Automatic Peristaltic Based Ampoule Filling Machine
High-Accuracy Sterile Filling Technology
The Harsiddh Automatic Peristaltic Based Ampoule Filling & Sealing Machine is specifically designed for the high-precision packaging of injectable liquids in glass ampoules ranging from 1ml to 25ml. By utilizing peristaltic pump technology instead of traditional piston pumps, this machine eliminates the risk of cross-contamination and ensures high accuracy (single dose from 0.5ml to 25ml), making it the preferred choice for biologicals, expensive liquids, and sensitive pharmaceutical products.
Operational Precision & Sequential Process
The machine utilizes the Slant Travel Principle, adapting seamlessly to various ampoule neck dimensions and glass thicknesses.
Sequence of Operation:
- Loading: Sterile ampoules are loaded into the slant hopper and synchronized via an eccentric rack and star wheel.
- Decontamination: Pre-gassing with nitrogen clears oxygen from the container.
- Precision Filling: The peristaltic pump system discharges the liquid without any mechanical contact with the pump parts, ensuring maximum sterility.
- Sealing: After post-gassing and pre-heating (for thick glass), the ampoules rotate smoothly while a mixture of LPG and Oxygen creates a hermetic seal.
- Collection: Filled and sealed ampoules are automatically discharged into a collection tray.
Why Choose Peristaltic Technology?
Peristaltic filling is ideal for manufacturers who prioritize fast changeover and easy cleaning. Since the liquid only touches the medical-grade tubing and SS 316L nozzles, the “Cleaning-In-Place” (CIP) process is significantly faster. Available in configurations from 1 to 8 heads, this machine can scale from R&D needs to high-volume production of up to 250 ampoules per minute.
Technical Specification
| Model No. | HFS-30P to HFS-225P |
|---|---|
| No. of Heads | 1, 2, 4, 6, or 8 Heads |
| Ampoule Sizes | 1ml to 25ml (Open & Closed Mouth) |
| Output / Minute | 20 to 250 Ampoules (Depending on model) |
| Filling Type | Peristaltic Pumps with Servo/Stepper Motors |
| Filling Accuracy | +/- 0.5% to 1% |
| Power Requirements | 0.5/1 H.P., 220 Volts, 1 Phase, 50 Hz |
| Gases Required | LPG & Oxygen (for Sealing) |
| Contact Parts | Stainless Steel AISI 316L |
Frequently Asked Questions
How accurate is the filling volume with a Peristaltic Based system?
Harsiddh utilize high-precision stepper or servo-driven motors to control the pump rollers. This technology allows for extremely accurate micro-dosing, achieving a filling accuracy of ±0.5% to 1%. It is particularly effective for small volumes ranging from 0.5ml to 10ml, ensuring minimal wastage of expensive pharmaceutical formulations.
Does the Peristaltic Filling system reduce "Downtime" during batch changes?
Yes, significantly. Since the liquid is contained entirely within the tubing, a "Changeover" often involves simply replacing the disposable silicone tubing set. This eliminates the need for time-consuming Cleaning-In-Place (CIP) or Sterilization-In-Place (SIP) of complex pump assemblies, allowing you to switch between different products in a fraction of the time.
Can this machine handle oxygen-sensitive injectable products?
Absolutely. The machine is equipped with integrated Pre-Gassing and Post-Gassing units. These stations flush the ampoule with Nitrogen (or another inert gas) before and after the filling process to displace oxygen. This ensures the chemical stability and extended shelf life of sensitive medications before the final hermetic seal is made.
What are the key cGMP and construction standards for this model?
As a cGMP-compliant unit, the machine is built for the most rigorous sterile environments:
Materials: All non-contact parts are SS 304, and the machine frame is designed with smooth surfaces for easy sanitization.
No Ampoule – No Fill: Electronic sensors ensure the pump only activates when an ampoule is present, preventing spills.
Control System: Features a centralized PLC with a Touchscreen HMI, allowing for digital calibration of fill volumes and real-time monitoring of production speeds.
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