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Using Extractables Data of Sterile Filter Components for Scaling Calculations
Ina Pahl1, Roberto Menzel2, Armin Hauk2
1Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany ina.pahl@sartorius-stedim.com.
PDA Journal of Pharmaceutical Science and Technology
|May 19, 2019
Summary
Extractables data from single-use (SU) components are crucial for biopharmaceutical safety assessments. This study validates a component approach and scaling concept for calculating SU filter extractables based on surface area and material composition.
Area of Science:
- Biopharmaceutical Manufacturing
- Analytical Chemistry
- Materials Science
Background:
- Single-use (SU) systems are widely adopted in biopharmaceutical manufacturing.
- Regulatory bodies require extractables data for material safety demonstration.
- Testing all SU system configurations individually is impractical.
Purpose of the Study:
- To present a standardized approach for comprehensive extractables data generation.
- To demonstrate the validity of a component approach and scaling concept for SU filters.
- To provide a method for calculating extractables for various SU filter sizes.
Main Methods:
- Extraction of sterile filter capsules (polyethersulfone membrane) with water and ethanol at 40°C for 24 hours.
- Identification and quantification of organic extractables using GC-MS and LC-HRMS.
- Assignment of detected extractables to filter construction materials.
Main Results:
- Extractables quantities are dependent on the surface areas of contact materials (membrane, plastics).
- A component approach and scaling concept were validated for SU filters.
- Membrane-related compounds scaled with membrane area; polypropylene-related compounds scaled with PP contact area.
Conclusions:
- The component approach and scaling concept provide a reliable method for assessing SU filter extractables.
- This approach simplifies the generation of extractables data for diverse SU systems.
- The findings support realistic risk assessments for SU devices in biopharmaceutical processes.
Keywords:
Component approachDiffusion and partition coefficientEffective filtration areaExtractables profileFilter cartridgesFilter familyUPLC-HRMS (QTOF)More Related Videos
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