BEC 475 (Global Regulatory Affairs for Medical Products) 5. A 200-L vessel will be used to transfer a polysorbate 80 excipient (formulation component) to a 1000-L formulation vessel where the final product will be prepared. The two vessels are connected by two, 50-foot sections of stainless steel pipe (with a sanitary connection equally-spaced between the pipes and two sanitary connections at the pipe connection to the vessels). Cleaning validation is currently being performed concurrently with the process validation. After the cleaning cycle of the entire circuit, this circuit must be tested for residual product (to prove cleanliness). What are two general approaches to sampling mentioned in this class to prove cleanliness? Describe the most effective sampling scheme for this process layout (above) based on cleaning approaches? Why is it the most effective in this particular case? At what locations would samplQ be taken