SED-FMGX-3 — Vial Powder Injection Production Line

Vials enter on a stainless infeed belt onto the vertical-drum washer, where ultrasonic pre-soak (1 kW) loosens debris, then a 16-station rotary head sprays each vial alternately with circulating water, WFI, and 0.22 μm filtered compressed air through 40 stainless cleaning needles, achieving ≥99% clarity and <0.01% breakage. Cleaned vials transfer to the SED-4350MJT-3 hot-air tunnel: pre-heat (~250°C, H13 HEPA laminar 1900 m³/h), sterilization (350°C peak, 30×2 kW heaters, holding ≥302°C for ≥5 min, 5000 m³/h H13 HEPA), and water-cooled cool-down zone (with 18×1.7 kW in-line sterilization heaters, 2500 m³/h H13). Heat distribution within ±10-12°C loaded, endotoxin reduction validated by biological indicator (≥3 log). Vials emerge ≤30-40°C, then enter the SED-150FZJ-3 filler under H14 LAF (0.45 m/s) - dual servo-driven screw heads (compatible with A and B antibiotic powders) doses 0.1-2.0 g (±3% at 0.5-1.0 g), magnetic-levitation pucks/molds carry vials past the dose station, then a vibratory bowl feeds rubber stoppers (low-bowl alarm) which a stoppering station presses on each vial under nitrogen purge. Capped vials go into the SED-10ZG-3 crimper (≥180 vials/min stable / ≥240 peak): aluminum caps gravity-feed onto each vial through an anti-overlap track and 6 kW spindle-roller heads crimp the alu-plastic combi-seal, with ≥99.95% pass rate and rejecting bottles missing stopper or cap. Each station tracks a Siemens S7-1200 + 12-inch HMI with user/password security, RABS door interlock, LOTO main switch, low-air/vacuum/nitrogen alarms, and CFR Part 11 PDF reporting.