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Vacuum Drum Filling for Balanced Pharma

Case Study

Supporting Balanced pHarma’s path to FDA trials with scalable development equipment

Client: Balanced pHarma
Sector:  Dental Anaesthesia

Our custom automation expertise enables customers to advance product and process innovation across diverse industries. In this project, we partnered with Balanced pHarma to support their FDA trials with scalable development equipment.

 

The Challenge

Balanced Pharma is developing an innovative approach to injectable anesthetics, aiming to improve patient comfort and streamline delivery for dental professionals. As they prepared for FDA clinical trials, they needed a way to produce representative, small-batch products that would accurately mimic future large-scale manufacturing, without the cost or complexity of full automation.

Our Approach

We designed and built a bespoke suite of equipment enabling Balanced Pharma to produce fully representative units of their novel dental cartridge system. The integrated system supports both powder and liquid filling, as well as key assembly and integrity testing steps, all designed to scale seamlessly toward commercial production.

process

Development of the Dental Lidocaine Cartridge Assembly

After the client’s initial enquiry, our team conducted a series of tests on their powder using multiple proprietary technologies. This allowed us to determine the approach that would deliver the best performance. It was discovered that our Vacuum Drum Filler was most suitable.

  • Stage one: Precision Powder Dosing: Accurately and repeatably dose a defined quantity of powder directly into a small, custom-designed container.
  • Stage two: Cap Insertion: Securely insert a simple cap to seal the powder-filled container. The closure design supports both containment and ease of downstream assembly.
  • Stage three: Container-to-Tube Assembly: Assemble the small, sealed container as a stopper at one end of a glass tube. The glass tube matches the dimensions of a standard dental cartridge, ensuring compatibility with existing dental delivery systems.
  • Stage four: Liquid Filling and Stoppering: Fill the glass tube assembly with liquid lidocaine solution under controlled conditions using our Liquid Fill-Finish technology.
  • Stage five: Vacuum Integrity Testing: Conduct deep vacuum testing to confirm Container Closure Integrity (CCI) and long-term stability. The assemblies are validated to withstand low-pressure environments such as those experienced in high-altitude facilities and air freight.

The Final Product

Balanced pHarma now has the capability to produce consistent, trial-ready cartridges that meet regulatory expectations and accurately reflect full-scale production methods. The process and equipment lay the foundation for future FDA-approved, scalable manufacture, helping lower the barrier to commercialisation and ultimately bringing a more efficient and patient-friendly anaesthetic solution to market.

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A Word from the Project Manager:

"A key driver to the success for this project was the fact that we were able to engage from the very early stages; running powder trials that helped shape a specification aligned with the right scale and budget. Rather than relying on existing solutions for our convenience, we were able to support the development of something truly suited to the process and to Balanced pHarma's end goals. As the project evolved, we were also able to provide broader context and advice on regulatory and industry insights, so that our equipment and process would fit seamlessly into the overall manufacturing path. While not always within our formal remit, we were glad to operate as an engineering partner, providing perspective beyond equipment alone." Jake Canner, Project Manager.