Foreign particular matter testing

Capabilities

LGC offers a world class particle counting and particle characterisation service:

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

Light obscuration is fast, automated, reproducible and non-biased. However, it is limited in its ability to identify particles by colour and shape and fails to differentiate between air/gas bubbles or handle high viscosity samples such as emulsions, colloids etc.  Viscous, turbid or samples with colloids/surfactants are analysed chiefly by microscopy.

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