What was putting a choke-hold on sterile filtration throughput? Spanish CMO Unolab switched to Pall’s polyethersulfone membrane filters and solved a challenging issue.
Liquid handling in blow-fill-seal systems is now sufficiently well developed to enable the filling of a broad range of formulations, including those which may be more difficult to process and prepare for filling. However, one particularly difficult process step for viscous formulations is sterile filtration.
Unolab’s process engineers identified an opportunity to update and improve filtration processes and remove a bottleneck that, among other things, diminished product yields. The design of the existing filters themselves (a 30-year-old technology employing a PVDF) membrane was the problem. They found that by upgrading to Pall’s Supor® EX grade ECV filters they were able to process all the fluid required to fill a 210-liter batch of viscous product without a change-out, resulting in ease of use and cost advantages over the existing technology with which they had encountered considerable challenges.
Supor EX Grade ECV filters provided a high-capacity, high flow-rate solution that improved flow rates and delivered a very economical solution for the filtration of viscous fluids by incorporating a laid-over pleat membrane geometry and narrow core, which in combination with their membrane performance, demonstrated outstanding performance efficiency.
- Fully validated 0.2 micron sterilizing-grade filters validated for the retention of B.diminuta (ATCC 19146) at a challenge level of 10 log 7 cfu per cm squared of membrane
- Available in 5 inch, 10 inch, 20 inch and 30 inch configurations for coverage of a broad range of fluid volumes
- Feature an asymmetric PES membrane for excellent flow rates and high capacity per unit membrane area
- Offer a laid-over pleat filter construction with narrow core design, maximizing the available area for high device throughputs
Ultimately, careful filter evaluation and successful implementation of Supor EX grade ECV filters delivered significant process improvements to Unolab’s highly critical process. In addition to benefitting from a reduction in consumable usage, minimized product losses and improved yields, Unolab is now enjoys savings in time-related costs including fewer start-ups, fewer sterilization cycles, reduced frequency of integrity testing and less information capture per lot.
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