Nanc
Published by the I S P E PNW Chapter
Serving Washington and Oregon
Editor: Laura Dougherty: aminc4@comcast.net
Ph 1.877.460.5880 Fax 1.253.265.3043
IN THIS ISSUE
February Event
Directors.
Welcome New Member
President’s Message
Jan 31st Event Recap
Advertise with ISPE
Critical Utilities & Aseptic
Conference
Communities of Practice
News from International
Submit Your
Articles!
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Click here to submit your articles for next month’s Newsletter.
All suggestions will be reviewed by the Board of
th
Georgetown Brewing Company
5200 Denver Ave. South, Seattle, WA 98108
Click here for directions
Agenda:
6:00 pm - Registration & Networking Followed by program, tours & tastings!
Light refreshments will be provided
Cost:
$20/ ISPE Members $40/ Non-Members FREE/ Student & 1st time ISPE
PNW Chapter attendees
Michael S. Weston, Evergreen EDC

194 active members as of February 7th.

ISPE PNW – Serving the biopharmaceutical industy since the mid-nineties.
Join us for a fun tour of Seattle's Georgetown brewery and sample their current selection of beers in their Tasting Room.
Location:
I S P E P AC I FI C N O R THW E S T C H AP TE R NE W SL E TTE R February 2013 PAGE 1

by Erik Westover
Thank you to all who attended the sustainability event last Month. We also thank our speakers, Dan Seng
(Perkins Will), James Jenkins (BNBuilder's
Sustainability Manager) and Brian Antonsen
(McKinstry), our host Perkins + Will and sponsor
McKinstry. We look forward to more discussions about the use of LEED and other sustainable strategies in pharmaceutical and life science projects at future events.
We hope to see you all on February 28 th
for our annual
Georgetown Brewing Company tour. The folks at the brewery are excited to show off their new automated keg wash/fill line and have you taste their latest creations. We will also have plenty of giveaways.
This is one of our most popular events so register early.
As I mentioned in my last letter we are looking to fill spots in our calendar with events that interest our members. If you have a topic of interest or a facility that you would like to show off please contact Katie at aminc2@comcast.net
or me.
Open Dates: March 21 st
, April, 25 th
, May 23 rd
.
Thank you again for your support and see you on the
28 th
.
Our January event focused on sustainability in the Life
Sciences market. With three speakers discussing three different projects and three different perspectives of sustainability, it was a very informative program. Discussion included the design of sustainable buildings that integrate with their surrounding habitat, re-using portions of retrofitted buildings, saving water through sterilization equipment, and reducing waste through innovative prefabrication.
Thank you to our speakers; Dan Seng (Perkins Will),
James Jenkins (BNBuilder's Sustainability Manager) and Brian Antonsen (McKinstry). And a big thanks to our host Perkins + Will as well as our sponsor,
McKinstry.
Networking with dedicated like-minded professionals!
ISPE offers some of the best networking opportunities you will find in the industry. Whether it's through our extensive international network of Affiliate and
Chapters , our discipline-specific Communities of
Practice , volunteering on ISPE initiatives or at dedicated networking events at ISPE conferences ,
ISPE is your gateway to connecting with the top technical minds in your region and all over the world.
Learn more
Your Board of Directors needs your help. Contact the
Association office at aminc2@comcast.net
if you are interested in joining a committee!
I S P E P A CI F I C N O RT HW E ST C HA P TE R NEW SL E T TE R February 2013 PAGE 2

ONLY $100 Per Quarter (3 newsletters per quarter) or $400 for an Entire Year (12 newsletters)!
It's a great, economical option for your advertising dollar!
Click here for more information!
As a Website Sponsor, your firm's logo will randomly rotate through six pages of the ISPE PNW Chapter website for all of 2013!
Cost – ONLY $150 per Ad!
Contact the Association Office at aminc2@comcast.net
or
Toll Free 1-877-460-5880 to secure your
Newsletter & Website sponsorship today!
Connect with like-minded pharmaceutical industry professionals through one of our 19 interactive online communities offering exclusive global networking opportunities and access to a community-specific body of knowledge.
COPs are now only available to ISPE Members. Join
ISPE today to ask questions and share your expertise in online discussions and access technical articles, E-
Letters and other valuable resources that will assist you in increasing your effectiveness.
Click here to join a COP today!
I S P E P A CI F I C N O RT HW E ST C HA P TE R NEW SL E T TE R February 2013 PAGE 3

(TAMPA, FLORIDA, USA, 06 February 2013)
–
ISPE , a leading authority on publishing best practices documents for the pharmaceutical industry, announced today that it has issued groundbreaking guidance to help companies involved in clinical trials determine which medications qualify as non-investigational medicinal products (or
NIMPs). The document also contains practical strategies for risk management as it relates to classifying, sourcing and packaging NIMPs.
“Until now, there has been no clear guidance to help define
NIMPs and their use. As a result, many pharmaceutical companies take a cautious approach and treat all study medications as investigational medicinal products. Since the regulatory requirements for IMPs are so much more stringent than for NIMPs, these companies are subjecting themselves to unnecessary complications and expense,” said Esther Sadler-Williams of Catalent Pharma Solutions, one of the Guide’s lead authors. “This guidance answers many of the questions surrounding what constitutes a NIMP versus an IMP, and gives practical advice for simplifying the use of NIMPs.”
The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products helps companies who operate studies in multiple countries devise strategies for risk-management that take into account country-specific rules and regulatory requirements. It clarifies issues related to NIMP supply chains and outlines how the sourcing strategy employed for NIMPs can impact a number of the manufacturing and clinical site aspects for the complete clinical trial.
The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products is available for purchase on the ISPE website .
Sponsored by ISPE, INTERPHEX, and Pharmaceutical
Processing magazine, the Facility of the Year Awards
(FOYA) is an annual program recognizing state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a superior project, as well as reduce the cost of producing high-quality medicines. Now in its ninth year, the awards program effectively demonstrates the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
The winning companies and respective award categories are:

Biogen Idec, winner of the Facility of the Year
Award for Facility Integration for its Flexible Volume
Manufacturing (FVM) Project in Research Triangle
Park, North Carolina USA.

F. Hoffmann – La Roche , winner of the Facility of the Year Award for Project Execution for its TR&D –
Building 97 Facility in Basel Switzerland.

MedImmune , winner of the Facility of the Year
Award for Equipment Innovation for its UK
Automation Upgrade Project in Speke, Liverpool UK

Merck & Co., Inc.
, winner of the Facility of the Year
Award for Operational Excellence for its Vaccine and Biologics Sterile Facility (VBSF) Project in
Carlow Ireland

Morphotek, Inc.
, winner of the Facility of the Year
Award for Sustainability for its Morphotek Pilot Plant in Exton, Pennsylvania USA

Novartis Vaccines and Diagnostics , winner of the
Facility of the Year Award for Process Innovation for its U.S. Flu Cell Culture Facility in Holly Springs,
North Carolina USA
The International Society for Pharmaceutical Engineering (ISPE) is an international society consisting of over 22,000 members in 90 countries. ISPE facilitates venues for networking, interaction, and information sharing within the region and provides publications, conferences, and trainings on a wide variety of topics from Good Engineering Practices to
Quality Risk Management. Our membership constituency is made up of professionals from the biotechnology, pharmaceutical and medical device manufacturers and other supporting industries such as academia, equipment manufacturers, and construction/architecture.
I S P E P A CI F I C N O RT HW E ST C HA P TE R NEW SL E T TE R February 2013 PAGE 4