Silicone droplets or protein aggregates? Vision Analytical’s Raptor 1788 answers the prefilled syringe particle question at PDA Universe of Pre-Filled Syringes and Injection Devices 2026

Vision Analytical Inc., a Miami-based manufacturer of Dynamic Image Analysis instruments, today shared highlights from the PDA Universe of Pre-Filled Syringes and Injection Devices Conference, held October 6–7, 2026, at the Palm Springs Convention Center in California, USA. Vision Analytical presented the Raptor 1788, a flow imaging system built for subvisible particle characterization in parenteral drug products, including prefilled syringes (PFS), biologics, and vaccines.

Image Credit: Vision Analytical Inc.

Prefilled syringes are now a primary format for biologics and high-volume injectables. Most are siliconized, and silicone droplets shed from the barrel look like particles to light obscuration counters. That makes it hard to tell a lubricant droplet from a protein aggregate. USP <788> sets subvisible particle limits, while USP <1788> recommends orthogonal methods such as flow imaging to characterize what those particles are.

The Raptor 1788 was designed for that question. Its capabilities include:

  • Direct prefilled syringe analysis. The sample is dispensed from the syringe straight into an interchangeable sample cell, with no decanting step that could add contamination. The test is non-destructive, so the sample is recovered.
  • Resolution down to 1 µm. High-resolution images cover the size range where silicone droplets and early protein aggregates are most common.
  • Morphology-based classification. Shape data separates silicone droplets from protein aggregates, fibers, and other subpopulations, with classification reported at the end of each run.
  • Representative sampling at high flow. Flow rates up to 40 mL/min keep particles in suspension, preventing the silicone droplet flotation and particle settling that bias counts. High flow also reduces silicone droplet coalescence.
  • Interchangeable, cleanable or disposable sample cells. Sample cells can be swapped, cleaned, or disposed of, cutting cross-contamination risk and downtime between samples.
  • Artifact rejection. A spot-removal algorithm filters stationary debris on the flow cell from the particle count.

Highlights from Palm Springs

Conversations in Palm Springs centered on three Raptor 1788 capabilities: imaging resolution, direct syringe-to-cell analysis, and high-flow representative sampling.

“A big hit was the image resolution. The Raptor 1788 delivers high-resolution images down to 1 micron,” said Peter Bouza, president of Vision Analytical Inc. “People focused on prefilled syringes also really liked that the Raptor 1788 has an interchangeable sample cell, with the syringe going directly into it. There’s no need to decant the sample somewhere else. Taking it straight from the syringe minimizes contamination and makes it a non-destructive test. You get your sample right back.”

“The Raptor 1788 also works at very high speed,” Bouza added. “You can run it at up to 40 mL per minute, which delivers highly representative sampling. It keeps silicone droplets from floating out and particles from settling.”

Laboratories interested in seeing how the Raptor 1788 handles prefilled syringe and biologic applications can request a live demonstration by emailing [email protected]. A practical overview of subvisible particle requirements is available in Vision Analytical’s USP <788> and <1788> guide: https://particleshape.com/usp-788-1788-guide/.

About Vision Analytical Inc.

Vision Analytical Inc. has designed and manufactured particle characterization instruments in Miami, Florida, for nearly two decades. Its Raptor line uses Dynamic Image Analysis to measure particle size, shape, and concentration for applications in biopharmaceuticals, vaccines, industrial fluids, and materials science. Learn more at https://particleshape.com.

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