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

| 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 |
| 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 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 | |
| Suitable for round HDPE/LDPE bottles | |
|---|---|
| Label types : | Sticker Labels |
| Machine type : | Linear labeling systems |
| In-built PLC with HMI | |
| 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 |
| 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 |
Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)'s material Contact Parts: is SS316L or USP Class VI compliant.
Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)'s type: is Tub/Nest-based pre-sterilized syringes (ISO 11040 compliant).
Automatic Pre-Filled Syringe Filling Stoppering Machine (PFS)'s syringe Sizes: is 0.5 ml to 20 ml.
Yes — it is built to cGMP and FDA-approved material standards.
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