E&L for Users of Single-Use Systems
Single-use systems can introduce leachables into a drug product during the manufacturing process. Therefore all users of single-use systems should evaluate the risk of leachables by performing extraction studies on all components that contact the drug product in single-use systems (e.g. bags, tubing, connectors, filters, etc.).
Similar to container closure systems, extraction studies performed by the user on single-use systems should be done using extraction solvents based upon the drug product that represent the “worst case” scenario. Usually this will require two solvents of decreasing polarity. The extraction conditions should be based upon the intended use of the component of the single-use system. The sample extracts are then analyzed for extractables using the same analytical methods used in an extraction study on a container closure system.
Once the extractables from the single-use system have been identified, the manufacturing process may be modified based on the results of the extraction study to minimize the risk of leachables. If the risk of the potential leachable cannot be eliminated with process changes, toxicological risk of the leachables or further studies to confirm the actual levels of the leachables may be needed.
Pine Lake Laboratories has extensive experience with performing extraction studies for single-use systems and design a study for your specific application.