RSSL’s well-equipped laboratories work to GMP standards and our staff have extensive experience in identifying foreign material in pharmaceutical raw materials, process intermediates and finished products.

We understand the potential consequences to you of a contamination incident - scrapping product batches, and down time on the production line whilst the root cause is investigated.  We support you in resolving issues with foreign material.

Our team can analyse foreign matter in the whole range of pharmaceutical matrices, for example powder, tablets, capsules and creams. We can identify particulates, precipitates, haze or discolouration observed in liquids using a range of specialised techniques, supporting you in finding and eliminating the source.

We also help solve less straightforward issues, where a contaminant is not easily available for analysis. Using X-ray microtomography (often called µCT-scanning) we non-invasively image contaminants or defects inside products or medical devices. If on-site investigation is necessary, we bring our analytical capabilities to you via portable X-ray spectroscopic equipment.

Our extensive industry expertise allows us to provide more than just a purely analytical service: we support you in interpreting results and identifying the cause. Our consultancy service is also available to advise on corrective action or process improvements.

We can help with identifying:-

  • Metal fragments, dusts and corrosion
  • Machinery wear debris, greases and oils
  • Glass or mineral fragments
  • Fibres and hairs
  • Visible particulates
  • Subvisible particulates
  • Discolouration of tablets
  • Insect fragments
  • Packaging materials: films, laminates and foils

Techniques

Light Microscopy

Scanning Electron Microscopy (SEM)

Energy Dispersive X-ray Microanalysis (EDS)

X-ray Microfluorescence (XRMF)

Fourier-Transform InfraRed (FT-IR) Spectroscopy

Differential Scanning Calorimetry (DSC)

X-ray Micro-Tomography

Cryo-scanning Electron Microscopy

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