Abstract
Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. Since such filters are in direct contact with the process fluid, profiling of the extractables is of utmost importance. The work presented here reveals the extractables profile from filter cartridges for sterilizing grade filtration, which were obtained from six different vendors. All filters contain a 0.2 μm polyethersulfone (PES) membrane for sterile filtration combined with a PES pre-filter with retention rates spanning from 0.4 to 0.6 μm. These filter cartridges are designed for use in stainless steel housings which allow for in-line steam ster-ilization. A combination of different analytical techniques such as (Headspace) GC-MS, UPLC-HRMS (ESI ionization), ICP-MS, total organic carbon (TOC), non-volatile residue (NVR), conductivity and pH value were applied to develop a comprehensive extractables profile on a qualitative and semi-quantitative basis. Pure ethanol and purified water were used as extraction media. The extractables pro-file consisted of various polyolefin related extractables, additives such as antioxidants (AO) and degra-dation products thereof, hydrocarbons and processing aids in addition to membrane related extractables.
- Antioxidant Degradation
- Extractables Profile
- Filter Cartridges
- Plastic Additives
- Polyethersulfone Membrane
- Sterilizing Grade Filtration
- Received October 4, 2017.
- Accepted January 8, 2018.
- Copyright © 2018, Parenteral Drug Association
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