Particulate Matter Contamination Analysis

Identification of particulate contaminants is the first step in the resolution of potentially critical contamination problems which might occur unexpectedly at multiple points along the supply chain for many industries. Once the source is known, however, action can be taken to control and prevent future contamination.

Particulate contamination investigations encompass the identification of microscopic particles, the isolation of different particulate phases of in-homogeneous production deposits and determination of the source(s) of the various contaminants. The impact of particles finding their way into valuable samples, such as pharmaceuticals and medical devices, for example, is wide-reaching; it can mean manufacturing processes inefficiencies, compromised product quality and delays in the delivery of product to patients.

Our particular contamination analysis team adopt a strategic approach to  identifying contaminants which includes expertise in sampling and sample preparation, visual / physical examination, chemical identification and root cause analysis. Our approach is focused on delivering scientific evidence-based insight, which is essential to facilitate informed decision making and so mitigate the negative impact of particulate contamination on product quality (and safety) or production efficiency. Using microscopy techniques, contaminant particles are digitally imaged to provide forensic traceability. Following the initial microscopical assessment, analysis can be performed using Energy- Dispersive X-Ray Spectroscopy (EDX) on isolated particles using Scanning Electron Microscopy (SEM) or vibrational spectroscopy (Infra-Red or Raman), as appropriate. To characterise the size or shape of contaminating particles, photomicrography; image analysis and particle sizing are used to assess and quantify so that comparisons with “latent” or “suspect” contaminants can be made to increase the weight of evidence relating to potential sources.

Intertek offers both standardised and rapid deployment services for the identification and characterization of particulate contaminants and impurities using the following techniques:

Microscopy: Light (and Polarised Light): 

• Confocal Raman Microscopy
• Attenuated Total Reflection Fourier-transform infrared spectroscopy (ATR-FTIR) Microscopy
• Transmission electron microscopy (TEM)
• Scanning Electron Microscopy (SEM, SEM/EDX)
• Molecular Spectroscopy: including Nuclear Magnetic Resonance Spectroscopy (NMR) and Raman Spectroscopy
• Surface analysis: X-ray photoelectron spectroscopy (XPS)
• Thermal analysis e.g. Differential scanning calorimetry (DSC

Examples of particulate contamination we have helped clients resolve typically involve:

We have the capability to fully review analytical results and assess the findings of analytical studies focused on contamination incidents associated with production, engineering and the supply chain, providing the guidance you need to define corrective and preventive measures. Our broad experience in many industries such as the chemical, consumer products, pharmaceutical, medical device, polymer and coating sectors gives us the necessary know-how to effectively identify unknown contaminants and assist with locating their source, driving greater knowledge about supply chains, processes and products while working closely with our clients to implement necessary contamination control actions or validate legal action.