In a competitive market, companies are looking for an edge wherever it can be found. Pharmaceutical companies are always being challenged to do more with less. Whether that is increased production, improved cost of goods, lower capital costs of projects, or speedier execution, they all need to be looked at as opportunities to optimize. 

As companies begin their facility design effort, it is important to start with a fundamental understanding of their process needs. In part, this information is derived from business side team members who skillfully calculate and project the size of the market for a product and predict the percentage of the population that will end up needing and ultimately using the medication over current and/or future competing treatments.

These projections allow the business to have input to ensure a proposed facility will meet demand. Clinical trials help to predict the amount of API per dose required and with these inputs initially predicted, the design effort can begin. Properly executed process modeling can assist companies to hone in on these requirements and even select the appropriate technology.

During feasibility, the goal is to develop data supporting the potential scale and amount of space required. In order to assess that, high-level design decisions should be discussed. Questions such as:

• Single Use or Stainless Steel
• Batch or Continuous operations
• Buffer/media makeup or purchase
• 1X or buffer/media concentrates
• Size or quantity of key equipment

A preliminary scheduling model (SchedulePro® as an example) can help provide guidance on some of these design decisions quickly.

It can help optimize the number of batches, the batches sizes and provide a sense of time and utilization of the equipment.  It can give guidance on the raw material strategy and potential benefit of utilizing 1X, buffer concentrates or perhaps even sourcing buffer and media (1X or greater) from a third party. It can help to clarify the wisdom of Single Use or Stainless Steel operating vessels for different unit operations. A standard block flow diagram can be easily produced from this information. This information can be crucial when looking at a high-level ROI on the investment.

As the project progresses into concept phase the granularity of the decisions should increase. It is important to develop an understanding of the material balance and flows as the facility design comes together. Some key information should be:

• Overall Critical Utility Consumption
• Unit Operation locations (adjacencies)
• Process Flow
• Material and Energy Balances
• Waste generation
• CIP skid count

Depending on the complexity of the process, a more detailed scheduling model can begin to track the raw material inputs for each step. If more rigorous knowledge is desired or if the project intends to move to a Basis of Design (BOD), this should be accomplished utilizing process modeling software (SuperPro® as an example). Process models have the advantage of containing more complex mass tracking tools.

It also produces simulations for production over extended time frames. These simulations may show spikes in usage or consumption that could otherwise be overlooked by normal analysis methods. It will also generate equipment utilization data which can be used as a basis for debottlenecking on key equipment.

When the project moves into BOD, the detail of key decisions should increase. It is important to have a detailed understanding of the material balances and flows. The goal of the model should be to produce an example of how the facility could operate on a day to day basis. Though limitations exist, some important information that can be derived is:

• Detailed operational analysis (equipment and personnel)
• CIP skid utilization and assignment
• Transfer line usage
• Utility Diversity

At the end of P&ID and BOD development, a detailed process model can help give insight into personnel, utility usage rates as well as transfer line usage and design. It can help provide a wealth of information for a detailed operational expenses discussion and overall reduce risk.

Schedule and process modeling can be a valuable addition to different design phases. As a result, the final product generated by these designs can better account for all the variables that impact design. To pharmaceutical companies striving to optimize their designs, an engineering firm wielding these tools correctly can be a strong partner.

(Source: IPS – Integrated Project Services, LLC)