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.
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 that uses on an agile approach adds value at every stage.
Insights & stories to share
With the milestone secured, focus immediately turned to reaching the market as soon as possible. However, a stringent quality focus was also needed to minimize the risk of any setbacks or delays due to incorrect product quality.
Our proposal was based on an integrated agile approach that would allow us to work closely with the customer from an early phase.
Focus also included early identification of key value-adding activities (e.g. standardization and achieving correct levels for applications, documentation and validation).
Key successes delivered during the project included:
- A Benefits and Value Management approach from the outset – reducing risk and enabling the project to quickly start generating value.
- Gaining early acceptance of a standard solution – reducing the time and cost for development, documentation and validation.
- Building a copy of the system for test and simulation – allowing errors to be picked up early, the final result to be visualised at an early stage, and enabling operators to be trained in the simulator while the solution was still under development.
- A smart, integrated engineering and documentation system – helping to reduce the scope for errors and shortening development time from idea to final factory.
- A close, articulated and well-established collaboration between the customer, validation and technical aspects – minimizing project time and ensuring fewer deviations.
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Business Area Manager, Process Technology
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