Regulators’ expectations for pharmaceutical products are extremely high, as patient safety is paramount.  Appearance is a critical indicator of quality, and so contamination - whether marks on tablets or suspended particles in parenteral solutions - can have severe consequences.

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 of a contamination incident: potential scrapping of 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 industry experience means we can analyse foreign matter in the whole range of pharmaceutical matrices, for example powder, tablets, capsules and creams, 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.

Our consultancy service is also available to advise on toxicity, corrective action or process improvements.

We can help with identifying:-

  • Metal:
    • Metal fragments, dusts and corrosion
    • Machinery wear debris, greases and oils
  • Glass:
    • Glass or mineral fragments
    • Defects in vials/needle strikes
  • Fibres and hairs
  • Subvisible particulates
    • Precipitates
    • Hazes
  • Discolouration of tablets
  • Packaging materials:
    • Films, laminates and foil
  • Insect fragments
  • large volumes of samples for analysis
  • Filter blockages and particles on filters
  • Nano-particles

Have you considered creating a foreign material reference library?

Provide us with examples of typical materials that might potentially come into contact with your drug product or raw material during manufacture – we will analyse them and create a searchable reference library. When you send in further foreign body complaints, we will then be able to compare the identification to your unique library to assist with root cause investigations.

Microscopy Case Studies

These case studies are based on real life scenario.

Metal Inclusion
Structural Analysis

Using microscopy techniques RSSL was able to identify foreign body contamination of an intravenous drug product.

Using microscopy techniques RSSL was able to help a client understand more about the nanoparticle content present in their raw materials.

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Cannula leakage
A client’s investigation into cannula leakage through the injection port in a production batch was supported by RSSL in order to determine the cause, as well as potentially preventing a recurrence of this issue.
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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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