• our science our science Our Science
    • By Industry

      • Bioprocessing

        • Upstream

        • Downstream

        • Fill/Finish

        • Oligonucleotides

      • Cell and Gene Therapy

        • Upstream

        • Downstream

        • Fill/Finish

        • Oligonucleotides

      • Pharmaceutical

        • Oligonucleotides

        • Small Molecule

    • By Application

      • Buffer Prep

        • Chemical and Bioprocessing Containers

        • Filtration and Purification

      • Bulk Fill

      • Cell Growth

      • Cell Separation

        • Filtration and Purification

      • Facilities/Bulk Chemicals

        • Chemical and Bioprocessing Containers

      • Fill/Finish

      • Freezing

      • Media Prep

        • Filtration and Purification

      • Medical Devices

        • Dental

        • Eye Care

        • Implantable Devices

        • Medical Ultrasound

        • Wound Care

      • Quality Control

      • RNA and DNA Solutions

        • Oligonucleotides

      • Small Molecule

        • Liquid Filters

        • Catalysts

        • Ligands

        • Organophosphorus Compounds

        • Filtration and Purification

      • Storage

        • Chemical and Bioprocessing Containers

    • By Location

      • Hangzhou Facility

      • Life Sciences Technology Center

  • product catalog product catalog Product Catalog
    • Single-Use Assemblies

      • 2D and 3D Bags

      • Mixing Systems

      • Motion Bioreactor Bags

      • Microcarrier and Cell Separation Systems

      • Tube Sets and Manifolds

    • Filtration and Purification

      • Liquid Filters

      • Vent Gas Filters

    • Fluid Management

      • Tube Sets and Manifolds

      • Cynergy® Valves

      • Cynergy® Fittings

      • Custom Dip Tubes, Tanks, and Containers

      • Tubing and Pipe

    • Process Monitoring

      • Particle Characterization

    • Chemical Packaging

      • FluoroPure® HDPE Blowmolded Drums

        • FluoroPure® Trilayer HDPE Blowmolded Drums

        • FluoroPure® Advantage Trilayer HDPE Blowmolded Drums

      • NOWPak® Liner-Based Systems

      • FluoroPure® Composite Drums

      • FluoroPure® Intermediate Bulk Containers

      • Sentry® Quick Connect Systems

      • Rigid Bioprocessing Support Containers

    • Specialty Chemicals

      • Catalysts

      • Ligands

      • Organophosphorus Compounds

      • Siloxanes

      • Specialty Acrylates and Methacrylates

      • Specialty Additives

    • Premium Graphite

      • Life Sciences Graphite Grades

      • Premium Graphite Components

      • Graphite Processing Options

    • Liquid Filters

  • resources resources Resources
    • Industry Insights

      • Aramus™ Shaped 2D Single-Use Bags

      • Cell and Gene Therapy

      • Cold Chain Bioprocessing

      • Filter Bag Assembly

      • High-Density Cell Banking

      • Life Sciences Filtration

      • Low-Temperature Bioprocessing

      • Nanoparticles

      • Pandemic Response

      • Particle Characterization

      • Single-Use Solutions for Bioprocessing

      • USP Subvisible Particulate Testing

    • Reference Materials

    • Technical Information

      • Chemical Compatibility

      • Material Properties and Safety

      • Particle Characterization Applications

    • Entegris Blog

  • about us about us About Us
    • Corporate Overview

    • Corporate Social Responsibility

    • Careers

    • Events

    • Investor Relations

    • Legal/Trademark Notices

    • Locations

    • News Releases

    • Media Coverage

    • Entegris Blog

Automated Solutions for USP Subvisible Particulate Testing

Companies manufacturing parenteral drugs and ophthalmic solutions need to test for subvisible particulates using a liquid particle counter. Parenteral drugs must be tested according to USP <788> or <787> for therapeutic proteins. The globule size of lipid injectable emulsions is tested per USP <729> for both the mean size and the percent > 5µm (PFAT5). Ophthalmic solutions are tested following USP <789>.

Choosing the best instrument for these tests involves matching the measurement requirements to system capabilities.

Important parameters include size range, minimum sample volumes (especially for USP <787>), validation, and automation. While the test requirements have not changed very much over the past several decades, instrument technology has improved considerably; both hardware and software.

The AccuSizer® system is the most advanced liquid particle counter used for these tests providing the highest specifications and sophisticated automation. Our unique single particle optical sizing (SPOS) sensors have the widest dynamic range – reporting results to the smaller sizes useful for differentiating stable protein formulations. Low sample volumes, push/pull mixing, and sample recovery facilitate protein testing using a minimal sample amount. An autosampler and microplate analyzer can automate the measurements, proving high throughput capability.