fill-finish-design

Behind-the-scenes of fill-finish design published in Pharma Manufacturing

May 7, 2020

CRB’s Lisa Dorn was featured in Pharma Manufacturing’s column, Engineering Angles. The piece, “Behind-the-scenes of fill-finish design,” discusses how understanding the design process and using modeling tools early in the process can help to address potential risks for optimal manufacturing.

Lisa identifies two tools that, if used early on, allow project teams a variety of approaches to keep operators safe and maintain product purity for the patients who need these medicines (excerpts below).

Computational fluid dynamics

Many times, computational fluid dynamics (CFD) modeling is used to simulate air streams over critical process areas such as the point of fill and open formulations operations. Modeling is performed to evaluate air flow and ensure a uniform, downward directional flow as well as identify any undesirable eddies within the space. Ideally, any air that could hit the floor and come back up should be eliminated, as it could lead to product contamination. This technology can also help engineers recommend table placement and the location of personnel within the room, and identify if their location results in turbulence. Adjusting the position of the table and directing the air to move away from any personnel is preferable and will help reduce contamination risks.

CFD is also instrumental in determining the most ideal placement of low wall return air ducts within the fill-finish area. Performing CFD during design helps predict the results of the “air flow visualization” i.e. smoke test, which is performed after installation to show unidirectional air flow. This is essential when engaging with regulatory agencies for qualification and commissioning the facility for a Grade A area. Environmental monitoring is key in fill-finish and understanding air flow is vital to ensure adherence to FDA and EMEA regulations.

Revit 3D Building Information Modeling

Another important tool for design optimization and risk reduction is Revit 3D Building Information Modeling (BIM) software. Through visualization and lean design principles, Revit helps to display any areas that could be easily overlooked, such as a common task performed by personnel where they may hit their head, or a piece of equipment that should be moved to allow for easier access. Recognizing these unanticipated situations early in the planning reduces manufacturing risks and costly design errors.

Engineering Angles: Behind-the-scenes of fill-finish design (full article)