At the same time, special attention is paid to interactions with the pharmaceutical preparation, including the separation of components from an elastomer mixture.
Extractables studies investigate these effects. Recently, Freudenberg-NOK Sealing Technologies (Freudenberg-NOK) performed a comprehensive extractables analysis using black and white EPDM (ethylene propylene diene monomer) materials as benchmarks, as well as the company’s Fluoroprene XP and Simriz perfluoroelastomers material lines. The result: Freudenberg-NOK materials outperformed competitive materials due to their superior hygienic properties.
Extractables studies are important for the documentation requirements of facility operators. Pharmaceuticals manufacturers also want to be aware of the ingredients in the formulation – even though this by itself provides no evidence relating to possible reactions. Even if seal materials meet the prevailing standards of the FDA, USP Class VI and EU Regulation 1935/2004, their migration values could be critical. There are no precise guidelines for this, however.
Further, extractables studies investigate packaging materials for their possible interactions, as well as examine how a seal behaves in contact with a medication. One example is the sealing of an inhalation spray head. Aside from quantification, an identification of the migrating substances for later toxicological evaluation is especially important. If the interactions between the seals and the process media are understood, contamination can be prevented through the use of secure processes. The purity of the delivered pharmaceutical ultimately protects patients’ health.
Freudenberg-NOK’s study investigated three of its own EPDM materials and five EPDM materials from other manufacturers. The chromatograms of the Freudenberg-NOK materials provided only a few peaks compared to the competition. The Freudenberg-NOK materials also displayed significantly lower extraction values in extraction and TOC (total organic carbon) studies.
The company then analyzed its Fluoroprene XP and Simriz material line including a white Simriz compound. Here as well, the extraordinary hygiene of Freudenberg-NOK materials was impressive. The extraction quantities in ethanol and hexane proved to be undetectable. In addition, the TOC values in the phosphate buffers were below the TOC values of the EPDM compounds, which the previous study had already shown to be “low-extraction.”