Interview with Sartorius Stedim on standardized extractables testing of single use systems

Ahead of her interview at Extractables & Leachables USA 2017 we spoke with Ina Pahl, Senior Scientist R&D at Sartorius Stedim about standardized extractables testing of single use systems, bio-pharmaceutical processes and more.

Your presentation looks at ‘Standardized extractables testing of single use systems: An overview of sterile filter extractables’, and looking at validated methodology investigating bio-pharmaceutical processes, why is this an important topic to discuss?

Today there is an intensive discussion about extractables and leachables from single-use equipment, such as storage bags, cultivation bags, tubing, and sterile filters, which is made from plastic materials, such as polyethylene, polypropylene, or silicone. A basic knowledge about extractable compounds is essential to assess the safety of the material(s) of the single – use components. Sartorius Stedim Biotech is providing so called worst-case extractables data from single-use components to customers as Extractables Guides since 20 years. Today, these documents include methodology of the extraction study, analytical tools and quantitative data about present organic compounds and elements. The presentation will show the extractables profile of state-of-the-art sterile filters used in the (bio)pharmaceutical industry. The intention and details of a worst-case extraction study, its capabilities and benefits is shown in this context. A discussion will clarify, how these information on extractables can be used to assess the safety of a material and how to link the data to the real processes.

How important is it to discuss validated methodology and processes with peers and colleagues in the same industry at E&L USA?

Sartorius Stedim Biotech has more than 20 years of experience in conducting extractables/leachables studies, and we regard a detailed definition of extraction parameters and analytical parameters as essential to provide E/L data to the customer. Nonetheless, standardized extraction protocols for extractable studies and similar analytical methods applied in the analytical laboratory will - in the best case - only lead to comparable results (e. g. same concentration range of extractables). With this background in mind, it is indispensable to present and discuss data obtained by different methodologies. To date, there is no unique and only true valid methodology for executing/performing an extractable study. A reasonable protocol depends on the intention of the study. This aspect makes the standardization so difficult because the intention and evaluation of the results are always related to the (bio) pharmaceutical process.

What are you most looking forward to at the E&L US conference in May and why?

I’m looking forward to meet well experienced colleagues working on the E/L topics and to meet SSB’s customers for discussing their needs and find solutions. Of course, this mixture of presentations will allow to be up-dated directly on the newest topics and insights of E/L from the industry point of view and from regulatory perspective.


Ina will be presenting as part of the E&L in biopharmaceutical manufacturing session at E&L USA 2017 alongside representatives from Triad Scientific Solutions, PPD, NIBRT, Lonza, Merck and VR Analytical. You can view the full programme here.