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Automatic Pre-Filled Syringe Filling Stoppering Machine

Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)

Description

An Automatic Pre-Filled Syringe Filling & Stoppering Machine is designed for accurate, aseptic filling and closure of pre-sterilized syringes used in pharmaceuticals and biotech applications. The machine handles nest-based syringes (RTU – Ready-To-Use) in compliance with cGMP, US FDA, and 21 CFR Part 11 standards, ensuring high accuracy, sterility, and minimal operator intervention.

Features of Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)

  • High-precision servo-driven filling system for biologics and injectables.
  • Minimal product contact – ideal for sensitive biologics and vaccines.
  • Quick format changeover for multiple syringe sizes.
  • 100% in-process control (IPC) for fill volume accuracy.
  • Option for integration with PFS assembly, labeling, and auto-insertion devices.
  • Compact, robotic handling option available for advanced aseptic lines.
Bottle Unscrambler

Syringe Handling System Technical Specification

Syringe Handling System

Type: Tub/Nest-based pre-sterilized syringes (ISO 11040 compliant)
Syringe Sizes: 0.5 ml to 20 ml
Handling: Automatic tub de-lidding, liner removal, and nest transfer
Material Contact Parts: SS316L or USP Class VI compliant

Filling System

Speed: 100 – 600 syringes/min (model dependent)
Filling Accuracy: ±0.5% or better
Filling Technology: Rotary Piston Pump (servo-driven, high accuracy)
Peristaltic Pump (for aseptic & easy product changeover)
Dosing Range: 0.1 ml to 20 ml
CIP/SIP compatibility
No syringe – no fill interlock
Optional inert gas flushing (pre & post filling)
Bottle Unscrambler
We Also Accept Customized Pharmaceutical Machinery Orders,
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Stoppering System

Stoppering Type: Plunger insertion (full/partial insertion as required)
Stopper Feeding: Vibratory or rotary feeder with vacuum-assisted placement
No stopper – no fill interlock
Class 100 (ISO 5) laminar airflow at stoppering station

Labeling Systems

Suitable for round HDPE/LDPE bottles
Label types : Sticker Labels
Machine type : Linear labeling systems
In-built PLC with HMI

Control & Compliance

Automation: PLC with HMI touchscreen control
Data Integrity: 21 CFR Part 11 compliance (audit trail, password protection)
Alarm & Rejects: Automatic rejection of unfilled, mis-stoppered syringes
Validation Support: DQ, IQ, OQ, PQ documentation provided
Compliance: cGMP, GAMP 5, WHO, FDA

Cleanroom & Utilities

Environment: ISO 5 (Class 100) at filling/stoppering area
Electrical Supply: 415V, 3 Phase, 50/60Hz
Compressed Air: 6 bar, oil-free
Optional: Nitrogen supply for inerting, vacuum for plunger placement