Automatic Four-Head Ampoule Filling & Sealing Machine
High-Throughput, Sterile Liquid Packaging for Pharmaceutical Excellence
In the stringent world of pharmaceutical manufacturing, maintaining absolute sterility, precision dosing, and consistent throughput is non-negotiable. The Harsiddh Unimach Automatic Four-Head Ampoule Filling & Sealing Machine stands at the forefront of sterile liquid processing technology. This industrial-grade, cGMP-compliant system is meticulously engineered to automate the delicate process of filling and hermetically sealing glass ampoules, delivering unmatched efficiency without compromising on cleanroom footprints.
Designed specifically for medium to large-scale pharmaceutical facilities, contract manufacturers (CMOs), and biotech laboratories, this advanced machinery features a synchronized four-head architecture. By handling four ampoules simultaneously per cycle, it maximizes your facility’s daily output while ensuring that each container undergoes rigorous pre-gassing, exact filling, and uniform flame sealing.
The Engineering Behind Sterile Integrity
Sterility is the core foundation of injectables manufacturing. Every mechanical action, surface contact, and structural curve of our 4-head ampoule filler is designed to meet and exceed international regulatory standards, including US FDA and EU GMP requirements.
Premium Material Selection for Cross-Contamination Prevention
- Product Contact Zones (SS 316L): Every component that comes into direct contact with your liquid formulations—including the filling needles, dosing syringes, delivery tubes, and manifolds—is fabricated from high-grade Stainless Steel AISI 316L. This material offers superior resistance to chemical corrosion, pitting, and degradation, ensuring that your high-value liquids remain completely pure and free from metallic or microbial contamination.
- Structural Frame and Enclosures (SS 304): The external chassis, safety guards, and non-contact mechanical structures are built using Stainless Steel AISI 304. The matte-finished, smooth surfaces prevent dust accumulation, resist aggressive cleanroom sanitizing agents, and facilitate rapid wipe-down procedures.
Advanced Mechanical Transport Mechanics
High-speed handling of fragile glass ampoules requires an incredibly smooth mechanical motion. Our machine employs a specialized Slant Travel Principle combined with a highly synchronized Rectangle Feeding System.
- Slant Travel System: Gently tilts and guides the ampoules through the processing stations, eliminating sudden shocks and minimizing glass-on-glass friction.
- Rectangle Feeding Grid: Ensures that the ampoules move forward in a perfectly timed, stepping-stone sequence. This precise mechanical indexing virtually eliminates ampoule breakage, tipping, and jam-ups, even when operating at maximum cycle speeds.
Technical Performance & Operational Specifications
The engineering brilliance of this four-head system reflects clearly in its technical capabilities, blending raw mechanical speed with micro-level volume accuracy.
| Technical Parameter | Specification Capability |
|---|---|
| Production Speed | 60 to 90 Ampoules per Minute (Variable Frequency Drive) |
| Compatible Containers | 1ml to 5ml Open-Mouth Glass Ampoules (Form B / Form C) |
| Standard Dosing Range | 1ml to 5ml Single Dose (Custom pumps available for micro-dosing) |
| Sealing System | Oxy-Hydrogen / LPG + Oxygen Gas Burners with Post-Seal Cooling |
| Flushing Capability | Pre- and Post-Filling Nitrogen ($N_2$) Gas Purging |
Micro-Precision Dosing Pumps
Equipped with highly accurate volumetric or positive-displacement syringes, the machine ensures that every single ampoule receives an identical dose. This minimizes expensive product giveaway—a critical factor when processing high-value oncological drugs, vaccines, biologics, and specialized veterinary injectables.
The Automated Processing Cycle
From the moment empty, sterilized ampoules enter the feed hopper, the machine executes a flawless, fully automated five-step sequence:
- Pre-Nitrogen Flushing: Drives out atmospheric oxygen from the empty ampoule to protect oxidation-sensitive liquid formulations.
- Precision Liquid Filling: Four synchronized filling nozzles descend smoothly into the neck of the ampoules, dispensing the exact liquid volume simultaneously.
- Post-Nitrogen Flushing: Displaces any oxygen remaining in the headspace immediately above the liquid layer, extending product shelf-life.
- Pre-Heating & Neck Sealing: Specialized gas burners evenly apply high-temperature flames to the ampoule necks while the containers gently rotate, creating a flawless, hermetic dome seal.
- Automated Discharge: Sealed ampoules are cleanly collection-guided onto the outfeed tray, ready for optical inspection and labeling.
Core Features and Strategic Business Benefits
Investing in the Harsiddh Unimach 4-Head Ampoule Filler means upgrading your production line with features designed to reduce overhead costs, optimize operator efficiency, and maximize machine uptime.
1. Smart “No Ampoule – No Filling” Sensor Technology
To eliminate product loss and messy cleanroom cleanups, the machine is integrated with an intelligent optical sensor arrays. If a gap is detected in the feeding line and an ampoule is missing from any of the four stations, the corresponding filling nozzle is instantly deactivated. This prevents the accidental dispensing of expensive fluids onto the conveyor bed, maintaining a clean workspace and protecting your bottom line.
2. Streamlined Changeovers and Minimal Downtime
In a modern pharmaceutical plant, flexibility is essential. Our 4-head ampoule machine is engineered with a modular philosophy that utilizes minimal changeover parts. Switching production parameters from a 2ml ampoule batch to a 5ml ampoule batch requires no complex tools or extensive mechanical overhauls. Operators can complete a full changeover within minutes, significantly improving overall equipment effectiveness (OEE).
3. Comprehensive cGMP Architecture
The entire machine footprint is optimized to integrate seamlessly into Laminar Air Flow (LAF) workstations or cleanroom barrier systems. The open-table design ensures that laminar airflow passes over the filling zone without turbulence or obstruction, maintaining Class A sterility conditions right at the point of filling.
4. Bespoke Engineering & Tailored Customization
Every pharmaceutical facility operates under unique constraints and specifications. While our standard 4-head model offers incredible versatility, Harsiddh Unimach provides extensive customized modification options. Whether you require specialized PLC automation with Touchscreen HMI controls, integration with data logging software for 21 CFR Part 11 compliance, or custom pump dimensions for unique fluid viscosities, our engineering team can custom-build the machine to fit your exact blueprint.
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. |
Why Choose Harsiddh Unimach?
Harsiddh Unimach is globally recognized for manufacturing high-caliber, reliable pharmaceutical packaging machinery. Our commitment to using premium metallurgy, precision electronics, and user-centric mechanical designs guarantees that your capital investment will deliver consistent performance for decades.
By combining low-maintenance mechanical drives with highly responsive safety interlocks, we ensure that your operations run smoothly with minimal technical intervention. Elevate your production quality, safeguard your liquid formulations, and scale your manufacturing output with the Automatic Four-Head Ampoule Filling & Sealing Machine.
Contact our technical sales team today to request a customized quote, review detailed engineering drawings, or schedule a live video demonstration.
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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