Pharmaceutical Testing
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Medicines are made to the strictest Quality Standards and controlled by Good Manufacturing Practice (GMP). Whilst we do not manufacture products at Rubber Consultants we do test pharmaceutical products in support of regulated manufacturing facilities, so analytical testing to GMP requirements is a significant part of our activity.

Drug products must be fit for purpose and that includes freedom from contamination or deterioration. Some rubber or plastic-related chemicals may be leached or extracted from Medical Devices or packaging and end up in the drug matrix, and it is these extractables and leachables that fall into the category of contamination. Various specific analytical techniques at Rubber Consultants are used to test rubber products and drug products for target chemicals.

Typical types of GMP testing activity include Leachables testing i.e. testing the drug matrix for specified compounds, Extractables testing i.e. testing extracts from delivery devices for specified compounds, Method Development and Method Validation. Validated methods are required, so these are either validated in-house or imported via Method Transfer from other accredited labs.

Rubber Consultants' capacity for pharmaceutical testing was increased last year with the purchase of a new Agilent GC/MS with the latest 5973 inert mass selective detector. This detector has improved inertness enabling analysis of reactive compounds to be carried out. Various validated analytical methods are available for the measurement of rubber and plastics additives, and monomers and nitrosamines, in both components and final products. The increased sensitivity has allowed for the development of a method to detect the presence of polynuclear aromatic hydrocarbons (PNAs) in rubber extracts.

For further information please contact contact us.

Other services offered by Rubber Consultants are:

Analytical Services
Biotechnology Services
Rubber in Engineering
Prototype Design & Manufacturing
Rubber Technology
Contract Research
Physical Testing
Tyre Testing
Expert Witnesses

If you require any of our services do not hesitate to contact us.

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