Air particle counters for cleanroom monitoring according to ISO 14644

Maximum data integrity: Versatile particle counters for 21 CFR Part 11 compliant cleanroom qualification and monitoring

Air particle counters for cleanroom monitoring according to ISO 14644

Maximum data integrity: Versatile particle counters for 21 CFR Part 11 compliant cleanroom qualification and monitoring

Particle monitoring made easy: Look forward to your next audit with peace of mind

Our comprehensive range of airborne particle counters will see you through any audit. Whether it’s cleanroom environmental monitoring, cleanroom qualification or air particle counting in aseptic filling systems, all air particle counters comply with EU GMP, Annex 1, CGMP, ISO 14644 as well as 21 CFR Part 11. The proven “Simply Paperless” feature of the MET ONE series lets you export your data directly as a PDF file to a USB stick, your Ethernet or to your chosen storage location via WiFi without any manual steps.

From handheld to online, select from a wide range of airborne particle counters

No matter for which application you need your air particle counter, Beckman Coulter Life Sciences offers the right instrument. The range spans from handheld devices to portable airborne particle counters to devices for integration into online systems. You need help to select the right air particle counter? Click the button and enter your question into the comment field.
MET ONE 3400 Portable Airborne Particle Counter
 

Tragbarer Luftpartikelzähler MET ONE 3400

Save hours of valuable time with the fastest airborne particle counter on the market

Portable air particle counters for cleanroom applications according to ISO 14644 and 21501-4. Set up your daily cleanroom particle monitoring routines with individually programmable locations and test procedures. During cleanroom qualification, the integrated wizard is there to help ensure operation according to the regulations.

Measuring range: 0.3 – 25 µm
Flow rate: 28.3 – 100 l/min

MET ONE 6000 Integrated Air Particle Counters

Remote airborne particle counters for continuous particle monitoring at fixed installation sites

The MET ONE 6000 integrated airborne particle counters meet all the requirements of ISO 21501-4. Compact and flexible with regards to sensitivity, flow rate and communication, they are specially designed for cleanroom environmental monitoring in the pharmaceutical, semiconductor, hard disk and flat panel display industries.

Measuring range: 0.5 and 5 µm plus optional sizes
Flow rate: 2.83 – 28.3 l/min

HHPC+ Handheld Air Particle Counters
Handheld Luftpartikelzähler HHPC+

Versatile handheld instrument for pharmaceutical and high-tech product manufacturing facilities

Fully equipped 2, 3 or 6 channel handheld particle counters for a variety of tasks where pharmaceuticals, semiconductors or flat panel displays are manufactured within cleanrooms and in ISO class 5 (or higher) controlled environments. The base station conveniently provides computer access to your particle count data via Ethernet or a USB stick.

Measuring range: 0.3 – 10 µm
Flow rate: 2.83 l/min

Scalable online solution for your monitoring needs
Skalierbare Online-Luftpartikelzähler FMS

MET ONE Facility Monitoring Systems can be integrated into any existing particle monitoring system

Thanks to their open communication architecture, they are easy to integrate into any existing particle monitoring system. All our fixed location and portable airborne particle counters comply with the ISO standards 14644 and 21501-4. In addition, the data management software is 21 CFR Part 11 compliant.

White paper: How to optimize cleanroom environmental monitoring workflows

Biopharmaceutical environmental monitoring is a time-consuming, labor-intensive task that the world’s most important regulatory authorities all require. In this white paper you will learn how Beckman Coulter’s innovative hardware and software solutions can help you to reduce the complexity of your monitoring tasks while achieving maximum data integrity.

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PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS

The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled “For In Vitro Diagnostic Use.”
ASR: Analyte Specific Reagents. These reagents are labeled “Analyte Specific Reagents. Analytical and performance characteristics are not established.”
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled “For Research Use Only. Not for use in diagnostic procedures.”
LUO: Laboratory Use Only. These products are labeled “For Laboratory Use Only.”
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.

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