The client was a small pharmaceutical company developing a hybrid drug / device product, who needed to scale up their clinical manufacturing operations.
The client had existing automated equipment for two particular manufacturing processes, but was interested in evaluating new and better technologies and methods for next generation equipment. At the same time, the new equipment would need to greatly increase throughput and yield in order to meet future production demands.
The project started with a proof-of-principal phase, wherein CKC Automation partnered with the client to propose and test several innovations to the client’s existing processes. This phase of the project involved technology surveys, design reviews with the client subject matter experts, design and build of multiple proof of principle (POP) machines, and process development on the POP machines. Ultimately, CKC Automation was able to recommend a clear path forward for the design of new production machines that would greatly improve upon the existing manufacturing processes. For the build phase of the project, CKC Automation designed and built an aseptic fill system and an aseptic assembly system. Both systems utilize real-time monitoring of critical process parameters to perform on-the-fly adjustments in response to part variability, thus allowing for optimal control of the process. Both systems employ servo-driven motion axes, pneumatic motion axes, multiple temperature zones, part status tracking, and robust safeguarding.
The two machines were installed in the client’s clinical manufacturing plant and successfully tested for product quality, throughput, and aseptic operation. In addition to the site acceptance test, the machines were put through the client’s equipment validation process, and CKC assisted with the drafting and successful execution of the qualification protocols.