Parameters Area Acceptance criteria Observation comply / not comply Temperature (°C) Vial filling area Cooling zone Vial washing room Vial sealing room NMT 24°C NMT 24°C NMT 26°C NMT 26°C comply Relative Humidity (%) Vial filling area Cooling zone NMT 30% NMT 45% comply Differential Pressure (mm) Vial filling vs Vial washing Vial filling vs Cooling zone Vial filling vs Air lock NLT 10 pascal NLT 10 pascal NLT 10 pascal comply Sterile Filling Area Particle Count Viable particle count Non-viable particle coun 1 CFU/m3 ≥ 0.5 μ=NMT 3520/m3 ≥ 5 μ= NMT 29/m3 comply Area Adjacent to Sterile Area Particle Count Viable particle count Non-viable particle count 2 CFU/m3 ≥ 0.5 μ=NMT 352000/m3 ≥ 5 μ= NMT 2900/m3 comply

Table 2: Environmental Condition of Manufacturing Area.