Foreign particle identification in pharmaceutical products and on medical devices

Most pharmaceutical products and medical devices need to be free from visible particles and may contain only a limited amount of sub-visible particles. Identification of the composition and characterization of the size and shape of this particulate matter contamination is crucial to ensure product safety and to assess potential health risks for patients.

TNO offers microscopic services for identification of particulate matter in  a wide array of pharmaceutical products and medical devices, including:

  • Vials, tablets, syringes, ampoules, product packaging
  • Catheters, stents, scissors, scalpels

TNO can identify and characterize particulate matter in these products, no matter whether the contaminant is of inherent origin (e.g. protein agglomerates), originates from the production process or from the product’s primary packaging (e.g. glass, rubber, aluminum, plastic) or is of extrinsic origin (e.g. synthetic fibers, paper, corrosion products, skin flakes).

Typical particulate matter investigations usually involve the following steps:

  • Collecting of background information about the particulate problem.
  • Selection of particulate matter samples and selection of reference materials that potentially are the source of the particulate matter contamination.
  • Isolation of the foreign particles from the pharmaceutical products / medical devices, including particle cleaning if appropriate.
  • Microscopic investigation and identification of the particulate matter.

Experts at TNO are highly skilled in handling and isolation of small particles from complex matrices, a step that is usually crucial for successful particle identification. Particle identification itself is usually performed using a combination of:

  • Optical microscopy
  • Field emission gun scanning electron microscopy (SEM)
  • Energy dispersive X-ray spectroscopy (EDX)
  • Micro Fourier transform infrared microscopy (m-FTIR)

These techniques are optimized for small particle analysis and thereby permit the identification of particles that are too small for identification with conventional chemical analysis techniques. The results of these analyses, together with the background information of the client and the expertise of the TNO experts usually enable the identification of the source of the particulate matter contamination.

Environmental modelling, sensing & analysis

Thérèse Maarschalkerweerd BSc

  • Failure analysis
  • Environmental forensics
  • Particle size distribution
  • Particle analysis
  • Fibre analysis

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