Foreign body identification
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.
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
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
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. This means that in the event of foreign body complaints we can quickly assist with root cause investigations, rapidly identifying contaminants and helping to safeguard the integrity of your products and ensuring patient safety.
We offer a comprehensive range of analytical techniques to support in the identification of foreign body contamination, including:
