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

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

• 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.

• 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)