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Sterile Powder Vial Filling Line-2

  • Magnetic-levitation positioning + 100% in-process weighing

  • Filling range 0.5–5.0 g, fill difference ±4%

  • Meet GMP standard, nitrogen filling (O₂ ≤ 3%)

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Sterile Powder Vial Filling Line (Magnetic-Levitation, 100% In-Process Weighing)

AIPAK Engineering sterile powder vial filling line is composed of an ultrasonic bottle washing machine, hot-air depyrogenation tunnel, magnetic-levitation screw powder filling machine and capping machine. It completes ultrasonic washing, inner/outer wall flushing, preheating, drying and depyrogenation, cooling, vial infeed, empty-vial weighing, screw powder filling, filled-vial weighing (100% in-process check), nitrogen filling, stoppering and capping — realizing automatic production of the whole process. Each machine can be used separately or in a linkage line.

The line is mainly used for sterile powder injectables in glass vials, and is widely applied to antibiotic and cephalosporin powder production. Product-contact parts are 316L stainless steel; the line runs under Siemens PLC control with Class 100 laminar flow, 21 CFR Part 11 and GAMP5 data integrity.

Vial powder example:

Vial powder

Vial Automatic Ultrasonic Washing Machine (QCK Series)

Vial Automatic Ultrasonic Washing Machine

Vertical ultrasonic non-contact washing uses cavitation to remove dirt from inner and outer walls, followed by alternating rinses of recycled water, purified water, WFI and sterile compressed air. A manipulator flips vials 180° for internal rinse and air-blow drying. Grade-1 terminal filters throughout (recycled water 0.45 µm, WFI & compressed air 0.22 µm); breakage rate ≤ 0.01%.

Depyrogenation Tunnel (GMS Series)

Depyrogenation Tunnel

Hot-air laminar-flow tunnel with preheating, high-temperature and cooling sections. HEPA filters use negative-pressure sealing; the high-temperature zone reaches up to 350 °C for endotoxin destruction (≥ 3 log, FH ≥ 1365, 325 °C ≥ 5 min). Mesh belt width 1250 mm, temperature accuracy ±2 °C.

Magnetic-Levitation Screw Powder Filling Machine (KFG Series)

Magnetic-Levitation Screw Powder Filling Machine

Vials ride on magnetic-levitation trolleys through weigh–fill–weigh stations: empty vials are weighed (station A), screw-filled by servo-driven dispensing screws, then weighed again (station B) for 100% in-process weight check. Out-of-spec vials are automatically rejected; qualified vials proceed to nitrogen filling, stoppering and capping. Tapered dispensing screws (no top adjustment) with ceramic bearings; multiple filling modes (2/4/6-head).

Capping Machine (KGL Series)

Capping Machine

Single-knife rotary crimper seals aluminum-plastic caps on vials with a planetary mechanism. Large cap oscillator (8,000–10,000 caps), electromagnetic cap sorting, no-plug cap rejection, and no-cap vial rejection after crimping. Outlet counting for production management.

Sterile Powder Vial Filling Line Features:

  1. The whole line meets new GMP requirements; cleaning effect meets the latest Pharmacopoeia standards.
  2. Straight-line or wall-to-wall L-shaped layout to reduce cross-contamination risk and provide aseptic protection.
  3. Applicable specification: 7–30 ml vial (as per user's requirement).
  4. Design production capacity: ≥ 400 vials/min (10 ml); tunnel design up to 420 vials/min.
  5. Magnetic-levitation trolley positioning — high accuracy, automatic zeroing, no manual realignment.
  6. 100% in-process weighing (IPC): weigh empty → screw fill → weigh filled → auto-reject out-of-spec vials.
  7. Filling range 0.5–5.0 g; fill difference ±4%; online weighing error ≤ ±5–8 mg.
  8. Tapered dispensing screw (no top adjustment) with ceramic bearings — no dead spots, no residue, easy to clean.
  9. Multiple filling modes: dual-head, four-head and six-head operation.
  10. Powder hopper in 316L, wet/dry-heat sterilizable, no plastic liner shedding; multiple cone angles for different powders.
  11. Variable-frequency powder mixing for uniform distribution and consistent dosing.
  12. Nitrogen filling before and after stoppering: oxygen content ≤ 3%, with nitrogen air-curtain, pressure sensor and flow meter.
  13. Non-vacuum stoppering system — energy-saving, fewer failure points, higher reliability.
  14. Metal-chip detector on the dispensing head — auto stop and alarm on foreign object.
  15. No-vial-no-fill via fiber-optic sensor; cap low-level alarm.
  16. Class 100 laminar flow over the sterile filling zone; Open-RABS configurable.
  17. Depyrogenation tunnel: endotoxin reduction ≥ 3 log, FH ≥ 1365, HEPA negative-pressure sealing.
  18. Capping machine with no-plug and no-cap rejection, aluminum-scrap extraction.
  19. Powder-barrel external reversal device (isolated by acrylic) for clean, sterile powder charging.
  20. Online monitoring of dust particles, planktonic bacteria, air velocity and pressure (configurable).
  21. Full-line linkage control; color touch-screen HMI, PLC control, frequency-conversion speed regulation.
  22. 21 CFR Part 11 & GAMP5 compliant, IEC-61131 PLC programming, three-level password, audit trail.
  23. Products customizable to actual customer demand.

Sterile Powder Vial Filling Line Technical Specification:

Item Specification
Applicable vial size 7–30 ml glass vials
Design capacity ≥ 400 vials/min (10 ml), tunnel up to 420
Filling principle Servo screw, magnetic-levitation positioning
Number of powder heads 6 heads (3+3); 2/4/6-head modes
Filling range 0.5–5.0 g
Fill difference ±4% (0.5–1.0 g) or per Chinese Pharmacopoeia
Online weighing error ≤ ±5–8 mg
Weight check 100% in-process weighing (station A/B)
Nitrogen filling O₂ ≤ 3% (e.g. 10 ml: 0.5–1.0 g N₂)
Vial tipping rate 0.1% (10 ml vial)
Tunnel temperature 100–350 °C (±2 °C), FH ≥ 1365, 325 °C ≥ 5 min
Tunnel mesh belt width 1250 mm
Sterile environment Class 100 laminar flow
Product-contact material 316L stainless steel
Data integrity 21 CFR Part 11, GAMP5, IEC-61131
Key configuration Siemens PLC/servo/HMI, ceramic bearings, Cognex vision (optional inspection)
Machine Model Key Data Weight Installed Power
Ultrasonic Vial Washer (servo) QCK-60/80 ≥ 400 vials/min (10 ml) 3,500 kg ~8 kW
Depyrogenation Tunnel GMS800-4350 / 1200-5100 Belt 1250 mm, 100–350 °C 7,000 kg 170 kW
Magnetic-Levitation Screw Filler KFG-3F/4F-CZ 3/4-head, 100% weighing, 0.5–5.0 g Refer to drawing Refer to drawing
Crimping Machine KGL-12/16 12/16-head Refer to drawing Refer to drawing

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