Automatic Four-Head Ampoule Filling & Sealing Machine
High-Speed, cGMP Compliant Sterile Processing
The Harsiddh Unimach Automatic Four-Head Ampoule Filling & Sealing Machine is a robust, cGMP-compliant solution designed for high-capacity pharmaceutical production. Engineered for efficiency and precision, this model leverages a four-head filling and sealing station to deliver bulk productivity while maintaining a compact footprint.
Engineering & Material Excellence
Constructed with superior materials to meet stringent international standards:
- Contact Parts: Manufactured from SS AISI 316L to ensure maximum chemical compatibility and sterility.
- Non-Contact Parts: Constructed from SS AISI 304 for durability and ease of cleaning.
- Drive System: Features a Slant Travel Principle combined with a Rectangle Feeding System to ensure stable ampoule transport and minimal breakage at high speeds.
Technical Performance
- Throughput: Delivers a high production capacity of 60 to 90 ampoules per minute, making it ideal for medium-to-large scale manufacturing.
- Precision Dosing: Specifically designed for 1ml to 5ml open-mouth glass ampoules, with a filling range of 5ml to 5ml in a single dose.
- Automated Cycle: Seamlessly integrates pre- and post-nitrogen flushing, material filling, heating, and hermetic sealing.
- Material Savings: Includes an advanced “No Ampoule – No Filling” sensor to prevent the wastage of high-value injectable liquids.
Core Features & Benefits
- cGMP Model: Designed for easy validation and adherence to Good Manufacturing Practices.
- Minimum Downtime: Engineered with fewer changeover parts, allowing for rapid transitions between different ampoule sizes.
- Dynamic Customization: While the standard model is highly versatile, Harsiddh Unimach offers bespoke modifications to meet specific client requirements.
- User-Friendly Operation: Simplified controls and low-maintenance mechanical drives reduce the need for specialized technical intervention.
Technical Specification
| Model No. | HFS-4 / Off Line model |
| Ampoule Sizes | 1ml to 5ml Open Mouth Glass Ampoules |
| Filling Capacity | From 0.5ml to 5ml in single dose |
| Filling Type | Piston Pumps Type Filling (Volumetric) |
| Contact Parts | Stainless Steel AISI 316L (For Filling Nozzle & Syringe / Pump) |
| Output / Minute | 60 to 90 Ampoules / Minute (Depend on ampoules sizes) |
| No. of Head For Fill & Seal | Four |
| Require Gases For Sealing | LPG & Oxygen (Mixture) |
| Nitrogen Purging | Available (Pre & Post) |
| Pre Heating | Available |
| Power Require | 1 H.P., 380 Volts, 3 Phase, 50 Hz (4 Wire Systems) OR 1 H.P., 220 Volts, 1 Phase, 50 Hz OR Customised |
| Over All Dimensions | 1050mm (L) X 800mm (W) X 1000mm (H) |
| Net Weight | 285 Kgs. |
| Gross Weight (With Wooden Case) | 460 Kgs. |
Frequently Asked Questions
How does the machine ensure accurate liquid dosing?
To meet strict pharmaceutical dosing requirements, the machine is equipped with four high-precision SS 316L volumetric syringes. These syringes provide a filling accuracy of ±1%. The machine also features a "No Ampoule – No Fill" sensor system, which prevents the dispensing of expensive medicinal liquids if an ampoule is missing from the transport rack.
Can the machine handle different types and sizes of ampoules?
Yes. The Harsiddh Four Head machine is highly versatile and can process open-mouth glass ampoules (Type B & C) ranging from 1ml to 25ml. The "Walking Beam" transport system and the centering grippers are adjustable, allowing for quick changeovers between different ampoule diameters and heights with minimal downtime.
What type of sealing mechanism is used to ensure a sterile closure?
The machine utilizes the "Draw-off Sealing" method. After filling, the ampoule necks are rotated and heated by precision Oxygen-LPG burners. Once the glass is molten, a mechanical gripper pulls away the waste glass tip (the "draw-off"), creating a smooth, hermetic, and rounded dome seal. This process ensures the contents remain sterile and leak-proof.
What are the key cGMP and safety features of this machine?
As a cGMP-compliant unit, the machine is built to the highest industry standards:
Material Integrity: All liquid contact parts are made of SS 316L, while the main structure and non-contact parts are SS 304 stainless steel.
Nitrogen Flushing: It includes pre- and post-filling nitrogen gas flushing stations to displace oxygen and increase the shelf life of sensitive drugs.
Safety Enclosure: The machine is housed in a transparent acrylic safety cabinet with interlock switches that stop operation if the doors are opened, protecting both the operator and the sterile environment.
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