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Grifols North Fractionation Facility / Fractionation Expansion

Ojective

Commission the facility, if possible. Break down problem areas into No Impact, Indirect Impact, or Direct Impact.

Services

CAI performed C&Q following evaluation by Risk Assessment of each individual system to evaluate its impact to the product as No Impact, Indirect Impact, or Direct Impact. Commissioning only was performed on No Impact and Indirect Impact systems, and a leveraged commissioning approach was utilized for all Direct Impact Systems. Leveraged commissioning efforts were completed by developing quality approved FAT and Commissioning testing documents to leverage into Qualification documents. Additionally, a family approach to testing was performed on Precipitation Vessels, Centrifuge Piping Skids, and Filter Presses to minimize the workload required to Commission and Qualify the operational features common to all similar pieces of equipment.

Project Success

We implemented lessons learned that we gleaned from a prototype project to tackle the Cleaning Verification phase of the project. This resulted in a more streamlined Cleaning Validation phase. Our use of preformatted report templates resulted in the reduction in the preparation time for the regulatory submissions, which helped keep the project on schedule in spite of equipment delivery delays and documentation issues. We quickly developed an excellent rapport with supporting departments, which is critical to project success. We will develop the same working relationship with your support departments to keep the project schedule on track.

Time Frame

2 Years

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