Physical Contamination in Pharmaceuticals
Regulators' expectations for pharmaceutical products are extremely high, as safety is paramount. Appearance is a critical indicator of quality, and so contamination - whether marks or black specks on tablets, or suspended particles in injectables - can have severe consequences. It's a serious issue – one we’re experts at tackling.
Our well-equipped laboratories work to GMP standards and our staff has extensive experience 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 root cause is investigated - which helps us expertly support you in resolving issues with foreign material.
The team can analyse foreign matter in the whole range of pharmaceutical matrix types: 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 specialize in visible and sub-visible particle analysis of injectables, parenterals, ophthalmics and drug production/storage/delivery components. We can offer routine testing to support product release and bespoke analysis to help your during product development, re-formulation and problem solving. Using complimentary techniques we can identify particles to determine the cause of high particle counts.
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 a purely analytical service: we support you in interpreting results and identifying root cause. Our consultancy service is also available to advise on corrective action or process improvements.
We can help with identifying:-
- Metal fragments and dusts
- Machinery wear debris
- Machinery greases and oils
- Glass or mineral fragments
- Fibres and hairs
- Visible particulates
- Subvisible particulates in clear fluids
- Discolouration of tablets
- Insect fragments
- Packaging materials: films, laminates and foils
Techniques and equipment used:-
- Light microscopy
- Scanning Electron Microscopy (SEM)
- X-ray Microanalysis (XMA)
- X-ray Microfluorescence (XMF)
- Fourier-Transform InfraRed (FT-IR) spectroscopy
- Differential Scanning Calorimetry (DSC)
- X-ray tomography
- Cryo scanning electron microscopy