Achieving Licensing for a Healthcare Solution

Achieving Licensing for a Healthcare Solution

This case study highlights a successful collaboration between 3P innovation and a leading supplier of unlicensed medicines.

The Client

The client sought to obtain regulatory licensing for their product and required a bespoke machine capable of accurately dosing three distinct powders into a PET bottle. Precision was paramount, ensuring each bottle was filled with accuracy while adhering to stringent regulatory requirements, including compliance with 21 CFR Part 11 for batch record-keeping.

Faced with the complexities of handling highly cohesive powders, the client engaged 3P innovation to develop a tailored solution. They were particularly impressed by our proactive approach, including initial feasibility trials to de-risk the project and validate the technical viability of our proposed solution.

The Solution

3P innovation identified the Vibratory Feeding technology as the most optimal filling method for this application. This technology enables gentle powder handling without compaction, ensuring precise, repeatable filling with adjustable flow rates. The existing technology aligned seamlessly with the client's requirements, successfully handling exceptionally cohesive powders while maintaining dosing accuracy and efficiency.

The solution delivered a transformative improvement in operational efficiency, filling one bottle every 25 seconds. Previously, the client required three operators per day to fill 300 bottles manually. Following implementation, a single operator could efficiently fill 800 bottles per day, significantly reducing labour costs and enhancing productivity.