Filter Sizing For Aqueous Pharmaceutical Solutions Using Sartopore® 2

By Niddhivinayak S Mishra, Balaji SS, Vaibhav Patil

Sterilizing filtration is essential for ensuring the safety of aqueous pharmaceutical formulations, particularly injectables and ophthalmic solutions. This white paper explores how to accurately size filters for these applications using Sartopore® 2 membranes. It examines factors such as flux, maximum throughput (V∞), and filter plugging across a range of formulations with varying viscosities, pH levels, and excipients. Key insights include the minimal impact of viscosity below 20 cP on flux, the role of formulation components in variability, and how water flux can serve as a reliable reference for sizing. The paper also introduces SIMCA^® analytics for predicting filter performance and provides practical calculations for determining required filter area, including safety factors for scale-up.

Learn how these findings can streamline process development and ensure sterility without compromising efficiency.