Abstract
Users of single-use (SU) components need extractables data to demonstrate material safety for regulatory bodies before implementation into the biopharmaceutical process. In this context, the correct use of such extractables data is key to deriving realistic risk assessments for SU devices. A standardized extractables approach was used which provides comprehensive extractables information including identity and quantity. In this paper, the combination of extractables data obtained from different components of a sterile filter capsule, such as the filter cartridge and housing, and the scaling thereof is presented. A sterile filter type including polyethersulfone (PES) membrane was extracted with pure water and pure ethanol at 40°C for 24 h. The organic extractables were identified and their concentration quantified using state-of-the-art analytical methods such as gas chromatography–mass spectrometry for semi-volatile compounds together with headspace sampling for volatile compounds, and liquid chromatography coupled with high-resolution mass spectrometry. The extractables detected were assigned to the materials of filter construction. The evaluation showed that the extractables quantities per device depended on the surface areas of the contact materials such as filter membrane and also the plastic parts. This paper confirms the validity of a so called component approach and a scaling concept to calculate extractables data for SU filters of different sizes for short-term contact.
- Component Approach
- Diffusion and Partition Coefficient
- Extractables Profile
- Filter Cartridges
- Filter Family
- UPLC-HRMS (QToF)
- Received October 29, 2018.
- Accepted April 26, 2019.
- Copyright © 2019, Parenteral Drug Association
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