Particle Counting & Characterization Business Unit
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
21 CFR Part 11 QC Instrument Suite
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This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
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
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
Quality Control Testing Instrumentation Solutions for GMP Manufacturing
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Raw Materials QC, Production QC, and Final Product QC product solutions


Technical Documents