Successful Bioreactor Installation: What it Takes - - BioPharm International


Successful Bioreactor Installation: What it Takes

BioPharm International
Volume 19, Issue 8

Defined Project Team Defining roles and responsibilities is critical to maintain order within a project team. It facilitates both task assignments and decision-making. It is also key to establish a single main point of contact for each party. This single point of contact is responsible for ensuring that all required team members are involved in different tasks. The contact is also responsible for ensuring that one part of the team does not unknowingly implement a design change that impacts another part of the design (i.e., a design engineer making a change to the piping on a certain flow path that impacts how a software control function needs to be sequenced).

Detailed Schedule Developing a detailed schedule enables the project team to track the progress of the project and identify critical path tasks. Assigning responsibility for each task and regularly updating percent completions helps a project team address any potential problems on critical path items early on. Any potential negative impacts to the overall project schedule can be mitigated.

Design Review A careful review of all design documents is necessary to guarantee that the system meets all requirements set forth in the URS. Many critical design elements and mundane details can be addressed at this time, such as control system design schemes, fabrication arrangements, and component specifications. The design review is essential in helping to ensure that the system will meet the user's requirements.

Factory Acceptance Testing Design reviews can identify potential problems and initiate solutions, but there is no substitute for hands-on experience and real-life testing of equipment and systems through a FAT. A FAT can reveal flaws in a design that appears perfect on paper. It is always easier to address functional or fabrication issues by testing equipment when it is on site at a manufacturer, before it is shipped to the customer. A thorough factory acceptance test is critical to help make certain that the system performs as the customer requires. The customer should also, be on site, if possible, to witness the factory acceptance testing to ensure the equipment or system meets the customer's satisfaction.

Communication A successful project team is like any other relationship. It is predicated on an open, honest, and constant line of communication. Frequent project meetings and updates are critical to keeping a project moving forward. Many potential miscommunications and misunderstandings can be quickly ironed out, and constant communication keeps both sides of the project team on the same page and working in unison down the same paths to attain a common goal.

Byron A. Spurr is a project engineer at Cytovance Biologics LLC, 840 Research Parkway, Ste. 400, Oklahoma City, OK 73104, Tel 405.319.8310 Fax 405. 319.8339

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