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E&L System Performance

Extractables & Leachables

The selection and qualification of a container for a pharmaceutical product includes extractables & leachables testing as per international regulations.

Volatile, semi-volatile, and non-volatile compounds are analyzed to ensure the safety of the drug. Especially when using packaging systems like syringes, that are built of different components and materials, a detailed E&L data-set is mandatory. We offer to organize and conduct your extractables & leachables studies tailored to your needs.

System Performance

In order to meet clients’ needs and the requirements of regulatory agencies, we have developed specialized tests for thorough characterization of pharmaceutical packaging. We can can provide pharmacopeia (US/EP/JP) and industry standard (ISO, DIN, ASTM) methods. Container closure integrity, functionality testing, analysis of tungsten levels, and free and total silicone oil quantification are among the most popular tests we carry out. Herewith we support our customers to better understand the performance of their pharmaceutical container systems.
Publication E&L Studies (Extraction profiles of stoppers after sterilization)

Extractables Study

Customer oriented extractables studies for determination of inorganic (including cations and anions) and organic substances extracted out of primary packaging materials. These substances are potentially hazardous directly or after interaction with the drug formulation.
Typical stoppers used as primary packaging material                                                          Extraction of container closures