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Spring 2008 - Volume 14, No. 1
The Newsletter of the ISPE Great Lakes ChapterWith hot links to ALL
email and web addresses
TheGreat Lakers
Presswww.ispe.org/greatlakes
President’s MessageAs the Great Lakes
Chapter Board looks forward to2008 we are excited about theprospects of closer collaborationwith ISPE Headquarters. Oneexample of this partnership is ourupcoming Chicago Spring TrainingEvent to be held April 14-17 at theHoliday Inn, Oakbrook, IL.
ISPE National Trainerswill provide courses which arefocused on industry issues such aslower production costs, improved
process efficiency, increased production quality andmeeting regulatory requirements. The Great LakesChapter will hold a vendor tabletop exhibition, a socialevent 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 Systems
Compliance (GAMP 5)• Biotechnology Basics• Pharmaceutical Water Operation
There are financial benefits to our members andthe Chapter. The Chicago location provides a low costmeans for our members to get the best industrytraining available. The Chapter receives financialsupport for each Chapter Member who attends thetraining. This is truly a win-win for everyone involved.
Chris Roerig
Our fall 2007 event was held inMerrillville, Indiana on September 18th.Education tracks covered “SolventRecovery in API Manufacturing” and“Modular versus Stick-built Manu-facturing Space”. After a one year trialof locating our meetings in a centrallocation, the board has decided to adopta rotating meeting location similar tothat used in the past.
Mark your calendars for our FallMeeting, to be held in IndianapolisSeptember 16th and 17th. We areplanning on a superior event and arehoping to reinstate the plant tourconcept with the help of Eli Lilly. Lookfor details later this year.
Finally, we will be once againsending you a survey to determine howthe chapter can best serve ourmembership. Please take some time toconsider the questions and completethem so we can know what you arethinking.
I look forward to seeing you inChicago this April.
The Great Lakers Press
Spring 2008 - Volume 14 No.1 Page 2
President’s Message ...................... 1Calendar of Events ........................ 2Board of Directors ......................... 3New Members ............................ 5-6
2007 Merrillville EventWrap Up ............................................ 7
ISPE FOYA Awards ....................... 8
“Recovery Testing aPharmaceutical CleanroomCase Study ”byMicael DiGiovanni& Thomas Spearman................. 9-14
2008 Chicago Training ............... 15
ContentsContents ISPE Educational &Exhibit Opportunities
INTERPHEX 200826-28 March 2008Grand Hall, Pennsylvania Convention CenterPhiladelphia, Pennsylvania, USAMake plans today to attend INTERPHEX 2008,sponsored by ISPE! For complete information,please visit http://www.interphex.com
Northeast Student Leadership ForumSaturday, 29 March 2008(right after INTERPHEX Philadelphia!)The Union League of PhiladelphiaPhiladelphia, Pennsylvania
ISPE Chicago Training Series14-17 April 2008Holiday Inn Oak BrookChicago, Illinois USAfor further information - see flyer on Page 4
MidWest Chapter - ExtendedEducation and Vendors Day24 April 2008Omaha, NE
MidWest Chapter - Golf Outing29 May 2008Minneapolis, MN
ISPE 2008 Engineering RegulatoryCompliance Conference2-5 June 2008Marriott Crystal GatewayArlington, Virginia, US
MidWest Chapter - Golf Outing26 June 2008St. Louis, MO
Great Lakes Chapter - Vendor Show &Education Program16-17 September 2008Indianapolis, IN
For more information regarding any of these events,please go to the Global Calendar at the ISPEwebsite at www.ispe.org.
Get Caught Up On Our WebCheck us out at
http://www.ispe.org/greatlakes
We Need Articles!
We need your input. If you have a potentialTechnical Article that you would like to seepublished in The Great Lakers Press, pleasemake sure to submit the article and any releventartwork or graphics for consideration toMatt Warhoverat [email protected]
If you have suggestions for improving The GreatLakers Press, please submit an explanation,with any details that might help define what weneed to do to make your newsletter moreinformative or useful. Please submit suggestionsto:Ron Dunn at [email protected],or phone 610-797-8381.
The Great Lakers Press
Spring 2008 - Volume 14 No.1 Page 3
2007 - 2008 Officers & Board of Directors
PresidentChristopher Roerig, CQS Innovation, [email protected] PresidentJohn Abee, [email protected]
Director, Student Chapter Committee ChairIyad Al-Rabadi, Autin [email protected]
DirectorThomas Cappelle, Abbott [email protected]
DirectorDiane Colson, Eli Lilly & [email protected]
DirectorTim Fry, the jdi [email protected]
DirectorDonald R. (DR) Foley, Eli Lilly & [email protected]
DirectorChip Rabbitt, Ben Venue [email protected]
Director, Communications Committee ChairMatthew Warhover, Commissioning Agents, [email protected]
DirectorDr. Mark Worden, Michigan State [email protected]
DirectorJoseph Zoghbi, Baxter [email protected]
Past PresidentCarl Wendell, Austin [email protected]
TreasurerMike Filary, Performance Validation [email protected], Membership Committee ChairJeffrey Bredeson, [email protected]
The Great Lakers Press
Spring 2008 - Volume 14 No.1 Page 5
Welcome To 180 New ISPE GLC Members
(New Member List continues on next page)
Noureen N. Abbas, Commissioning Agents David 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
The Great Lakers Press
Spring 2008 - Volume 14 No.1 Page 6
(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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For further informationplease contact Ron Dunn
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The Great Lakers Press
Spring 2008 - Volume 14 No.1 Page 7
The Fall 2007 Great Lakes Chapter event was held in Merrillville, Indiana at the RadissonHotel at Star Plaza on 18 September 2007. This event was the culmination of a one-year rotationexperiment of a one-day schedule. Starting with our Fall 2008 event in Indianapolis, we’ll begoing 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 APIManufacturing” got under way, hosted by Tom Cappelle, Director Plant Engineering at Abbott.The main topic, “Technical and Organizational Challenges to Recycling and Reuse in thePharmaceutical Industry” utilized the following speakers: Bruce Parker, Engineering Consultantwith Eli Lilly & Co., Jim King, Engineering Consultant with Eli Lilly & Co., Mike Egan, PlantEngineering Services Manager with Abbott, Jeff Terpstra, Manager, Project Management atPfizer, and Tom Shafer, Koch Modular Process Systems.
Our lunch break was filled with the latest Chapter information and networking opportunitieswhile wandering the vendor area.
The afternoon educational session was “Stick-Built, Modular, or Both: ImportantConsiderations When Planning Your Pharma/Biotech Facility”, hosted by Iyad Al-Rabadi, ProcessEngineer at Austin AECOM. The speakers were Steve Van Wormer A/E/C Representative withAustin AECOM, Gordon Leichter , Modular Facilities Supplier Representative with Pharmadule,Ken Choudhary, A/E/C Representative with Fluor Daniel, and Elias Kerzabi, OwnerRepresentative 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 SystemsAstro Pak CorporationAustin AECOMAWS Bio-Pharma TechnologiesBosch PackagingBrock SolutionsCamfil Farr/Farr APCCRB Engineers & BuildersEaton CorporationKoch Modular Process SystemsLife Scientific Inc.PBM Inc. - Valve SolutionsPCIPerformance ValidationProPharma GroupSartorius Stedim Biotech Inc.Rees Scientific.
Fall 2007 Merrillville Event Wrap-UpFall 2007 Merrillville Event Wrap-Up
Vendors and attendees interact with lively conversations.
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Spring 2008 - Volume 14 No.1 Page 8
2008 Facility of the Year Awards (FOYA) Winners Announced
(TAMPA, FLORIDA, USA, 1 FEBRUARY 2008) – Five pharmaceuticalmanufacturing facilities constructed by companies located in Germany, Swit-zerland, and the United States have been selected as Category Winners inthe fourth annual Facility of the Year Awards program sponsored by ISPE,INTERPHEX, and Pharmaceutical Processing magazine. The companies andrespective award categories include:
• Boehringer Ingelheim Pharma GmbH & Co.KG, located inBiberach, Germany, winner of the Facility of the Year Award forFacility Integration
• 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 Process Innova-tion
• F. Hoffmann La Roche AG, located in Basel, Switzerland, winner of the Facility of the YearAward for Project Execution
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Spring 2008 - Volume 14 No.1 Page 9
Recovery Testing a PharmaceuticalRecovery Testing a PharmaceuticalCleanroom Case StudyCleanroom Case Study
Michael DiGiovanni; Team Leader, Eli LillyThomas R Spearman, PE, Associate Eng’g Consultant, Eli Lilly
Reprinted with the permission of the Controlled EnvironmentTesting Association (CETA). Originally published in the Spring2006 edition of the CETA Journal Performance Review.
AbstractThis 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 RecoveryTime, and Cleanliness Recovery Rate. Lessons-learned are also included.
IntroductionPurposeThe Recovery Tests described here were performed in three cleanrooms in a pharmaceuticalmanufacturing facility located at Eli Lilly and Company in Indianapolis, IN. The room numbershave 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 recoverfrom particulate excursions quickly. This is a compliance subject for European regulatedpharmaceutical manufacturing. The European Medicines Evaluation Agency (EMEA)requirement is: The particulate conditions given in the table for the “at-rest” state should beachieved in the unmanned state after a short “clean up” period of 15-20 minutes (guidancevalue), 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 HistoryRecovery Testing has been conducted in Lilly European facilities for over a decade and on alimited basis in Lilly United States (US) facilities. This project was the first larger scaleRecovery Test execution for Lilly in the US.
(Recovery Testing continues on next page)
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Project BackgroundThe cleanrooms are located in a manufacturing area that supports solution formulation andfiltration. The area underwent a major renovation, which included replacement of the HVACsystem. The existing Air Handling Unit (AHU) was more than twenty-five years old and wasnearing the end of the equipment’s useful life. The construction and qualification phase of theproject lasted 16 weeks. The new system was designed to provide 25 air changes per hour. TheHVAC system includes two High Efficiency Particulate Air (HEPA) filters in series. The firstset of HEPA filters is located in the final compartment of the AHU, upstream from the secondset of terminal HEPA filters located at all points of use.
The Recovery Tests were executed during operational qualification (OQ) of the new HVACsystem. The testing was performed in an at-rest condition: The installation was complete andequipment was operating in a manner agreed upon by the customer and supplier, but with nopersonnel present.2 During the execution of these tests, the HVAC system and UnidirectionalAirflow (UAF) Hoods were operating. Only the technicians conducting the Recovery Test werepresent in the room.
Recovery Tests were performed in thirty-five separate cleanrooms, from which three ofdiffering sizes were selected for this Case Study. Table B provides pertinent information foreach cleanroom.
Methods
Sample LocationsThe 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 perroom, as shown by Equation (1). The samples were taken at approximately 3 feet (0.9 meter)from floor level (working height).
25
ANL = (1)
whereNL is the minimum number of sample locations (rounded up to the nearest wholenumber, 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 minimumof 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 wereselected. The sample locations are shown in Figure 2.
(Recovery Testing continues on next page)
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Spring 2008 - Volume 14 No.1 Page 11
For Room C, using one sample location per 25 square meters (269 square feet) results in26 sample locations. Due to the number of instruments required, there was concern that theRecovery Test would be difficult to execute. This room is used to store portable vessels. Toreduce the number of sample locations, computational fluid dynamics (CFD) was used to modelthe Recovery Test with the portable vessels in the room. It was expected that one of the highestparticle concentrations would occur in the area between the vessels stored next to each otherdue to lower air velocity. The fourteen locations with the highest particulate concentration inthe 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 otherlocations within the room. The sample locations are shown in Figure 3.
(Recovery Testing continues on next page)
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Spring 2008 - Volume 14 No.1 Page 12
Sample Particle SizeThe airborne particulate classification specifies the limits of particles 0.5 micron and larger andparticles 5.0 micron and larger.2 For Recovery Testing, the 0.5 micron and larger particles wereselected. ISO/FDIS 14644-3 recommends that the particle size used for Recovery Testing be lessthan 1 micron.3
Equipment and MaterialsThe following equipment and materials were used to conduct the Recovery Test.
• 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 Paddles
Diluters allow Particle Counters to measure higher concentrations of particles without sufferingfrom coincidence loss or contamination. A Diluter mixes the sampled air with a known ratio offiltered air. The Diluter and Particle Counter combination increases the concentration limit by the10:1 ratio. For this Case Study, the Particle Counter had a concentration limit of 5.0 x 106 particlesper cubic meter. (1.4 x 105 particles per cubic foot). The 10:1 Diluter increased the measurableconcentration 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 aninhalation hazard; however, prolonged exposure to vapor or aerosol concentrations may result intransient irritation. People who will work directly in the fog should consider at a minimum wearinga Powered Air Purifying Respirator with particulate filter. As with all safety precautions, the risksand hazards must be carefully evaluated by the person responsible for performing the work. TheMaterial Safety Data Sheet (MSDS) is typically available at the manufacturer’s web page.
PrerequisitesThe 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 thecleaning needed after the test is performed. Placement of the drape must not interfere withairflow. For the portable vessels, only the top was protected with drape. If the room is foggedmore than two successive times, consider mopping the floor prior to fogging the room again toprevent 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 IntroductionThe 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 andlarger particles. NOTE: The particle counters cannot measure above 5.0 x 107 particlesper 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 2003Manufacture of Sterile Medicinal Products, European Commission, 2003, p. 2
2. Cleanrooms and Associated Controlled Environments–Part 1: Classification ofAir Cleanliness, ISO 146441-1, First Edition, International StandardsOrganization (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 SterileManufacturing Facilities, First Edition, International Society of PharmaceuticalEngineers (ISPE), 1999, p.146
6. Cleanrooms and Associated Controlled Environments – Part 1: Classification ofAir Cleanliness, ISO 146441-1, First Edition, International StandardsOrganization (ISO),1999, p. 6
7. Sterile Drug Products Produced by Aseptic Processing — Current GoodManufacturing Practice, Food and Drug Administration, 2004, p.7.
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Spring 2008 - Volume 14 No.1 Page 14
Acknowledgements
The contributions of the following people to the development of this Case Studywere greatly appreciated.
Diane M Colson, Eli LillyBeverly K Flick, CREW Technical ServicesDean Hale, Eli LillySharyl D Hartsock, Eli LillyWilliam M Huibregtse, PE, Eli LillyDan Milholland, Milholland & AssociatesDonald R Moore, PE, Eli LillyJames Wagner, Controlled Environment Consulting
Author Biographies
Michael DiGiovanni is a Team Leader at Eli Lilly and Company. He isresponsible for Utilities and HVAC serving a parenteral manufacturingfacility. He obtained a BA in Economics in 1992 from the University ofPittsburgh. He obtained a BSc in mechanical engineering in 1997 fromthe University of Pittsburgh. He is a member of the InternationalSociety for Pharmaceutical Engineering (ISPE).
Thomas R Spearman, PE is an Associate Engineering Consultant at EliLilly and Company. In his 28 years with Lilly, he has held a variety ofassignments and is currently leading the global parenteral HVAC coreteam. He obtained a BSc degree in mechanical engineering in 1992 fromPurdue University at Indianapolis. He obtained his and professionalengineering license in Indiana in 1998. He is a member of the AmericanSociety of Heating, Refrigerating and Air-Conditioning Engineers(ASHRAE) and the International Society for PharmaceuticalEngineering (ISPE). He is a corresponding member of the ASHRAEClean Space Technical Committee. He is a member of the Board ofDirectors of the Controlled Environment Testing Association (CETA).
Part Two of this article is availableon the ISPE GLC web site at this link.
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Spring 2008 - Volume 14 No.1 Page 15
REGISTER NOW !
Chicago Training SeriesHoliday Inn Oakbrook
Chicago, Illinois
14-17 April 200814-17 April 200814-17 April 2008
Limited Edition Vendor Exhibit(15 Vendor Tabletop Exhibits) Sold Out
Ron Dunn, Chapter ManagerEmail address: [email protected]
Phone: (610) 797-8381 Fax: (610) 351-9135
Performance ValidationProPharma GroupSAVISVeriteq InstrumentsW. Soule & Company
George Butler AssociatesHach UltraMar Cor PurificationMonal, Inc / Monal LabsPBM Inc.
Astro Pak Corp.Austin AECOMAutomated Systems, Inc.Camfil Farr / Farr APCCommissioning Agents, Inc.Eaton
In conjunction with the ISPE Chicago Training Series, being held14-17 April 2008, ISPE Great Lakes Chapter will be holdingits’ Spring Meeting, which will include a Vendor TabletopExhibition with 15 exhibitors, a Student Poster Competition, anda Social Event with refreshments within the Vendor Area.
By registering to attend any of the educational programs presentedby ISPE, you will automatically be eligible to attend this GLCevent. Or, you can register to only attend the vemdor area.
Student Poster Competition winners will be eligible to competein the International Student Poster Competition at the 2008 ISPEAnnual Meeting in Boca Raton, Florida, 26-29 October 2008.
Links to Information and Registration
• ISPE Chicago Training Series overview• Course Descriptions• Course Scheduling• Chicago Training Series ( Fees and
Registration )• ISPE GLC Vendor Registration (closed)• ISPE GLC Refreshment Sponsorship
Opportunities ( 3 available )• Student Poster Competition Registration• Holiday Inn Oakbrook , Oakbrook Terrace, IL (Venue Information)
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Spring 2008 - Volume 14 No.1 Page 16
