Studies of extractable and leachable components within packaging and closures are required to meet safety requirements for new medicines. Intertek Pharmaceutical Services has the necessary expertise and experience to carry out these studies for a wide range of drug products in a variety of packaging types. Intertek is able to offer these services to the relevant regulatory standards of GLP and GMP/cGMP.
Studies are carried out as regulatory projects in line with the specific needs of the regulators. The full breadth of Intertek's scientific expertise and advanced analytical facilities are available to ensure that the project findings are based on good science. Intertek has extensive experience of characterizing and quantifying potential migrants from plastics, rubber and coatings including species such as residual monomers, plasticizers, antioxidants, colorants and other additives, rheology modifiers, rubber vulcanizing agents and accelerants.
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