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.
Subvisible Particulate Matter Testing
This paper provides an overview of all related USP tests, instrument standardization tests, system preparation, and validation. It reviews calibration, sensor resolution, and USP count standard testing. Read how our AccuSizer system software automates and facilitates these important procedures.
USP Particulate Testing
Speaker Mark Bumiller, technology manager at Entegris, discusses particle sizing methodology, equipment selection, software validation, and compliance to meet the USP standards. He provides an overview of each of these USP standards, instrument and sensor selection, protocols, software, and reporting. Mark wraps up with the sizing lipid emulsions and automated testing options.
Read detailed descriptions of how AccuSizer systems meet and exceed all requirements for USP particulate testing.
USP <788> Particulate Matter in Injections
Explains how our AccuSizer® Syringe Injection System (SIS) is designed to meet and exceed all requirements in USP <788> Particulate Matter in Injections test, which is used to quantify the count and size of subvisible particles in parenteral drugs.
USP <787> Testing Therapeutic Protein Injections
Explains how our AccuSizer® SIS syringe injection system is designed to meet and exceed all requirements in USP <787> Particulate Matter in Therapeutic Protein Injections test.
USP <789> Particulate Matter in Ophthalmic Solutions
Explains how our AccuSizer® A7000 SIS syringe injection system is designed to meet and exceed all requirements in USP <789> Particulate Matter in Ophthalmic Solutions test, which is used to quantify the count and size of subvisible particles in eye care products.
USP <729> Globule Size Distribution in Lipid Injectable Emulsions
This application note explains how the USP <729> Globule Size Distribution in Lipid Injectable Emulsions test is used to determine critical size characteristics of injectable lipid emulsions, and how our Nicomp® DLS system and AccuSizer® SPOS system are ideal solutions for achieving reliable results.
BROCHURES AND DATA SHEETS
For specifications, features, and other technical details download these brochures and data sheets:
This particle size analyzer and integrated auto-sampler was designed for high throughput particle size analysis of alumina and other slurries, yielding the most accurate and repeatable size results.
The Nicomp® nanoparticle size analyzer uses dynamic light scattering (DLS) technology to measure size and zeta potential of nano sized particles from 0.3 nm to 10 µm.
This sophisticated particle size analyzer is the most advanced instrument available for USP <788> testing. It meets or exceeds all requirements for USP <788> by providing size and count data at the required 10 and 25 µm.
This particle analyzer has an integrated microplate reader for performing particle count and size analysis. Automated USP <787> calculations are reported along with detailed size distribution, if desired.
The AccuSizer® AutoSampler has been designed to meet the needs when higher throughput or repetitive analyses are required. The autosampler is compatible with all AccuSizer® and Nicomp® system configurations.
Learn more about our particle characterization applications
Our particle sizing instrumentation is ideal for liquid applications in semiconductor, life sciences, and other industries.
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PROTEIN FORMULATION AND AGGREGATION
Therapeutic protein injections hold both promise and challenges throughout the entire development and manufacturing life cycle. The Nicomp® dynamic light scattering (DLS) system analyzes size and zeta potential of proteins at low volumes and with high resolution. The AccuSizer system is not only used for USP testing but also as a sophisticated analytical tool to help formulate proteins to minimize aggregation.
These technical documents explain how the Nicomp DLS system and AccuSizer SPOS system are used to quantify key protein physical properties to minimize aggregation.