Foreign body identification

RSSL can provide both analytical and consultancy services to support the identification and resolution of foreign body contamination.


Foreign body contamination in pharmaceutical products can pose a major threat to patient health and can have severe consequences. For example, discarding entire product batches and extending production line down time during root cause investigation can result in costly delays.


Working to GMP standards, RSSL’s state-of-the-art laboratories and experienced team of scientists can identify foreign materials in pharmaceutical raw materials, process intermediates and finished products. Crucially, we can analyse foreign matter in the whole range of pharmaceutical matrices, including powders, tablets, capsules and creams, using a range of specialised techniques.   

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RSSL can help identify:


Metal fragments, dusts and corrosion

Machinery wear debris, greases and oils 



Glass or mineral fragments

Defects in vials/needle strikes


Fibres and hairs




Subvisible particulates



Plant matter 


Tablet discolouration 


Packaging materials  


Films, laminates and foil 


Insect fragments 


Large volumes of samples for analysis Filter blockages and particles on filters



Creating a foreign material reference library


By analysing examples of the typical materials that might come into contact with your drug product or raw materials during manufacture, we create a searchable reference library. In the event of foreign body complaints, this library can be used to assist with root cause investigations. 



We offer a comprehensive range of analytical techniques to support in the identification of foreign body contamination, including: 


  • Light Microscopy  
  • Scanning Electron Microscopy (SEM)  
  • Energy Dispersive X-ray Microanalysis (EDS)  
  • X-ray Microfluorescence (XRMF)  
  • Fourier-Transform InfraRed (FT-IR) Spectroscopy  
  • RAMAN Spectroscopy  
  • Confocal laser scanning microscope (CLSM)  
  • X-ray Micro-Tomography  
  • Cryo-scanning Electron Microscopy  
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Case studies

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Foreign body contamination in intravenous drugs

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Foreign material in pre-filled syringes

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Cancer treatment using a T-Cell therapy candidate

Contact us

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Customer Services: +44 (0)118 918 4076

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