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Please use this identifier to cite or link to this item: http://hdl.handle.net/1860/1324

Title: Proposal submission: filter integrity testing for pfizer global manufacturing
Authors: Hockman, George
Hunking, Josh
Stablum, Jason
Ziedonis, Adam
Issue Date: 26-Mar-2007
Abstract: A project is currently underway at Pfizer Global Manufacturing’s Lititz, PA facility to upgrade the raw materials storage and delivery systems to support increased product output. Included in this project is the incorporation of multiple Rigimesh® filtration systems (manufactured by Pall Corporation) into the raw materials delivery lines. Existing Rigimesh® filtration systems are currently installed within the Listerine® finished product delivery lines. The economic losses associated with the installation of inadequately cleaned filters have led to the need for more accurate integrity testing. There is a desire to perform in-house integrity testing to ensure both the achievement of proper cleaning and specified filter performance. At present there is no readily available, method of testing units in existence for immediate purchase by pharmaceutical companies. With no standard equipment or procedures in use, data collected from different vendors is not comparable. Designing and building an inhouse testing unit for Pfizer Global Manufacturing will allow for the development of standard testing procedures and will ensure compliance with all applicable federal regulations. The specific deliverables of this design project will be the development of the bubblepoint test bed (Figure C1) and the forward flow test bed (Figure C2) to test the integrity of the filter elements. These two test beds will provide the necessary technology and procedures to establish the largest filter pore size (bubblepoint tests) and the filter element filtration efficiency (forward flow test) for each individual filter element. The main element of engineering design utilized in this project will be the application of fluid dynamics principles. Both the bubblepoint test bed (Figure C1) and the forward flow test bed (Figure C2) will rely on these principles for proper operation and accurate testing. A ten-year present worth economic analysis was performed, comparing the cost due to our testing with Pfizer’s current cost to have the filters shipped and vendor tested. Total savings over the conservative ten-year period amounted to almost $200,000 (see Table E1). Additionally, Pfizer has quoted us the cost of one day of downtime at $1,000,000. Our testing system is designed with the intention of preventing such downtime inefficiencies.
URI: http://hdl.handle.net/1860/1324
Appears in Collections:Senior Design Projects (COE)

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