Aseptic Powder Fill-Finish Line | Case Study

Aseptic Powder Fill-Finish Line

Install location: Canada

We partnered with a pharma CDMO headquartered in Toronto, Canada, to design and deliver a fully automated, robotic, aseptic powder fill-finish line.

The project formed part of Dalton’s strategic investment in advanced manufacturing technology aimed at increasing production capacity and flexibility while maintaining the highest standards of sterility, compliance and operational efficiency.

The Challenge

The client faced rising demand for its aseptic powder filling services and had reached the limits of its existing capacity. To support growth, they needed a new system that could increase throughput, handle challenging powders, and meet evolving EU GMP Annex 1 requirements, all while fitting into its existing cleanroom without major modifications.

To address these requirements, Dalton identified us as the most suitable equipment provider for the application, based on our extensive experience in designing and delivering advanced aseptic powder and liquid filling systems for the pharmaceutical industry. Working together, the two teams set out to develop a solution that would increase capacity and integrate smoothly into Dalton’s existing facility.

Identifying the right filling technology: Fill2Weight™ Gravimetric Powder Filler

Upon project commencement, engineers from 3P collaborated closely with Dalton to evaluate the most suitable powder filling technology for the application.

We offer a comprehensive selection of aseptic fill-finish equipment and have a strong legacy in pharmaceutical powder filling technologies. Choosing the most suitable technology for each project is critical. Initial feasibility studies with Dalton highlighted the advantages of Fill2Weight Gravimetric technology.

Fill2Weight is one of our core powder filling technologies that ensures each container - vial, syringe, or custom container - receives an exact target weight of product. Unlike volumetric filling, Fill2Weight continuously monitors the actual weight of the container during filling and automatically adjusts the fill to achieve the desired dose weight.

Real-time adjustment: Dynamic feedback during filling ensures consistent results, even with variable powder properties.
Smart dosing algorithm automatically optimises dispensing parameters, ensuring accuracy even with the most challenging powders.
Target dose weights are set directly through an intuitive HMI - no need for complex change parts or time-consuming adjustments.

The Solution

By integrating our Fill2Weight technology into a robotic isolator, we provided Dalton with a fully automated system capable of handling RTU tubs and multiple container formats with exceptional filling accuracy. The solution provides seamless automation, significantly reducing manual handling and the associated risk of contamination, while offering flexible operations that allow quick changeover between vials and syringes without complex adjustments. The solution supports full cGMP compliance, delivering complete traceability and documentation for every filled unit, ensuring consistent quality and adherence to regulatory standards.

Designed as a compact isolator, the system consists of multiple chambers that maintain strict environmental control throughout the filling process. Within this enclosed environment, operations such as filling, stoppering, capping, and crimping are performed automatically, providing a fully contained aseptic workflow. This modular approach allowed the system to be installed in Dalton’s existing cleanroom with minimal site modification. The equipment was purpose-built with modern regulatory expectations in mind, meeting stringent sterility assurance and contamination control requirements and supporting compliance with EU GMP Annex 1.

lid remove

Automated lid removal

The system features automated lid removal for RTU tubs upon entry. As tubs enter the system, lids are automatically removed in a sterile manner. This automation eliminates manual handling, helping to reduce contamination risk.

individualised filling

Individualised containers

Each vial is carefully removed from the nest for individual filling, ensuring 100% quality inspection. Vials are only returned to the nest once all tests are successfully passed, enabling advanced reject management.

powder fil

Aseptic powder filling

Our Fill2Weight Gravimetric Powder Filler is integrated into the system, delivering highly accurate dosing of sterile powder directly into vials.

crimping

Rotary crimping

Integrating our fully configurable, rotary crimping platform to provide 100% stopper compression force verification, ensuring consistent container closure integrity.

asryil

Vision pick and place feeder

Our vision-guided feeder seamlessly handles press/crimp caps & stoppers - eliminating
the need for bowl feeders.

output

Outfeed

Delivering a fully finished RTU tub of vials. The entire process can be adjusted to accommodate syringes if required.

Outcome and Installation

The new robotic fill-finish line will enable Dalton Pharma Services to expand its aseptic powder filling capabilities and support a broader range of client requirements. By combining automation with precise gravimetric dosing technology, the system delivers increased throughput, improved process consistency and enhanced sterility assurance. As a result, Dalton is now better positioned to serve larger global patient populations and respond quickly to growing demand for aseptic pharmaceutical manufacturing services.

Building the system at 3P innovation

Isolator and internal filling technology were designed, manufactured, and fully assembled by the 3P engineering team, on-site in Warwick, UK. Our single source solution provided the client with seamless compatibility between all components, simplified project management and reduced the risk of delay or miscommunication during the build.

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Factory Acceptance Testing (FAT)

Before leaving the 3P innovation facility, the complete system underwent rigorous Factory Acceptance Testing (FAT) on site, validating accuracy, automation, sterility, and compliance with cGMP standards. This thorough testing ensured the system was fully operational and ready for rapid deployment upon arrival.

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Rapid installation in Canada

Innovation isn’t just about advanced automation, it’s about delivering solutions that work fast and reliably in the real world. While many competitors quote installation times of 4–8 weeks, our robotic system for Dalton was installed in just 4 days. Engineered from the ground up for efficiency, the modular, self-contained design allowed the system to be wheeled directly into place with minimal disruption to existing facilities.