Automatic Pre-Filled Syringe Filling Stoppering Machine

Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)

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. It is built to cGMP and FDA-approved material standards. Request a detailed specification sheet or a quote from Harsiddh Engineering.

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.

Where the Pre-Filled Syringe Filling & Stoppering Machine fits in your production line

Pre-filled syringes are often produced alongside vial and ampoule injectables. See our automatic liquid vial filling line, automatic ampoule filling line and visual inspection machines to complete your sterile production area.

Other models in this range

Need help choosing? Send your requirement with your container size, fill volume and output, or contact our team in Ahmedabad.

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)

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

Frequently Asked Questions

What materials are the Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)'s contact parts made from?

Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)'s material Contact Parts: is SS316L or USP Class VI compliant.

What is the Type: of the Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)?

Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)'s type: is Tub/Nest-based pre-sterilized syringes (ISO 11040 compliant).

What is the Syringe Sizes: of the Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)?

Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)'s syringe Sizes: is 0.5 ml to 20 ml.

Is the Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS) built to pharmaceutical industry standards?

Yes — it is built to cGMP and FDA-approved material standards.