Dr. Roberto Menzel has a Ph.D. in Chemistry from the University in Jena.
He started his career as an assistant editor in the natural science book section at Wiley VCH, Weinheim followed by a position as group leader for the organic trace analysis in the environmental analytical division at Eurofins Scientific.
In 2015, he joined Sartorius Stedim Biotech where he established and is heading the internal Extractables analysis laboratory.
He is responsible for material and product qualification studies for single-use systems and components for the biopharmaceutical industry.
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.