Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing

By Weibing Ding, Gary Madsen, Ekta Mahajan, Seamus O’Connor, and Ken Wong

General requirements for Extractables and Leachables (E&L) are already mandated by regulatory agencies. Biopharmaceutical companies must meet these requirements in demonstrating equipment suitability and GMP compliance whether the equipment is of traditional design or single-use. However, because of the absence of specific regulatory requirements for extractables testing of Single-Use Systems (SUS) components, companies have needed to generate SUS extractables testing methods by extrapolating from their interpretation of regulatory requirements for existing container closure testing methods.

Extractables testing studies conducted by suppliers of SUS for biomanufacturing comprise filling or soaking SUS components in model solvents, and testing the resultant extracts for compounds that were released to the solvent by the treatment. Exposure times and temperature ranges are extended to exaggerate the chemical conditions of actual use. However, there are currently no industry standards for such studies, and while solvents used are often more aggressive than what is typical in biomanufacturing, the full range of conditions encountered by SUS components in actual use is not always represented. In addition, this lack of standardization in extractables testing creates difficulties for end-users in interpreting and comparing test data from different SUS suppliers.