Particle analysis From precise observation to root-cause investigation
CONTACT USIdentifying 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.
Confirm your expected root cause with SCHOTT Pharma’s particle analysis
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.
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.
Global presence – With labs in North America and Europe, our experts are always close and able to provide a fast response during business hours.
Sample preparation included – You can provide samples the way they are. SCHOTT Pharma will take care of isolating the sample particles for analytical purposes.
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.
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).
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.
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.
4. Sample submission
You then send the samples to our laboratories with a completed submission form, proforma invoice, and material safety data sheet.
