Ina Pahl*+, Roberto Menzel*, Armin Hauk*, Samuel Dorey**
*Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, 37079 Göttingen, Gemany
+phone: 0049 551 3082 241
** Sartorius Stedim FMT S.A.S., Avenue de Jouques, CS91051, ZI des Paluds, 13781 Aubagne Cedex, France
Sartorius Stedim Biotech (SSB) provides complete extractables data for SU components such as storage bags, tubing or sterilizing grade filters obtained e.g. from pure ethanol and water extracts using state-of-the-art analytical methods such as (headspace) GC-MS, LC-HRMS, HPLC-UV, and ICP-MS. The extractables are identified and quantified using standard compounds, if available. The source of the identified compounds can be derived from the material of construction. This set of data allows users to perform a material safety assessment of the SU components, e.g. during the installation qualification phase of the biopharmaceutical process.
This poster presents exemplarily how extractables data from the supplier can be used for the material safety assessment of sterilizing grade PESU filters. Toxicological information available from literature for selected extractables compounds is combined with the extractables data and assessed.
With our approach we are able to provide state-of-the-art extractables profiles with almost no unknowns and therefore risk assessment is possible straight forward.