filter integrity testing for pfizer global manufacturing

Transcription

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PROPOSAL SUBMISSION:
FILTER INTEGRITY TESTING
FOR PFIZER GLOBAL MANUFACTURING
Submitted to:
Timothy A. Kuhn, Project Engineering Manager, Project Co-Advisor
Dr. Mun Choi, Project Academic Advisor
MEM Senior Design Team 12:
George Hockman
Josh Hunking
Jason Stablum
Adam Ziedonis
Department of Mechanical Engineering and Mechanics
Fall AY 2003-2004
Submitted Monday, November 24th, 2003, 6:00 p.m.
MEM Sr. Design Team 12
Fall Term AY 2003-2004
11/24/2003
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.
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TABLE OF CONTENTS
Introduction
1
Problem Background
1
Problem Statement
2
Constraints on the Solution
2
Statements of Work
3
Methods of Solution
3
Alternative Solutions
5
Project Management Timeline
6
Economic Analysis
8
Societal and Environmental Impact Analysis
9
References
10
TABLE OF FIGURES
Figure C1: Proposed Forward Flow Test Schematic…….……………………………………...C1
Figure C2: Proposed Bubble Point Test Schematic……………………………………………..C1
TABLE OF TABLES
Table D1: Filter System Economic Data…….……………………………………
D1
Table D2: Forward Flow Economic Data……………………………………………………….D2
Table D3: Forward Flow Economic Data (cont.)……………………………………………….D3
Table D4: Bubble Point Test Economic Data…………………………………………………...D4
Table E1: Present Worth Economic Analysis…………………………………………………...E1
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INTRODUCTION
Problem Background
Pfizer Global Manufacturing located in Lititz, PA produces 98% of the world’s
Listerine® mouthwash and many other consumer health care products. Raw materials used
during production include: alcohol, n-propanol, mineral oil, glycerin, and sorbitol. It is
imperative that these raw materials are introduced at their highest quality and are maintained at
that level throughout the production process. Large storage tanks supply the various production
lines with the required raw materials. In order to retain the high quality of the materials, various
filtration systems are installed within the piping network. These filters serve to remove any solid
contaminants, larger than 25 microns present within the raw materials. The filters currently
installed within the Listerine® finished product lines serve to remove any solid contaminants
present within the raw materials. The removed contaminants, ranging from gasket material to
various unknown particles entering the material during manufacturing or delivery, become
retained within the filter element. The accumulation of the contaminants reduces filter efficiency
and ultimately leads to replacement of the filter.
Initially, Pfizer’s filter elements were manufactured from polypropylene and were single
use elements. A business decision was made to replace these elements with a reusable element.
Investigating several potential retrofits, Pall Corporation’s Rigimesh® filter elements were
chosen as the best possible replacement. The Rigimesh® filters consist of a tightly woven wire
mesh manufactured from sintered 316L/316 stainless steel. The wires are sintered within a high
temperature vacuum furnace and bonded at each woven connection to create an extremely strong
metallic medium. This manufacturing process was designed so that the wires would not shift
under stress, thus maintaining pore size and continuous integrity. By adjusting the tightness of
the weave, different filtration levels can be reached.
A project is currently underway at the Lititz facility to upgrade the raw materials storage
and delivery systems. Included in this project is the incorporation of multiple Rigimesh®
filtration systems into the raw materials delivery lines. Several hundred of these filter elements
are currently in use in the plant, and the number is about to increase with the addition of the new
systems in the raw materials lines. The cost of the Rigimesh® filtration system is based on the
number of filter elements per system, which determines the filter housing size. The filtration
system cost ranges from $3960 - $6600. In addition to the initial cost of each system, periodic
cleaning and integrity testing of the filter elements are required.
Currently, Pfizer ships these Rigimesh® filter elements to outside vendors for cleaning
and integrity testing. Integrity testing validates whether or not the proper filtration level can be
attained, and is performed by two different vendors. The cleaning is performed by only one
outside vendor, and is sufficient to remove all contaminants – although some degradation
eventually occurs within the filter elements. The accuracy of the integrity testing utilized by the
two vendors is questionable, because both vendors routinely give different results, and do not
account for individual filter element traceability. In addition, several incidences have occurred
where a cleaned filter has been placed back into operation and reached its performance limit
within several days. This is due to the lack of knowledge regarding filter performance after
cleaning. Immediately following these occurrences the questionable filter elements are returned
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to the vendor for one or more subsequent cleanings. The inability to properly trace the filter
elements through their successive cleanings results in the potential misplacement of degraded
filters back into plant operation. A few of the negative consequences from the filter degradation
include lost profits resulting from an increase in production interruptions, and increased
downtime due to the frequent filter element changes. In-house Rigimesh® filter testing will
provide Pfizer with an economical method for perfoming a traceable, repeatable testing process
while confirming that specified filter pore size is maintained, and will also ensure adequate filter
cleaning ultimately decreasing any potential downtime for unscheduled filter maintenance.
Problem Statement
The economic loss associated with the installation of inadequately cleaned filters has led
to the need for more accurate post-cleaning integrity testing. There is a desire to perform inhouse integrity testing to ensure both the achievement of proper cleaning and filter performance
at its specified level.
Currently there is no readily available, method of testing units in existence for immediate
purchase by pharmaceutical companies. Integrity testing is currently performed by vendors who
have manufactured their own units capable of performing the required testing at a limited level
useful for Pfizer’s application. With no standard equipment or procedures in use, data collected
from different vendors is not accurately comparable. In order to meet stringent industry
standards, it is imperative that any testing equipment be repeatable and accurate and that the
testing process achieves NIST 1 (National Institute of Standards and Technology) traceability,
ensuring that all equipment is properly calibrated and provides accurate results.
Designing and building an in-house testing unit for Pfizer Global Manufacturing will
allow for the development of standard testing procedures and will ensure compliance with all
applicable best practices. By utilizing a standard test, it will be possible for Pfizer to determine
the condition of each filter through a comparison of post-cleaning testing values to the values
obtained during initial testing when the filters arrive on site. This will allow for early detection
of any loss of integrity of the element, thus reducing production downtime or possible product
release holds.
Constraints on the Solution
Solution constraints will be further identified as the project continues to progress. Due to
the well defined project scope and the procurement of the components needed to construct the
test systems, the constraints are difficult to identify. Also, Pfizer is procuring the project with
the intent of implementing the systems into operation within the facility. Therefore, there are no
visible purchasing constraints within the solution. The only identifiable constraint for the
solution will be the lead times for delivery of some of the necessary equipment. The lead times
are the only factors outside of the control of this design group. Specific pharmaceutical codes
1
NIST (http://www.nist.gov/) is an agency of the Department of Commerce. As such, NIST has the responsibility
"to develop, maintain and retain custody of the national standards of measurement, and to provide the means and
methods for making measurements consistent with those standards; to assure the compatibility of United States
national measurement standards with those standards; and to assure the compatibility of United States national
measurement standards with those of other nations." [15 U.S.C. 271] The job of NIST is twofold: to ensure U.S.
national standards are accurate realizations of the SI units and to transfer the values of those standards to the U.S.
measurement system through calibrations and other types of measurement services.
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and requirements as published by ASTM, (American Standards for Testing and Materials),
ASME BPE (American Society of Mechanical Engineers Bioprocessing Equipment) and NIST
will be provided by Pfizer to insure all requirements are met.
Guidelines as published by ASTM, (American Standards for Testing and Materials),
ASME (American Society of Mechanical Engineers) and NIST, will also be heavily researched
in efforts to develop the project under established standards. Pharmaceutical companies, filter
Guidelines as published by ASTM, (American Standards for Testing and Materials), ASME
(American Society of Mechanical Engineers) and NIST, will also be heavily researched in efforts
to develop the project under established standards.
Pharmaceutical companies, filter
manufacturing companies, and the ISPE may also be additional resources used during the
progression of this project.
STATEMENTS OF WORK
Methods of Solution
The assembled team proposes to provide analysis and design of two testing systems that
will produce integrity results regarding both pore size and overall performance efficiency of
PALL Rigimesh® Filters: the “bubblepoint” test (see Figure C1) and the “forward flow” test
(See Figure C2). These systems will present Pfizer with a cost savings of almost $200,000 over
the initial ten-year life of the testbeds by eliminating redundant filter element cleaning;
establishing reproducible filter integrity testing procedures compliant with industry standards;
and delivering NIST traceable testing results. Pfizer will gain the ability to track the test history
of each filter element all the way from the initial purchase until the filter is no longer able to
perform to its specifications, which will be determined from the testing. This will provide Pfizer
with assurance that the filter test data meets NIST traceability throughout the entire life of the
filter. The elimination of redundant cleaning requirements will also decrease Pfizer’s operation
downtime, providing for a more maintained, efficient operation that will ultimately increase
Listerine® production.
The specific deliverables will be the development of the bubblepoint test bed (Figure C1)
and the forward flow test bed (Figure C2). 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. Both the
bubblepoint and forward flow testing system design packages include P&ID (piping
instrumentation and diagram) test schematics (Appendix C), full-up system component part lists
including a general price listing (Appendix D), a project timeline, and an economic analysis
including the proposed savings resulting from the ability of Pfizer to test Rigimesh® filters inhouse. All system calculations – such as pump sizing, pipe lengths upstream and downstream of
the forward flow filter housing, rotameter correction factor2, and system pressure drop
minimization – will be included with the design. The design package will be submitted to Pfizer,
and once approved the testing systems will be machined and assembled at Pfizer’s Lititz, PA
plant. Upon assembly, initial Rigimesh® filter testing will be performed on site and the acquired
test data will be compared with the filter design specifications as well as the researched test data
2
Rotameter correction factor is based on the atmospheric pressure reading during instrument calibration, the
operating atmospheric pressure, and the system operating pressure.
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trending for similar delta P (forward flow) and pore size (bubblepoint) testing concepts.
Establishing valid, verified filter integrity results will provide filter elements in which the
filtration performance efficiency will be traceable at all times whether after the initial
manufacturing or after any of the cleaning processes.
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 (FigureC2) will rely on these principles for proper operation and accurate testing. The major
applications of fluid dynamics will involve sizing of the centrifugal pump to be used in the
forward flow testing system. The pump will be sized according to the expected system pressure
drop, which will be calculated after the system design is completed. By accounting for the
pressure drop and desired flow rate, the proper motor and pump size can be selected.
Other main components of the forward flow test will include the stainless steel piping,
centrifugal pump, valves, fittings, gauges, the filter housing, differential pressure sensors coupled
with high accuracy transmitters, and the working-fluid (de-ionized water) containment vessel.
The MAWP (maximum allowable working pressure) of the installed valves, fittings and sensors
will be determined and documented so as to ensure testing traceability. MAWP’s for the filter
housing and containment vessel will also be important in the system design, and this data will be
readily available. A small variable frequency drive may be added to adjust the flow rate of the
pump and to generate a differential pressure vs. flow rate plot for each filter. The major design
consideration for the forward flow test will lie in the operating ranges for the differential
pressure gauges that will be used. Highly sensitive differential pressure gauges that give more
accurate test results will be required for brand new filters as well as the relatively new,
thoroughly cleaned filter meshes. Older, more occluded filter meshes will exhibit a higher delta
P and will not require such sensitive pressure readings. The delta P test results will be critical for
determining the efficiency level of the Rigimesh® filtration media.
Engineering design of the bubblepoint tester will require parameter adjustments including
the sizes of air compressor, a pressure reducing valve, pressure regulators, flow rotameter,
throttling valve, water manometer, flex hose, rubber stoppers, and a tank to house mounted, 20”length Rigimesh® filters. The bubblepoint test bed will support two types of testing: “first
bubble,” and “open bubble.” For the testing process, each filter element will be horizontally
mounted and immersed in an open tank full of denatured ethyl alcohol to achieve adequate
surface tension against the filter mesh. In the “first bubble” test compressed air flow will be
applied to the immersed filter, and the air flow will be adjusted until visual inspection of the
filter bath reveals the first air bubble released from the filter pore, at which time the manometer
water level height must be recorded. There is a direct correlation between first bubble pressure
and the largest filter pore size. Denatured ethyl alcohol or an equivalent fluid surface tension
plays a key role, and must be accounted for as well. “Open bubble” testing will involve a
constant air flow through the filter, and the manometer water level height will be recorded for the
fixed flow rate.
Minimizing the system pressure drop will be a crucial aspect of the system design,
including minimizing the amount of flex hose used to connect the air compressor to the filter
inlet. In particular, all lines and connections after the water manometer need to avoid any
restrictions – usual problem areas occur at quick disconnects. In our bubblepoint testing
configuration, quick disconnects will occur where the flex hose plugs into the system piping, and
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the tube at the end of the flex hose that fits through the stopper for sealing into the filter element.
Material selection for the rubber stoppers, tubing, and especially the test bed will also be
important. These material components must either have the ability to withstand denatured ethyl
alcohol or an equivalent fluid, or be surface treated as such. Bubblepoint testing components
will not experience pressures greater then 40 PSIG from the compressor (due to the built-in
redundancy of the pressure reducing valve). Therefore, engineering judgement eliminates the
need for any type of advanced stress analysis or finite element analysis on the system.
Alternative Solutions
Alternative filter integrity testing solutions include both a brief overview of similar
testing systems that exist in the pharmaceutical industry, and also any alternative designs for our
specific deliverables. Research of pharmaceutical filter integrity testing processes has shown
that there exists two general testing means: determination of filter pore size, and validation of
acceptable pressure drop across the filter. All testing methods have been found to utilize the
applications of fluid dynamic principles. Most of the existent filter testing is performed by filter
manufacturing companies, such as Pall Corporation and Millipore. These tests are all similar in
principle, and all are purpose-designed for testing to specific operating environments. Many of
the testing systems have not been patented, and are simply built by a filter manufacturer to
support pharmaceutical testing validation requirements.
In order to gain firsthand knowledge of such testing processes, our design team
coordinated a visit to Pall Corporation in Cortland, New York on November 18, 2003 and met
with a project engineer. Pfizer has a well established working relationship with Pall Corporation
due to their large demand for filter use inside their pharmaceutical plant. Our team met with a
Senior Engineering Manager of Industrial Process Filters, including the Rigimesh® filters. We
were able to enhance our understanding of the Rigimesh® filter properties through an overview
of the Rigimesh® filters technical design specification data, which will be critical in our test data
analysis. We were also able to witness some filter testing demonstrations. Some examples of
Pall Corporation’s current testing processes for sterile gas filters include: aerosol penetration,
diffusive flow, water intrusion, pressure drop test, and the multipoint diffusion test. Aerosol
penetration tests measure the penetration of aerosolized particles (NaCl) or droplets of oil (such
as general mineral/vegetable oils). The diffusive flow test measures nitrogen flow through a
membrane wetted with the appropriate liquid for adequate surface tension, much like our “open
bubblepoint” test. Multipoint diffusion is very similar. The principle of the water intrusion test
detects the presence of the larger pores in the filter element by filling the filter assembly with
water and pressurizing the assembly. The nature of the porous filter membrane prevents bulk
flow of the liquid through the filter until the intrusion pressure is reached. Lastly, the pressure
drop test uses a similar principle to our “forward flow” test.
Specific to our proposed testing systems, the first bubble test is the most economical and
practical means of establishing the largest pore size in the filter. Optical/laser scanning
techniques were considered as a unique alternative, but immediately dismissed due to high cost
and unnecessary added complications. Visual first bubble verification is simple and effective.
With respect to acceptable pressure drop verification we have also selected the most
practical and economic solution. Through use of open bubble and forward flow, we will
determine the delta P across the filter through use of both air as the working fluid (open bubble)
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and liquid (de-ionized water for the forward flow test). Pressurized air was considered for the
working fluid in the forward flow test. However, the pressure drop across the filter inlet is to
large to effectively evaluate the pressure drop across the filter element membrane based on the
air permeability specifications (0.000055 – 0.00085 psid-ft2/scfm). The high pressure drop
across the inlet of the filter would exist as a result of high velocity air in small diameter piping.
Water is a more appropriate working fluid in the case of the forward flow test.
PROJECT MANAGEMENT TIMELINE
The project management responsibilities will be co-advised by Timothy Kuhn, Project
Engineering Manager at Pfizer Global Manufacturing, and Dr. Mun Choi, Department Head of
the Mechanical Engineering and Mechanics department at Drexel University. The project
management timeline (Appendix A) was developed to meet Pfizer’s needs and requirements,
while at the same time ensuring that Drexel University’s Senior Design project course deadlines
were met. The major timeline mile markers consist of the deadlines required by Drexel, while
the additional task items provide a detailed schedule for Pfizer to view the progress of the
project. Project management responsibilities associated with this project will be outlined in the
following paragraphs.
Major project responsibilities consist of design, budget development, timeline
development, design implementation and construction, operational testing, and project
completion evaluation. The final step of the project involves implementing the test systems into
the Pfizer facility for operational use.
Such implementation will require additional
responsibilities, collectively governed by established internal requirements of both the Pfizer
Engineering and Quality departments. Additionally, the main tasks are bracketed by subtasks
that act as building blocks for the success of this project.
Many criteria are faced in the approach of the design of this project. Pfizer provides
specifications and requirements that become the established deliverables of the project.
Research of existing technology and procedures in the market are required to provide Pfizer with
a custom application, which will meet their specific requirements. The design of the systems
must provide Pfizer with retainable, valuable data for quality assurance and performance
integrity. Researching current available technology or lack of technology creates a diversified
approach to the project. It also ensures that the most technological advances are present within
the test systems. Another critical tool available to the successfulness of the project is the filter
element manufacturer, PALL Corporation. Understanding the properties of the filter elements
provides guidelines in which quality testing parameters are able to be developed. Also,
understanding the potential responses of the filters to the test system parameters provides a
baseline in which data comparisons can occur. Utilizing research and the filter design
specification tools are crucial steps in the design development of the test systems.
Once the specifications and requirements for the test systems are developed and
incorporated into the design a budget must be developed. The budget will be utilized to obtain
funding for the project and associated equipment. Critical components that must be captured
within the budget include design labor, parts list, fabrication and machining costs, installation
and construction, and a contingency for lab trials and redesign if required. Equipment and
instrumentation must be tracked closely for capitalization requirements. Depreciation of
equipment is also important in developing the budget. Other items of interest are annual
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maintenance and calibration costs. These upfront initial costs are the components required for
the budget development.
Microsoft project is the software program that will provide a structured process of
developing the project timeline. A Gantt chart is automatically created along with the timeline.
The Gantt chart provides a visual aid of the timeline and how each task is linked or dependent
upon previous tasks. The timeline will consist of the milestones set by the Drexel senior design
course requirements. The majority of the timeline will consist of the sequential steps and
deliverable dates for the development of the tests systems. Microsoft project also contains useful
tools to which percentages of each task can be tracked to completion to give a close indication as
to the progress of the project.
Design implementation and construction is the step in the project where the test systems
become a part of reality. The design is issued for construction and the physical work begins.
The parts list becomes critical to ensure that all the necessary materials are ordered and available.
One difficult task with ordering the parts and components is the delivery lead time. An increased
lead time can create unexpected delays in the timeline and push successful deliverables further
back. A well developed timeline is important to reassure that all the steps are known and
organized in a sequential process in order to maintain an efficient managed project.
Operational testing measures the success of the project. Useful data, which provides
information as defined by the specifications and requirements, is proof that the deliverables have
been met. Operational testing can also provide an indication that further design and development
is mandatory in order to meet the specifications and requirements. This step provides the team
with the conclusions needed for a thorough evaluation of the design and the deliverables.
Project completion evaluation is critical in understanding the successfulness of the
project. Creating time for the team to reflect and discuss the different events, problems,
difficulties, conflicts, approaches, solutions, results, and conclusions allows for the experience to
be fully effective. Reflecting on these characteristics enables future projects to utilize the
successful tools or painful experiences to increase that next project’s efficiency.
Additional tasks are crucial in the success of this project. These additional tasks require
identifying deliverables necessary within Pfizer to implement the test systems into the facility
once the project has successfully been developed. The implementation of the test systems into
the facility requires certain specifications and standards in order to be operational.
Understanding these specifications and requirements demand research and knowledge in order to
incorporate them into the initial design specifications. Pfizer as the customer has committed to
the procurement of the project and will be responsible for completing the furnishing and
construction of necessary equipment. Bid issuing and machining possess lead times and
requirements as defined by Pfizer. These tasks need to be captured within the management of
project timeline. Also, implementation of the test systems into the facility requires standard
regulatory compliance procedures and documentation. These requirements need to be included
into the design and timeline in order to turnover the project to the customer, Pfizer.
These listed characteristics are crucial in the completion of a successful project. The
project management process is by nature the part of the project for which these responsibilities
are captured. The project management will determine the successfulness of the project and when
the deliverables are received by the customer. Project structure requires the project management
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to be the backbone of every project and therefore must provide the support and development for
the project.
Guidelines as published by ASTM, (American Standards for Testing and Materials),
ASME (American Society of Mechanical Engineers) and NIST, will also be heavily researched
in efforts to develop the project under established standards. Pharmaceutical companies, filter
manufacturing companies, and the ISPE may also be additional resources used during the
progression of this project.
ECONOMIC ANALYSIS
Established filter integrity systems will provide effective cost savings for Pfizer’s
filtration systems along with verified performance and efficiency results required for quality
assurance. Valid filter element performance will provide Pfizer with optimal filter operation
assurance with increased proficiency in filter maintenance and performance. This increase in
filter maintenance and performance will provide Pfizer with the opportunity to maintain the filter
elements with minimal operational downtime and provide optimal performance for product
manufacturing.
In order to provide a proper economic analysis, history of filter element testing and cleaning
costs as well as downtime associated with unscheduled filter maintenance was required from
Pfizer. With this data, it was be possible to calculate an average yearly cost for filter testing.
Once the average cost was obtained, it was possible to generate a present worth analysis for a
valid cost comparison. The initial costs for the project include both the costs of the open bubble
point testing apparatus as well as the forward flow testing apparatus. For each subsequent year, a
savings will be generated by performing the testing internally and reducing production losses.
The annual savings was calculated using the average cost for external cleaning and downtime
minus the annual internal cleaning costs. The internal cleaning costs consist of operating costs
for the machines, comprised mainly of the cost of an operating technician to perform the testing.
The economic analysis appears in Appendix E, Table E1, and conservatively assumes a
ten year life span of the equipment, when in fact it should be much greater. The increase in
annual savings reflects an inflation rate of three percent applied to both the external and internal
testing costs. Initial assumptions will include:
•
one full day of filter testing per month
o technician salary of $25 / hr.
•
one full day of downtime per year resulting from unscheduled maintenance
o see discussion below Table 1
•
3% inflation rate of all costs
•
initial project cost of $45,000 (Appendix D)
•
average yearly cost of filter testing: $5000/year
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The savings amount quoted in Table E1, totaling close to $200,000, is a conservative
minimum figure for savings that will be realized by this project. The real savings and economic
benefits of this project will come from minimizing, and even potentially eliminating, the
unscheduled downtime by introducing the forward-flow test, ensuring Pfizer that the filters are
ready to go back in line before they are actually installed for operational use. Ultimately this is a
main goal of the test system design, if not the main force behind its initiation. Unfortunately we
unable to obtain a clear cost figure from Pfizer as to the average amount of unscheduled
downtime due to filters being placed back online that were not properly cleaned or had out-lived
there ability to be cleaned back to design specifications. Therefore, we could not quantitatively
include this figure in our analysis, but it is nevertheless exceptionally important to look at it from
a qualitative standpoint. If production is up and running and there is a problem with a filter that
leads to system shutdown, a lot of work needs to go into troubleshooting, changing out the
dysfunctional filter, and getting back up and running. Such a problem may cause no more than 2
hours total downtime. Even if our forward-flow project saves this from happening to just one
filter a month, then over 12 months we would save one full day of downtime (2 hours/month x
12 months/year). Pfizer has quoted us the cost of one day of downtime at $1,000,000. In reality,
our testing system is designed to prevent such downtime inefficiencies. So as previously stated
we can not quantify this savings to an exact number, but let us reiterate that it has the potential to
generate millions of dollars in savings for Pfizer and thus is the driving force behind the project.
SOCIETAL AND ENVIRONMENTAL IMPACT ANALYSIS
Unpredicted failure of the filter system habitually occurs during operation. As a result,
the product lot (Listerine®) within the manufacturing system must be held for investigation and
the product cannot be released. Investigation typically leads to results indicating filter failure and
the filtration effectiveness specific to that particular lot becomes unknown. The quality of the
product becomes unknown and cannot be guaranteed. Therefore, the product must be disposed
as waste. The development of these test systems will reduce the quantity of waste disposal by
reducing filter failures.
Listerine® provides a societal benefit for mankind in increasing the freshness of breath
and cleanliness of teeth. Ensuring filter integrity will enhance the Listerine® production of
Pfizer Global Manufacturing, increasing the overall potential for fresh breath and clean teeth.
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REFERENCES
1. “Pall Porous Inorganic Media Guide.” Copyright 2002, Pall Corporation.
2. “Pall Backwash Filter Systems: For Solid/Liquid Separation.” Copyright 1996, 2000, Pall
Corporation.
3. “The Pall Water Intrusion Test for Integrity Testing Sterile Gas Filters,”
http://www.pall.com/biopharm_3911.asp
4. McMaster-Carr Online Catalogue, http://www.mcmaster.com/.
5. Chem Associates Online Catalogue:
http://shop2.chemassociates.com/PAS-ethylalcohol.html
6. Newnan, Donald G; Lavelle, Jerome P; Eschenbach, Ted G. Engineering Economic
Analysis, 8th Ed. Engineering Press, 2000.
7. Kuhn, Timothy A. Project Engineering Manager, Pfizer Global Manufacturing.
Page 10
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APPENDIX A: TASK TREE
11/24/2003
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APPENDIX B: GANTT CHART
11/24/2003
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APPENDIX C: TEST SCHEMATICS
Page C1
Figure C1: Proposed Forward Flow Test Schematic
Figure C2: Proposed Bubble Point Test Schematic
Page C1
APPENDIX D: ECONOMIC DATA
11/24/2003
TABLE D1: FILTER SYSTEM ECONOMIC DATA
Raw Material
N-Propanol
Alcohol
Mineral Oil
Glycerin
Filter Element Description
25 micron, 20" code 8
Filter Element Quantity
6
6
6
10
Filter Element
Cost/each
$660.00
$660.00
$660.00
$660.00
Filter Element Total
Cost
$3,960.00
$3,960.00
$3,960.00
$6,600.00
Filter Housing Description
6 round, 20" housing with 3" raised face
flange
6 round, 20" housing with 3" raised face
flange
6 round, 20" housing with 3" tri-clover
10 round, 20" housing with 3' tri-clover
Filter Housing Quantity
Filter Housing
Cost/each
Total Cost **
1
$8,280.00
$12,240.00
1
1
1
$8,280.00
$8,050.00
$8,050.00
$12,240.00
$12,010.00
$14,650.00
** Total Cost = Filter Element Total Cost + Filter Housing Cost/each
Page D1
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TABLE D2: FORWARD FLOW ECONOMIC DATA
Materials of Construction 316L Stainless Steel
Flow Path
Flow Path Components
Quantity
Cost
30'
$3.50/ft.
Globe Valve
1
$62
Back Pressure Valve
1
$1200
1
$600
3-way Tees
5
$3.90 each
4-way Tees
1
$8.30 each
1
$600
1
$250
1
$1700
1
$1500
Test Filter Housings
1
$8000
Variable Frequency Drive
(VFD)
1
$3800
Pipe - 30' (Sched. 40s – 1” diameter )
Flow meter (0-60 GPM)
Inline 0.2 micron filter & head (1" NPT)
30-Gallon Storage Tank**
Pump (50 GPM @ 100 psi, 6 ¾” impeller)**
Motor (5 HP, 3-Phase, 1750 rpm)
Page D2
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TABLE D3: FORWARD FLOW ECONOMIC DATA (CONT.)
Non-Flow Path
Quantity
Pipe - 5' (Sched. 40s)
Cost
$3.50/ft.
Relief Valve (Set a@ MAWP Filter
Element)
5’
1
$1075
Temperature Gauge (0° – 100°F)
1
$110
Pressure Gauge (0 – 60 PSIG)
1
$75
Differential Pressure Gauge Low Range
1
$3500
Differential Pressure Gauge Medium
Range
1
$3500
1
$3500
1
$155 each
Differential Pressure Gauge High range
Ball Valves - 6 (Swagelock Fittings ½” SS Tube)
$1.70/ft.
½” SS Tube
Cart
20’
1
$5000
Assorted Bushings/Unions/NPT
lots
Varies
Total Cost, Rounding Up
(Flow Path & Non-Flow Path)
$33,000
Page D3
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TABLE D4: BUBBLEPOINT TEST ECONOMIC DATA
Bubble Point Test
Materials of Construction 316L Stainless Steel
Quantity
Cost
$1.70/ft.
Pipe - 20' (Sched. 40s ½” diameter)
Four foot manometer
20’
1
$1500
Low Pressure PRV Station
1
$5000
Filter Element Trough
1
$500
Flex Hose (10’ extension @ ¼”)
2
$35 each
Throttling Valve
1
$1000
Pressure Gauge (0 – 60 PSIG)
1
$75
Cart
1
$3000
3-way Tee
1
$3.90 each
Assorted Bushings/Unions/NPT
lots
Varies
Total Cost, Rounding Up
$12,000
Page D4
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APPENDIX E: ECONOMIC ANALYSIS
Page E1
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Table E1: Present Worth Economical Analysis
Expenditure
350 filters tested
per year x $80
per filter to test
redundant filter
cleanings after
premature failure
and other filter
maintenance
TOTAL
COSTS(TC)
Current Pfizer Costs
Amount
Costs After Project
Expenditure
Amount
initial costs to build the
$45,000
two test beds - $33,000
+ $12,000
$28,000
cost for technician to
work on filters 2 days
per month, 24 day per
year = 192 hours;
round-up and say 200
hrs/year at $25/hr
$5,000
$33,000
$5,000
Present Worth after 10 years of series amount
PW = TC[(1+i)n $281,497
1/i(1+i)n]
Present Worth after 10 years of series amount
IC+PW =IC + TC[(1+i)n
$87,651
- 1/i(1+i)n]
where PW = present worth, TC = total cost, n = 10 years,
and i = 3% inflation
where PW = present worth, IC = initial cost, TC = total cost,
n = 10 years, and i = 3% inflation
TOTAL SAVINGS OVER 10 YEARS =
$281,497 $87,651 =
$193,846
Page E1

filter integrity testing for pfizer global manufacturing

Transcription

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