The purpose of this cleaning validation is to demonstrate and record that the HEV vaccine stock solution workshop (B03) bacterial fragmentation system and its components have been cleaned according to the cleaning method specified in the "Standard Operating Procedures for Cleaning and Disinfection of Bacterial Fragmentation System (2-1A208-04-X)" (IX-SOP-001540), and that the residual active components, process aids, cleaning agents, and microbial load levels in the system are within the pre-defined acceptable standards, To prevent pollution that can have adverse effects on the safety and quality of the next batch of production products.
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