Injectable drug manufacturing demands extreme accuracy, sterility, and efficiency. Many pharmaceutical companies still operate separate production lines for ampoules and vials, which increases equipment costs, takes up extra cleanroom space, and causes downtime during format changes.
The Snowbell Combi Ampoule and Vial Filling and Sealing Line solves these challenges with a single integrated system. It allows manufacturers to produce both ampoules and vials on one aseptic filling line, with fast changeovers and full regulatory compliance. As a result, companies can reduce costs, improve productivity, and maintain consistent product quality.
Why a Flexible Combi Filling Line Matters
Modern pharmaceutical production requires flexibility. Companies often need to produce multiple injectable products in varying batch sizes. Using two separate lines for ampoules and vials is inefficient. A combi filling line reduces downtime, simplifies operations, and improves space utilisation.
By switching easily between ampoules and vials, production stays smooth, and contamination risks remain low. This flexibility helps manufacturers respond quickly to market demand without compromising product sterility.
Key Benefits of the Snowbell Combi Filling Line
The Snowbell Combi Filling Line offers several advantages:
- Fast changeovers between ampoule and vial formats without rebuilding the line.
- High precision filling to minimise product loss.
- Compact design that saves cleanroom space while supporting small and large batch production.
- Regulatory compliance with GMP guidelines and 21 CFR Part 11 for data integrity and traceability.
Integrated Design for Maximum Efficiency
The line integrates washing, depyrogenation, filling, sealing, stoppering, and capping into one continuous workflow. This reduces manual handling, minimises contamination risks, and improves production speed.
Its unified design also makes maintenance simpler and operational control more effective. With all critical processes in one line, manufacturers can achieve better consistency and reliability.
Ampoule Filling and Sealing Process
Ampoules are loaded onto a mesh belt conveyor and inverted for thorough internal and external cleaning. The washing process uses recirculated water, compressed air, purified water, and a final WFI rinse to ensure complete sterility.
After washing, ampoules enter a three-zone depyrogenation tunnel. The drying zone removes moisture, the sterilisation zone heats above 350°C to destroy bacteria and pyrogens, and the cooling zone gradually returns ampoules to room temperature.
Filling is highly precise, using syringe pumps with load cell monitoring. Nitrogen flushing removes oxygen from the headspace, protecting sensitive formulations. The “no ampoule, no filling” system prevents dosing errors. Finally, ampoule tips are sealed using controlled flame burners with synchronised rotation, producing uniform, leak-proof seals. Finished ampoules are collected for inspection and packaging.
Vial Filling, Stoppering, and Capping Process
Vials undergo the same cleaning and depyrogenation process as ampoules, ensuring consistent sterility.
After sterilisation, vials are filled with precise volumes. Nitrogen purging is applied for oxygen-sensitive products. Stoppers are automatically loaded via a vibratory bowl feeder and positioned using a pick-and-place mechanism, eliminating human contact and maintaining aseptic conditions.
Next, pre-sterilised caps are applied using automated roller sealing units. The system includes a rejection mechanism to remove improperly stoppered or capped vials. Optional torque monitoring ensures seal quality. Only correctly sealed, high-quality vials proceed to packaging.
Advanced Aseptic Protection with Open RABS
The line includes an Open Restricted Access Barrier System (RABS) made of stainless steel and toughened glass. This system maintains a controlled aseptic environment while allowing operator access through glove ports.
Vertical laminar airflow with HEPA filtration maintains Class 100 cleanroom conditions in critical zones. Door interlocks and safety sensors protect both operators and products, ensuring production remains contamination-free.
Digital Control and Compliance
The line is operated through a modern touchscreen HMI, allowing real-time monitoring of all production parameters. SCADA connectivity, batch data recording, alarm logging, and audit trails ensure complete traceability.
With full compliance to GMP guidelines and 21 CFR Part 11, the Snowbell Combi Line guarantees data integrity and simplifies regulatory inspections.
Applications
This filling and sealing line is suitable for a variety of injectable products, including antibiotics, vaccines, biologics, and critical care drugs. It is ideal for pharmaceutical manufacturers, contract manufacturing organisations (CMOs), and R&D facilities requiring high sterility and flexible production.
Conclusion: A Smart Choice for Injectable Manufacturing
The Snowbell Combi Ampoule and Vial Filling and Sealing Line provides a future-ready solution for injectable production. By combining flexibility, sterility, and regulatory compliance in one integrated system, it reduces downtime, improves productivity, and ensures consistent product quality.
Pharmaceutical companies looking to modernise their injectable production should consider this combi line for a reliable, scalable, and efficient solution.
