Particle Counting (Particle Counter)

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

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.

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

• MET ONE R4800 series remote air particle counters use standard RS-485 serial communications
• MET ONE R4900 series remote air particle counters use industry standard 4-20mA interface
• Stainless steel enclosure compatible with most process environments
• Compact size for easy mounting with a vacuum source, DC power & communication line

• MET ONE R4800 & R4900 counters respond to simple ASCII command instructions, including start, stop and report counts, send location number, etc.
• Reporting data includes counter status & particle counts in two size ranges
• Multiple display options via continuous monitoring feature (Particle Vision® Online & CIMScan® software

• User-programmed alarm level detects high counts on first channel triggering an alarm
• Auto alarm reset at start of the next count cycle
• Long-life laser technology for superior performance & extended service life
• No fan allows proximate placement to sensitive processing areas

• Sensitivity ranges of 0.5um & flow rates of 1.0 cfm
• Onboard status indicator sets signal at connector for alarm Stay resident RS-485 configuration programming (count/hold times, alarm level/delay & scaling) maintained through power cycles
• Sensor resistant to vaporous hydrogen peroxide (VHP)