Whether you’re manufacturing an active pharmaceutical ingredient, an OSD (oral solid dose), a biopharmaceutical or a MedTech product, developing an effective production process is central to successful operations.
When designing a new production line, or upgrading an existing one, there are many aspects to consider and selections to be made, for example: incorporation of new techniques; complying with current and future regulations; the need for flexibility and capacity, and introducing higher levels of automation. There are also overriding project goals, including budgets and time to market, etc.
To ensure your investment delivers sustainable value it is essential to start with INSIGHT. Building a complete picture, including people, processes and solutions, helps to unify stakeholders around a shared vision and prepares your organization for change – so everyone understands the goals and is committed to achieving them.
Three development phases
At the design phase, there are three stages that will determine the success of your project.
- The first is to define “HOW to do it”. The Conceptual Design phase is crucial to creating an efficient project and minimizing the risk for delay and additional costs. Spending a few more hours in this phase can lead to significant savings later on.
- Once the design is “locked” focus switches to driving the project according to the time schedule and budget. Project management is, of course, important, but success can only be achieved with full support from the rest of the team. That means always having the right skills available at the right time.
- Finally, you need to make sure everything is working according to the project’s specifications. Commissioning and qualification of equipment, media, facilities and computerized systems need to be carried out effectively to ensure you deliver a fully validated and reliable process.
By taking an agile project approach, each stage adds successive levels of value. The final solution becomes a platform that can be maintained over time, supports continual improvement and delivers long-term sustainable value.
A process engineering project based on an agile approach adds value at every stage.