Table 72: Comparison of Manufacturi

Table 72: Comparison of Manufacturing Process ParametersProcess Steps Process Parameters Clinical Manufacturing Commercial Manufacturing Comparison and ExplanationFormulation Addition of excipients To achieve formulation concentration To achieve formulation concentration Scale upFormulation pH pH adjustment 6.9 - 7.5 6.8-7.8 ComparableSterile filtration Filter integrity ≥ 3180mbar ≥ 3180mbar No changeSterilization of vials Sterilization tunnel temperature Set temperature 320℃ 320℃ - 340℃ Improved sterilizationSterilization of stoppers and seal Temperature, time, F0 121℃, 30min 121℃, 30min No changeFill volume volume 1.05 - 1.15mL 1.05 - 1.15mL No changeseal capping effect Surface smooth, no wrinkle, no warping phenomenon Surface smooth, no wrinkle, no warping phenomenon No changeVisual inspection Foreign matters and defects Manual light inspection Automatic light inspection machine Improved accuracy and efficiency Labelling and packaging Inspection Batch number, manufacturing date, and expiry date of printing are consistent with the packaging instructions, and the coding effect is clear Batch number, manufacturing date, and expiry date of printing are consistent with the packaging instructions, and the coding effect is clear No changeFinished product Storage Cold rooms 2℃ - 8℃ 2℃ - 8℃ No change