August 2, 2023

Overview
Grantek was approached by a radioisotope manufacturer to automate their Liquid Waste Management and introduce a Vessel Cleaning System to their radioactive drug manufacturing line. The two main challenges for the client were tight deadlines to submit a New Drug Application with the US Food & Drug Association (FDA) and the need for engineering expertise to translate an on-paper automation system into a production-ready process automation. Based on the results of the development of their Radioactive Drug Manufacturing line, they reached out to Grantek to reduce the time loss by about 6-7 months on their project timeline.

Challenges
The project kicked off with the involvement of Grantek’s experienced engineers who worked with the client to break down the process and understand their requirements. Grantek’s engineering depth and expertise in pharmaceutical process automation came into play by providing valuable input during meetings, and assisting the client’s process engineers to convert their process into automation-friendly documents, staying within the periphery of industry standards.

Respecting the timeline constraint, we used the depth of our engineering department to pull together a larger team of programmers to work towards writing the code to convert the documented automation sequence into executable software. During the same time, COVID-19 was shutting down various facilities and creating a constraint on the supply chain for the hardware to be procured for the project; Grantek supported the client with expertise to coordinate with different trades and various vendor teams by filling out engineering gaps to coordinate on-floor activities such as IO installation, emergency stop verification, and calibrating the analog devices to be able to move past challenges by either communicating to the concerned individual or resolving them on the fly and achieve a mammoth task of hardware installation.

The ultimate challenge was to complete the commissioning and testing of the system and hand it over to the client to be able to use it for testing their processes before the New Drug Application submission to the FDA. Testing was successful and both systems were delivered with sufficient documentation, this was used by the client as they continued with the FDA submission process.

Conclusion
As a result of this effort, Grantek was awarded the project to begin expansion of these systems and assist the client towards continuous improvement of these processes. Despite the challenges of this project, efficient and honest communication was used in pursuit of a reliable solution.