Spring 2008 - Volume 14, No. 1
The Newsletter of the ISPE Great Lakes Chapter With hot links to ALL email and web addresses
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www.ispe.org/greatlakes
President’s Message
As the Great Lakes Chapter Board looks forward to 2008 we are excited about the prospects of closer collaboration with ISPE Headquarters. One example of this partnership is our upcoming Chicago Spring Training Event to be held April 14-17 at the Holiday Inn, Oakbrook, IL.ISPE National Trainers will provide courses which are focused on industry issues such as lower production costs, improved process efficiency, increased production quality and meeting regulatory requirements. The Great Lakes Chapter will hold a vendor tabletop exhibition, a social event and Student Poster Contest.
Spring Event Educational Courses:
•
Auditing for GMP•
Complying with Part 11 – Risk Management•
Application of Commissioning and Qualification•
Pharmaceutical Water Generation•
HVAC for Pharmaceutical Facilities•
Basic Principles of Computerized SystemsCompliance (GAMP 5)
•
Biotechnology Basics•
Pharmaceutical Water OperationThere are financial benefits to our members and the Chapter. The Chicago location provides a low cost means for our members to get the best industry training available. The Chapter receives financial support for each Chapter Member who attends the training. This is truly a win-win for everyone involved.
Chris Roerig
Our fall 2007 event was held in Merrillville, Indiana on September 18th. Education tracks covered “Solvent Recovery in API Manufacturing” and “Modular versus Stick-built Manu-facturing Space”. After a one year trial of locating our meetings in a central location, the board has decided to adopt a rotating meeting location similar to that used in the past.
Mark your calendars for our Fall Meeting, to be held in Indianapolis September 16th and 17th. We are planning on a superior event and are hoping to reinstate the plant tour concept with the help of Eli Lilly. Look for details later this year.
Finally, we will be once again sending you a survey to determine how the chapter can best serve our membership. Please take some time to consider the questions and complete them so we can know what you are thinking.
I look forward to seeing you in Chicago this April.
The Great Lakers Press
President’s Message ... 1 Calendar of Events ... 2 Board of Directors ... 3 New Members ... 5-6 2007 Merrillville Event Wrap Up ... 7 ISPE FOYA Awards ... 8“Recovery Testing a
Pharmaceutical Cleanroom
Case Study ”
byMicael DiGiovanni
& Thomas Spearman... 9-14
2008 Chicago Training ... 15Contents
Contents
Exhibit Opportunities
ISPE Educational &
INTERPHEX 2008
26-28 March 2008
Grand Hall, Pennsylvania Convention Center Philadelphia, Pennsylvania, USA
Make plans today to attend INTERPHEX 2008, sponsored by ISPE! For complete information, please visit http://www.interphex.com
Northeast Student Leadership Forum
Saturday, 29 March 2008
(right after INTERPHEX Philadelphia!) The Union League of Philadelphia Philadelphia, Pennsylvania
ISPE Chicago Training Series
14-17 April 2008
Holiday Inn Oak Brook Chicago, Illinois USA
for further information - see flyer on Page 4
MidWest Chapter - Extended
Education and Vendors Day
24 April 2008
Omaha, NE
MidWest Chapter - Golf Outing
29 May 2008
Minneapolis, MN
ISPE 2008 Engineering Regulatory
Compliance Conference
2-5 June 2008
Marriott Crystal Gateway Arlington, Virginia, US
MidWest Chapter - Golf Outing
26 June 2008
St. Louis, MO
Great Lakes Chapter - Vendor Show &
Education Program
16-17 September 2008
Indianapolis, IN
For more information regarding any of these events, please go to the Global Calendar at the ISPE website at www.ispe.org.
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2007 - 2008 Officers & Board of Directors
President
Christopher Roerig, CQS Innovation, Inc.
Vice President
John Abee, Pfizer
Director, Student Chapter Committee Chair Iyad Al-Rabadi, Autin AECOM
Director
Thomas Cappelle, Abbott Laboratories
Director
Diane Colson, Eli Lilly & Co.
Director
Tim Fry, the jdi group.
Director
Donald R. (DR) Foley, Eli Lilly & Co.
Director
Chip Rabbitt, Ben Venue Laboratories
Director, Communications Committee Chair
Matthew Warhover, Commissioning Agents, Inc.
Director
Dr. Mark Worden, Michigan State University
Director
Joseph Zoghbi, Baxter Pharmaceutical [email protected]
Past President
Carl Wendell, Austin AECOM
Treasurer
Mike Filary, Performance Validation LLC
Secretary, Membership Committee Chair
Jeffrey Bredeson, Siemens
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Welcome To 180 New ISPE GLC Members
(New Member List continues on next page)
Noureen N. Abbas, Commissioning AgentsDavid O. Abram, BioConvergence LLC Rob Ahlers, University of Akron
Joseph V. Alexander, University of Kentucky Matthew S. Alexander, University of Kentucky David Andersen, Eli Lilly and Company Bernard P. Baier, Camfil Farr (Canada) Inc. Rick W. Balek, Watson-Marlow Bredel Pumps Deivya Bansal, University of Illinois-Chicago Timothy Barber, Takeda Pharmaceutical James Barry, Cox Automation Systems Inc. Brian Beachnau, CQS Innovation
Amanda E. Bell, Alkermes
David B. Bennett, Albemarle Corporation Chase M. Bouman, Western Michigan University Michael D. Braden, Jacobs Engineering Group Inc Beth A. Brock, Eli Lilly and Company
Don Brooks, Magnetrol International Darien F. Brost, Emergent BioSolutions, Inc. Chris Brown, SunSource Process Filtration Jenna M. Brown, Michigan State University Kris Brown, Emergent BioSolutions, Inc. Michael M. Bryden, BHDP Architecture Richard Burks, Paladin, Inc.
Michael J. Burt, CIBA Vision Sterile Manufacturing James A. Butschli, Summit-Healthcare Packaging Hye Jea Byun, Purdue University
Andrew J. Cance, Western Michigan University Greg Carstensen, GE Healthcare
Parol Chansoria, University of Illinois-Chicago Yamei Chen, Eli Lilly and Company
Ronald S. Ciaglia, Fluid Air, Inc. John W. Clarke, Akorn, Inc Andre J. Colarossi, Pfizer Inc. Robin A. Comein, Abbott Laboratories
Robert N. Compton, Rose-Hulman Institute of Technology Nancy E. Conder, Bristol Myers Squibb
Aaron G. Cook, University of Akron Abagail Cornette, University of Kentucky Kimberly A. Dahmen, Abbott Laboratories Scarlet Daniel, Ultrapure Technology, Inc. Gary Dean, Baxter Pharmaceutical Solutions Stacey Detrick, DHR International
Gordon DeYoung, Dan Vos Construction Compnay Inc Larry DiGennaro, BHDP Architecture
Peter H. Do, Michigan State University
John R. Duffin, Clarke Engineering Services, Inc. Thomas Edwards, Baxter Pharmaceutical Solutions David T. Elsbury, ELANCO
Ben W. Esker, Boehringer Ingelheim Richard S. Estes, MedPointe Pharma April Eubanks, Columbia College Chicago Stephanie Evans, Multi Packaging Solutions Kelly T. Finnerty, Amylin Ohio LLC Donald R. Foley II, Eli Lilly and Company Jorge A. Fontes, Michigan State University Kerri Fortman, Alkermes
Guy E. Franz, Hach Ultra Analytics Hilary E. Froman, Purdue University Gayle Galloway, WorldBridge Partners
Camila A. Garces, University of Akron Mark S. Goldsmith, Boston Scientific Chris Gossett, BioMerieux Industry, Inc David Grant, STERIS
John A. Grant, Clayton Industries Ben Greenlee, E2i Automation Jeremy S. Griffin, Propharma Group
Trevor S. Guldstrand, Rose-Hulman Institute of Technology Sachin S. Gupta, Grantek Systems Integration
Anes Halilovic, Baxter
Roderick Hamblen, Lechler, Inc. John A. Hamilton, Eli Lilly and Company Karla B. Harris, Jacobs Engineering Matthew P. Hartman, Eli Lilly & Co Ashley M. Hawkins, University of Kentucky Gary L. Hedrick, Eli Lilly and Company Michael L. Hegner, Chase Doors
Andrew J. Heidenreich, University of Akron
Chad M. Herrman, Bureau Veritas North America Inc. Amber L. Herron, Brock Solutions
Curtis R. Hormel, Commissioning Agents Jenny Marie House, Indiana University Rachel J. Ispas, MonoSol Rx
Steven E. Jacoby, KMPT USA Inc David Jeatran, Cook Pharmica, LLC
Brian Joesten, Barry Wehmiller Design Group William A. Jones, Battelle Memorial Institute Anas Kaakeh, Purdue University
James K. Kamanda, Western Michigan University Jeffrey M. Katz, University of Michigan
Kevin Keating, Eli Lilly and Company Michael S. Kelly, Amylin Ohio LLC Srujana Koganti, University of Akron
Benjamin G. Kremkow, Michigan State University Shirley E. Kreutzfeldt, Abbott
Daniel S. Larrimore, Cook Pharmica LLC Chen-Min Lee, Michigan State University Ambrose Lessard, Michigan State University Jennifer L. Lilly, University of Akron
Aaron J. Linenthal, Western Michigan University Jennifer L. Lisiak, Pfizer
Andrew L. Lynch, University of Kentucky Yvonne M. Machiniak, Emergent Biosolutions John W. Masengale, Eli Lilly & Company John M. Masucci, STERIS
Kenneth J. Matheis, Sr., The Complete Companies Jon T. McCabe, STERIS Corporation
Dr. Scott J. McClellan, Rose-Hulman Institute of Technology John McLain, BioConvergence LLC
Amit B. Meghani, University of Illinois-Chicago Kara Meyer, A&B Process Systems Corp Eric R. Miller, Michigan State University Danielle K. Modglin, Eli Lilly and Company
Stutay Monga, Rose-Hulman Institute of Technology Gladys R. Montenegro-Galindo, University of Akron Kent A. Moraga, Eli Lilly and Company
Paul I. Mowry, Jacobs Engineering Kavitha M. Nair, Eli Lilly
Alan J. Needler, Michigan State University Alexander D. Nezich, Michigan State University
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(New Member List continues)
Kee-Koon Ng, Purdue University Alice Nicklow, Mylan Pharma
Michael G. Nothnagle, Corium International Judy L. Obenchain, Eli Lilly and Company Kevin J. Olsen, The Chao Center for Industrial Pharmacy & Contract Manufacturing Michael J. Orr, Brock Solutions Inc. Clara S. Ortiz, PACIV
Gregorio Padin-Nieves, Perrigo Company David S. Pangle, Michigan State University Nathan A. Parker, Eli Lilly and Co Brandon Patterson, Kymanox
Justin Pawlik, Lake Forest Graduate School of Mgmt. Ernest A. Perkins, Eli Lilly and Company
Shawn Perkins, PACIV
Robert Perks, Baxter Healthcare Corporation Austin R. Picklesimer, CH2M HILL Lockwood Greene Andre M. Pipkin, PACIV
Dean E. Rainbolt, Eli Lilly & Co
Kristyn M. Ratliff, Coldstream Laboratories Daniel N. Reid, Emergent BioSolutions
Jeremy Edward Retzsch, Barr Laboratories, Inc. Karla J. Rigsby, Eli Lilly and Company
Regan Riley, Pharmaceutical Processing Christopher Rodkey
Idubijes L. Rojas, University of Illinois-Chicago John P. Russo, Eli Lilly and Company
Brian C. Rutkowski, ProPharma Group Megan J. Ryle, University of Kentucky Jeremy Sandnas, Optima Machinery Corp Kendra L. Schmitz, Eli Lilly & Co
Paul R. Schultz, University of Kentucky Lisa M. Schuster, Safis Solutions, LLC Ajay S. Shah, Abbott
Megha Shah, Purdue University
Shivani A. Shah, Illinois Institute of Technology Dusyant A. Sharma, University of Illinois-Chicago Diane E. Sheffer, STERIS Corporation
Rohan Sheth, Eli Lilly Rajit Singh, Purdue University
Sneha Snaminathan, University of Akron Thomas J. Spahn, Boehringer-Ingelheim Roxane David R. Spillman, Baxter Pharma Solutions Lisa Sponseller, Perrigo Company
Erica L. Stolz, CH2M HILL Robert Tedquist, Fike Wayne Theusch,
Amy L. Tomczyk, Western Michigan University Katie J. Trella, Rose-Hulman Institute of Technology Ross Tsapyak, Takeda
Srinivas Vengala, Drexel Univ./Allegheny General Hospital Otis Watson III, Eastern Michigan University
Thomas M. Webber, University of Kentucky Greg Weber, Brock Solutions Inc
Robert Weston, Eli Lilly
John R. Whitney, The S/L/A/M Collaborative Kathy L. Wills, Ben Venue Labs Inc
Di Wu, Purdue University Dr. Abdelqader Zamamiri, Abbott Robert Zebrowski, King Pharmaceuticals
Shantell M. Ziegel, CRB Consulting Engineers Inc
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The Fall 2007 Great Lakes Chapter event was held in Merrillville, Indiana at the Radisson Hotel at Star Plaza on 18 September 2007. This event was the culmination of a one-year rotation experiment of a one-day schedule. Starting with our Fall 2008 event in Indianapolis, we’ll be going back to more popular two-day schedule for our events.
With a window of good weather, 18 September was a coats-off kind of day.
While our vendors were setting up their displays, our morning track,“Solvent Recovery in API
Manufacturing” got under way, hosted by Tom Cappelle, Director Plant Engineering at Abbott.
The main topic, “Technical and Organizational Challenges to Recycling and Reuse in the
Pharmaceutical Industry” utilized the following speakers: Bruce Parker, Engineering Consultant
with Eli Lilly & Co., Jim King, Engineering Consultant with Eli Lilly & Co., Mike Egan, Plant Engineering Services Manager with Abbott, Jeff Terpstra, Manager, Project Management at Pfizer, and Tom Shafer, Koch Modular Process Systems.
Our lunch break was filled with the latest Chapter information and networking opportunities while wandering the vendor area.
The afternoon educational session was “Stick-Built, Modular, or Both: Important
Considerations When Planning Your Pharma/Biotech Facility”, hosted by Iyad Al-Rabadi, Process
Engineer at Austin AECOM. The speakers were Steve Van Wormer A/E/C Representative with Austin AECOM, Gordon Leichter , Modular Facilities Supplier Representative with Pharmadule, Ken Choudhary, A/E/C Representative with Fluor Daniel, and Elias Kerzabi, Owner Representative from Eli Lilly, with an”Owner’s point of view”.
The Chapter would like to thank the following exhibitors for their support:
Air/Pro Inc.
ASI CleanSeal Door Systems Astro Pak Corporation Austin AECOM
AWS Bio-Pharma Technologies Bosch Packaging
Brock Solutions
Camfil Farr/Farr APC CRB Engineers & Builders Eaton Corporation
Koch Modular Process Systems Life Scientific Inc.
PBM Inc. - Valve Solutions PCI
Performance Validation ProPharma Group
Sartorius Stedim Biotech Inc. Rees Scientific.
Fall 2007 Merrillville Event Wrap-Up
Fall 2007 Merrillville Event Wrap-Up
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2008 Facility of the Year Awards (FOYA) Winners Announced
(TAMPA, FLORIDA, USA, 1 FEBRUARY 2008) – Five pharmaceutical
manufacturing facilities constructed by companies located in Germany, Swit-zerland, and the United States have been selected as Category Winners in the fourth annual Facility of the Year Awards program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. The companies and respective award categories include:
•
Boehringer Ingelheim Pharma GmbH & Co.KG, located inBiberach, Germany, winner of the Facility of the Year Award for Facility Integration
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Bristol-Myers Squibb, located in New Brunswick, New Jersey,USA, winner of the Facility of the Year Award for Equipment Inno-vation
•
IDT Biologika GmbH, located in Dessau-Rosslau, Germany, winner of the Facility of the YearAward for Operational Excellence
•
Pfizer, located in Illertissen, Germany, winner of the Facility of the Year Award for ProcessInnova-tion
•
F. Hoffmann La Roche AG, located in Basel, Switzerland, winner of the Facility of the YearThe Great Lakers Press
Recovery Testing a Pharmaceutical
Recovery Testing a Pharmaceutical
Cleanroom Case Study
Cleanroom Case Study
Michael DiGiovanni; Team Leader, Eli Lilly
Thomas R Spearman, PE, Associate Eng’g Consultant, Eli Lilly
Reprinted with the permission of the Controlled Environment Testing Association (CETA). Originally published in the Spring 2006 edition of the CETA Journal Performance Review.
Abstract
This article is a Case Study of Recovery Tests performed in three pharmaceutical cleanrooms. The data analysis includes an evaluation of the Twenty Minutes Reduction Ratio, 100:1 Recovery Time, and Cleanliness Recovery Rate. Lessons-learned are also included.
Introduction
Purpose
The Recovery Tests described here were performed in three cleanrooms in a pharmaceutical manufacturing facility located at Eli Lilly and Company in Indianapolis, IN. The room numbers have been changed to protect proprietary information.
The purpose of the Recovery Test is to determine the ability of the Heating, Ventilating, and Air-Conditioning (HVAC) system to remove airborne particles from the room and to recover from particulate excursions quickly. This is a compliance subject for European regulated pharmaceutical manufacturing. The European Medicines Evaluation Agency (EMEA) requirement is: The particulate conditions given in the table for the “at-rest” state should be achieved in the unmanned state after a short “clean up” period of 15-20 minutes (guidance value), after completion of operations.1 A summary of the table is given in Table A. Currently, there is not a similar requirement by the Food and Drug Administration (FDA).
Previous History
Recovery Testing has been conducted in Lilly European facilities for over a decade and on a limited basis in Lilly United States (US) facilities. This project was the first larger scale Recovery Test execution for Lilly in the US.
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Project BackgroundThe cleanrooms are located in a manufacturing area that supports solution formulation and filtration. The area underwent a major renovation, which included replacement of the HVAC system. The existing Air Handling Unit (AHU) was more than twenty-five years old and was nearing the end of the equipment’s useful life. The construction and qualification phase of the project lasted 16 weeks. The new system was designed to provide 25 air changes per hour. The HVAC system includes two High Efficiency Particulate Air (HEPA) filters in series. The first set of HEPA filters is located in the final compartment of the AHU, upstream from the second set of terminal HEPA filters located at all points of use.
The Recovery Tests were executed during operational qualification (OQ) of the new HVAC system. The testing was performed in an at-rest condition: The installation was complete and equipment was operating in a manner agreed upon by the customer and supplier, but with no personnel present.2 During the execution of these tests, the HVAC system and Unidirectional Airflow (UAF) Hoods were operating. Only the technicians conducting the Recovery Test were present in the room.
Recovery Tests were performed in thirty-five separate cleanrooms, from which three of differing sizes were selected for this Case Study. Table B provides pertinent information for each cleanroom.
Methods
Sample Locations
The number of sample locations was determined by providing one sample location per twenty-five square meters (269 square feet) rounded up with a minimum of two sample locations per room, as shown by Equation (1). The samples were taken at approximately 3 feet (0.9 meter) from floor level (working height).
25
A
N
L=
(1)where
NL is the minimum number of sample locations (rounded up to the nearest whole number, and not less than 2).
A is the area of the cleanroom or clean zone in square meters.
Since the floor area for Room A was less than 50 square meters (538 square feet), the minimum of 2 sample locations was selected. The sample locations are shown in Figure 1. For Room B, using the one sample location per 25 square meters (269 square feet), 7 sample locations were selected. The sample locations are shown in Figure 2.
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For Room C, using one sample location per 25 square meters (269 square feet) results in 26 sample locations. Due to the number of instruments required, there was concern that the Recovery Test would be difficult to execute. This room is used to store portable vessels. To reduce the number of sample locations, computational fluid dynamics (CFD) was used to model the Recovery Test with the portable vessels in the room. It was expected that one of the highest particle concentrations would occur in the area between the vessels stored next to each other due to lower air velocity. The fourteen locations with the highest particulate concentration in the working height plane as predicted by the CFD model were selected as sample locations. These locations were predicted to have a particle concentration ten times greater than other locations within the room. The sample locations are shown in Figure 3.
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Sample Particle SizeThe airborne particulate classification specifies the limits of particles 0.5 micron and larger and particles 5.0 micron and larger.2 For Recovery Testing, the 0.5 micron and larger particles were selected. ISO/FDIS 14644-3 recommends that the particle size used for Recovery Testing be less than 1 micron.3
Equipment and Materials
The following equipment and materials were used to conduct the Recovery Test.
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Portable Particle Counter with 50 liter per minute (1.77 cubic feet per minute) sample rate•
Diluter with 10:1 ratio
•
Fog Machine•
Fog Fluid•
Wand and hose•
Plastic Drapes•
Handheld Fans or PaddlesDiluters allow Particle Counters to measure higher concentrations of particles without suffering from coincidence loss or contamination. A Diluter mixes the sampled air with a known ratio of filtered air. The Diluter and Particle Counter combination increases the concentration limit by the 10:1 ratio. For this Case Study, the Particle Counter had a concentration limit of 5.0 x 106 particles per cubic meter. (1.4 x 105 particles per cubic foot). The 10:1 Diluter increased the measurable concentration to 5.0 x 107 particles per cubic meter (1.4 x 106 particles per cubic foot).
The Fog Fluid is a solution of Propylene Glycol and Deionized Water. Fog Fluid is not an inhalation hazard; however, prolonged exposure to vapor or aerosol concentrations may result in transient irritation. People who will work directly in the fog should consider at a minimum wearing a Powered Air Purifying Respirator with particulate filter. As with all safety precautions, the risks and hazards must be carefully evaluated by the person responsible for performing the work. The Material Safety Data Sheet (MSDS) is typically available at the manufacturer’s web page.
Prerequisites
The following prerequisites were required prior to performing the Recovery Test. 1. The room is not in use and has been placed on HOLD.
2. The room has been cleaned to meet operational standards, but not sanitized.
3. Equipment is protected with a plastic drape that is not less than 3 mm (0.12 inch) thick. 4. The HVAC system (and UAF hoods if applicable) is available for operation.
5. The room differential pressure is monitored and is not in an alarm state. 6. Test equipment and instruments are in current calibration.
7. Test materials are within their expiration dates.
The Fog Fluid leaves a residue or film on most surfaces. The plastic drape is used to reduce the cleaning needed after the test is performed. Placement of the drape must not interfere with airflow. For the portable vessels, only the top was protected with drape. If the room is fogged more than two successive times, consider mopping the floor prior to fogging the room again to prevent fall hazards. Mopping was not needed for this Case Study.
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Equipment SetupThe following procedure was used to set up each Particle Counter. 1 . Install Diluter with 10:1 ratio.
2. Turn on the Particle Counter.
3. Set the Particle Counter sample size for 0.5 micron. 4. Set the Particle Counter date and time.
5. Clear the Particle Counter stored data.
6. Set the Particle Counter to an infinite number of samples.
7. Set the Particle Counter to record to memory and to print out data. 8. Place the Particle Counter in the sample locations shown in the diagram. Particle Introduction
The following procedure was used to introduce the fog and collect particle counts.
1. Ensure the room is cleared of all personnel except for technicians conducting the testing. 2. Ensure the safety precautions are being followed.
3. Ensure the Particle Counters are on. 4. Start the Particle Counters for sampling.
5. Begin fogging. Use handheld fans or paddles to distribute the fog through the room. 6. Continue fogging until the particulate level for all Particle Counters is greater than 3.5
x 107 particles per cubic meter (9.91 x 105 particles per cubic foot) for 0.5 micron and larger particles. NOTE: The particle counters cannot measure above 5.0 x 107 particles per cubic meter (1.42 x 106 particles per cubic foot).
7. Stop fogging.
8. Remain as motionless as possible in the room for a minimum of twenty-five minutes. 9. Stop the Particle Counters.
10. Turn off the Particle Counters.
11. Photocopy thermal printout sheets, number, sign and date. References
1. EC Guide to Good Manufacturing Practice Revision to Annex 1 May 2003 Manufacture of Sterile Medicinal Products, European Commission, 2003, p. 2 2. Cleanrooms and Associated Controlled Environments–Part 1: Classification of
Air Cleanliness, ISO 146441-1, First Edition, International Standards
Organization (ISO), 1999,p.2
3. Cleanrooms and Associated Controlled Environments – Part 3: Test Methods,
ISO/FDIS 14644-3, International Standards Organization (ISO), 2005, p. 47
4. Cleanrooms and Associated Controlled Environments – Part 3: Test Methods,
ISO/FDIS 14644-3, International Standards Organization (ISO), 2005, p. 48
5. ISPE Baselineâ Pharmaceutical Engineering Guide, Volume3 Sterile
Manufacturing Facilities, First Edition, International Society of Pharmaceutical
Engineers (ISPE), 1999, p.146
6. Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness, ISO 146441-1, First Edition, International Standards
Organization (ISO),1999, p. 6
7. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, Food and Drug Administration, 2004, p.7.
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AcknowledgementsThe contributions of the following people to the development of this Case Study were greatly appreciated.
Diane M Colson, Eli Lilly
Beverly K Flick, CREW Technical Services Dean Hale, Eli Lilly
Sharyl D Hartsock, Eli Lilly
William M Huibregtse, PE, Eli Lilly Dan Milholland, Milholland & Associates Donald R Moore, PE, Eli Lilly
James Wagner, Controlled Environment Consulting
Author Biographies
Michael DiGiovanni is a Team Leader at Eli Lilly and Company. He is responsible for Utilities and HVAC serving a parenteral manufacturing facility. He obtained a BA in Economics in 1992 from the University of Pittsburgh. He obtained a BSc in mechanical engineering in 1997 from the University of Pittsburgh. He is a member of the International Society for Pharmaceutical Engineering (ISPE).
Thomas R Spearman, PE is an Associate Engineering Consultant at Eli Lilly and Company. In his 28 years with Lilly, he has held a variety of assignments and is currently leading the global parenteral HVAC core team. He obtained a BSc degree in mechanical engineering in 1992 from Purdue University at Indianapolis. He obtained his and professional engineering license in Indiana in 1998. He is a member of the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) and the International Society for Pharmaceutical Engineering (ISPE). He is a corresponding member of the ASHRAE Clean Space Technical Committee. He is a member of the Board of Directors of the Controlled Environment Testing Association (CETA).
Part Two of this article is available
on the ISPE GLC web site at this link.
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Chicago Training Series
Holiday Inn Oakbrook
Chicago, Illinois
14-17 April 2008
14-17 April 2008
14-17 April 2008
Limited Edition Vendor Exhibit
(15 Vendor Tabletop Exhibits)
Sold Out
Ron Dunn, Chapter Manager Email address: [email protected] Phone: (610) 797-8381 Fax: (610) 351-913
5
Performance Validation ProPharma Group SAVIS
Veriteq Instruments W. Soule & Company George Butler Associates
Hach Ultra
Mar Cor Purification Monal, Inc / Monal Labs PBM Inc.
Astro Pak Corp. Austin AECOM
Automated Systems, Inc. Camfil Farr / Farr APC Commissioning Agents, Inc. Eaton
