Foreign Particulates and Contaminants Testing Service by LGC

Manufacturer LGC  |  Available Worldwide
Within the pharmaceutical sector, there is an increasing regulatory requirement for the characterisation and counting of visible and sub-visible foreign particles in pharmaceutical products from a safety, quality and efficacy perspective.


Foreign Particulates and Contaminants Testing Service by LGC product image
Foreign Particulates and Contaminants Testing Service
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The presence of Foreign Particulate matter (FPM) in sterile pharmaceutical products can affect their efficacy and safety and recently has been one of the reasons for a major increase in the number of product recalls. 

Particle Counting

  • USP <788> Particulate Matter in Injections
  • USP <789> Particulate Matter in Ophthalmic Solutions
  • USP <790> Visible particulates in Injection
  • USP <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions

Techniques

  • Sample isolation and preparation - ISO14644 Class 5 standard (FS 209 Class 100) laminar flow cabinets minimising sample contamination
  • Light obscuration single particle counter - Size
  • Optical microscopy with image analysis – Size, Shape, Colour

Particle Characterisation

It is a regulatory requirement for manufacturers in the pharmaceutical and biopharmaceutical sector to be able to show a detailed understanding of their process. Consequently there is increasing pressure on companies to be able to determine the identity and origin of such matter rather than to merely rely on the counting of the particles.

Techniques

  • Sample isolation and preparation - ISO14644 Class 5 standard (FS 209 Class 100) laminar flow cabinets minimising sample contamination
  • Optical microscopy with image analysis
  • Light obscuration single particle counter
  • High Resolution Scanning Electron Microscope with EDX for qualitative elemental analysis
  • Fourier Transform Infra Red (FT-IR) Spectroscopy and Microscopy
  • Image Analysis
  • X-Ray Diffraction
  • Waters SynaptTM G2 high-resolution mass spectrometers (HRMS) with Ion Mobility
  • Inorganic analysis techniques e.g. ICP-OES, ICP-MS