ispe
ISPE Delaware Valley Chapter cordially invites you to our monthly program
 
Dual Track Event
Track One: Need for Systems Approach to Sustainability from HVAC and Energy Utilization Perspectives
 
Track Two: CIP Technology in GMP Manufacturing: A Case Study Applying BPE Design Standards 

 

DVC Monthly
Program:

Location:

Doubletree Guest Suites - Philadelphia West
 
Date: 
 
April 13, 2010
 
Time:  5:00pm
 
Directions:
 
Click Here For Directions
Upcoming DVC Monthly
Events:  
 
April Education Event
 
April 27, 2010
 
Annual Golf Outing
 
May 3, 2010




 
ispe
 

Dear Member: 

 
Welcome to our April program!  This month we have an excellent Dual Track offering for our members and guests. 
 
For Track One, we have an expert speaker from Penn State who will educate us on high performance building initiatives.  This continues to be a key industry issue for both new construction and existing facilities.
 
Our second track will overview the new edition of the ASME BioProcessing Equipment standard, issued in Fall 2009.  Both of our Track Two speakers are active members of the BPE standards committee and will provide case study examples of how the standard has been applied from an Owner and Vendor perspective.
 
Please register below, feel free to bring guests, and we look forward to seeing you on April 13th.

Dan Bristow
VP Programs
Program Details
 
WHEN:
Tuesday, April 13, 2010
 
WHERE:
Doubletree Guest Suites Philadelphia West
640 W. Germantown Pike
Plymouth Meeting, PA 19462
 
TIME:
Registration: 5:00 - 6:00pm
Dinner: 6:00 - 7:00pm
Presentation starts: 7:00pm 
 
COST:
Members - $60 
Non-Members - $85
Students - Free 
 
REGISTRATION:
 
If you believe there will be a large attendance from your company, please contact Ron Dunn (610-351-3874) to discuss the details of a group rate
Program Topic Summary
 
Track One 

As leader of Penn State University's Center for High-Performance (CHiPBS) and the newly-formed, DOE-sponsored Clean Energy Alternatives Center (CEAC), Dr. Freihaut is a recognized authority in the efforts to promote more energy-efficient and environmentally benign building operations.  His talk will focus on historical performance of the US building stock, barriers to improvement and key technologies and systems necessary to transform building operations by reducing energy consumption and greenhouse gas emissions.  Dr. Freihaut will also give a brief presentation about Penn State's CHiPBS and CEAC and how these consortia of business, industry, academia and government are structured to bring about this change.

 Track Two

 

This presentation will provide a brief on the requirements and resources published in the new 2009 edition of the BPE, and provide case studies on how the standard has been applied to improve GMP manufacturing operations.  The publication of the ASME BPE standard last year nearly doubled the content relating to the design of process systems and facilities in the pharmaceutical industry.  The focus of this presentation will be on applications of the BPE to new and existing facilities for enhanced process equipment cleanability and bioburden control.

Speaker Bios
 
SPEAKER BIOS  
 
Track One
JAMES D. FREIHAUT, PhD.
 The Pennsylvania State University
Associate Professor, Director, Indoor Aerosol Laboratory
 
Dr. Freihaut is James Freihaut holds a B.A. in Chemistry/Philosophy from Christian Brothers University in Memphis, Tenn., a M.Sc. in Natural Science - Physical Chemistry from Rensselaer Polytechnic Institute in Troy, New York, and PhD. in Fuel Science from Pennsylvania State University. 
 
Before returning to Penn sate University to assist in the formation and research of the Indoor Environment Center, Dr. Freihaut served in various environmental research and research management positions at United Technologies Research Center, including Director of the UTRC + Carrier Corporation Indoor Air Quality Program. 
 
Dr. Freihaut holds six patents spanning inventions in environmental remediation technology, hydrogen storage, independent dehumidification, and photocatalytic air filtration. His current research emphasis focuses on the re-suspension of biocontaminant particles in building air systems, the dispersion of allergen and toxin in building air systems; real time detection, capture and active neutralization of the allergic and toxic properties of such aerosols and single building applications of novel combined heat and power systems.
 

Track Two
PRESENTERS: David Marks (DME Alliance, ASME BPE Design Chair) and Scott Hartner (sanofi pasteur)
 
 
David M. Marks is president and founder of DME Alliance Incorporated.  He has 25+ years of experience in the specification, design and implementation of process systems.   He is a frequent author, speaker and consultant on bioprocess technology, facility/equipment design & compliance topics.  His professional experience is concentrated in the design, scale-up and implementation of bioprocess systems for FDA-licensed facilities.  Areas of expertise include bioprocess equipment design, cell culture & fermentation process systems, contamination control, Single Use, CIP and SIP technology applications.  Prior to founding DME Alliance in 1998, he managed the engineering department for Associated BioEngineers and Consultants.  He is active on the ASME Bioprocess Equipment (BPE) standard committee, and serves as chairman of the design for cleanability and sterility subcommittee.  A graduate of Lafayette College, Mr. Marks holds a BS in Chemical Engineering and is also a registered Professional Engineer. 
 
Scott Hartner is a Deputy Director of Process Engineering with sanofi pasteur.  He has 17+ years of experience in the specification, design and implementation of process systems, 10 years in Biopharm.   His professional experience is concentrated in process design, startup and operational support of Biopharmaceutical facilities. Areas of expertise include process equipment, CIP, SIP and filtration systems.  He began his career in the oil & gas and air separations businesses before joining Aker Kvaerner in 1998. He has been with sanofi pasteur since 2003.  He is active on the ASME Bioprocess Equipment (BPE) standard committee, serves as a member of the design for cleanability and sterility subcommittee.  A graduate of Rutgers University, Mr. Hartner holds a B.S. in Chemical Engineering and is also a registered Professional Engineer.
 
Both David Marks and Scott Hartner serve on the design subcommittee for the ASME BPE and participated in the task group to develop the new CIP design section in the 2009 BPE standard.
Program Sponsors
 
DME Alliance

DME Alliance

 

International Society for Pharmaceutical Engineering

International - www.ispe.org

 
 

Delaware Valley Chapter -www.ispe.org/delawarevalley

 
 
ISPE - Delaware Valley Chapter
1797 Chapel Avenue
Allentown, PA 18103

Phone - 610/351-3874

Fax - 610/351-9136    
www.ispe.org/delawarevalley
 
Chapter Manager: Ron Dunn
 
 
ispe
 

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