Rubber Consultants' capacity for pharmaceutical testing was increased during 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. Many medical devices contain rubber and plastic components in the valve assemblies and consequently there is a possibility of leached chemicals appearing in the drug material. 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 Sue Stephens in Materials Characterization.