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

Metal fragments, dusts and corrosion

Machinery wear debris, greases and oils 

 

Glass

Glass or mineral fragments

Defects in vials/needle strikes

 

Fibres and hairs

 

Bone

 

Subvisible particulates

Precipitates  

Hazes 

Plant matter 

 

Tablet discolouration 

 

Packaging materials  

 

Films, laminates and foil 

 

Insect fragments 

 

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

 

Nanoparticles 

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. 

Techniques

 

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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Contact us

Need to get in touch? Either complete the enquiry form or call us:

Switchboard: +44 (0)118 918 4000

Customer Services: +44 (0)118 918 4076

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