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Proposal submission: filter integrity testing for pfizer global manufacturing
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|Title: ||Proposal submission: filter integrity testing for pfizer global manufacturing|
|Authors: ||Hockman, George|
|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.|
|Appears in Collections:||Senior Design Projects (COE)|
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