This report is being filed to provide additional information in h.6 and h.10.Investigation: in regard to the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.For the leukocyte reduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.Only the filter media that have passed the standards are incorporated into the housing.We reviewed the manufacturing record of the lot numbers in question and confirmed that no abnormalities occurred in any process, and the products were manufactured as usual.We also confirmed that the filter media were all within the quality standards.Release testing, which includes measurements of solution concentration and volume and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the lot numbers in question and confirmed that there were no abnormalities in all release testing items.The product conformed to the standards.Regarding the retained sample of the lot numbers concerned, three sets were visually inspected, respectively.There were not any occlusions in tubing, blocking, or any abnormalities in their appearances.Root cause: as mentioned above, no abnormalities were observed in the manufacturing record or the testing and inspection record of each lot number, and the filter media all within the quality standards.The lots concerned were manufactured as usual; therefore, we were not able to identify the cause of the multiple occurrences of the issue.
|