Identification of Particulate Contamination

Foreign particles in drug powder is a major area of concern in pharmaceutical manufacturing. Contamination due to excessive particulate matter in drugs can lead to quality, safety, and efficacy problems. Particle contamination in manufacturing sites results in suspension of drug production and increased costs.

Understanding the nature of contaminants is the first step towards their elimination. We use a range of analytical techniques (SEM, EDX and FTIR) to identify the type and source of contaminant particles.

Foreign particles consist of two main types: intrinsic and extrinsic.

  • Intrinsic particulate matter – part of the original product that was not removed by filtration prior to filling or made up of particles that resulted from a precipitation in the solution.
  • Extrinsic or extraneous particles – introduced into the process due to insufficient cleaning of the production environment, product assembly protocols, or standard manufacturing processes such as milling, filling, and freeze-drying.

Automated particle analysis using Scanning Electron Microscopy (SEM) and Energy Dispersive Spectrometry (EDX) can be used to detect these particles.  MCS provide automated particle identification using a Zeiss EVO SEM coupled with an Oxford Instruments X-Max detector and INCAFeature routine. This powerful combination provides methods for feature detection and classification chemistry, morphology and position. Following identification, particles can be further analysed for composition and origin using our JASCO Micro-FTIR system.