Particle Counting (Particle Counter)

MET ONE 6000 air particle counters are a compact design with flexible sizing, flow rate and communication options that address the specific needs of cleanroom environments within the pharmaceutical, semiconductor, hard disk drive and flat panel

MET ONE 6000 air particle counters are a compact design with flexible sizing, flow rate and communication options that address the specific needs of cleanroom environments within the pharmaceutical, semiconductor, hard disk drive and flat panel display industries providing ISO 21501 accuracy for continuous particle monitoring. Reduce initial installation cost with MET ONE 6000 remote air particle counter’s integrated multi-parameter measurements.

• Industry leading particle counting on-line reliability
• Flexible for all your remote air particle counter applications
• Flexible particle count size in 0.3µm or 0.5µm; 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
• Count alarm and alerts enable visual notification via built-in status lights.
• Optional relative humidity and temperature probe integrates RH/T data with particle count data in same data stream.
• In compliance with ISO 14644, FDA CGMP and EU GMP Annex 1

• ISO21501 compliance ensures accuracy and instrument to instrument repeatability
• Data security to enable 21 CFR Part 11 compliance

• The MET ONE 6000 remote air particle counter is specifically designed to manage all aseptic fill clean room fixed location applications
• Enables compliance with 21 CFR Part 11, FDA cGMP, and EU GMP Annex 1

• Industry’s most accurate particle counting fully complies to ISO21501 calibration standards and assures increased yield

• Increase yield and eliminate contamination concerns in flat panel production
• Low cost of ownership price-per-point particle counting with industry leading high quality

PharmSpec Software works with the HIAC 9703+ liquid particle counter system to test parenteral products for sub

PharmSpec Software works with the HIAC 9703+ liquid particle counter system to test parenteral products for sub-visible particle content using light obscuration in accordance with USP<787>, <788> and EP 2.9.19. Flexible calibration at multiple flow rates improves ease of sampling for varying sample viscosities and volumes. Ease of use and data integrity are prioritized in PharmSpec with features such as login credentials controlled by Microsoft Active Directory, multi-level user rights, automated pass/fail compendial reporting, comprehensive audit trail, and auto-flush routines for improved walkaway operation. In addition to the built-in compendial test routines, user-defined SOPs can be programmed into the counter using PharmSpec Software’s Procedure Builder.

• PharmSpec software is 21 CFR Part 11 ALCOA compliant
• Secure database is either sited on the local pc operating the HIAC 9703 sampler, or sited remotely on a networked server
• Periodic database backup can be selected for additional database security
• Specially designed vial clamp holds sample in place and small-bore sampling probe enables full application of USP<787> for protein based drug products, such as vaccines

• Small volume injectable (SVI)
• Large volume injectable (LVI)
• Research & development
• Troubleshooting
• Stability testing

• Instant particle contamination notification
• Small vial holder & tare volume conserves costly samples
• Configurable flow rates & interchangeable sensors for 0.5 µm - 600 µm particle size detection
• Interchangeable sample probes & syringes

• Program custom SOPs to eliminate manual counter configuration and pass/fail calculations
• Multi-level security for 21 CFR Part 11 compliance
• Automatic database backup & recovery loss feature protects valuable results and data

• Expert SOP & IQ/OQ validation services available
• Routine onsite service available for maximum uptime
• ISO 21501 compliant calibrations

MET ONE HHPC+ Series handheld particle counters allow easy ISO Class 5 to 7 monitoring in hard-to-reach places. Lightweight with a high-resolution display, these handheld counters are ideal for routine monitoring of controlled environments and

MET ONE HHPC+ Series handheld particle counters allow easy ISO Class 5 to 7 monitoring in hard-to-reach places. Lightweight with a high-resolution display, these handheld counters are ideal for routine monitoring of controlled environments and mini-environments, easy filter leak troubleshooting for particle-contamination issues, spot-checking critical areas, and targeting particle generation within process equipment.

• ISO 14644-1 industry standard
• CFR 21 Part 11 compliance enabled
• 0.3 μm - 10.0 μm particle detection
• 2-6 channel detection
• Single-hand operation
• PC access to particle counting data via Ethernet, USB, or cable for data transfer options

• ISO 14644-1 Class 5 (FED STD Class 100 or higher) compliant sampling
• Counting efficiency to ISO 21501-4
• Zero count level to JIS B9921

• On-the-spot process profiling for fast particle event tracking
• Easy network connectivity for 21 CFR Part 11 compliance
• Store up to 10,000 records
• Convenient charge cradle for access to particle counting data via Ethernet or USB cable
• Data download via Ethernet
• Connectivity through USB and memory card

• Easy-to-read high resolution display
• Fully configurable display
• Slim & lightweight design (0.7 kg) for single-hand use

• Routine monitoring in high-tech manufacturing & GMP-regulated cleanrooms
• Particle contamination troubleshooting in critical processing areas
• Spot checking & troubleshooting in mini-environments & workstations

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