At this year’s PDA Universe of Pre-Filled Syringes and Injection Devices conference, we spent two days showing scientists, QC leaders and device engineers what the Raptor 1788 can do. We filmed a short video each day. Together they run about two minutes and cover the features that got the most attention at our booth. If prefilled syringe particle testing is part of your work, the video below is a quick look at why speed, sample handling and automatic classification change the results you get.
Why Representative Sampling Matters in Prefilled Syringe Particle Testing
A particle count is only as good as the sample it comes from. Prefilled syringes are a hard matrix to measure because the particles in them don’t stay put.
Silicone oil droplets float. Silicone oil is lighter than most drug formulations, so droplets rise toward the top of the sample over time. They can also merge into larger droplets, which changes both the count and the size distribution.
Heavier debris settles. Glass, metal and rubber fragments sink to the bottom.
If an instrument draws the sample slowly, the sample being analyzed is not representative. Silicone oil can float out of the measured volume, and dense particles can settle before they reach the camera. The result can undercount the very particles you most need to find.
40 mL/min vs 0.2 mL/min: What Speed Really Buys You
Conventional flow imaging systems typically run at about 0.2 mL per minute. The Raptor 1788 analyzes up to 40 mL per minute.
That difference changes what is practical in the lab:
-
- Larger volumes in less time. At 0.2 mL/min, 10 mL takes about 50 minutes. At 40 mL/min, the same volume can be done in seconds.
-
- A truly representative sample. Measuring quickly means silicone oil droplets don’t have time to float out and debris doesn’t have time to settle.
-
- Better statistics. More volume means more particles counted, which gives more confidence in rare-particle results.
For prefilled syringe particle testing, speed isn’t just about throughput. It’s about getting a result that reflects what is actually in the syringe.
Disposable, Interchangeable Sample Cells
Customers consistently tell us this is one of their favorite features. The Raptor 1788 uses a disposable, interchangeable sample cell, so you can swap cells in seconds between samples.
-
- No long flow-cell cleaning routines between runs
-
- Lower risk of carryover from one sample to the next
-
- Less downtime when a cell gets contaminated
AI-Assisted Particle Classification, No Expert Required
Counting particles is only half the job. To investigate a result, you need to know what the particles are.
The Raptor 1788 does full particle classification. Its AI-assisted classification automatically sorts particles into categories such as silicone oil droplets, protein aggregates, fibers, glass fragments and air bubbles. Your team doesn’t need to be image-analysis experts or build custom filters to get there. Every particle is classified automatically, so analysts can focus on what the results mean instead of how to sort them.
This is especially valuable for prefilled syringes, where telling silicone oil from protein aggregates is one of the most common and most important questions.
Spot Removal Tool for Cleaner Data
Sometimes a particle or residue sticks in the field of view. On many systems, that stuck spot gets counted again and again and inflates the results. The Raptor 1788’s spot removal tool identifies and removes these artifacts so they don’t bias your data.
Built for USP 788 and USP 1788 Workflows
The Raptor 1788 was designed around subvisible particle testing for parenteral products, including USP 788 counting and the flow imaging methods described in USP 1788. To learn more about the regulatory side, see our USP 788 and USP 1788 guide and our page on USP 1788.3 flow imaging compliance.
New to the technology? Read how dynamic image analysis works, or see how dynamic image analysis compares to micro-flow imaging.
Frequently Asked Questions
How fast does the Raptor 1788 analyze samples?
The Raptor 1788 analyzes up to 40 mL per minute, compared with about 0.2 mL per minute for conventional flow imaging systems.
Why does sampling speed matter for prefilled syringes?
Silicone oil droplets float and heavier particles settle over time. A fast measurement captures the sample before time changes what is being measured, so the result is representative of the whole syringe.
Does the Raptor 1788 distinguish silicone oil from protein aggregates?
Yes. AI-assisted classification automatically sorts particles by type, including silicone oil droplets and protein aggregates, without requiring an expert user.
Do I need to clean the flow cell between samples?
Yes, you should clean your sample cell between runs. However, if needed, the Raptor 1788 uses disposable, interchangeable sample cells that can be swapped in seconds.
See the Raptor 1788 in Action
Want to see how your own prefilled syringes measure up? Contact us to schedule a demo or send samples for analysis.