Pre-filled Syringe (PFS) Filling Production Line Functions

The pre-filled syringe (PFS) filling production line is a highly automated system composed of multiple critical equipment units, ensuring efficient, sterile, and precise operations from empty syringe handling to finished product packaging. Below are the typical equipment functions:

1. Empty Syringe Handling

Unboxing/Unpacking Machine

Automatically extracts pre-sterilized pre-filled syringes from cartons or bags and transfers them to the production line.

Syringe Alignment & Positioning Device

Uses vibratory bowls or robotic arms to orient syringes uniformly for precise downstream operations.

2. Cleaning & Sterilization

Siliconization Unit (Optional)

Applies silicone coating to syringe inner walls to reduce friction (may be skipped for pre-siliconized syringes).

Ultrasonic Cleaner (Optional)

Removes residual particles from syringe interiors/exteriors (for non-pre-sterilized syringes).

Sterilization Tunnel (EO or Radiation)

For non-pre-sterilized syringes, uses ethylene oxide (EO) or irradiation for sterilization.

3. Filling & Stoppering

Filling Machine (Core Equipment)

Dosing System: Utilizes peristaltic pumps, piston pumps, or time-pressure methods for high-precision liquid filling (accuracy: ±1%).

Aseptic Barrier: Operates in ISO Class 5 (A级) environments (isolators or RABS) to prevent contamination.

In-line Weight Check: Monitors fill volume in real time and rejects non-conforming units.

Nitrogen/Inert Gas Purging (Optional)

Fills headspace with nitrogen for oxygen-sensitive drugs to prevent oxidation.

Stopper (Plunger) Insertion Machine

Precisely inserts rubber stoppers into syringe barrels to ensure sealing integrity.

4. Assembly & Labeling

Plunger Rod & Needle Assembly Unit

Attaches plunger rods to syringe barrels.

Labeling Machine

Applies labels with drug name, specifications, batch number, expiry date, barcode, etc.

5. Inspection Systems

Vision Inspection System (Optional)

Checks for defects like foreign particles, liquid level, stopper position, or label misalignment.

Weight Checker (Optional)

Verifies fill volume accuracy as a secondary control.

6. Packaging

Cartoning Machine

Loads syringes into inner trays/blisters and secondary packaging (e.g., cartons).

7. Auxiliary Systems

Conveyance System

Transfers syringes between stations via belts, star wheels, or robotic arms.

CIP/SIP (Clean-in-Place/Sterilize-in-Place)

Cleans and sterilizes equipment pipelines automatically.

Environmental Controls

Maintains cleanroom parameters (temperature, humidity, pressure differentials, particle counts per ISO Class 5).