Vacuum Drum Filling | FDA Trials | Scalable Development Equipment | Balanced Pharma

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

Client: Balanced Pharma
Sector: 503A Compounding Pharmacy

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.

Operating as a 503A/B Compounding Pharmacy, their production environment differs from our typical aseptic manufacturing clients. This required a flexible and precise solution that would deliver pharmaceutical-grade performance while fitting the specific needs and regulatory framework of a compounding setting.

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.

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.