Our particle counters, particle size analyzers, and TOC analyzers provide you with reliable, real-time data; help you understand and optimize air and water quality; ensure precision and efficiency for various applications; and provide high-resolution and precision insights into your samples.
Air Particle Counters for Cleanroom and Environmental Monitoring →
Our particle counters can support your sterile manufacturing processes for easy integration into your workflows.
Our MET ONE series of air particle counters offer support for cleanroom classification and environmental monitoring in compliance with industry standards ISO 14644, GMP Annex 1, and FDA cGMP. Additionally, our HIAC 9703+ liquid particle counting solution is the industry gold-standard and helps you meet compliance standards for USP <788>, <787>, and <789> as well as Ph. Eur. 2.9.19, JP, and KP for final product testing.
For TOC monitoring and cleaning validation, our PAT700 and QbD1200+ TOC Analyzers offer reliable measurements, meet the requirements of USP <643> and Ph. Eur. 2.2.44 by ensuring complete oxidation of samples and clearly discriminating between organic and inorganic carbon. The PAT700 TOC Analyzer meets the requirements of USP <645> for conductivity as well.
Our particle analyzers rely on techniques like the Coulter principle, laser diffraction, and our unique polarized intensity differential scattering (PIDS) technology to give you the critical data you need for a variety of applications.
Our Multisizer 4e Coulter Counter relies on the innovative Coulter principle enables detection of particles based on electrical zone sensing, which helps identify and count particles regardless of their nature or optical properties. This approach measures the volume and reports the diameter of particles with extremely high accuracy.
The LS 13 320 XR Laser Diffraction Particle Size Analyzer leverages laser diffraction and PIDS to provide particle size distribution with extremely high resolution. This is largely due to the high number of detectors within the instrument and our PIDS technology which specifically provides higher accuracy in the submicron range.
air-particle-counters
Air Particle Counters for Cleanroom and Environmental Monitoring
MET ONE air particle counters are industry leaders in providing solutions for Cleanroom Classification and Routine Environmental Monitoring of air cleanliness, adhering to ISO 14644-1, FDA CGMP, and EU GMP Annex 1 standards. Available in portable, remote, and handheld models, these air particle counters are designed for seamless integration into your standard operating procedures (SOPs) for cleanroom and flow bench validation, routine environmental monitoring, air filtration troubleshooting, spot-checking, and assessing particle generation within process equipment. Compliant with ISO 21501-4, MET ONE air particle counters are reliable, durable, and can easily be incorporated into your 21 CFR Part 11 compliant workflow.
liquid-particle
Liquid Particle Counters
The HIAC 9703+ Liquid Particle Counter can be used through all stages of pharmaceutical product development, from discovery to quality control, to monitor quality of products. With its flexible calibration at multiple flow rates, the HIAC 9703+ improves ease of sampling for varying sample viscosities and volumes. The HIAC 9703+ and PharmSpec software provide peace of mind and trust in the results thanks to the design that allows installation in a laminar flow cabinet, and to alarms when bubbles and/or sensor contamination impact particle counting results.
particle-size
Particle Size Analyzers
Deliver reliable measurements and detect subtle variations with our cutting-edge Coulter Principle- and Laser Diffraction-based particle size analyzers. Our advanced technologies deliver high resolution particle size distributions (PSD) on sample materials like tissue cultures, protein aggregates, abrasives, pigments, emulsions, flavorings, and many more. Best in class performance enables you to consistently identify sample-to-sample variations that can profoundly influence your product quality.
total-organic
Total Organic Carbon (TOC) Analyzers
Discover our range of total organic carbon (TOC) analyzers, offering a cost-effective and user-friendly solution that ensures compliance with pharmacopeial requirements. Our analyzers provide accurate and reproducible results along with a low cost of ownership and are designed to streamline processes and enhance compliance in water quality testing.
What is the range of particle sizes that the analyzers can measure?
All solutions mentioned below support compliance with 21 CFR Part 11, ensuring data integrity.
MET ONE series
- Measurement range: 0.3 μm to 10 μm
- Common applications: ISO 14644, GMP Annex 1, cGMP
HIAC 9703+
- Measurement range: 1.3 μm to 600 μm
- Common applications: USP <788>, <787>, and <789> as well as Ph. Eur. 2.9.19, JP, and KP
PAT700
- Measurement range: 0.5 to 2,000 ppb
- Common applications: USP <645>, USP <643> and Ph. Eur. 2.2.44
QbD1200+
- Measurement range: 0.4 ppb to 100 ppm
- Common applications: USP <643> and Ph. Eur. 2.2.44
Multisizer 4e
- Measurement range: 0.2 μm to 1,600 μm
- Common applications: Counting and characterization
LS 13 320 XR Laser Diffraction Particle Size Analyzer
- Measurement range: 10 nm to 3,500 μm
- Common applications: Characterization
How do the air and liquid particle counters, size analyzers, and TOC analyzers ensure data integrity and security?
All our particle counters, size analyzers analyzers, and TOC analyzers support FDA's 21 CFR Part 11 compliance, guaranteeing robust data integrity and security measures in compliance with regulatory standards.
What makes Danaher’s liquid particle counting system stand out in the market?
Our liquid particle counting systems, coupled with the PharmSpec Software, exemplify our commitment to excellence and ensures compliance with rigorous standards such as USP<787>, <788>, <789>, and Ph. Eur. 2.9.19 for final product testing of parenteral drugs.
What industries can benefit from the air particle counters?
Air particle counters cater to diverse industries that rely on manufacturing in cleanrooms or clean zones, including pharmaceuticals, semiconductors, hard disk drives, and flat panel displays, ensuring compliance with ISO 14644, FDA cGMP, and EU GMP Annex 1 standards.
How does the PAT700 TOC Analyzer support root-cause analysis?
The PAT700 TOC Analyzer aids in root-cause analysis by automatically collecting water samples during TOC or conductivity excursions, assisting in collecting relevant samples to identify and resolve potential issues in compliance with EU GMP Annex 1:2022 paragraph 6.14.
What networking capabilities does the MET ONE 3400+ air particle counter offer?
The MET ONE 3400+ Air Particle Counter supports advanced networking features, including full web browser access, as well as Lightweight Directory Access Protocol (LDAP) integration.
Can the Multisizer 4e Coulter Counter be used in biomedical research?
Yes, our particle size analyzers are crucial instruments in biomedical research, precisely identifying and enumerating various particles, including mammalian cells, bacteria, yeast, abrasives, toner particles, cell aggregates, and spheroids.
Can the LS 13 320 XR particle size analyzer measure both dry and wet samples?
Yes, the particle size analyzer equipped with laser diffraction technology is capable of measuring both dry and wet samples. Its versatility in accurately determining particle size allows it to handle various sample types, ensuring optimal measurement accuracy for specific sample conditions, whether dry or wet. This makes it a valuable tool in a range of applications where the nature of the sample may vary.