Extractables & Leachables
Summit 2019
Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
- 15 Oct 2019
- Berlin, DE
- Pharma
Day 1: Tuesday, 15 October 2019
CASE STUDY: Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.
Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. They are in direct contact with the process fluid, and the profiling of the extractables is of high importance, especially in process steps “close to patient” such as single-use final fill. The talk will compare and discuss the extractables profiles of sterilizing-grade 0.2 μm polyethersulfone membrane filter cartridges from different vendors. Pure ethanol and purified water were used as extraction media. Several orthogonal analytical techniques such as HS GCMS and GC-MS and LC-HRMS in combination with ICP-MS for single analyte detection and the sum parameters total organic carbon, nonvolatile residue, conductivity, and pH were used to obtain a most comprehensive extractables profile. Various extractables were found such as antioxidants and degradation products thereof, hydrocarbons, and processing aids. The identified compounds can all assigned to the materials of construction, such as plastic parts or membranes. Focus is given also on the challenges one encounters in Extractables screening studies for example in the analysis of hydrophilizing agents. A basic toxicological evaluation for material safety assessment will be presented showing the overall low risk of the extractables toward patient safety.
- Quantitative extractables profile for widely used polyethersulfone membrane filters for sterile filtration
- The relationship between raw material production and membrane manufacturing to the main membrane-related extractables
- Relevance and limits of the TOC reconciliation of screening studies
- Toxicological evaluation for material safety assessment of Extractables results to process conditions
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