Particle Analysis
Multisizer 4e Coulter Counter
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. t 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, Spheroids, Cells and Large protein aggregates etc.
LS 13 320 XR Particle Size Analyzer
The LS 13 320 XR offers best-in-class particle size distribution data from advanced PIDS ( (Polarization
Intensity Differential Scattering) technology, which enables high-resolution measurements and an expanded dynamic range. Like the LS 13 320, the XR particle size analyzer provides fast, accurate results, and helps you streamline workflows to optimize efficiency. Some big improvements help you reliably spot small differences that can have a huge impact on your particle analysis data. Direct measurement range from 10 nm – 3,500 µm Automatically highlights pass/fail results for faster quality control Enhanced software that simplifies method creation for standardized measurements New control standards to adequately verify instrument/module performance.
HIAC 9703+ Pharmaceutical Liquid Particle Counter
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.
MET ONE HHPC+ Handheld Air Particle Counters
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
MET ONE 3400+ Series GMP Cleanroom Routine Environmental Air Particle Counter
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.
MET ONE 6000 / 7000 Remote Air 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 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.
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.
Facility Monitoring Systems (FMS)
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.
