Vendor Innovation - new technologies in practice
Technologies by themselves rarely provide a business advantage in a manufacturing setting. Manufacturing is inherently complex and therefore the use of technology typically is very complicated and risky. This is even more evident in a regulated environment where introduction of new technologies require extensive testing and robustness. That is why when evaluation new technological advances the benefits have to be evaluated based on a sound technology architecture that is rooted in the business drivers. With that in mind we can take a look at some very interesting innovations and technologies that with the right implementation can provide substantial business value.
Now we have to challenge our industry to take the leap to see if we can move the productivity, quality and flexibility needle.
Customer benefits of using building information modelling
The key principle is that BIM is not any single act or process. It is not creating a 3D model in isolation from others or utilizing computer-based fabrication. It is being aware of the information needs of others as you undertake your part of the process.
A BIM model can contain information/data on design, construction, logistics, operation, maintenance, budgets, schedules and much more. The information contained within BIM enables richer analysis than traditional processes. Information created in one phase can be passed to the next for further development and reuse.
Concurrent engineering – breaking down the silos
Engineering and design of a pharmaceutical facility requires extensive collaboration and communication between many engineering disciplines. Yet in the pharma industry, it is still common practice to engineer and design in disciplinary silos. This reduces the effectiveness of the project team due to silo communication, misalignment of deliverables\ approach, and lack of cohesiveness. Leading to increased cost and timelines.
Concurrent engineering sometimes also called Integrated Design presents a method in which engineering activities are performed in parallel with simultaneous activities leading to a higher quality process design and a more effective engineering process. The benefits include the ability to achieve specific design goals such as flexibility, decreased project timelines through parallel activities, integrated project quality, effective and efficient qualification, reduced project cost, and much more.
Risk-based conceptual design delivery
The regulatory focus of facilities that manufacture therapeutic products for humans is centered on a product-process-facility attribute driven methodology where risk identification and mitigation are critical quality attributes. Under this methodology, the manufacturing process and the product requirements, not the building, become not only the main drivers for CD efforts, but must also provide a clear approach and understanding of how the building elements must be defined and operated in order to ensure patient safety in the manufacture of the product. This requires an enterprise approach to facility design focusing on:
- Process-driven understanding around operational analysis
- Regulatory philosophy
- Business drivers
- Management needs
- Integrated handoff to detailed design activities