Scientists examining samples infront of a network pattern

Particle analysis From precise observation to root-cause investigation


Identifying the origin of particle formation using precise particle analysis

The presence of particles in drugs for injection constitutes a major risk to patient health. It also indicates that uncontrolled events have occurred. Once particles have been observed, detailed investigation is required. Firstly, to understand the underlying root cause, and secondly, to enable the far-reaching decisions which will ensure product safety in the future. The focus on patient safety prevents the occurrence of systematic risks in product development, as well as uncontrolled process or product variations during the commercial phase.

SCHOTT Pharma Services conducts investigative studies for customers that analyze the shape, size, morphology, and material composition of obtained particles. Our experts have extensive knowledge of primary packaging materials and related phenomena, and understand the connection between analytical results and the effects that may result from these particles.

Gain detailed insights into root causes using SCHOTT Pharma’s scientific particle analysis

The investigation studies of particle analysis begin with microimaging using scanning electron microscopy (SEM) to understand the dimensions, macrostructure (such as fibre and spherical shape), and microstructure of the particle.

In a second step, the chemical composition is analyzed using energy dispersive X-ray spectroscopy (EDS) for inorganic elements and Raman spectroscopy for supplementary organic materials. In most cases, combining these observations provides a good description of the observed particles and allows experts to narrow down the number of potential root causes. Additional analytical methods can be applied to test and exclude hypotheses using the wide range of equipment available at the SCHOTT Research Center as needed.

SCHOTT Pharma Services helps pharmaceutical companies resolve their particle analysis challenges

Confirm your expected root cause with SCHOTT Pharma’s particle analysis

To create a final confirmation or explain a root-cause mechanism, SCHOTT Pharma Services can mimic any potential variation in process parameters (such as washing or depyrogenation conditions) or drug composition. This enables us to reproduce and verify the failure mechanism under controlled laboratory conditions, and study the relationships between associated parameters.
Icon Advanced analytics

Advanced analytics – A wide variety of state-of-the-art analytical methods, including cross-section analysis of glass samples using focused ion beam (FIB) technology.

Icon Unrivaled expertise

Unrivaled expertise – 40 years of insights into materials and the practice of pharma packaging provide a sound basis for linking the results of particle analysis to root causes.

Icon Global presence

Global presence – With labs in North America and Europe, our experts are always close and able to provide a fast response during business hours.

Icon Sample preparation included

Sample preparation included – You can provide samples the way they are. SCHOTT Pharma will take care of isolating the sample particles for analytical purposes.

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“Glass Flakes” whitepaper by SCHOTT Pharma

Particle analysis: How to proceed

SCHOTT Pharma Services’ team of specialists is available to offer support and advice about particle analysis and your pharmaceutical packaging challenge. We offer a complete process that will take you from initial request to effective solution.

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1. Get in touch

Tell us about your current needs using the contact form below, or phone us directly (see number in contact information below).

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2. Receive a study proposal

Based on your information, our scientific experts will advise you and create a customized study proposal that conforms to the latest regulatory guidelines.

Icon Quotation and sample requirements

3. Quotation and sample requirements

Based on your feedback, we will provide a quotation, comprising a detailed study protocol and instructions for sample selection, packaging, and submission.

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4. Sample submission

You then send the samples to our laboratories with a completed submission form, proforma invoice, and material safety data sheet.

Get in touch

Dr. Matthias Bicker

Dr. Matthias Bicker

Scientific Advisor Pharma Services

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