Particle Counting (Particle Counter)

We provide scalable Facility Monitoring Systems (FMS) that can be configured to meet a wide spectrum of cleanroom management needs for various industries—including pharmaceutical production. Among parameters that can be efficiently and reliably

We provide scalable Facility Monitoring Systems (FMS) that can be configured to meet a wide spectrum of cleanroom management needs for various industries—including pharmaceutical production. Among parameters that can be efficiently and reliably monitored using a Beckman Coulter FMS are non-viable/viable air sampling, differential pressure, air temperature and relative humidity. All of the company’s FMS solutions are based on an open-architecture platform designed to enable easy, streamlined integration with existing customer systems (SCADA). Each instrument is built around proven MET ONE technology, including the portable MET ONE 3400 series for routine monitoring and cleanroom classification, as well as the 6000 and 7000 series of fixed, non-viable air particle counters. MET ONE software platforms feature intuitive interfaces to help make them easy to use, thereby reducing the potential for human error that can occur with manual SOP monitoring. To avoid losses from product contamination, stack lights, audible alarms and process shutdown signals from a Beckman Coulter FMS can prompt an immediate production line response whenever an excursion happens. In addition, to help centralize reporting and simplify EUGMP/FDA compliance (e.g., for ISO 14644 and 21 CFR Part 11), Beckman FMS data can be integrated into a single-release, electronically signed paperless report.

• Workflow-optimized, integrated solutions to monitor your cleanroom
• 21 CFR Part 11 enabling software workflow to ensure secure data management
• Integrate portables and remote air particle counters
• Industry standard interfaces (OPC, ODBC) for integration with other systems
• Support for 32 location manifold integration for automated routine environmental monitoring

• Nonviable and viable particle monitoring compliant with EU GMP
• Annex 1 and FDA 21 CFR Part 11
• Built in Audit Logging
• Custom reports to record results
• IQ/OQ documentation for simple validation

• Small scale, rapidly deployed pre-packaged software and hardware for isolators and small production line
• Batch workflow system for one or more production lines with several monitoring points
• Custom workflow optimized solutions for monitoring complex production methods across several production lines

• Regional Service Professionals provide onsite ISO 21501-4 calibration and service
• Service agreement options for pre-scheduled onsite calibration and maintenance (including discounts for repairs)

• Graphical user interfaces available on the system or via remote access terminals
• Color coded indication of system status
• Alarms clearly identified for acknowledgement
• Single click reports to generate auditable records for compliance

Our new MET ONE 3400+ Series Portable Airborne Particle Counter allows users to load their routine environmental monitoring SOP sampling map and sampling configuration for each location directly into the counter, so that the SOP becomes an interactive sampling map directly on

Our new MET ONE 3400+ Series Portable Airborne Particle Counter allows users to load their routine environmental monitoring SOP sampling map and sampling configuration for each location directly into the counter, so that the SOP becomes an interactive sampling map directly on the counter screen to guide users doing daily sampling. This helps reduce training requirements and sampling data errors/omissions.

Accessed remotely via a web browser, features such as review/approve workflow, SOP version control and electronic record export are all in the counter – there’s no external software needed. Secure on-board searchable/filterable Audit Trail provides fast reporting during audits combined with Microsoft Active Directory for User Name and Password control for log-on and electronic signatures to support 21 CFR Part 11 compliance.

Using a web-browser interface, load your SOP map into the counter, mark sample locations, and define SOP sampling requirements for each.

Onscreen instructions help operators navigate your map and perform sampling according to the SOP. Location names turn green after sampling, making it easy to track progress at a glance.

The MET ONE 3400+ can provide electronic records straight from the counter via USB, wired Ethernet or built-in WiFi.

• Rugged design for cleanrooms with industry leading quality & reliability
• Stainless VHP, wash-down and chemically tolerant NEMA 4X enclosures
• Built-in flow sensor for CFR21 data accuracy and reliability
• Particle size 0.5µm and 5µm sensitivity at 0.1cfm or 1.0cfm flow rates
• Long life laser diode for guaranteed continuous monitoring
• Easy to integrate with any facility monitoring system
• Open architecture design to communicate seamlessly with your system
• Pulse, Serial Modbus, Ethernet, Wireless and Analog options

• Stainless VHP, wash-down and chemically tolerant NEMA 4X enclosures.

• ISO 21501 compliant with built-in flow sensor for CFR21 data accuracy and reliability.

• Flexible particle count size in 0.5um and 5um sensitivity at 0.1cfm or 1.0cfm flow rates.

• Long life laser diode for guaranteed continuous monitoring.

The Multisizer 4e particle sizer and counter is the most accurate and flexible particle characterization device available, boasting an unparalleled sizing range of 0.2 - 1600 μm. The new 10 μm Aperture allows users to study sub-cellular and micro-

The Multisizer 4e particle sizer and counter is the most accurate and flexible particle characterization device available, boasting an unparalleled sizing range of 0.2 - 1600 μm. The new 10 μm Aperture allows users to study sub-cellular and micro-particles as small as 200 nm, while the advanced noise reduction system for small apertures improves measurement accuracy.

Generated data are processed using patented digital pulse processing technology and can be saved and later re-analyzed. This technology provides ultra high resolution and accuracy unattainable through any other technologies: detection of 1 particle in 1 ml of a sample with the optimal instrument configuration. Analysis results are not dependent on particle shape, structure, or optical properties.

It uses the Coulter principle to detect particles via electrical zone sensing, regardless of the particle’s nature or optical properties. This makes it an ideal tool for detecting and counting a wide variety of particles, such as:

• Mammalian cells
• Bacteria
• Yeast
• Abrasives
• Toner particles
• Cell aggregates
• Spheroids
• Large protein aggregates

• Aperture sizes from 10 µm - 2000 µm in diameter for current & future needs
• Multiple aperture options & data overlay capability for analyzing complex samples over wide particle size distribution

• Analyze materials in aqueous or non-aqueous solvents
• Ideal for biological or non-biological samples
• Detect particles regardless of material type or optical properties

• Typical sampling rates up to 10,000 counts per second
• Detect & count particles from 0.2 µm - 1600 µm in diameter
• Sample volumes as small as 5 mL

• Digital pulse data can be stored & re-analyzed as needed
• CFR 21 Part 11 compliant software for audit control & security
• Variety of calibration beads & V-check validation controls