Automatic Lab Scale Ampoule Filling & Sealing Machine
Precision Engineering for R&D and Pilot Batches
In pharmaceutical research, formulation development, and clinical trials, precision is not just a requirement—it is a mandatory standard. The Automatic Lab Scale Ampoule Filling & Sealing Machine manufactured by Harsiddh Unimach Pvt. Ltd. is specifically engineered to bridge the gap between laboratory-scale experimentation and full-scale commercial manufacturing. Designed meticulously for small-scale production, pilot plants, and research institutions, this compact equipment brings industrial-grade accuracy, sterility, and repeatability right onto your laboratory benchtop.
Whether you are developing complex liquid injectables, stability testing new chemical entities, or running small clinical trial batches, this monobloc system provides an uncompromised sterile packaging environment for glass ampoules ranging from 1ml to 25ml.
The Necessity of Automation in Pharmaceutical R&D
Transitioning from manual or semi-automatic filling methods to an automated system is critical for modern pharmaceutical validation. Manual operations introduce human variance, risk of contamination, and inconsistent seal integrity, which can jeopardize weeks of research.
By integrating a fully automated lab-scale solution, research facilities achieve:
- Process Validation: Replicate the exact mechanical, filling, and sealing parameters used in high-speed commercial lines, making future scale-up seamless.
- Minimized Product Loss: High-value active pharmaceutical ingredients (APIs) require precision dosing to eliminate waste.
- Enhanced Sterility: Reducing human intervention near open containers ensures compliance with strict regulatory standards for sterile injectables.
Advanced Monobloc Design and Operational Sequence
The equipment operates as a synchronized, comprehensive Monobloc system. In a single, continuous, and highly controlled mechanical sequence, it flushes, fills, and seals glass ampoules with absolute stability.
At the core of its mechanical stability is the advanced Angle Travel Principle. This specialized engineering approach ensures that the ampoules are held securely at an optimal angle during transit, effortlessly accommodating minor variances in ampoule neck dimensions, bottom concentricity, and glass wall thickness without causing breakage or misalignment.
Step-by-Step Sequence of Operation:
- Precision Feeding System: Sterilized, empty glass ampoules are loaded onto a structured, rectangular feeding grid. This geometry minimizes glass-to-glass friction, prevents tipping, and ensures a smooth, individual transfer to the main transport rack.
- Pre-Gassing (Nitrogen Purging): To safeguard oxygen-sensitive formulations and prolong shelf life, the machine features a dedicated nitrogen gas flushing station. Pre-gassing displaces atmospheric oxygen inside the empty ampoule before any liquid is introduced.
- Volumetric Liquid Filling: Dosing accuracy is managed by a high-precision, cam-operated piston pump system. This mechanical synchronization ensures that the exact preset volume of liquid injectable is discharged without dripping, splashing, or wetting the inner neck wall of the ampoule (which can cause carbonization during sealing).
- Post-Gassing & Pre-Heating: Following the liquid fill, a secondary nitrogen flush (post-gassing) secures the head-space environment. The ampoule then smoothly progresses through a pre-heating zone to gradually condition the glass neck, preventing thermal shock.
- Hermetic Fusion Sealing: The sealing process utilizes a delicate, continuous rotating unit. A finely tuned mixture of Liquefied Petroleum Gas (LPG) and Oxygen creates a consistent, high-temperature flame. As the ampoule neck melts, a precise mechanical gripper removes the waste tip, forming a flawless, rounded hermetic seal.
- Automated Collection: The securely sealed ampoules are smoothly diverted out of the processing zone and collected systematically into an organized vertical collection tray, ready for inspection and autoclaving.
Technical Features & Engineering Excellence
Every machine built by Harsiddh Unimach Pvt. Ltd. is constructed to withstand rigorous laboratory cleaning protocols while maintaining tight mechanical tolerances.
- cGMP Compliant Construction: All contact parts with the product formulation are fabricated from premium-grade Stainless Steel (SS 316L), ensuring total chemical compatibility and resistance to corrosion. Non-contact structures are encased in SS 304 for effortless sanitization.
- Versatile Tooling Changeover: Recognizing that R&D laboratories switch between different formulation volumes frequently, the machine is designed for fast changeovers. Tooling parts required to switch between 1ml, 2ml, 5ml, 10ml, and 25ml ampoules can be adjusted with minimal down-time and basic tools.
- Integrated Waste Management: The sealing mechanism includes an integrated stainless steel waste tip collector. Slanted chutes ensure that trimmed glass tips drop cleanly into a removable collection bin, maintaining a clean, glass-shard-free processing zone.
- Independent Controls: Fine-tuning valves for LPG, Oxygen, and Nitrogen gases are conveniently located on the front panel, allowing operators to easily optimize flame length and gas pressure depending on the glass thickness and ampoule profile.
Optimizing for Sterility and Cleanroom Integration
A critical challenge in lab-scale sterile packaging is managing airflow and avoiding particle generation. The compact footprint of this Automatic Ampoule Filling & Sealing Machine makes it uniquely suited for installation inside standard Laminar Airflow (LAF) Benches or Isolator Containment Systems.
The mechanical design minimizes horizontal surfaces where particles could accumulate, allowing undisturbed vertical laminar air to flow over the open ampoules during the critical feeding and filling stages. Furthermore, the smooth mechanical linkages run quietly, reducing vibration and maintaining the integrity of adjacent delicate laboratory balances and analytical instruments.
Technical Specification
| Specification | Details (Model: HFS-30) |
|---|---|
| Number of Heads | Single Head (Filling & Sealing) |
| Production Output | 10 to 15 Ampoules / Minute |
| Ampoule Handling Range | 1ml to 25ml Open Mouth Glass Ampoules |
| Filling Accuracy | +/- 1% |
| Gases Required | LPG & Oxygen (Mixture) |
| Power Requirements | 0.5 H.P., 220V/415V, 50 Hz |
| Contact Parts | Stainless Steel AISI 316L |
| Overall Dimensions | 750mm (L) X 500mm (W) X 1000mm (H) |
Why Partner with Harsiddh Unimach Pvt. Ltd.?
As an established global provider of industrial and pharmaceutical packaging technology, Harsiddh Unimach Pvt. Ltd. infuses industrial-strength durability into lab-scale machinery. We understand that research data is only as good as the integrity of the sample container. That is why our laboratory-scale machines do not compromise on the core engineering concepts found in our high-capacity production lines.
By integrating this automated ampoule filling and sealing solution into your workflow, you unlock a repeatable, validated, and efficient path toward product commercialization.
Key Applications:
- Pharmaceutical R&D Laboratories
- Biotechnology Pilot Plants
- Hospital Pharmacy Compounding Units
- Stability Testing Facilities
- Cosmetic and Essential Oil Sampling
- Academic Research Institutions
For detailed technical drawings, customized dosing pump configurations, or to discuss your specific injectable formulation requirements, visit our product page:
👉 Harsiddh Unimach Ampoule Filling & Sealing Machine or contact our technical sales team at info@harsiddhunimach.com.
Frequently Asked Questions
What is the production capacity of this Lab Scale model?
The Lab Scale (typically a Single Head or Double Head) machine is optimized for precision over high volume. It generally achieves an output of 15 to 40 ampoules per minute (approximately 900 to 2,400 per hour). This allows researchers to produce enough samples for stability testing or clinical trials without the massive utility requirements of a full-scale production machine.
Can the machine handle different ampoule sizes and volumes?
Yes. Versatility is a core feature of the Harsiddh Lab Scale model. It can accommodate glass ampoules ranging from 1ml to 25ml (Type B and C). The "Quick-Change" parts allow lab technicians to switch between different ampoule diameters and heights in minutes, making it ideal for facilities that work with multiple product formulations throughout the day.
How does the machine ensure dosing accuracy for expensive R&D materials?
To minimize the loss of costly experimental drugs, the machine uses a high-precision SS 316L Volumetric Syringe system with a filling accuracy of ±1%. It is also equipped with a "No Ampoule – No Fill" sensor, ensuring that the dosing pump only activates when an ampoule is correctly positioned, preventing liquid wastage and keeping the work area clean.
What are the key cGMP and cleanroom features?
Despite its smaller size, this machine is built to the same cGMP industrial standards as our high-speed models:
Material Integrity: All contact parts are made of SS 316L, and the exterior is polished SS 304 stainless steel.
Sterile Environment: Its compact, slim-line design is specifically optimized for placement inside a Laminar Air Flow (LAF) bench or a glove box.
Gas Flushing: Includes integrated Pre- and Post-nitrogen flushing stations to protect oxygen-sensitive formulations from oxidation during the sealing process.
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