Assurance of sterility throughout drug manufacturing is paramount to patient safety. Drug products must be free of contamination from microbes, particulates, and chemicals. To that end, we see continued and increased regulatory scrutiny, with adoption of US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards outside the United States and the European Union. To consistently make microbe-free products, drug manufacturers must implement robust, validated processes that include sterilizing filtration. Sterilizing-grade filtration is used in a number of…