Automatic Pre-Filled Syringe (PFS) Filling & Stoppering Machine
High-Precision Aseptic Filling for PFS
The Harsiddh Automatic Pre-Filled Syringe (PFS) Filling & Stoppering Machine is a cutting-edge solution for the pharmaceutical and biotech industries. Engineered to handle the delicate nature of pre-sterilized nested syringes, this machine automates the critical path of liquid dosing and stopper insertion. It is the ideal choice for high-value biologicals, vaccines, and complex injectables that require absolute dosage precision and a contamination-free environment.
Operational Precision & Advanced Workflow
The machine is designed to minimize mechanical stress on the product while maximizing sterile integrity throughout the filling cycle.
Sequence of Operation:
- Tub Loading: The nested tub containing pre-sterilized syringes is placed onto the machine platform.
- Precision Filling: Servo-controlled nozzles descend into the syringes for bottom-up, bubble-free filling with ±0.5% to 1% accuracy.
- Vacuum Stoppering: Syringes move to the stoppering station where a vacuum is created to insert the rubber plunger without trapping air.
- Discharge: Successfully filled and stoppered syringes are indexed for final inspection and secondary packaging.
Technical Specification
| Specification | Details (PFS Series) |
|---|---|
| Production Output | 20 to 40 Syringes / Minute (Based on Model) |
| Syringe Capacity | 0.5ml to 20ml (Glass or Plastic PFS) |
| Filling Accuracy | ± 0.5% to 1% |
| Filling System | Servo Piston / Peristaltic Pump |
| Stoppering Method | Vacuum Assisted Plunger Insertion |
| Contact Parts | Stainless Steel AISI 316L |
| Control System | PLC with Color Touchscreen HMI |
| Air Supply | 5-6 Bar (Dry & Filtered) |
Frequently Asked Questions
How does the machine handle syringes without causing damage?
PFS units are typically supplied in sterile "Tubs" or "Nests." The Harsiddh machine uses a high-precision robotic or mechanical nest-handling system that moves the syringes through the filling and stoppering stations without glass-to-glass or glass-to-metal contact. This "No-Touch" processing is critical for maintaining the structural integrity of the syringes and preventing cosmetic defects.
What filling technology is used to ensure dosing accuracy?
To protect sensitive biologicals and vaccines, the machine utilizes Servo-Driven Peristaltic Pumps or high-precision Ceramic/SS 316L Volumetric Syringes.
Accuracy: Achieve a filling precision of ±0.5% to 1%.
Bubble-Free Filling: The machine employs a "Bottom-Up" filling technique where the needles rise as the liquid is dispensed, preventing turbulence and air entrapment in the syringe barrel.
How are the rubber plungers (stoppers) inserted into the syringes?
The machine uses a specialized Vacuum-Assisted Stoppering or Vent-Tube Stoppering method. This ensures that the rubber plunger is placed at the precise depth within the syringe barrel without creating high pressure or leaving air gaps between the liquid and the stopper. Plungers are fed via a sterile vibratory bowl feeder to ensure a continuous, aseptic supply.
What are the key cGMP and sterile design features of this machine?
As a cGMP-compliant unit intended for high-stakes pharmaceutical applications, the machine includes:
Material Integrity: All contact parts are SS 316L or medical-grade polymers, and the main frame is SS 304.
Isolator/LAF Compatibility: The compact, slim-line design is specifically engineered to fit under Laminar Air Flow (LAF) hoods or within RABS (Restricted Access Barrier Systems) to maintain a Class 100 sterile environment.
Advanced Control: A centralized PLC with a 21 CFR Part 11 compliant HMI allows for data logging, audit trails, and precise digital calibration of all filling and stoppering parameters.
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