THE SOCIETY FOR

LIFE SCIENCE
PROFESSIONALS

Volume 10
Issue 4
NEWS
2003 Message From President
Denise Luckhurst

IN THIS ISSUE: D on’t look now ….

… but the holidays are just around the

corner. It seems like only a short time ago the
2003-2004 year was new and we were looking forward to
all that would be happening in 2003. Now, as
Chapter Calendar we enter the fourth quarter, we pause to take a
short look back at where we’ve been and
another look forward to where we are going.

USC & The Annual ISPE-LA Golf Tournament was a

great success. It was a beautiful, windy and
Cal State Fullerton clear day and we couldn’t have asked for a bet-
Student Chapter ter location. Our upcoming quarterly dinner
meeting will be taking place on November 13.
Update Photo from Sicor Pharmaceuticals Tour in August.
(Look for details elsewhere in this newsletter.)
After the Tour, members met at Dave and Buster’s in
In December, we take a break from these
Irvine for dinner and socializing. L-R: Board member
events to allow everyone more time to celebrate
Damon Jones, McGuff Pharmaceuticals, Inc.; tour
with their friends and families. But while the
host, Steve Muehlberger of Sicor Pharmaceuticals;
bulk of our membership is attending holiday
TECHNICAL and Board member and tour facilitator Scott Tiedge of
parties and shopping, a few members of our
Alphabio.
ARTICLE: Chapter take on a very important mission to
close out our year.
Process Piping and
the Codes ISPE’s Greater Los Angeles Chapter partici-
“Evening With An Industry pates in a Christmas tradition of adopting a
Executive” family and providing a Christmas celebration
they might not be able to provide for them-
Art Le Blanc, President of selves. Our adopted families have all been
Photos from amazing people who are blessed with wonder-
Sicor Pharmaceuticals, Inc.
Sicor ful children. In most cases, one of the children
To Speak on November 13th is dealing with a life-threatening illness. They
Pharmaceuticals might be undergoing a demanding regimen of
Tour chemotherapy, radiation treatments, or surgery

and
Golf Tournament
T he next Chapter dinner meeting will be held at
the Irvine Marriott on November 13. We are
happy to announce that Art Le Blanc,
President of Sicor Pharmaceuticals, will be presenting
at Children’s Hospital in Los Angeles. Their
families have their hands more than full in try-
ing to provide the best care and support for
their children at the same time they are strug-
the vision for his company and his opinion on the gling to meet the basic demands of everyday
future of the pharmaceutical industry. life.

In August, members toured the Sicor facility in Irvine.
Now members and non-members have the chance to
hear an executive’s vision for his company. (See regis-
tration form inside).
We all should be proud of the work we do to
help improve the lives of patients around the
world. At this one time every year, we come
face-to-face with the knowledge that we can
also do a little something extra.
 STUDENT CHAPTER UPDATE
STUDENTS BACK TO SCHOOL WITH NEW OPPORTUNITIES FROM ISPE
GREATER LOS ANGELES CHAPTER WORKING WITH USC AND CSUF STUDENTS
by Damon Jones, Student Affairs Chairman
I SPE has a long history of reaching out to the communi-
ty and providing needed resources for the benefit of its
members and the community at large. The Greater Los
Angeles Chapter continues this tradition by working to establish
local ISPE Student Chapters at Colleges and Universities located
throughout the Greater Los Angeles area.
Our most recent efforts have been applied to the University of
Southern California (USC student chapter president Jay Padhya)
and California State University at Fullerton (CSUF student chap-
ter president Debbie Hlava). Both of these schools have new
student chapters and are seeking student members that have an
interest in the healthcare technology industry and ways to estab-
lish and promote their own careers.
Each of the student chapters is led by dynamic and energetic
students that have a keen desire to help ISPE meet its student
member’s needs and goals. The USC and CSUF student chap-
ters are led by their founding student chapter presidents Jay
Padhya and Debbie Hlava, respectively. The student chapters,
through the vision of their founding presidents, have plans for
student educational events, networking, and presentations on
interviewing tips from some of the healthcare technology indus-
try’s top executives and technical professionals. The USC and
CSUF student chapters continue their work to provide their stu-
dent members with a rich variety of professional enrichment
opportunities.
If you have an interest in participating in student programs or
want to help establish a new student chapter at your teaching
institution, please contact Damon Jones, Chairman of ISPE,
Greater Los Angeles Chapter, Student Affairs Committee.
Damon is there to assist students and professionals in ISPE stu-
dent activities.
You can reach Damon at damon@mcguff.com or via telephone
at 714-918-7277.
*******************************************************************
The following excerpt from the ISPE web site provides some
insight into ISPE’s student outreach programs. Students and
other interested parties are encouraged to visit the ISPE web site
for further information and opportunities:
http://www.ispe.org/Template.cfm?Section=Students&
CONTENTID=3010&TEMPLATE=/ContentManagement/Content
Display.cfm
The Benefits of Joining an ISPE Student Chapter
Set Your Career in Motion
Instead of just thinking about where you want to be after gradua-
tion, you should be acting on how to get there.
Being a student member of ISPE provides you with many oppor-
tunities to help you make choices. Meeting and networking with
professionals, fine-tuning your skills, and developing solid inter-
viewing practices are just some of the benefits our student mem-
bers reap. Membership in ISPE introduces students to one of the
most dynamic industries and the professionals working in it -
the healthcare technology industry. The healthcare technology
industry has opportunities for the following disciplines:
• Engineering (Chemical, Industrial, Mechanical,
Electronic/Electrical, Civil, Process, and Environmental)
• Pharmacy & Pharmaceutical Sciences
• Life Sciences (Biology, Microbiology, Biochemistry,
Chemistry)
• Architecture, Construction, and Design
• Computer Science and Engineering
Begin Now
The ISPE/Student relationship is one that should begin early in
your undergraduate career. Many stages of assistance and
mentoring are available and students are encouraged to take
advantage of those opportunities. The sooner you begin to
nurture relationships with Society professionals and become
familiar with and understand the industries they represent, the
sooner you will find the direction you want to pursue and the
better your development will be.
What comes after graduation?
Your involvement with ISPE will help you answer this question.
Consider the advantages of student involvement in ISPE. The
Society offers exceptional educational programs, unique net-
working opportunities, and a promise of developing profession-
al relationships within ISPE, as well as its affiliated industries,
which are extremely valuable - especially when it comes to
landing a job.
Who You Know
The underlying strength of involvement in an ISPE Student
Chapter is the relationship with its parent society, ISPE. You
may often hear people say finding a job is about "who you
know." ISPE is the "who" to know. With more than 15,000
members working in major markets of the world, the
ISPE/ISPE Student partnership offers a vast network of poten-
tial employers.
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 “EVENING WITH AN INDUSTRY EXECUTIVE”
ART LEBLANC, PRESIDENT
ISPE GREATER LOS ANGELES
SICOR PHARMACEUTICALS, INC.
CHAPTER
THURSDAY
The Society for Life Science
Professionals NOVEMBER 13, 2003
www.ispe.org/greaterla
IRVINE MARRIOTT
18000 VON KARMAN AVENUE, IRVINE, CA • (949) 553-0100
5:00 - 6:00 pm Networking Hour
6:00 - 7:00 pm Dinner
7:00 - 8:00 pm Presentation/Q & A
Join us as our distinguished speaker shares Sicor Pharmaceutical’s vision of the future in the pharmaceutical industry.
Mr. LeBlanc will discuss the growth of Sicor Pharmaceuticals from a small generic pharmaceutical company to its current
position as a multi-national corporation and will examine Sicor’s long-range plans for the company’s growth and develop-
ment.
Among issues to be discussed:
• Sicor Pharmaceutical’s capabilities and technical areas of expertise
• How Sicor looks to distinguish itself from the competition
• Growth of the company from a small generic firm to a mid-size branded pharmaceutical firm
• Technical issues that affect the business
• How the regulatory environment has driven Sicor’s business plans
• Experience with the FDA: System-based inspections and other current issues
• Sicor Pharmaceutical’s plans for the future

REGISTRATION FORM
To Pay with a Check: Complete this form and fax it to (949) 366-1057 or (949) 366-1059, then mail with your check made
payable to: ISPE Greater Los Angeles Chapter, 111 E. Avenida San Gabriel, San Clemente, CA 92672. To Pay by Credit
Card: Complete this form and Fax It To (949) 366-1057 or (949) 366-1059. PARKING INCLUDED. Tel: 949-366-1056

DINNER MEETING ❑ MEMBERS $55 MEMBER NUMBER:________________________

❑ NON-MEMBERS $75 CHAPTER:______________________________

Due to our commitment with the venue, No Shows will be billed unless your reservation is cancelled by November 6. After the can-
cellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may
attend in your place (non-member fee will apply if alternate is a non-member). Receipts and name badges will be given at the event.

First Name: Last Name:

Title: CREDIT CARD INFORMATION
Company: Type of Credit Card
Address: Circle One
City: Name on Card:
State: Zip: Credit Card #:
Tel Number:
Exp Date:
Fax Number:
Signature:
E-Mail:
 TECHNICAL ARTICLE
Process Piping and the Codes
By Christopher G. Ziu, P.E.
RePrint From: PM Engineer: http://www.pmengineer.com
Issue: 05/02/2003

H ere is an in-depth look at process piping systems

and the codes that govern their design.

The term "process piping" generally refers to piping systems

that convey chemicals under pressure or vacuum. It also is
used to describe utility piping systems that are used in, or in
support of, a chemical process, such as plant water. Also, cer-
tain drainage piping -- where corrosive or toxic fluids are being
transported and severe conditions may be present, or where it
is simply outside the scope of plumbing codes -- is also some-
times classified as process piping. Some places where process
piping is used are obvious, such as chemical and petrochemi-
cal plants, petroleum refineries, pharmaceutical manufacturing
facilities and pulp & paper plants. However, there are many
other not so obvious places where process piping is common-
place, such as semiconductor facilities, automotive and aircraft
plants, water treatment operations,
waste treatment facilities and many
others.
moplastic and FRP piping. However, make no mistake; the B31.3
Code is the first document that attorneys will reference when
there is an accident or injury involving process piping. When it
comes to process piping, this is the only code that exists in the
Western Hemisphere, and it does cover all materials.
The ASME B31.3 Process Piping Code excludes piping designed
for internal gauge pressure at or above zero but less than 15 psi
(105 kPa), provided the fluid is nonflammable, nontoxic, and not
damaging to human tissue, and its design temperature is from -
20 degrees F (-29 degrees C) and 366 degrees F (186 degrees
C). In other words, if piping is between 0 and 15 psig (105 kPa),
it can still be governed by the rules of the code if the material
being conveyed is flammable or toxic or damaging to human tis-
sue. Also excluded from the code is internal piping of fired
heaters; packaged equipment such as heat exchangers, pressure
vessels or other processing equipment; as well as
piping related to boilers (which is typically gov-
erned by the B31.1 Power Piping Code).

ASME Process Piping Codes Codes vs. Standards

In North America, the code that gov- One common misperception is that if nonmetallic
erns the design, fabrication, compo- process piping systems utilize components and
nent standards, installation, inspec- installation procedures that conform to some
tion and testing of process piping is ASTM standards, then the ASME B31.3 Code is
the ASME B31.3 Process Piping somehow irrelevant. At the heart of this misper-
Code. This code is also an ANSI ception is confusion over what a code is and what
standard and is a subset of the a standard is. A standard, such as ASTM man-
ASME Code for Pressure Piping, Complex process piping arrangements dates, typically covers the manufacture of specific
B31. The ASME B31 Code for shown in a hydrogenation reaction unit components or installation techniques, which
Pressure Piping consists of a num- at an ibuprofen manufacturing facility. make up only a part of a system. A code, on the
ber of individually published sec- other hand, covers an entire system from design
tions, each an American National Standard. The ASME B 31.3 to installation and testing, and references which standards (e.g.
Code is mandated by law in Canada, is a requirement in the ASTM Standards) are approved or listed by that code. Thus, a
U.S. according to OSHA for all process piping, and is further code is more encompassing than a consensus standard and
mandated by many industrial insurance carriers for industrial does not replace a standard, but explains how to incorporate that
facilities. There is a lot of misconception regarding the applica- standard into a functioning system.
tion of this code, particularly in facilities such as semiconductor
plants and others where nonmetallic piping is prevalent. In fact,
many engineers, owners and contractors are mistakenly under continued on next page
the impression that it does not apply to systems that involve ther-

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 Process Piping and the Codes (continued)

Materials of Construction polypropylene), and the fluoropolymers (PVDF, VF2/HFP copoly-

As for what materials of construction can be utilized in a mer or Kynar(R) Flex, ECTFE), and the various grades of fully
process piping system, there is an almost limitless selection of fluorinated polymers more commonly referred to as Teflon(R)
metallic, nonmetallic and nonmetallic-lined metallic materials (PFA and FEP). The common RTR materials include glass-rein-
to choose from. The fluid services to be handled will dictate forced epoxy, glass-reinforced vinyl ester, and the more exotic
the material requirements. Metallic materials typically include glass-reinforced furan. The most common plastic-lined metallic
various grades of carbon steel, low and intermediate alloy piping includes both steel and austenitic stainless steel materials
steels, austenitic stainless steels, duplex stainless steels, and lined with polypropylene, Kynar(R) Flex, ECTFE, ETFE or
for more corrosive applications, nickel and its alloys, and tita- Tefzel(R), and Teflon(R) (PFA, FEP and PTFE). In pharmaceuti-
nium and its alloys. Requirements for metallic materials are cal and fine chemicals processing, ceramic-lined steel is also
listed in Chapter 3 of the B 31.3 Code. Nonmetallic materials quite common for high temperature corrosive services.
typically include thermoplastic materials, reinforced thermoset-
ting resin materials (commonly called FRP or fiberglass), ther- Qualifications of the Designer
moplastic or glass-lined metallic piping, and in some special- According to the Process Piping Code, the designer of a process
ized pharmaceutical research applications, borosilicate glass piping system must be experienced in the use of the code. The
piping. exact qualifications and experience required of the designer
depend on the complexity and criticality of the system. The
The advantages of thermoplastic piping and reinforced the- designer should either have a four-year engineering degree plus
mosetting resin (RTR) piping systems are that they are highly five years of experience, a two-year engineering associates
corrosion resistant to very aggressive compounds and usually degree and 10 years of experience, a Professional Engineering
cost effective from an overall installed cost consideration. registration and pressure piping experience, or 15 years of expe-
There are some limitations placed on nonmetallic piping, how- rience in the design of related pressure piping. If the designer of
ever. For instance, thermoplastic piping is not allowed in flam- record does not meet
mable fluid service above ground (although thermoplastic- any of these criteria,
lined metallic piping is permitted) and should be safeguarded then they would
when used in hazardous fluid services. PVC and CPVC are require the approval
specifically prohibited from use in compressed gas services of of the owner to serve
any kind. RTR, borosilicate glass and porcelain piping are as the designer of
required to be safeguarded when used in toxic or flammable record.
fluid services.
Design Criteria
Typical thermoplastic piping includes the vinyls (PVC, CPVC), Aside from material
the polyolefins (high-density polyethylene or HDPE, and selection based on
Dual containment polypropylene fluid service, some of
process sewers and dual containment the basic factors that
the designer has to
FRP process waste lines being
consider for a process
installed at an inorganic pigment piping system include
manufacturing facility. the design pressure;
design temperature;
design minimum temperature; various ambient effects such as
cooling, fluid expansion, and atmospheric icing; dynamic effects
such as impact, wind, earthquake, vibration and discharge reac-
tions; weight effects; live loads; thermal expansion and contrac-
tion effects (including thermal loads due to restraints, loads due
to temperature gradients and differential expansion effects);
effects of support, anchor and terminal movements; reduced duc-
tility effects; cyclic effects; and lastly, air condensation effects.

Pipe, Valves and Fittings

The so-called listed pipe, valve and fitting components (those
standards that are listed by the code) are contained in Chapter
IV of the code for metallic components and in Chapter VII for
nonmetallic components. Other components can be used that are
not listed; however, they must meet certain criteria. For an unlist-
ed component or element to be used in a process piping system,
its pressure design must be proven by calculations consistent
with the code and shall further be substantiated by one or more
means. These means include extensive, successful service under

continued on next page

 Process Piping and the Codes (conclusion)

comparable conditions, experimental stress analysis, proof test-
ing, or detailed stress analysis (e.g. finite element analysis).
Fabrication and Assembly
Chapter V of the code covers the requirements for fabrication,
assembly and erection of metallic piping systems. This includes
the requirements for the qualification of weld-
ing procedures and the qualification and train-
ing requirements for welders. There are
detailed requirements stated for all of the vari-
ous steps in fabrication and assembly, includ-
ing preheating requirements and heat treat-
ment requirements after welding. Bending and
forming requirements are also covered, as are
detailed requirements for assembly and erec-
tion (e.g. flange and threading procedures).
Chapter VI of the code covers all of the
requirements for inspection, examination and
testing, including such items as required visual
tests; pressure testing requirements; radiogra-
phy; ultrasonic, magnetic particle and liquid
penetrant examination requirements; and
acceptance criteria. Unless otherwise specified
in the design, the code requires a minimum
retention of records for at least five years after
a record is generated for a project.
Welders welding carbon steel
piping for plant water in a
Chapter VII of the code is essentially a minia-
ture code unto itself and covers all of the
pharmaceutical process plant.
requirements for nonmetallic piping within this
one chapter. One notable difference in nonmetallic piping sys-
tems with respect to assembly and erection criteria is that indi-
viduals performing bonding (making of thermoplastic joints
by any means) must be requalified if they have not per-
formed a specific bonding process within a six-month period,
or if there is specific reason to question the individual's ability
to make nonmetallic joints under the specific bond qualifica-
tion procedure. This requirement exists mostly due to the fact
that a vast majority of problems with the use of
nonmetallic piping has occurred in the past due
to problems in the installation of these materials.
Conclusion
In closing, the ASME B 31.3 is the only accept-
ed code that exists for process piping systems. It
is directly required by law in Canada and indi-
rectly in the U.S. by means of OSHA process
safety requirements and insurance mandates.
However, the fact that the code is required
should not be the only reason to compel users
to follow it. If followed, it is an excellent means to
insure the safe, reliable installation of process
piping, as evidenced by the excellent record that
exists in chemical plants and petroleum refiner-
ies throughout North America.
Christopher G. Ziu, P.E., CIPE, is vice president
of engineering for Flo Safe, Inc., as well as its
sister company, Orion Fittings, Inc., Kansas City,
KS. He has more than 20 years of experience in
process piping. He is the author of the McGraw-
Hill handbook titled, "Handbook of Double
Containment Piping Systems," as well as Ch. B13 of the 7th
edition of McGraw-Hill's Piping Handbook on "Double
Containment Piping Systems." He has been a voting mem-
ber of the ASME B31.3 Committee since 1989, which writes
the ASME/ANSI B31.3 Process Piping Code. He has a B.S.
in Chemical Engineering and an MBA from the University of
Connecticut. He can be reached at cziu@orionfittings.com.

Article reprinted with permission from RSiCopyright.com

Copyright, 05/02/2003, Business News Publishing Co. All
rights reserved.

n Control Systems Engineering Bay-Tec Engineering Inc.

n System Integration
n Instrumentation
n Panel Fabrication
n Installation/Commissioning
n Validation
535 Airpark Road
Napa, California 94558-7514
telephone 707.252.6575
facsimile 707.252.2027
e-mail: slaskey@bay-tec.com
 Sicor Pharmaceuticals New Manufacturing Facilities Tour
Overview by Scott Tiedge, Alphabio
S icor Pharmaceuticals, Inc. (Formerly GensiaSicor
Pharmaceuticals, Inc.) hosted the ISPE Los Angeles
Chapter facility tour Thursday, August 28th. Dave Nielsen,
Director of Manufacturing, Steve Muehlberger, Sr. Mgr. of Project
and Process Engineering, and Ken Domagalski, V.P. of QC and QA
opened the evening with a presentation on Sicor’s corporate struc-
ture, marketing alliances, global manufacturing locations and capa-
bilities, as well as current product offerings that include anesthetics,
oncolytics, critical care and antipsychotic drugs.
The facility tour was conducted by Sicor’s engineering staff which,
included Michael Gagne, Ali Azami, Duane Hively, Ray Pablo, and
(L-R) Robert Hemedes of Baxter Healthcare and Ike
Stranathan of cGMP Validation LLC.
(L-R) Paul Smith of Siemens Building Technologies and
Chapter Vice President, Zawdu Eshetu of Watson
Laboratories.
(L-R) Herric Chan of Amphastar IMS and Greg
Palascak of Flow Components, Inc. battle one-another
in a mean game of pool after the Sicor Tour.
Tim Yu. The three groups did a walk-through of the new line seven
compounding room, aseptic fill room, and packaging line. The
groups then toured the existing manufacturing facility. Group lead-
ers gave a very in-depth description of all of the equipment and
processes, leaving tour participants with a greater understanding
of facilities design and construction, current drug manufacturing,
and cGMP facilities. Dinner, drinks and pool followed at Dave and
Busters with some of us displaying tremendous shuffleboard
prowess (Kimberly)! Thanks again to all who helped make this a
very satisfying event!
The ISPE Los Angeles Chapter invites any of our member compa-
nies who would like to open their facilities for a member tour to
please contact Scott Tiedge or Michelle Gonzales. Demand for
facilities tours far outweighs our ability to provide opportunities to
do so. Please let us know! (see contact information under Board of
Directors list).
Turning VALIDATION EXPERIENCE
and
PROJECT MANAGEMENT SKILLS
into SUCCESS for our clients
Validation and Compliance Consulting
Including Computer Validation, Analytical Methods
Validation and Cleaning Validation
1101 California Ave, Suite 215, Corona, CA 92881
Phone: 909-280-4740 Fax: 909-280-4744
www.valicor.com ~ info@valicor.com
California~Kansas~Massachusetts~N.Carolina~Pennsylvania~Puerto Rico
Annual Golf Tournament Overview
by Kimberly Syre, Chapter Manager

T his year’s Annual Golf Tournament held on September

18 at Robinson Ranch in Santa Clarita proved to be well
worth the drive. The Chapter’s Social Chair, Bill Neal of
Duhig Stainless (photo on the right) put on a great show.

The highlight of the day was a guest appearance by Miss

Venezuela runner-up, Susana Stephanie De Fazio. Susana,
sponsored by AV Infinity Construction, posed in several photos
with golfers during the awards banquet.

Talking about awards, here are the official results:

Longest Drive: Ky Phan, Kinetics

Closest to the Pin: Jon Hemmati of Watson Labs (see photo on

top right of Jon accepting $120 cash prize)

1st Place Team: Kinetics with players Ian Larson, Andy Springer,
Jimmy Taylor and Ky Phan

2nd Place Team: AV Infinity Construction with players Ariel Vera,

Scott McNay, Dave Hines and Steve Gonzales

Thank you to Marvin Davis of MD Stainless and Ken Balmer of

Cal-Chem Corporation for providing t-shirts for the tournament.
Also to Marvin for providing expert chauffer services for Susana Pharmaceutical Services Corp showed
and being an excellent drink-giver-outer. great sportspersonship accepting their
“stud finder” prizes as the last place group.
L-R: Larry Lien, Matthew Thomas,
May-Lin Wong and Vichara Ouk.

Thank you very much for your donations!

T-Shirts Cal-Chem Corporation
M.D. Stainless Services
Towels Kinetics
Hats Gemu
Balls GXP Consulting
Pharmaceutical Services Corp.
Drinks AV Infinity Construction
Prizes INTERPHEXCalifornia & BIOPHEX
Orange Fluid Systems (Swagelok)
Fluor Daniel team teams up with (L-R) Dale Christiansen of ISEC
Sicor Pharmaceuticals
Inc., Peter Elden, Gideon Graza, Kurt Sigler and Wadi Farah.
Bags Pro-Tech Process
Tees Duhig Stainless
More Drinks Anheuser Busch

Thank you Hole Sponsors!

Alphabio

AV Infinity Construction Inc.

DL Engineering

Kinetics

Pharmaceutical Services Corp.

First Place Team Kinetics and 2nd Place Team AV Infinity
Construction pose with Susana Stephanie De Fazio. Vector Corporation
 INTERPHEXCalifornia Overview
by Kimberly Syre, Chapter Manager

S everal ISPE members worked to put on this year’s ISPE

San Francisco/Bay Area and Greater Los Angeles
Chapter seminars at INTERPHEXCalifornia in San Jose
on September 24th. The speakers and program managers all
volunteered their time and talents to put together well rounded
presentations to help educate our members.
A special thank you goes out to Manmohan Sihra of
Pharmaceutical Systems, Inc., the Chapter’s Past President, who
inspired executives from the industry’s top firms to present.
Manmohan was the program manager for the morning session
“GMP for Pharmaceutical & Biotech Industries”. Ross A. Caputo,
Ph.D., CEO of PSI (Pharmaceutical Systems, Inc.) flew from
Mundelein, Illinois to make the presentation. Topics covered
were design, construction, commissioning, and qualification of
biopharmaceutical facilities and the challenges to meet cGMP
regulations.
Issues in Research Facilities”. The facilitator was Jim
Andrews, Associate Director, Technical Operations, Nektar
Therapeutics.
Presenters:
Gerhard Knutson, Knutson Ventilation in Edina, MN presented
“An Application of Low Flow Hoods In a Biochemical
Research Building”.
Broken arm and all, Jeff Tarter, Principal Chemical Engineer
at Integrated Engineering Services presented “Corralling sol-
vents within Fire Code Limits: Solvent Waste & Solvent
Distribution”.
A Panel discussion followed with the speakers and
Jim Messelbeck, Director EHS and San Francisco Chapter
Co-President, Melody Spradlin, Senior Manager Labs &
Office Group both of Genentech in South San Francisco.

Thank you to Denise Luckhurst of DL Engineering, the Chapter’s

current President for managing the afternoon session “Global
Standardization: Challenges and Opportunities: How Do
Companies with Multiple Locations Standardize their
Operations?”

Presentations on this session were made by:

Christine Farner, Director of Engineering, Corporate Engineering
Capital Projects, Amgen in Thousand Oaks. Christine spoke
about the standards at Amgen: Corporate Engineering and
Capital Projects.

Jon Reed, Executive Director, Site Services/Engineering Aventis

in New Jersey presented “Best Practices Standardization”.

John Quick, former Corp Vice President, Worldwide Quality,

Baxter in Deerfield, IL was the presenter for “Management’s Role
in Quality Management”.

Bruce Little, Consultant, Quality Systems Consulting Services

KMI, a division of PAREXEL International, LLC from Gainesville,
FL presented “Global Standardization Through Quality Systems”.

The second afternoon session was sponsored by ISPE San

Francisco Chapter “Engineered Solutions to Environmental
 WELCOME NEW CHAPTER MEMBERS
August - September 2003 ISPE Greater Los
Chris Ballew, Sani-Tech West
John Becker, AIA, Architect, Perkins & Will
Michael Ferletic, President, MDF & Associates, Inc. Angeles Chapter
LoriAnn Gazzola, Invensys
Paul R. Genis, Amgen Inc
Amada Hammonds, Benefits Coordinator - HR, NBTY extends our thoughts
Aaron C. Jenkins, Engineer, The Norac Co Inc
Douglas M. Kennett, Clinical Liaison, Amgen Inc
Nick Kosowski, Principal Eng, Baxter BioScience and prayers to all who
Allison Marks
Alejandra Ortiz, Validation Specialist, PharmBio Inc
Romesh Patel, Quality Engineer, Watson Pharmaceuticals Inc have suffered a loss in
Bede Rafols, CAD Designer, Watson Pharmaceuticals
Susan R. Sandoval, Supervisor Maint Planning & Sched, AMGEN
Vanessa Seto, Project Engineer, Pharmaceutical Services Corp
the recent southern
Peggy Smith, MRI of Huntington Beach
Ted Torosian, QC Compliance Specialist, Grifols Biologicals
Jamie W. Watts, Student, St Micro
California firestorms.
James Yeates, Sr. Compliance Auditor, Gilead Sciences

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 DOES YOUR COMPANY OFFER SERVICES OR SUPPLIES TO THE
PHARMACEUTICAL OR BIOTECH INDUSTRIES IN CALIFORNIA?

2004
ISPE C ALIFORNIA
RESOURCE DIRECTORY
5
T HE S O C I E T Y FOR LIFE SCIENCE PROFESSIONALS
101

Sacramento
River

sponsored by the ISPE California Chapters

80

Sacramento
YOSEMITE
NATIONAL
Oakland Stockton PARK
San Francisco
580

GREATER LOS ANGELES

680
Sunnyvale San Jose KINGS CANYON
San Joaquin NATIONAL
River PARK

Fresno
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SEQUOIA
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5 NATIONAL
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MONUMENT

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101 Pasadena Colorado
San Bernardino River

SAN FRANCISCO/BAY AREA

Los Angeles
Riverside
Long Beach 10

8
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The ISPE California Resource Directory is an invaluable way

for companies to inexpensively reach the decision makers and
connect with those purchasing products and services.
Why Advertise?
* ISPE is experiencing an incredible growth as an organization,
here is your opportunity to share the excitement
* In one year, the ISPE California Chapters have experienced a 25% growth
(from 1700 members last year to 2120 currently)
• Directory Distribution is to the 2120 ISPE members in California
• Also Distributed at Chapter events to reach non-members
• Available in book format and CD
• Discounted rates for ISPE members
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• Each ad or listing includes: Deadli nt
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• Your Company Listing ork:
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• Non Member ad fee includes One year
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2003 advertisers - watch your email box

for 2004 Insertion Order. Q UESTIONS ? C ALL 949/366-1056
F ROM S AN F RANCISCO CALL 888/275-0189
www.ispe.org/greaterla
F ROM S AN D IEGO C ALL 800/869-9621
 DAVID P. SISTO
9265 Dowdy Dr., Suite 114 1933 O’Toole Ave., Ste. 104
San Diego, CA 92126 San Jose, CA 95131
Tel: (858) 566-5442 Tel: (408) 435-9119
Fax: (858) 566-5564 Fax: (408) 435-1155

Visit our Website at

www.puritysystems.com

tion
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ontro
C

ISPE LA BOARD OF DIRECTORS

President Denise Luckhurst DL Engineering (818) 525-1827 denise@dlengineering.net
Vice President Zawdu Eshetu Watson Laboratories (909) 493-5720 zeshetu@watsonpharm.com
Treasurer Matthew Atwong Baxter Bioscience (818) 550-2458 matthew_atwong@baxter.com
Secretary Stu Levenshus M.D. Stainless Services (562) 904-7022 stulevenshus@aol.com

Director Ken Balmer Cal-Chem Corp. (626) 442-6784 kbalmer@cal-chem.com

Program Co-Chair Michelle Gonzalez Amgen, Inc. (805) 447-6358 mgonzale@amgen.com
Director Howard Greene, Ph.D. Optimum YIeld (949) 218-9450 hgreene@optimumyield.org
Student Affairs Chair Damon Jones McGuff Pharmaceuticals (714) 918-7277 damon@mcguff.com
Communications Chair Bob McCollough Baxter Healthcare Corp. (805) 480-2253 bob_mccollough@baxter.com
Education Chair Elaine Messa Quintiles Consulting (949) 737-1505 elaine.messa@quintiles.com
Vendor/Social Chair Bill Neal Duhig Stainless (323) 263-7161 wneal520@attbi.com
Director John Sosoka P2S Engineering Inc. (562) 497-2999 jrs@p2seng.com
Director Doug Stockdale Stockdale Associates, Inc. (949) 888-9488 douglas@stockdale-inc.com
Program Co-Chair Scott Tiedge Alphabio (949) 858-4999 stiedge@alphabio.com

Past President Manmohan Sihra Pharmaceutical Systems Inc. (949) 458-6553 msihra@pharmsystems.com
 ISPE LA CHAPTER CALENDAR OF EVENTS
The Society for Life Science Professionals

www.ispe.org/greaterla
111 E. Ave San Gabriel, San Clemente CA 92672
(949) 366-1056 phone • (949) 366-1057 fax • ksyre@ATDManagement.com
Fed Tax I.D. #95-4452996

2003
Nov 2-6 ISPE Annual Meeting, New Orleans Marriott, New Orleans, LA

Nov 13 Evening With An Industry Executive

Presenter: Art Le Blanc, President, Sicor Pharmaceuticals at Irvine Marriott

Dec 4 Commuter Conference TBD

Dec 12 Newsletter Deadline - Issue #1, 2004

2004
Feb 12 FDA Dinner Meeting

March 12 Newsletter Deadline - Issue #2, 2004

May 13 ISPE LA Vendor Night at the Queen Mary

July 12 Newsletter Deadline - Issue #3, 2004

Sept 3 Newsletter Deadline - Issue #4, 2004

Sept 28-30 INTERPHEXCalifornia at Moscone in San Francisco

Oct 24-28 ISPE Annual Meeting, San Antonio Marriott River Center, San Antonio, TX

Nov 4 Evening with Industry Executives

Dates subject to change based on availability of speakers and venues.

Meeting announcements are sent via email.