By Michael Francis, Product Manager at Colder Products Company
Single-use technology (SUT) has afforded drug manufacturers greater flexibility, but downstream processing for biologic drugs often requires the use of harsh chemicals that can damage SUT components. During filtration and chromatography, chemicals like sodium hydroxide, dimethyl sulfoxide (DMSO), benzyl alcohol, and others can compromise the structural integrity of SUT tubing and connectors, leading to leaks and spills and increasing the likelihood of leachables contaminating the drug product.
For manufacturers that have identified and characterized their preferred SUT equipment and methods, it can be frustrating when a new drug project is incompatible with the system and materials in place. Searching for a new connector that can withstand harsh chemicals adds time, cost, and uncertainty to a project. Companies may find what they are looking for in the moment but sacrifice the assurance of supply chain security or the comfort of familiarity and ease of use.