Laser particle size analyzer

laser diffractionfor biopharmaceutical applicationsfor research

Overview
The Aggregates Sizer is an aggregation analysis system for biopharmaceuticals that enables quantitative evaluation of particle amounts from 0.1 µm to 10 µm expressed as concentration (units: µg/mL or particles/mL). Aggregates are categorized into nanometer (<100 nm), submicrometer (100 nm–1 µm), subvisible (1–100 µm) and visible (>100 µm) ranges. Concentration results are obtained after calibration using polystyrene latex (PSL) standard particles. The system applies quantitative laser diffraction (qLD) using a violet laser to measure particle size distribution.

Measurement principle and outputs
The instrument uses laser diffraction (violet laser) to derive particle size distributions; calibrated PSL data are used to convert scattering results into concentration values (µg/mL or particles/mL). Output formats and software options support data export for QMS and regulatory workflows.

Key capabilities
1. Quantitative evaluation across a wide particle size range
Enables concentration-based quantification of aggregates from 100 nm to 10 µm with a single instrument, covering submicrometer to subvisible regions.

2. Low sample volume measurement
Micro cell capability allows accurate measurements with sample volumes as low as 0.125 mL (125 µL), reducing material consumption for development and QC.

3. Real‑time aggregation monitoring
Real‑time measurement function records changes in particle size and concentration at minimum intervals of 30 seconds. A stirred batch cell (5 mL) permits measurement of aggregation under applied stress; interchangeable stirring rods enable evaluation of material-dependent aggregation tendencies.

4. Temperature control option (Aggregates Sizer TC)
Optional temperature‑controlled cell permits measurements under a constant temperature range (20 °C to 42 °C) to assess temperature‑dependent aggregation behavior.

5. Software and compliance
Dedicated software (WingSALD bio) performs quantitative concentration evaluation (µg/mL or particles/mL). Optional modules provide compliance with FDA 21 CFR Part 11 for regulated environments.

Features (summary)

• Measurement principle: quantitative laser diffraction (qLD) using violet laser.
• Single‑system coverage: particle sizes ~0.1 µm to 10 µm measurable with one instrument.
• Concentration output: µg/mL or particles/mL after PSL calibration.
• Micro cell volume: 0.125 mL (125 µL); reduced from 400 µL in TC version.
• Batch cell volume: 5 mL for stirred/real‑time aggregation studies.
• Real‑time measurement interval: minimum 30 seconds.
• Temperature control option: 20 °C–42 °C (Aggregates Sizer TC).
• High linearity, high repeatability and high resolution for multi‑peak detection.
• Software: WingSALD bio; optional FDA 21 CFR Part 11 compliant modules.

Applications and documentation
Application notes and technical documents illustrate qLD methods applied to subvisible protein particles, blood particle quantification, beverage particle sizing and other use cases relevant to biopharmaceutical development, QC and formulation studies.

Technical specifications

• Measurement principle: quantitative laser diffraction (violet laser).
• Measured particle size range: 0.1 µm (100 nm) to 10 µm.
• Concentration units: µg/mL and particles/mL (after PSL calibration).
• Micro cell sample volume: 0.125 mL (125 µL).
• Batch cell sample volume: 5 mL (stirred measurements).
• Real‑time measurement minimum interval: 30 seconds.
• Temperature control option (Aggregates Sizer TC): 20 °C to 42 °C.
• Stirring capability with rods of different wetted materials.
• Software: WingSALD bio; optional FDA 21 CFR Part 11 compliance.
• Calibration: concentration determined after calibration using PSL standard particles.