Expert analysis to meet your toughest challenges

Regulatory demands, unexpected test results, and tight timelines can all put pressure on development teams. Particle characterization is vital to reducing that risk—ensuring your materials and products meet safety, performance, and compliance expectations from the outset. Eurofins Medical Device Services network of laboratories offers comprehensive particle characterization services tailored to support every stage of medical device development. Our scientists have decades of experience in analyzing powders and particles across a range of applications, from verifying material quality to identifying contaminants. We work with clients of every scale, from startups unsure of regulatory requirements, to large developers facing time pressures and evolving timelines. Whatever your challenge, we provide expert insight, dependable turnaround times, and guidance throughout the testing process.

At Eurofins Medical Device Services network of laboratories, our capabilities cover the full spectrum of particle characterization needs. We provide detailed analysis of raw materials, in-process samples, and finished powdered products. Our laboratories offer contaminant detection and documentation using advanced digital microscopy, as well as precise assessment of particle size distribution and surface morphology. We conduct elemental analysis and surface structure evaluations, support the qualification of raw material suppliers to inform the impact of process changes on product performance and consistency.

Our laboratories are equipped with advanced instrumentation capable of accurate analysis at every scale, from nanometres to bulk powders greater than 1 mm. We perform sub-visible particulate matter testing aligned with USP <788> and other applicable standards across a wide range of devices, including implants, infusion systems, packaging materials, and more.

Gain clarity and control over your particle analysis.

Testing available

Analytical sieving

Sieving is usually the method of choice for classification of the coarser grades of single powders or granules. It is a particularly attractive method in that powders and granules are classified only on the basis of particle size, and in most cases, the analysis can be carried out in the dry state. Mechanical sieving is most suitable where the majority of the particles are larger than about 75 μm. For smaller particles, other means of agitation such as air-jet sieving may be more appropriate.

Dynamic light scattering

Particle size distribution of sub-micron particles is measured at a 90-degree scattering angle using Dynamic Light Scattering.

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Volume requirements: 0.1 g – 0.5 g per sample determination.

Particle sizes: 0.0003 μm - 5 μm.

Instrumentation: Malvern Zetasizer Nano ZS90.

Laser light diffraction

Particle size distribution is measured by the dispersion and absorption of light (red and blue) generated by a laser using either the wet or dry dispersion techniques.

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Volume requirements: 0.1 g – 0.5 g per sample determination for wet dispersion. 0.5 g – 5 g per sample determination for dry dispersion.

Particle sizes: 0.01 μm – 600 μm for wet dispersion and 0.2 μm – 3,500 μm for dry dispersion.

Instrumentation: Malvern Mastersizer 3000 with Hydro MV wet dispersion unit and the Aero S dry dispersion unit, Malvern Mastersizer 2000, Microtrac S3500, Beckman Coulter LS 13 320.

Microscopic particle count test

Our experts will utilize a Microscopic Particle Count Test when certain test articles cannot be analyzed by the Light Obscuration method due to color, reduced clarity and/or viscosity. This method can also be utilized in the event the product does not meet the USP criteria for the Light Obscuration Method.

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Volume requirements: A minimum of 25 mL sample solution is required to meet the harmonized USP/EP/JP requirements. If the fill volume is >25 mL then only one container is needed for testing. However, if the fill volume is <25 mL than a minimum of 10 containers are required. Dilution of samples can be performed as required.

Particle Size: The compendia requirement is to detect particles at ≥10 µm and ≥25 µm. Particles < 10µm cannot be accurately detected using the Microscopic Particle Count Method.

Instrumentation: Testing utilizes our Fein Optic IMA/USP 788 Pharmaceutical Microscope.

Multi-angle light scattering (MALS)

A static light scattering technique which can be used in conjunction with Size Exclusion Chromatography (SEC) as an in-line detection technique or it can be used for non-fractionated samples in the batch mode of operation.

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Volume requirements: Approximately 100 μg (i.e., 100 μL injection of 1 mg/mL solution for in-line SEC operation) and1,000 μg (Direct 1000 μL infusion of 1mg/mL solution for batch mode operation).

Particle Sizes: 0.01 μm - 0.5μm.

Instrumentation: Wyatt Technologies HELEOS II.

Particle size testing

Sub-visible particulate matter testing

Sample Types

The Light Obscuration Test is based on the principle of light obscuration and allows for the automatic determination of the number of particles according to their size. The test is performed in a biological safety cabinet, under conditions that limit foreign particulate matter.

Zeta potential (Electrophoretic light scattering)

Zeta potential is a measurement of the electrokinetic potential in colloidal dispersions. The Zeta Potential is measured at a 90-degree scattering angle using Electrophoretic Light Scattering.