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Extractable and Leachable Studies
Assess migration from container closure and manufacturing components.
During product development it is important to evaluate the potential for components to migrate from container closure systems, manufacturing components or packaging devices into pharmaceutical solutions.
Regulatory bodies require extractables and leachables (E&L) testing for pharmaceutical drug products and medical devices. We have relevant expertise to deliver extractable studies for a range of components.
Components we cover
- Vials and stoppers
- Gaskets
- Pre-filled syringes (PFS)
- O-rings
- Polymer tubing
- LDPE / HDPE bags
- Filters
E&L assessment is an important step in drug product development and materials qualification.