| Description | HIAC 9703+ Pharmaceutical Particle Counter Overview
HIAC 9703+ liquid sampler and PharmSpec Software for Parenteral Drug Final Product Testing to USP<787>, <788> & EP2.9.19
PharmSpec Software works with the HIAC 9703+ liquid particle counter system to test parenteral products for sub HIAC 9703+ Pharmaceutical Particle Counter Overview
HIAC 9703+ liquid sampler and PharmSpec Software for Parenteral Drug Final Product Testing to USP<787>, <788> & EP2.9.19
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
HIAC 9703+ Liquid Particle Counter Features
Applications
- Small volume injectable (SVI)
- Large volume injectable (LVI)
- Research & development
- Troubleshooting
- Stability testing
Sample management
- 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
Software
- 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
Support
- Expert SOP & IQ/OQ validation services available
- Routine onsite service available for maximum uptime
- ISO 21501 compliant calibrations
... Read More | MET ONE 7000 Remote Air Particle Counter Overview
The MET ONE 7000 provide high accuracy non-viable particle monitoring for cGMP/FDA compliance. Stainless steel wash-down resistant enclosure and VHP tolerant optics protect the instrument while ISO 21501 certified calibration assures accurate MET ONE 7000 Remote Air Particle Counter Overview
The MET ONE 7000 provide high accuracy non-viable particle monitoring for cGMP/FDA compliance. Stainless steel wash-down resistant enclosure and VHP tolerant optics protect the instrument while ISO 21501 certified calibration assures accurate continuous monitoring in aseptic and sterile pharmaceutical production environments. - 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
Features
Rugged design for cleanroom use - Stainless VHP, wash-down and chemically tolerant NEMA 4X enclosures.
Industry leading particle counting on-line reliability - ISO 21501 compliant with built-in flow sensor for CFR21 data accuracy and reliability.
Flexibility - Flexible particle count size in 0.5um and 5um sensitivity at 0.1cfm or 1.0cfm flow rates.
Industry leading quality and reliability - Long life laser diode for guaranteed continuous monitoring.
... Read More | MET ONE Facility Monitoring System Overview
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 MET ONE Facility Monitoring System Overview
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
Features
Particle Monitoring Compliance
- 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
Scalable Solutions
- 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
Service Options
- 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)
Ease of Use
- 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
... Read More | MET ONE R4800 and R4900 Remote Air Particle Counters Overview
The MET ONE R4800 and R4900 series remote air particle counters are affordable, reliable and provide accurate data in particle monitoring systems. A compact design with flexible sizing, flow rate and communication options address the MET ONE R4800 and R4900 Remote Air Particle Counters Overview
The MET ONE R4800 and R4900 series remote air particle counters are affordable, reliable and provide accurate data in particle monitoring systems. A compact design with flexible sizing, flow rate and communication options address the specific needs of cleanroom operations in pharmaceutical, semiconductor, hard disk drive and flat panel display industries.
Features
Easy Integration - 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
Data Management - 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
Operation - 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
Flexible - 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)
... Read More | Multisizer 4e Coulter Counter Overview
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- Multisizer 4e Coulter Counter Overview
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
Features
Versatility
- 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
Sample Detection
- Analyze materials in aqueous or non-aqueous solvents
- Ideal for biological or non-biological samples
- Detect particles regardless of material type or optical properties
Rapid Particle Counting
- 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
Data Management
- 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
... Read More |