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. http://blog.ispe.org/standardized-extractables-testing-protocol-part-2
blog article
STANDARDIZED EXTRACTABLES TESTING PROTOCOL FOR SINGLE-USE SYSTEMS IN BIOMANUFACTURING – PART 2
The extractable testing information package to be provided by an SUS supplier is not intended to be passed directly to a regulatory agency without a process- and product-specific evaluation. Rather, the purpose of the information package is to allow the SUS end user to rigorously estimate the types and amounts of leachable that will be generated by the SUS component during its intended bioprocessing use in order to assess risks to patient safety and to demonstrate product compatibility, process performance, and fitness of the functional design for its intended purpose.5–16 The use of standardized protocols also provides a baseline which can be used for comparative assessments of SUS from different suppliers as backups or alternate sources. Such an approach greatly facilitates the long-term success of SUS for biopharmaceutical manufacturing. WEIBING DING READ MORE