Particle Counting (Particle Counter)

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

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

• 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.

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