Contract Testing

Contract Testing

Send them our way

Unchained Labs gets it. You have particle problems, sub-visible or visible, and you need to know what they are — right now. Or you’re evaluating siliconized delivery devices and you need to know if they are coated just right for performance and quality. Our ISO-certified, FDA-inspected contract testing facilities will figure it out and give you a comprehensive report in as fast as three days. Free yourself up and get the data you need to make the right moves to quickly fix your problem.

Particles

  • Chemical identification
  • Elemental identification
  • Particle isolation
  • Particle count and size
  • Particle characterization

Silicone coatings

  • Layer thickness
  • Distribution
  • Mass

General services

  • Method development
  • Method validation
  • Root cause analysis
  • Compliance
 

Need contract testing?

Get some

Particle ID and characterization

Hound nails particle identification with its unique spectroscopy combo. Raman fingers the usual suspects like fibers, rubber and proteins. Laser-Induced Breakdown Spectroscopy (LIBS) roughs up the inorganic and metal particles to shake out the elements. Even if your particles are in the sub-vis range, we’ve got the tools to find them too.

Silicone thickness and distribution

Wonky silicone coatings for injectable devices can jam them up or result in excess oil interacting with your drug. Bouncer makes it easy to find out if the coating’s too thick, too thin or good to go. Its quantitative measurements on silicone layer thickness and distribution lets us confirm that you’ve found the sweet spot for your device.

We analyze it all

It doesn’t matter where your particle comes from — inhalers, topical creams, medical devices — we have all bases covered. Unchained Labs provides thorough foreign particulate matter identification, method development and validation for metered-dosed inhalers, dry-powder inhalers and nasal spray formulations. We’ll provide the particle size distribution data you need for topical creams to show that your distribution stays consistent during the drug’s shelf-life. We’ll also develop the methods for routine analyses of catheters, implants and stents, for the isolation, detection and identification of particle contaminants for these devices.

Our toolbox

We’ll use the right tool for the job to find and identify particles or determine the silicone coating of your device. Tell us what you want done or let us help you develop a new method — you’ll get the answers you’re looking for.

Particle ID and characterization
Hound Particle imaging, sizing, counting
Raman spectroscopy
Laser-induced breakdown spectroscopy (LIBS)
Bruker LUMOS ATR Infrared spectroscopy (ATR FT-IR)
PAMAS SVSS Light obstruction
FlowCam VS Dynamic imaging particle analysis
Bruker QUANTAX EDS Scanning electron microscopy (SEM)
Energy dispersive X-ray spectroscopy (EDS)
Silicone thickness and distribution
Bouncer White light reflectometry
Laser interferometry