Extractables and Leachables Testing for Pharmaceutical Packaging Compatibility

Intertek ASG Laboratory, Manchester, UK

Extractables and Leachables:

Testing for Pharmaceutical Packaging Compatibility

Studies of extractable and leachable components within packaging and closures are required to meet safety requirements for new medicines. Intertek ASG 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 ASG is able to offer these services to the relevant regulatory standards of GLP and GMP/cGMP.

Typical examples of drug delivery devices, product types and packaging materials for testing include:

Metered dose inhalers (MDI's)
Dry powder inhalers (DPI's)
Aerosols and nasal sprays
Implantable devices
Injectables
Solid, liquid and paste formulations

Plastic containers and closures
Valves and elastomer seals
Syringes
Labels

Studies are carried out as regulatory projects in line with the specific needs of the regulators. The full breadth of Intertek ASG's scientific expertise and advanced analytical facilities are available to ensure that the project findings are based on good science.

Intertek ASG 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.