A/E Disciplines - Educational Series
November 10, 2009
Through
May 25, 2010
Session:
Part 5 - ABC's - All about Bioreactor
Controls
March 30, 2010
5:30PM - 9:00PM
Location:
GSK's Upper Merion Campus in King of Prussia, PA
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Dear Member:
This month the ISPE-DVC Education Committee is teaming up with the International Society of Automation (ISA) to present a three-hour workshop covering the "ABC's" of Bioreactor Process Controls and Automation. Our presenters from ISA, GSK and Centocor will offer their knowledge, experience, and perspective on this challenging topic. As with our other monthly education series events, this event will be priced at $30 for members and $50 for non-members, and this offer is extended to our friends at the ISA as well. For this special education evening, we have reserved the main auditorium at GSK's Upper Merion site in King of Prussia. The session will run from 5:30-9:00pm and dinner will be provided. We hope to fill most of the seats, so if necessary, attendance will be held to the first 200 people to register between the two societies. In other words, you'll want to register early for this one!
Part of the goal of this year's education theme is to encourage cross-training. To this end, our April event will be a wrap-up session and engineering design competition to see what everybody has learned so far. Our presenters for next month will be developing a faux design scenario to develop a bioreactor suite. We plan to split up our attendees into design teams where each team member will put on the hat of an architect or an engineer in a discipline other than their own. The teams will be turned loose for 2 hours to develop their designs, and then present their designs to the group. A winning team will be crowned, and a prize will be awarded. This is an original event for DVC, so we hope everybody will come out to show their engineering chops in a discipline that's not their own.
Looking forward to seeing you at one or more of these Education events!
Alan Levy
VP Education
ISPE DVC Chapter |
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| Fifth Session Overview |
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The fifth training session of this year's education series will focus on "automation". This session, "ABC's - All about Bioreactor Controls, an Industry/ISA perspective" will run from 5:30 PM to 9:00 PM on Tuesday, March 30, 2010, at GSK's Upper Merion campus in King of Prussia.
The focus will be on automation and controls, and the use of standards for bioreactors in a Pharmaceutical Research & Development environment. The program has multiple speakers from our local industry. After a brief overview of the automation society, ISA and introduction of their standards, what follows will be an overview of Industrial R&D Bioreactors, a State-Of-The-Art Application Case Study, known as Mini-Reactor Flexi Benches, and finally a broader Manufacturing perspective, addressing today's challenges and the benefits of standards and practices like offered by ISA.
Topics covered within these sessions include:
Introduction to ISA (International Society of Automation):
Overview of ISA Standards S88 (Batch) and S95 (Enterprise-Control System Integration)
Bioreactors and Biotechnology Industry Overview:
R&D Bioreactor Cell Platforms, Technology, Materials, Modes of Operation, BioSafety, Bioreactor Controls Overview:
1. Automation Elements, Level of Automation
2. Control Schemes for R&D Bioreactors:
a. Temperature, pH, Dissolved O2, Dissolved CO2, Feed Pumps, Pressure, Weight, Other
State-Of-The-Art Case Study, Mini-Reactor Flexi Benches:
Key to project: Portability of Equipment & Controls. Facility Issues, Additional Equipment, Updated Instrumentation and New Online Probes, Controls: Memory Capacity, Hardware Footprint & Software Conversion, Process Ergonomics, and Process Storage
Connecting Pharmaceutical R&D to the Manufacturing Partner:
1. Recent business realities and new challenges
2. Data Management Challenge and background of an R&D Company in the Pharmaceutical Sector
3. Turning to the standards and how applying ISA standards helps |
| Speaker Bio |
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William Dugary - Session Director - Applied Control Engineering (ACE):
With over 30 years engineering, consulting and marketing experience in the Automation Systems and Engineering field, much of Bill's career focus has been with pharmaceutical process and facility/utility applications. Presently, as the Philadelphia ISA (International Society of Automation) Program Chairman, Past Education Chairman and Course Director, Bill has brought together a group of local industry engineering professionals to talk about automation from their perspectives in a pharmaceutical R&D environment. Bill is a Senior ISA and Delaware Valley ISPE Member, and is presently in his 5th year as an Account Manager with Applied Control Engineering, Inc. "ACE" is a diverse and independent Systems Integration firm headquartered in Newark, DE with seven offices including a new office in Quakertown, PA. Now approaching 20 years in the automation business, ACE's largest client base is in the pharmaceutical industry. Bill has a Bachelors degree in Environmental Engineering & Science from the University of Florida.
William Bunk - Engineering Manager - GSK UM BioPharm R&D:
Part of GlaxoSmithKline (GSK), one of the world's leading research-based pharmaceutical and healthcare companies, the GSK Biopharm R&D Unit seeks to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with debilitating and life threatening diseases. As Engineering Manager, Bill is responsible for Engineering and Automation supporting Product Development and GMP Clinical Production for their pilot plant and supporting automation infrastructure in Upper Merion, PA. With over 20 years of automation experience, Bill has spent the last 11 years at GSK in a number of engineering positions leading to his current role. Prior to joining GSK, Bill worked for Moore Products / Siemens Energy & Automation as an Automation Engineer, and has a Bachelors degree in Electrical Engineering Technology from the NJ Institute of Technology.
Martin Lotito PE - Senior Project Manager - GSK UM BioPharm R&D:
As Senior Project Manager, Marty is responsible for Capital Projects at GlaxoSmithKline Biopharm R&D in Upper Merion, PA. Marty has presented "High Containment of Potent Compounds" for both ISPE and PDA. He has been with GSK Biopharm R&D for 10 years, previously was with Merck & Co. in Vaccine R&D and Manufacturing, and also worked with Rorer Pharmaceutical in engineering and production of various oral and topical dosage forms. Marty holds a Bachelors degree in Chemical Engineering from Princeton University, a Masters in Chem. Eng. from Villanova University, including a Certificate in Process Control, and is a registered Professional Engineer.
Shaun McWeeney - Senior Systems Engineer - Centocor R&D:
As a Senior Systems Engineer in the Strategic Operations group, Shaun is responsible for planning and coordinating data structures and information flow for Janssen Pharmaceutical Companies of Johnson & Johnson, a large global R&D organization, which is responsible for both small and large molecule development, clinical supply, and manufacturing technical support. Shaun has been with the company for 6 years in a variety of engineering and management roles. Shaun has presented automation topics in past ASME BioProcess Technology Seminars. Previously, Shaun worked for 7 years as an Automation Engineer at Moore Products / Siemens Energy & Automation. Shaun holds a Bachelors degree in Chemical Engineering from Lehigh University and a Masters in Chem. Eng, from Villanova University. | |
| Directions: |
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Directions to Upper Merion:
709 Swedeland Road
King of Prussia, PA 19406
610-270-4800
FROM PHILADELPHIA INTERNATIONAL AIRPORT & POINTS SOUTH:
Take I-95 South to I-476 North (Plymouth Meeting)
Follow I-476 North 15 miles to Exit 16B (I-76 West/King of Prussia)
Take I-76 West, keep right for 100 YDS. ONLY to Exit 330 (Gulph Mills)
Turn left at the bottom of the ramp (stop sign) onto Balligomingo Road
Go to stop sign (25 yds.) and turn right onto 320 North
Cross stone bridge and bear right to stay on Route 320 North
GSK West Campus entrance is approximately ½ mile on the right
Continue straight on Route 320 North past the West Campus entrance
Enter at the East Campus entrance, approximately ¼ mile further down on the right
FROM CENTER CITY PHILADELPHIA (FRANKLIN PLAZA/FOUR SEASONS):
Take I-76 West (Valley Forge) approximately 17 miles to Exit 330 (Gulph Mills)
Turn left at the bottom of the ramp (stop sign) onto Balligomingo Road
Go approximately 25 yds. and turn right onto Route 320 North
Cross stone bridge and bear right to stay on Route 320 North
GSK West Campus is approximately ½ mile on the right
Continue straight on Route 320 North past the West Campus entrance
Enter at the East Campus entrance, approximately ¼ mile further down on the right
FROM NEW YORK & POINTS NORTH:
Take New Jersey Turnpike to Exit 6 (PA Turnpike, I-276)
Follow I-276 West to Exit 20 (Mid-County) - follow signs for Chester / Philadelphia / Allentown
Take Route 476 South (Blue Route) to Exit 16 (I-76 West, Valley Forge)
Take I-76 West (Valley Forge) approximately 50 yds. To Exit 330 (Gulph Mills)
Turn left at the bottom of the ramp (stop sign) onto Balligomingo Road
Go approximately 25 yds. and turn right onto Route 320 North
Cross stone bridge and bear right to stay on Route 320 North
GSK West Campus is approximately ½ mile on the right
Continue straight on Route 320 North past the West Campus entrance
Enter at the East Campus entrance, approximately ¼ mile further down on the right
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