Incoming President`s Message

Published by the ISPE San Diego Chapter
Serving Southern California San Diego to Orange County
Editor: Kimberly Syre Email: ksyre@cox.net
Information: Phone 1.949.387.9046 and Fax 1.949.387.9047
NEWSLETTER • Volume 16, No. 2 • www.ispe.org/sandiego
ISPE’s 2007 and 2008 Platinum First Place Award Winner for Excellence and Innovation
In this issue
President’s Message
PAGES 1 & 2
Nov 6 Genentech Tour and
Energy Optimization Workshop
PAGES 3-4
September Meeting at Amylin
Overview
PAGE 5
2009 ISPE Directory Now
Taking Submissions
PAGE 6
Padre Game Photos
PAGE 7
ISPE Brings Training to
San Diego
PAGE 8
Golf Tournament Photos and
Winners
PAGES 9-11
Board of Directors
PAGE 12
Vendor Night Photos and
Thank You to Exhibitors
PAGES 13-14
New Chapter Members
PAGE 15
Technical Article:
T-Tube Insulation
PAGE 16
ISPE Tampa Conference
PAGE 17
2008 ISPE Event Calendar
PAGE 18
At the September meeting at Amylin, President Andy Darragh gives a donation to the Juvenile
Diabetes Research Foundation. The Chapter makes several donations each year.
Incoming President’s Message
by Andy Darragh of Ferguson Pape Baldwin Architects
Fall is upon us and the year is quickly coming to a close. Our Chapter has had an exciting summer with a variety of educational programs and social events including two events in
September, a Padres vs Dodger game coordinated by Ashlee Ujifusa of ProcessHQ a case
study of Amylin’s Ohio Manufacturing Campus hosted by Dan Cooper of Amylin.
Vendor Night in August featured a presentation by Tunde Osunsanmi who is part of the Team
Biologics for the FDA. She explained how the FDA performs Quality Systems Audits, offered
tips on what to expect, how to manage it and how to make it go smoothly. She also cited
examples of some common and not-so-common 483 citations and how to avoid making similar
mistakes.
This was preceded by a roundtable discussion comparing single-use bag technologies with
traditional stainless steel vessels for bioreactors in the biopharmaceutical industry. Thanks to
E.J. Brandreth, Ed Domanico and George Moyer for participating. We learned that each system has ideal applications and the decision will most likely be based on size of initial cost vs.
the cost of operating the facility over its lifespan.
(continued on next page)
President’s Message (continued)
The following day, 170 golfers teed off at Twin Oaks Golf
Course in San Marcos. Hole sponsorships were expanded
this year to allow theme holes which made the tournament a
lot more fun and interactive. Hats off to Albert Marquez and
the Golf Committee for another great event.
Efficiency: Doing More with Less. That theme will apply to
energy savings, operational efficiency, automation, risk-based
validation, lean manufacturing and several other topics we
have planned. These topics will be relevant to industry trends
and the current situation for most of our Members.
Thank you to all of the local companies who have sponsored
and hosted events this year. Biogen Idec, Amylin, Genentech,
Invitrogen, Biosite and Mira Costa College (see next newsletter for photos) have all opened their doors to us and that benefits our Chapter tremendously.
We are actively seeking Members to serve on all of our
Chapter committees. You can join Membership, Programs,
Golf, Vendor Night, Communication or the Student Affairs
committee by contacting Kimberly Syre at ksyre@cox.net.
We hope that you all are riding out these tough economic
times and remain employed in the industry. If you are one of
the unfortunate ones to be unemployed, we encourage you
take advantage of the vast resources that ISPE has available
on both the local and international level. Post your resume
and search job listings in the Career Exchange section of
the Web site (www.ispe.org/career), join a Community of
Practice (www.ispe.org/cops) to broaden you education base
and attend events taking advantage of the Chapter’s new discounted rate. For instance, the price to attend the November
6 meeting at Genentech for our unemployed Members is $25.
We want to do everything we can to support our members
and maintain a thriving local life-science community.
We are looking forward to another great tour at the Genentech
facility in Oceanside on November 6, and an ISPE training
event at the Marriot in Old Town November 17-20.
We plan to continue this momentum into next year. The Board
of Directors has just returned from our Strategic Planning
retreat, where we generated lots of ideas for programs and
social events for next year. The theme for 2009 will be
As I start my term as Chapter President, I’d like to thank Ed
Domanico for his leadership and dedicated efforts over many
years and especially during the last year while he has been
our President.
Andy
I look forward to seeing all of you at an event very soon.
CCS Bus Card Ad
5/30/08
11:02 AM
Page 1
CONTROLLED CONTAMINATION SERVICES, LLC
Specializing in:
• Biotech
• Pharmaceutical
• Medical Device
• Aerospace
• Semiconductor
• Training and Consulting
• Hi-Performance Green Cleaning
Servicing accounts throughout
the USA for over 15 years.
Call Toll-Free:
1.888.263.9886
www.cleanroomcleaning.com
Engineering
Architecture
Process Technology
Process Automation
Systems Integration
Construction Management
Nino Borsoni, PMP - Senior Vice President
borsoni@eichleay.com
p. 925.363.3112
f. 925.689.7006
Startup & Commissioning
Procurement
Project Management
2
Genentech
Facility Tour
with
Energy Optimization Workshop
Thursday, November 6, 2008
Location: Genentech
One Antibody Way, Oceanside, CA 92056
Program Managers:
Mike Barbera, Senior Project Manager, Project Management Advisors, Inc.
Carl Hixon, Senior Engineer, Genentech, Inc.
Host: Carl Hixon, Senior Engineer, Genentech, Inc.
Sponsored By:
Dynalectric
Siemens Building Technologies
Veriteq Instruments
SCHEDULE
3:45 - 4:00 pm
Registration
4:00 - 4:15 pm
Welcome by Carl Hixon of Genentech
4:15 - 5:30 pm
Energy Optimization Workshop
Presented by Pete Myers and Eric Neinheist of Siemens
5:30 - 6:00 pm
Q&A
6:00 - 6:15 pm
Overview of Genentech
Presented by Christoph Lebl of Genentech
6:15 - 7:30 pmTour of Genentech and Reception with Appetizers and Drinks
COST: $50 Members / $70 Non-Members / $25 Student/Government/Unemployed Member Rate
Please Note: This is a unique opportunity for those interested in joining ISPE. Typically our facility tours are open
to ISPE Members only, however, we have decided to open this event up to Members and those interested in joining
but want to attend a meeting first.
3
Genentech Facility Tour
with
Energy Optimization Workshop
Thursday, November 6, 2008
4:00 - 7:30
pm
Location: Genentech
One Antibody Way, Oceanside, CA 92056
Program Manager:
Mike Barbera, Senior Project Manager, Project Management Advisors, Inc.
Host and Program Manager:
Carl Hixon, Senior Engineer, Genentech, Inc.
Sponsorships are available
Please contact Kimberly Syre to inquire: ksyre@cox.net
Please Note: This is a unique opportunity for those interested in joining ISPE. Typically our facility tours are open to
ISPE Members only, however, we have decided to open this event up to Members and non-members interested in
joining but who want to attend a meeting first.
REGISTRATION FOR ISPE SAN DIEGO GENENTECH EVENT - November 6, 2008
For an immediate receipt and confirmation, please use our online processing system:
http://event-confirmation.com/ispesd_meetings.htm
Otherwise you can use this form to register. Complete this form with credit card payment and fax it to
one of these fax numbers 949-266-8461, 949-387-9047 or 949-387-9043.
If paying by check, first fax your registration form to secure your spot, then mail your check made payable to:
ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641, Irvine, CA 92612. Tax ID #33-0551783.
Chapter Hotline 800-869-9621 or 949-387-9046. Sorry, No Substitutions or Walk-Ins.
First Name:
q
q
q
Last Name:
Title:
$50 ISPE Members
$70 NonMembers
$25 Student/Government/Unemployed Member Rate
ISPE Member:
Chapter Affiliation:
Company:
Address:
CREDIT CARD PAYMENT
City:
State:
Tel Number:
Fax Number:
E-Mail:
Zip:
Type of Credit Card
Circle One
Name on Card:
Credit Card #:
Exp Date:
Signature:
S
September Dinner Meeting Overview
by Dan Cooper of Amylin Pharmaceuticals, Inc.
ixty ISPE members attended the September dinner meeting hosted by Amylin Pharmaceuticals, Inc. The evening began
with a donation by the Chapter to the Juvenile Diabetes Research Foundation.
The presentations included a one hour session on conducting a Hazard Review (Hazop). The presenter was Dan Drown, Sr.
Manager of EH&S at Amylin. Some of the topics covered were the purpose of performing Hazop, issues encountered, types of
Hazop, timing, Basic Hazop worksheet, who participates in these activities, and common mistakes in performing Hazop.
This was followed by dinner and a presentation on the Amylin Ohio construction project presented by Mujtaba Ali, Director of
Project Engineering at Amylin Pharmaceuticals, Inc. Some of the main topics covered were the facility size, facility layout, construction timelines, and lessons learned on the project. Thank you to our sponsors of the event: Parsons and Siemens Building
Technologies.
5
DOES YOUR COMPANY OFFER SERVICES
PHARMACEUTICAL
OR
BIOTECH INDUSTRY
OR
SUPPLIES
ON THE
TO THE
WEST COAST?
2009
ISPE WEST COAST
RESOURCE DIRECTORY
ALL ADS
ARE
4-COLOR!
sponsored by the following ISPE Chapters
GREATER LOS ANGELES
PACIFIC NORTHWEST
SAN DIEGO AND
SAN FRANCISCO/BAY AREA
The ISPE West Coast Resource Directory is an invaluable way for
companies to inexpensively reach the decision makers and connect with those purchasing products and services.
Available in Book, CD and Electronic Versions:
• Book version is mailed to nearly 2800 ISPE members on the West Coast.
• CDs are available at Chapters events.
• The electronic version is posted on all four ISPE Chapter Web sites:
www.ispe.org/greaterla
www.ispe.org/sandiego
www.ispe.org/sanfrancisco
www.ispe.org/pacificnorthwest
Reserve Your Ad Today by Visiting:
http://event-confirmation.com/ispela_meetings.htm
QUESTIONS? CALL 949/387-9046
FROM SAN FRANCISCO
CALL
888/275-0189
FROM SAN DIEGO CALL 800/869-9621
6
ne for
Deadli Artwork
nt &
Payme
r 19
be
Decem 8
200
Padre Game Overview
by Ashlee Ujifusa of ProcessHQ
A
s a Chapter we offer educational and social events. In early September, the Chapter offered another great networking
event, a Padres vs Dodgers game in San Diego. We had a great turnout for this event even though our Padres didn’t do
so well this season and ended up losing the game to the Dodgers. The tickets sold out quickly, a lot in part to the great
success of last year’s event. We all enjoyed food, drink and networking as we watched the game from the picnic terrace. We had
a lot of positive feedback from everyone who attended. This event seems to bring attendees who aren’t at all the other events so
it’s been a great way to network and meet new people. We’d like to thank everyone who attended; it was a lot of fun!
7
http://www.ispe.org/cs/2008_san_diego_training/2008_san_diego_training
For Contamination and
Corrosion Headache Relief
Phone: 760-496-7091 Cell: 760-685-6232
www.crbusa.com www.crbbuilders.com
CONSULTING  DESIGN  CONSTRUCTION  COMMISSIONING  QUALIFICATION
8
Contact Us
AS
T
christy.pavano@crbusa.com
RO
PAKE
L
active ingredients
NO
Christy Pavano
Winners Announced for August Golf Tournament
Photos by Andrew Shipps of Advanced BioHealing and Kimberly Syre
T
he Chapter’s Annual Golf Tournament was expanded this year to include hole sponsors, a putting contest and also included
the dunk tank which made it’s debut at last year’s tournament. We would like to congratulate the winners and sponsors:
1st Place Open Category
2nd Place Open Category
1st Place Handicapped Category
2nd Place Handicapped Category
Blind Draw Champs
Blind Draw Champs
Ladies Longest Drive
Closest to the Pin Winners
Hach Ultra Analytics (Chris Syrengelas, Brian Croll, Mordi Iheme, Louie Halias)
Rudolph and Sletten (Tom Levy, Tony Garcia, Chris Jadwin, Jose Garcia)
CRB Consulting Engineers (Don Holden, Clay Seese, John Landford, Bob McCourt)
Reno Contracting (Erik Kissner, Chris Helm, Phil Pape, Bruce Stokey)
Astro Pak Corporation (Erik Frankl, Kyle Tiedge, Tony Lopez, John Martin)
X-nth (Tim Price, Ed Domanico, Jeff Robertson, Gee Kim)
Becky Moore of ITT Pure-Flo
Joe Hohn, Mark Nelson, Chris Jadwin and Marcus Webb
Dedicated Hole
GF Piping Systems
NextPharma Technologies (formerly Bioserv Corp)
Pacific Rim Mechanical
Multiple Hole Sponsors
Pro-Tech Process
The Validation Company
William-Mateo Regulatory Consultants
Hole Sponsors
Biotek Systems/ProcessHQ
DPR Construction
Harrington Industrial Plastics
Project Management Advisors
Rudolph and Sletten, Inc.
Siemens Water Technologies
Stainless Fabrication
The Valve Shop
Turner Construction
University Mechanical & Engineering
Valin
Wonderware West
X-nth
Theme Hole Sponsors
Advanced Reprographics (dunk tank)
Astro Pak
Calibration Consultants
CRB (putting contest)
Ferguson Pape Baldwin Architects
Siemens Building Technologies
X-Controls
Bloody Mary Sponsor
Coffee Sponsor
Hat Sponsor
Ball Sponsor
Ball Sponsor
Ball Sponsor
Ball Sponsor
Golf Towel Sponsor
Bag Sponsor
Shirt Sponsor
Tee Sponsor
Snack Sponsor
Water Sponsor
Tee Pouch Sponsor
Lip Balm & Sunscreen
Raffle Prizes
Raffle Prizes
9
Pacific Validation
University Mechanical
Bay-Tec Engineering
Dynalectric
Gemu
Pacific Rim Mechanical
Siemens
Turner Pharmaceutical
CRB
Biotek Systems / Process HQ
Duhig Stainless
Attention To Detail
Siemens Water Technologies
Pacific Rim Mechanical
Siemens Building Technologies
University Mechanical
Carbite Golf
More Golf Photos by Andrew Shipps of Advanced BioHealing and
Kimberly Syre, Chapter Manager
10
More Golf Photos by Andrew Shipps of Advanced BioHealing and
Kimberly Syre, Chapter Manager
ROD LEAVITT
Leavitt-Pacific Corp.
Representatives
11
1361 High Street
Tel: 510-865-1655
e-mail: rleavitt@leavitt-pacific.com
Alameda, CA 94501
FAX 510-865-0979
web: www.sharpemixers.com
STERIS
®
STERIS Corporation
STERIS
Life Sciences Group
Southern California
800-989-7575
www.steris.com
In A Sea
Of Change,
Stacey Betts
Some Things
Consumables
Ext.
23218Constant.
Are
®
STERIS Corporation
stacey_betts@steris.com
David J. Spencer
Equipment
ALLEGHENY BRADFORD
CORPORATION
Ext. 23178
david_spencer@steris.com
Regional Manager - Dori Carlson
Skids • Tanks • Valves • Pumps
Heat Exchangers • Filter Housings
STERIS
®
STERIS Corporation
STERIS
®
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
1522 South Ave., Lewis Run, PA 16738
800-542-0650 • www.alleghenybradford.com
STERIS
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
®
STERIS Corporation
Julie Lees
Regional Manager, Southern CA
Life Sciences Group
Southern California
800-989-7575
www.steris.com
STERIS Corporation
STERIS
®
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
619.395.3748 cell
Equipment
Ext.julie.lees@hyde-ec.com
23178
www.hyde-ec.com
david_spencer@steris.com
Life Sciences Group
Southern California
800-989-7575
www.steris.com
STERIS Corporation
Stacey Betts
ISPE Stacey
SanBetts
Diego Chapter Board of Directors
Consumables
Consumables
Ext. 23218
PHONE
stacey_betts@steris.com
J. SpencerFerguson Pape Baldwin Architects (619) 231-0751
President
Andy Darragh,David
Vice President,
Equipment
Ext.Electrical
23178 Designer, CRB Consulting Engineers
Vice President Don Holden, Sr.
(760) 496-3714
david_spencer@steris.com
Treasurer
Christy Pavano, West Reg Dir Bus Devel, CRB Engineers/Builders (760) 496-7091
Secretary
Director
Daniel Cooper, Sr Mgr Instrumentation/Controls, Amylin Pharmaceuticals(858) 642-7185 dcooper@amylin.com
Steven ®Chung,Life
Control
Systems
Sciences
GroupEngineer, Dynalectric San Diego
Southern California
Marty Becerra,800-989-7575
Controller, Pro-Tech Process
www.steris.com
Laura Ellery, Account Executive, Siemens Building Technologies
(858) 712-4723® schung@dyna-sd.com
Life Sciences Group
Southern California
(858) 495-0573 marty@protechprocess.com
800-989-7575
www.steris.com
(858) 693-8711 laura.ellery@siemens.com
Stacey Betts
Mike Fino, Professor,
MiraCosta College
Consumables
Ext. 23218
Carl Hixon, Senior
Engineer, Genentech
stacey_betts@steris.com
DavidEngineer,
J. Spencer
Tim Price, Process
X-nth
Equipment
23178
Ashlee Ujifusa,Ext.
Field
Sales Representative, ProcessHQ
david_spencer@steris.com
Jerry Yaddgo, Sr. Facilities Engineer, Biogen Idec, Inc.
Stacey Betts
(760) 757-2121 mfino@miracosta.edu
Consumables
Ext. 23218
(760) 231-2819 cjhixon@gene.com
stacey_betts@steris.com
David J. Spencer
(858) 597-0555 tprice@x-nth.com
Equipment
Ext. 23178
(760) 730-9376 ashlee@processhq.com
david_spencer@steris.com
(858) 401-8062 jerry.yaddgo@biogenidec.com
STERIS
Director
Director
STERIS
STERIS Corporation
Director
Director
Director
Director
Director
Ext. 23218
EMAIL
stacey_betts@steris.com
David J. Spencer
adarragh@fpbarch.com
Equipment
Ext. 23178
don.holden@crbusa.com
david_spencer@steris.com
christy.pavano@crbusa.com
Past President Edward Domanico, Director of Engineering, Vical Incorporated
STERIS
®
STERIS Corporation
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
STERIS Corporation
(858) 646-1329 edomanico@vical.com
STERIS
®
STERIS Corporation
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
12
Thank You to This Year’s Exhibitors at Vendor Night
Photos by Andrew Shipps of Advanced BioHealing and Kimberly Syre
ABEC, Inc.
Allegheny Bradford
Alphabio Inc.
ARS Enterprises
Astro Pak Corporation
Atlas Copco Compressors
Austin/AEcom
Bay-Tec Engineering
Biokinetics
Cal-Chem Corporation
Camfil Farr/Farr APC
CFM San Diego, Inc.
cGMP Validation LLC
Commissioning Agents, Inc.
CRB Engineers + Builders
DPR Construction, Inc.
Duhig Stainless
Dynalectric
Eichleay Engineers, Inc.
Endress+Hauser
Feldmeier Equipment Co. Inc.
Flow Components Inc
Flow Sciences, Inc.
Fluid Line Technology
Fluor
Gemu Valves, Inc.
GF Piping Systems
GXP Consultants
Hach Ultra Analytics
Harrington Industrial Plastics
Heyes Filters
Hyde Engineering + Consulting
ITT Pure-Flo
Kinetic Systems, Inc.
Magnetrol
MAR COR Purification
Masy Systems INc.
MECO
MKS Instruments
Oakridge Industries, Inc.
Optek-Danulat, Inc.
Pacific Rim Mechanical
Parametric
Paul Mueller Company
PBM Inc. Valve Solutions
Powers of Automation, Inc.
ProcessHQ
Pumping Solutions Inc.
Puretec Industrial Water
Purity Systems, Inc.
Q Applied Systems
Quadrants Scientific Inc.
Reno Contracting
Reotemp Instruments
Rockwell Automation
13
Roplan Inc.
RPA
Rudolph & Sletten Inc
Ryan Herco Flow Solutions
Saint Gobain
San Diego Fluid System Technologies
Sani-Tech West
Sharpe Mixers
Siemens Building Technologies, Inc.
Siemens Water Technologies
Spears Mfg. Co.
Stainless Fabrication, Inc.
Stainless Solutions
Statco Engineering
Steriflow Valve
Steris Corporation
Stonhard, Inc.
SVF Flow Controls
Technical Safety Services, Inc.
The Validation Company
The Valve Shop
Top Line Process
Turner Pharmaceutical
Ultimate Labs
Ultraviolet Sciences
Validation Technologies, Inc.
Valin Corp.
Veriteq Instruments, Inc.
Water Works, Inc.
William-Mateo Regulatory Consulting
X Controls, Inc.
Thank You to This Year’s Exhibitors at Vendor Night
Photos by Andrew Shipps of Advanced BioHealing and Kimberly Syre
14
WELCOME NEW CHAPTER MEMBERS
August - September 2008
Tim Breece, Engineer, Genentech
William Brown, Project Manager, Rutter Hinz
Rick Devenport, Facilities Manager, Amylin Pharmaceuticals
Al Egan, Edwards Lifesciences
Meriber Gonzalez, Student, San Jose State University
Juan Guiterrez, QA Specialist, NovaRx Corp
Randi Hammond, Validation Coordinator, Pacira Pharmaceuticals
Erin Lettow, Dir., Project Mgmt, ISIS Pharmaceuticals
Erin Long, Validation Assistant, Bioserv
Sarah Maruccia, Automation Eng, Genentech Inc.
James McMahon, Abbott Vascular
Vanessa Nguyen, Student, Solano Community College
Jessica Ocampo, QA Associate, Quadrants Scientific, Inc.
Selma Olsen, Solano Community College
Christina Orsini, Validation Specialist III, Sangart, Inc.
Himesh Patel, Student, San Jose State University
Daaniya Rahman, Student, San Jose State University
Philip Russ, Principal Consultant, Innovative Consultants, LLC
David Schultz, Technical Lead, Rutter Hinz
Muhammad Shafiue, San Jose State University
Leslie Stonebraker, Mgr, CTM, Amylin Pharmaceutical, Inc
Myles Sumlin, Automation Engineer, Genentech
Diana Wing, Student, Solano Community College
Brian Wong, Graduate Student, San Jose State University
Cindy Wong, Student, San Jose State University
Lance Wysocki, Senior Validation Compliance Analyst, Amylin Pharmaceuticals
Kenneth Wzorek, Associate Director, Facilities, Biogen Idec
3URFHVV+4,QF
%LRSKDUPDFHXWLFDO3URFHVV6\VWHPVDQG&RPSRQHQWV
$VKOHH8MLIXVD
15
67ZLQ2DNV9DOOH\5G
6DQ0DUFRV&$
WHO
FHOO
ID[
DVKOHH#SURFHVVKTFRP
ZZZSURFHVVKTFRP
T
T-Tube Insulation
by Jay Phillips of CRB Consulting Engineers
here has been a lot of buzz from clients on T-Tube
insulation due to its kynar PVDF material and ease of
installation. T-Tubes were developed in June 2006
specifically for a major biotech manufacturer’s cleanroom
specifications. Their intention was to step away from fibrous
and open-celled materials and they asked UFP Technologies
(T-Tubes manufacturer) to develop a superior insulation that
would replace them.
• Hydrophobic: does not wick moisture or water • Rebounds
upon impact: does not crack or distort • Fire resistant
(extremely low smoke and flame generation, and low toxicity)
• No fungus or bacteria growth • Accepts labels well
Material is unique in terms of the foaming process as well.
Most plastics are foamed using chemical foaming agents,
which introduce toxicity and impurities to resins. In foaming
Kynar PVDF, only nitrogen, an inert gas, under high pressure and temperature is employed. In a 10,000 psi, 500F
autoclave, nitrogen is forced inside the resin and trapped after
rapid cooling. In a lower pressure chamber, resin is slowly
heated in order to get the escaping nitrogen to amplify the cell
walls of PVDF. This result is a highly pure material that is not
contaminated with chemical blowing agents.
UFP Technologies, in a joint effort with Zotefoams, presented
a Kynar PVDF based foam insulation. This resin was chosen
due to its high temperature and chemical resistance qualities. After several months of testing, the client was extremely
pleased with the results and specified the material for cleanroom use for all future installations. In the beginning of
2007, in light of excellent performance reports from the client,
T-Tubes were launched as an alternative cleanroom insulation
for the pharmaceutical, biotech and semiconductor industries.
There are now 18 companies using the product. The largest
users are Wyeth, Genentech, Allergan and Genzyme. And it is
the only insulation and foam in the world approved by Factory
Mutual for cleanroom use.
T-Tubes are available in industry standard stainless steel tube
diameters from 3/8” to 3”, including elbows and tees. Straights
come in 3 ft. sections. They can accommodate reducers, custom fittings and valve covers. Cost is approximately $10 per
linear foot, but the labor savings is upwards of 50%.
From an enduser who is actually using it: “The T-tube stuff
looks great so far...On the main steam header (one inch line,
40psi) I can hold the piping without a problem; it’s slightly
warm but I can hold my hand on it forever. As for cooling I
have not seen any condensation issues. So far the decision to
use this has been a good one. We plan to remove some of the
insulation for periodic checks.”
Some of T-Tubes’ features are as follows: • Accommodate
both steam and chilled lines (Continuous operational temperature range is -50C to 160C) • Takes up little space (1/4” thick
wall) and no jacketing required • Easy to install, modify, and
remove • Can be cut and installed in a live cleanroom, does
not particulate • Re-usable if cut at the tape and reclosed with
fresh tape • Resistant to cleanroom chemicals (up to pH 12)
High Purity Liquid Handling
Products for Pharmaceutical &
Biotech Industries
!
1-800-726-4835
Chris Ballew
Technical Sales Representative
(805) 906-1533 Cell
cballew@sani-techwest.com
321 Irving Dr., Oxnard, CA 93030
www.sani-techwest.com
16
www.ISPE.org/tampa
ISPE
Tampa
Conference
Implementing Development
and Manufacturing Technology
2-5 March 2009
Grand Hyatt Tampa Bay
Tampa, Florida, USA
Sponsorship and Table Top Exhibit
Opportunities Available
>Stand-alone temperature & humidity loggers
>10-Year battery life
>Validation equipment rentals
Keith Loftin
k lo f tin@ve r iteq.com
480 657 9911
w w w.veriteq.com
A Foster Wheeler Company
Susanne Lage’ Cost
Vice President,
17
Business Development
• Process Development
Emeryville, CA
& Scale-Up
Direct: 1.510.594.3003
• Critical Utility Design
sue.cost@biokinc.com
• cGMP Upgrades
www.biokinc.com
• cGMP Facility Design
• Debottlenecking
• Custom Process Equipment
• Commissioning/Qualification/Validation
ISPE Event Calendar
Theme for 2008 ISPE San Diego Chapter
R&D to GMP
ISPE SAN DIEGO
CHAPTER
5319 University Dr., Suite 641
Irvine, CA 92612
Chapter Hot Line:
(800) 869-9621 or
(949) 387-9046
-------------------Fax:
(949) 387-9047 or
(949) 266-8461
For advertising information:
www.ispe.org/SanDiego
_______________________
ISPE is a global, not-for-profit
membership organization that
provides education, training, and
technical publications to
pharmaceutical manufacturing
professionals.
Join ISPE Today For Great
Membership Benefits:
• Member Only Events/Facility Tours
• Discounts to Educational Programs
and Technical Documents
• Subscription to Pharmaceutical
Engineering magazine, with access to
on-line article archives
• Connection to more than 25,000
Members from 90 countries through
an on-line Membership Directory
and More!
PHOTO CREDITS
Cover Photo from fotolia.com:
by photographer Armin Sepp
Other Photos
Marty Becerra, Pro-Tech Process
Kimberly Syre, Attention To Detail
6 November
Energy Optimization Workshop
and Genentech Tour
17-20 Nov
ISPE San Diego Training
Lower Production Costs, Improve Process
Efficiency, Increase Production Quality, and
Meet Regulatory Requirements
Theme for 2009 ISPE San Diego Chapter
Efficiency: Doing More With Less
15 January
Social Event
19 February
Dinner Meeting “Energy Savings”
at Biogen Idec
2-5 March
ISPE Tampa Conference
25 March
Full Day Risk Based Validation Class
at Biogen Idec
16 April
Dinner Meeting “Lean Manufacturing”
1 May
Spring Golf Tournament
1-4 June
ISPE Washington Conference
July
Padre Game Social Event
August
Vendor Night and Golf Tournament
24 September Full Day Automation Class
15 October
Full Day Bioprocessing Class
at MiraCosta College
15 October
Oktoberfest
8-12 Nov
ISPE Annual Meeting in San Diego
All events subject to change due to availability of venue/speakers.
To Register for Any ISPE SD Meetings:
http://event-confirmation.com/ispesd_meetings.htm
Chapter Web site: www.ispe.org/sandiego
ISPE’s Global Calendar
and Additional ISPE Educational Offerings and Publications:
www.ispe.org
18