Smart Combo Filling System

The global pharmaceutical is going significant with the advent of new parenteral products, small batch personalized therapies, and high value drugs for small patient populations. There is a formidable challenge to bring these drugs to market fast as well as keeping costs under control. Ready-to-use (RTU) packaging with the features of pre-sterilized / pre-treated container-closure systems, which can bring the benefits in product safety, filling efficiency and flexibility in small-batch production, are becoming a promising alternative to conventional bulk primary packaging.

However, the pharmaceutical and biopharmaceutical companies face the challenges of batch sizes continue to dwindle and flexibility in fill-and-finish. While the pharmaceutical machinery solution providers have developed innovative and flexible multi-format Ready-to-Use (RTU) filling line system to address the challenges of changeovers among multi-format containers.

The multi-format filling line system has combined manufacturing process that allows multiple container formats to be filled and finished on a single system. However, it usually integrates with high degree of automation but larger footprint relatively. And if the production system is equipped with full containment isolator, the purchasing cost will be much higher as well as with much bigger footprint in the clean room.

And if the production system with smaller footprint, it will be simple function and low degree of automation, or without the key functions, such as fillers without the function of 100% In-Process-Control (IPC)

As some emerging biopharma companies have launched projects filling an increasing number of drugs themselves, at the same time, the share of drug filling operations being outsourced to C(D)MOs keep increasing; and the larger C(D)MOs have embraced smaller clinical trial fills; and big pharma has encountered batch sizes continuing to dwindle and flexibility in fill-and-finish. All these trends and challenges are gearing the focus to flexible filling equipment for small batches with high degree of automation and fast changeovers among different containers, while can save much cost as well as be in compliance with relevant regulations.

Tofflon have developed Smart Combo Filing line, which can fully meet the requests mentioned above.

High Flexibility

One filling line can be capable of filling multiple container formats & sizes on a single modular platform, which can bring benefits of less footprint in clean room and less maintenance cost. Tofflon Smart Combo Filing line can fill different RTU container sizes from 0.2—50ml including PFS/RTU Vials/RTU Cartridges

Smaller Footprint

Usually, a conventional Combo filling line occupy 6-10 m2 in the clean room while the footprint of Tofflon Smart Combo Filing line is only 1/4 - 1/2 of the Combo filling line. It means that there is much smaller clean room, less energy consumption in operation, shorter sterilization times, and lower engineering costs.

High Integration

With the use of robotic system and compact design, Tofflon Smart Combo Filing line integrates all the processes of debagging, de-lid& de-liner, filling ,stoppering , de-nesting, and capping in a single system. This system can incorporate an IPC statistic check weighing unit as well.

High Automation and Aseptic Assurance

Robotic system integration into the filling line process offers reliable repeatability of the movements while carefully manipulating the nest and vials, which is essential to reduce particle generation, air disturbance and unexpected vial shaking.

With the integration of the RABS/isolator, the robotic arm offers a safe and clean operation under the aseptic environment, avoiding the potential contamination generated by human intervention during tub transfer and lid&liner removal.

Multi-filling Systems Integration

Tofflon Smart Combo Filler has integrated versatile filling systems (peristaltic pump, piston pump, time-pressure) to cater to different selection of filling methods based on different process for different products (such as high viscous product, low viscous product, small dose, etc.) in containment area (RABS/Isolator)

Tofflon Smart Combo Filler can integrate with single use filling system to avoid tedious cleaning and validation of components which directly contact with drugs. It is much suitable for biologics, due to the high cost of cleaning and validation during the production.

Integration of IPC

Tofflon Smart Combo Filler can incorporate an in-process control(IPC) statistic weight checking unit to improve the quality of filling.

Minimize Liquid Loss

As the high value of biologics, Tofflon Smart Combo Filler incorporate innovative filling method to minimize the liquid loss. Especially, at the start of the production , with the removal of the air in the tube to ensure the precise filling volume ; at the end of the production , with the removal of the air in the tube to ensure the last drop of liquid to be filled. During the production , the filling system is incorporated with sampling in-process control(IPC)or 100% in-process control(IPC) to ensure the precise filling accuracy of each filling dose.

Versatile Plunger/Stoppering Methods

For prefilled syringes, usually after filling, the plunger is done mechanically, that is, plunger is performed through a guide tube to seal the syringe. With the boom of biologics development, rubber-coated plungers are the ideal solution for sensitive drugs in prefilled syringe applications. Vacuum technology offers an alternative: vacuum is created inside the syringe, followed by the addition of rubber-coated plungers, which is inserted into the syringe by a pressure differential (Figure 5).

For cartridges and vials, due to their own rubber stoppers and different container sizes, Tofflon Smart Combo Filling system also has different stoppering configuration.

Conclusion

Tofflon's Smart Combo Filling System is the innovative solution offering a flexible, compact, and highly automated solution, it addresses the evolving needs of the industry, ensuring that high-value drugs can be produced efficiently and safely, in compliance with the most stringent regulations. This system is not just a step forward; it is a leap towards the future of pharmaceutical production.