Design, build and qualification of a new and fully automated assembly line for medical devices
Our client – a molecular diagnostics company developing highly innovative oncology molecular diagnostic solutions – wanted to install a new manufacturing line that is compliant with all GMP requirements to enable worldwide supply of their product. Agidens Life Sciences took on the challenge, what resulted in a manufacturing line that is now capable of supplying up to 5 times the company’s initial capacity.
The challenge that our customer faced is one that many companies have while introducing a new product or process. The number of units in the supply chain needs to multiply with the market demand of the product. The number of variables in this introduction process makes it complex and requires skills, experience and enough manpower to make it happen.
The design and build of a new manufacturing line is always challenging, as clients want a balance between state-of-the-art and proven technology. Agidens offers both: proven technology as we helped eliminate the issues from the existing line in the past, and innovative as we have the people that bring fresh ideas to the design and engineering. Key players at the customer already worked with Agidens and had experienced Agidens’ capability of providing practical solutions in an earlier project resulting in an improvement of the performance of the existing manufacturing line, using V-model, Six Sigma and Lean methods. This was a solid base to involve Agidens in the design, build and start-up phase of the new manufacturing line.
The other challenges our client faced were Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), all in line with the various GMP requirements to enable worldwide supply of the product. Here too, Agidens could demonstrate know-how, experience and drive to get the desired results within the proposed time frame and budget.
- To attain an optimal process window and tune the manufacturing equipment with DOE methods (Design of Experiment) for processes with many variables.
- To combine this with a risk-based product FMEA to identify the most critical processes and potential risks.
Fine tuning and qualification of the manufacturing line was the main challenge during the project. Various parts of the processes needed tuning to reach desired product quality and equally important quantity to fully supply the worldwide demand in a compliant and qualified manner.
Implementation of the solution
- By translating the existing product FMEA into a process FMEA, Agidens Life Sciences identified where processes could possibly fail, and set up validation and test plans for both Installation Qualification and Operational Qualification.
- Extensive structured testing of the equipment according to risk-based protocols guarantee that only qualitative products are released to the market.
- By teaching IPCs (Inline Process Controls), we learned the machines to be self-checking for possible product quality deviations. The testing of these controls was done in Operational Qualification.
Final result and next steps
The new manufacturing line at our client is now capable of supplying up to 5 times the output of the first manufacturing line in a worldwide market in the medical devices sector, with very strict regulations.
In the near future, more product configurations (Assays) will be transferred to or developed on the new manufacturing line: a challenging new project that Agidens is invited to take a role in.