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Controlled Environment Testing Association
April 12-16, 2013 • Caribe Royale • Orlando, Florida
ProgrAm And ExhibiTor informATion
21st Annual meeting
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8:00 - 8:10 am Conference WelcomeSpeaker: Nick Flynn, 2013 Program Chair
8:10 - 8:30 am President’s AddressSpeaker: Tony McGrath, CETA President 2012-13
8:30 - 9:00 am Microbial Awareness Speaker: Edward S. Balkovic, Ph.D.of Genyzme, a Sanofi Company
9:00 - 9:45 am Presentation: New England Compounding Center (NECC) Aftermath Discussion - Part I Speaker: Eric S. Kastango of Clinical IQ, LLS
Certifiers play important role in helping pharmacists provide extemporaneously compounded sterile preparations (CSPs) that are sterile and safe. Very effective standards are outlined in the United States Pharmacopeia (USP, Chapter 797) that serve as the foundation for sterile admixture programs; yet we know from two recent surveys of USP Chapter 797 compliance that the need for ongoing education and general acceptance of these standards remains significant. Eric S. Kastango, MBA, RPh, FASHP will review lessons still being learned from the tragic 2012 fungal meningitis outbreak, associated with thousands of vials of methylprednisolone that were compounded by a Massachusetts-based New England Compounding Pharmacy (NECC).Learning Objectives:1. Describe the key findings in the FDA Form 483 issued
to New England Compounding Pharmacy (NECC) in October of 2012.
2. Review the critical steps necessary to achieve a state of control that reduces the risks associated with sterile compounding activities.
9:45 - 10:30 am Presentation: New England Compounding Center (NECC) Aftermath Discussion - Part II Speaker: Jim Wagner of Controlled Environment Consulting
10:30 - 11: 00 am break/ ExhibitorsCaribbean I&II
11:00 - 11:30 am New England Compounding Center (NECC) Aftermath Discussion Q&A
11: 30 am - Noon Presentation: The Essential Role of Environmental Monitoring (EM) in a Drug Production/ Compounding Facility Speaker: Jeanne Moldenhauer of Excellent Pharma Consulting, Inc.
This presentation will discuss some of the guidance documents available for environmental monitoring and how these documents are being used for various types of processes.
Schedule of Events
CETA 21st Annual meeting April 12-16, 2013 • Caribe Royale • Orlando, Florida
Friday, April 12, 20131:00 - 7:00 pm Wally Whitt Memorial Golf Tournament
Orange Lake Golf
3:00 - 5:00 pm nuAire manufacturer Update (.25 rU credits)Grand Sierra A
6:00 - 9:00 pm rCCP-SCf Written multiple Choice ExaminationGrand Sierra A
Saturday, April 13, 2013 11:00 am - 8:00 pm registration
South Registration (near the Caribbean ballroom)
8:00 am - noon CETA board of directors meetingBoca 5
11:00 am - 7:00 pm Exhibits SetupCaribbean I&II
8:00 - 10:00 am Baker Company Manufacturer Update (.25 rU credits) Grand Sierra A
10:00 am - noon Labconco manufacturer Update (.25 rU credits)Grand Sierra A
1:00 - 5:00 pm CETA Series Presentation: CAg 003 Compliance Testing Speakers: Troy Tillman of TSI, Inc., Ken Mangis of Controlled Environmental Systems, Jim Wagner of Controlled Environment Consulting and Tom Mullen of Shortridge Instruments Grand Sierra B
Presentations to include:1. Airflow measurement methods2. Airflow measurement instrumentation theory of
operation and proper use3. HVAC airflow control valves theory of operation and
demonstration4. Overview of CAG -003 airflow measurement
requirements
7:00 - 9:00 pm opening receptionCaribbean I&II
Sunday, April 14, 20137:15 am - 1:30 pm registration
South Registration
7:00 am - 8:00 pm breakfast/ExhibitsCaribbean I&II
8:00 am - 2:30 pm CETA Annual meeting general SessionGrand Sierra A&B unless otherwise noted
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Learning Objectives:1. Describe the regulatory guidance for environmental
monitoring2. Explain concerns with requirements for aspectic
processing and use in other processes3. Warning Letter observations on Environmental
Monitoring in the last year will be identified4. Identify some key considerations in setting up your
program
Noon - 1:00 pm Lunch sponsored by Shortridge InstrumentsCaribbean I&II
1:00 - 2:00 pm Presentation: A Risk-Based Approach for Investigating Environmental Monitoring Excursions Speaker: Robert Westney, M.S, RAC,CMQ/OE of Cryologics, Inc.
This presentation will provide a pragmatic, step-by-step, risk-based approach for investigating environmental monitoring excursions. The information that will be presented can easily be incorporated into a concise Standard Operating Procedure that will provide for an efficient process for investigating EM excursions which will meet regulatory expectations.
Learning Objectives:
Attendees will learn about the following aspects of an effective EM excursion investigation program:1. Elements of an Investigation Plan2. Key Investigation Points3. Root Cause Analysis4. Corrective Action and Assessing Effectiveness5. Assessing Facility and Product Impact
2:00 - 5: 00 pm Equipment manufactures’ forum (See chart at right)Boca V-VII
4:00 - 5:00 pm NSF Steering CommitteeHibiscus
Monday, April 15, 20137:00 - 8:00 am breakfast/Exhibits
Caribbean I&II
7:15 am - 1:30 pm registration South Registration (near the Caribbean ballroom)
8:00 am - noon CETA Annual meeting general SessionGrand Sierra A&B unless otherwise noted
8:00 - 8:15 am Conference UpdatesNick Flynn, CETA Program Chair
8:15 - 8:45 am Presentation: Good Documentation PracticesSpeaker: Kevin Martin of Azzur Group, LLC
Good documentation practices are essential in any regulated environment. This presentation will address good documentation practices for certifying
Schedule of Events (continued)
Equipment manufacturer’s forum2:00 pm
Nuaire ................................................................................................................ Boca V DRS Laboratories .............................................................................................. Boca VICamFill Farr ...................................................................................................... Boca VII Flow Sciences .................................................................................................. Boca VIII
2:30 pmClordisys Solutions, Inc. ...................................................................................... Boca V DRS Labortories ................................................................................................. Boca VI Camfill Farr ....................................................................................................... Boca VII Flow Sciences .................................................................................................. Boca VIII
3:00 pmTSI ...................................................................................................................... Boca V ESCO Technologies, Inc. ..................................................................................... Boca VI Holland Safety ................................................................................................. Boca VII Labconco ......................................................................................................... Boca VIII
3:30 pm TSI ...................................................................................................................... Boca V ESCO Technologies, Inc. ..................................................................................... Boca VI ThermoScientific. ............................................................................................. Boca VII Labconco ......................................................................................................... Boca VIII
4:00 pmThe Baker Company............................................................................................ Boca V Update 2 ........................................................................................................... Boca VI Update 3 .......................................................................................................... Boca VII Update 4 ......................................................................................................... Boca VIII
4:30 pmThe Baker Company............................................................................................ Boca V Update 2 ........................................................................................................... Boca VI Update 3 .......................................................................................................... Boca VII Update 4 ......................................................................................................... Boca VIII
5:00 pmUpdate 1 ............................................................................................................ Boca V Update 2 ........................................................................................................... Boca VI Update 3 .......................................................................................................... Boca VII Update 4 ......................................................................................................... Boca VIII
officersPrESidEnT: Tony McGrath, The Baker Company
PrESidEnT-ELECT: Nicholas T. Flynn, B&V Testing Inc.SECrETAry/TrEASUrEr: david brande, PSC Biotech Corporation
immEdiATE PAST PrESidEnT: Kenneth W. mangis, Controlled Environmental Systems, Inc.
directors Tony Caughron, TEC Services, Inc.
Wayne A. Copeland, CEPA Operations, Inc.marc dubois, Advanced Testing and Certification
Kym Faylor, Microbiological Environmentsrob Peat, H.E.P.A Filter Services, Inc.
Jeff Serle, Germfree Laboratories, Inc.Todd Urton, Agape Instruments Service, Inc.
Jim Wagner, Controlled Environment Consulting
StaffExecutive director: Felicia Kenan Boyles
membership Services: Holly Currie
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Schedule of Events (continued)
controlled environments and draw parallels to other FDA GMP environments. Examples of good and poor documentation practices observed during certification audits are included.
8:45 - 9:15 am Presentation: ANSI Standard Z9.14 “Testing and Performance Verification Methodologies for Ventilation Systems for BSL-3 and ABSL-3 Facilities”Speaker: Louis DiBerardinis of M.I.T.
AIHA and the American National Standards Institute (ANSI) have embarked on an initiative to develop a national standard titled “Testing and Performance Verification Methodologies for Ventilation Systems for Biological Safety Level 3(BSL-3) and Animal Biological Safety Level 3 (ABSL-3) Laboratories” known as ANSI/AIHA Z9.14. The purpose is to develop a methodology that allows one to establish a minimum performance ventilation standard based on risk assessment that can be used on a voluntary basis to improve operations and maintenance of biosafety and biocontainment laboratories and animal facilities at the BSL-3 level. It will help to provide accountability that ensures proper and regular design, maintenance and operation of the ventilation system. The process, status and your role will be discussed.
Learning Objectives:1. Understand the purpose of the new standard2. Learn how ANSI standards are established.3. Understand the key ventilation issues in ANSI Z9.144. Learn how to comment on the standard
9:15 - 9:45 am Presentation: ISO 14644-1 Revision, Coming Key ChangesSpeaker: Joe Gecsey of Hach Ultra Analytics
The main international standard for cleanroom/clean zone certification, ISO 14644-1, has been undergoing review for several years; a new revision is in process and will soon become effective. The presenter is one of the two American Subject Matter Experts on the revision committee and can bring an intimate knowledge of the evolution on this key document. There are several notable changes that will impact the design and execution of cleanroom/clean zone certification; the changes will be discussed in detail and their potential impact on the certification process explored.
Learning Objectives:1. Understanding revision process for ISO standards2. Knowing probable effective date of revision for ISO
14644-1 standard3. Hearing about the most significant impacts of
revision to classification/certification process4. Gaining awareness of impact of ISO 21501-4
calibration method on instrumentation used for certification.
9:45 - 10:15 am Presentation: Conversion of Direct-Connected Class II/Type A BSCs to Meet NSF 49: Case StudiesSpeaker: Dan Ghidoni of Northeast Scientific Associates
Recent revisions to NSF 49 state that Class II Type A biosafety cabinets can no longer be hard connected to a facility’s exhaust system and are required to have an alarm. This presentation reviews how three facilities in Massachusetts converted their direct-connected cabinets to meet the new standards. The future direction of NSF requirements and some recommendations will also be discussed.
Learning Objectives:1. Understand new revision of NSF/ANSI Standard 49 in
terms of exhausting Class II Type A2 cabinets2. Learn about real-world examples of facility’s
experience meeting new canopy exhaust connection standards with their existing hard connected cabinets
3. Understand the implications of new the requirements and where the requirements are heading in the future
10:15 - 10: 45 am Break/ExhibitsCaribbean I&II
10:45 - 11:00 am Update: Presentation: ANSI/AIHA Z9.5Speaker: Bill Peters of NuAire
11:00 - 11:15 am Update: Presentation: HEPA Photometer Probe Size ProjectSpeaker: Todd Urton of Agape Instruments
11:15 - 11: 30 am Update: Presentation: CETA National Board of Testing ActivitiesSpeaker: Jeff Serle, CNBT Chair
11:30 - Noon Update: Presentation: CETA Spec GuideSpeaker: Rob Peat, CETA Spec Guide Committee Chair and Jamie Smyth of The Smyth Group
noon - 1:00 pm LunchCaribbean I&II
1:00 - 5:00 pm CETA Series Presentations: Establishing & Executing an Environmental monitoring (Em) ProgramSpeakers: Ed Balkovic of Genyzme, a Sanofi Company and Kiee Garland, B&V TestingGrand Sierra A & B
Establishing & Executing an Environmental Monitoring (EM) Program will provide a general understanding of current USP 797 Environmental Monitoring requirements, Industry regulations and applicable best practices. The discussion will primarily focus on understanding what’s needed when designing and implementing an EM program that will meet or exceed 797 requirements. Emphasis will be placed on risk assessment, sampling methods, instrumentation, execution and delivery. Segment 1 of the presentation
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Schedule of Events (continued)
will be lecture format and Segments 2 and 3 will be comprised of an interactive case study and hands-on demonstrations.
Learning Objectives:
The primary objective will be to provide an awareness of the regulatory requirements and fundamental processes currently in place by which to develop a successful Environmental Monitoring (EM) program.
The workshop will also give a comprehensive overview of the EM program, touching on the following related subject matters: risk assessment, proper instrumentation, methods of implementation, frequency selection and more.
5:30 pm depart for Annual banquetConvention Center Lobby Entrance
6:30 - 10:00 pm CETA Annual banquetSleuth’s Mystery Dinner Show 8267 International Drive, Orlando, FL
Tuesday, April 16, 20137:00 - 8:00 am breakfast/Exhibits
Caribbean I&II
8:00 am - noon CETA Annual meeting general SessionGrand Sierra A&B unless otherwise noted
8:00 - 8:10 am Conference UpdatesSpeaker: Nick Flynn, 2013 Program Chair
8:10 - 8:30 am CETA Business Meeting
8:30 - 9:00 am Presentation: An Efficacy Study in HEPA Filtration for Hazardous Drugs and CSTDsSpeaker: Deborah V. Hirst, PhD, PE/Ken Mead, PhD, PE of CDC- NIOSH
This presentation is an update on the NIOSH project, “An Efficacy Study of HEPA Filtration for Hazardous Drugs and CSTDs.” The purpose of the project is to test the efficacy of Type C HEPA filtration for cleaning of antineoplastic-contaminated airstreams within a laboratory setting. The workshop will focus on our second aim of the study: to report on real-world efficacy of HEPA filtration systems. The workshop will review the objectives and proposed methods of the real-world phase of the study, modify these based upon expert input from the certifiers, and subsequently train interested certifiers on the wipe sample collection and submission protocol.
Learning Objectives: 1. The long-term objective of this project is to reduce
occupational health effects among healthcare workers with potential occupational exposure to hazardous drugs.
2. Research results will provide data to support specific recommendations for the development of engineering design, equipment selection, and
operational guidance to protect potentially exposed workers from unnecessary exposure to these hazardous drugs.
9:00 - 10:00 am Workshop: NIOSH Hazardous Drug Sampling in Compounding Pharmacy Environments Speaker: Deborah V. Hirst, PhD, PE/Ken Mead, PhD, PE of CDC- NIOSH
Learning Objectives:1. Identify certifiers potentially interested in
participating in the NIOSH field sampling activities.2. Gather certifier expert input on proposed objectives
and methodologies. 3. Instruct certifier attendees on the wipe sample
collection and submission protocol. 4. Identify an effective initiation strategy, targeted start
date, and targeted duration for the field sampling initiative.
10:00 - 10:40 am CAG 003Working GroupModerators: Kym Faylor & Jim Wagner
10:40 - 11:20 am CAG 009 Working GroupModerators: Kym Faylor & Jim Wagner
11:20 am - Noon CAG 002 Working GroupModerators: Kym Faylor & Jim Wagner
1: 00 pm - 4:00 pm RCCP - SCF Practical ExaminationGrand Sierra A
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Platinum SponsorsThe Baker Company
Labconco
NuAire, Inc.
gold SponsorsTEC Services, Inc.
bronze SponsorsAir Techniques International
Camfil Farr
Germfree Laboratories, Inc.
ThermoFisher Scientific
TSI Incorporated
A Special Thanks to our Sponsors and Exhibitors
ExhibitorsBooth 1: U.S. Micro-Solutions, Inc. Booth 2: TSI, Inc.Booth 3: Clordisys Solutions, Inc.Booth 4: Camfil Farr Booth 5: Holland Safety EquipmentBooth 6: Shortridge Instruments, IncBooth 7: Aerobiology Laboratory Associates, Inc.Booth 8: Flow Sciences, Inc.Booth 9: Germfree Laboratories, Inc.Booth 10: TEC Services, Inc. Booth 11: Evergreen Telemetry, LLCBooth 12: EMD MilliporeBooth 13: Flanders CorporationBooth 14: Thermo ScientificBooth 15: Lighthouse Worldwide SolutionsBooth 16: ENVIROFLO, Inc.Booth 17: PathCon LaboratoriesBooth 18: Esco Technologies, Inc.Booth 19: NuAire Inc.Booth 20: EMLab P&KBooth 21: Airflotek, Inc.
Booth 22: Air Techniques InternationalBooth 23: American Biological Safety AssociationBooth 24: Filtration Group LLC Booth 25: LabconcoBooth 26: AAF InternationalBooth 27: DRS Laboratories, Inc.Booth 28: Eagleson InstituteBooth 29: The Baker Company
Exhibiting Times Sunday 7:00 - 8:00 am ...............Breakfast/Exhibiting 10:30 - 11:00 am ...........Break/Exhibiting Noon - 1:00 pm .............Lunch/Exhibiting
Monday 7:00 - 8:00 am ...............Breakfast/Exhibiting 10:15 - 10:45 am ...........Break/Exhibiting Noon - 1:00 pm .............Lunch/Exhibiting
Tuesday 7:00 - 8:00 am ...............Breakfast/Exhibiting
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booth 1: U.S. micro-Solutions, inc. U.S Micro-Solutions, Inc. specializes in the laboratory analysis of USP 797 culturable air, contact, and finger tip plates. We provide our customers with a specialized ISO classification report that enables them to accurately identify violations of USP 797 regulations. Call 724-853-4047 or visit www.usmicro-solutions.com for more information on USP 797 testing and analysis.
www.usmicro-solutions.com
booth 2: TSi, inc.TSI Incorporated is a leading supplier of Instrumentation for Certifiers. Products include AeroTrak™ Particle Counters, VelociCalc™ Thermal Anemometers, DP-Calc™ Micromanometers, and EBT731 Capture Hoods that can be used as Direct Inflow Measurement (DIM) devices for Biological Safety Cabinets. TSI also supplies fume hood monitors and laboratory controls.
www.tsi.com
Booth 3: Clordisys Solutions, Inc.Clordisys provides chlorine dioxide gas decontamination equipment for use on BSC’s, HEPA housings, Incubators, Isolators, Rooms, and other enclosures. Chlorine dioxide gas is a safer alternative to formaldehyde and our CHEM-CD process is a simple, easily portable, NSF approved replacement for the decontamination of BSCs.
www.clordisys.com
Booth 4: Camfil Farr World leader in air filtration technology, Camfil Farr offers state-of-the-art filtration solutions for cleanrooms and high containment spaces. Camfil Farr manufactures HEPA and ULPA filters with flows as high as 600 fpm; and adsorbers for removing gaseous contaminants. Camfil Farr’s highly-engineered filter housings have reset the industry standard for biocontainment systems.
www.camfilfarr.com
Booth 5: Holland Safety EquipmentHolland Safety Equipment is the North American distributor for Temperature Electronics Ltd. TEL offers air flow alarms for fume hoods and bio-safety cabinets, room pressure alarms and VAV control products. HSE also offers smoke sources for airflow visualization and other consumables for CETA certifiers.
www.hollandsafety.com
Exhibitor descriptions
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booth 6: Shortridge instruments, incAirData Multimeter kits include industry-standard pitot tubes, static pressure probes, tubing and two proprietary probes, which make air-balancing faster and easier. The AirFoil probe is a single-point velocity probe with a straight shaft design for easy duct insertion. The VelGrid is a 16-point, velocity-averaging grid, which is useful for exhaust hoods, cleanroom filter outlets, laminar flow workstations and large filters and coils.
www.shortridge.com
Booth 7: Aerobiology Laboratory Associates, Inc.Aerobiology Laboratory Associates, Inc. is an accredited microbiology laboratory focused on analyses of regulated USP <797> testing for pharmacies and microbial monitoring analyses for all your decontamination services. We offer nationwide support with laboratory locations in Atlanta, GA, Denver CO, and the Washington D.C. area. Our technical capabilities and outstanding levels of customer support allow us to provide accurate, cost effective and timely results.
www.aerobiology.net
booth 8: flow Sciences, inc.Flow Sciences’ mission is to provide containment systems for laboratory, pilot plant and manufacturing areas. The products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.
www.flowsciences.com
booth 9: germfree Laboratories, inc.GERMFREE specializes in the design and production of all-stainless steel laminar flow equipment for hospital and pharmacy use. GERMFREE manufactures a full line of USP <797> and NIOSH compliant barrier isolators as well as horizontal and vertical laminar airflow hoods and chemo hoods. GERMFREE has extensive experience with high containment applications, working with organizations including the United States military to develop equipment for the handling of biological and chemical agents. GERMFREE brings this experience in design and construction to the hospital and pharmacy markets. With over 50 years in the industry, GERMFREE has the experience to provide the best protection for patients, personnel and products.
www.germfree.com
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Exhibitor descriptions (continued)
booth 13: flanders CorporationFlanders provides the most complete line of filtration products available, specializing in high efficiency air filtration products. We design, manufacture and market the highest quality filter and containment filtration systems necessary to filter and contain dangerous airborne contaminants for the medical, biological and pharmaceutical industry. Flanders is Foremost in Air Filtration.
www.flanderscorp.com
Booth 14: Thermo ScientificInnovative technologies and our global commitment are what make Thermo Scientific biological safety cabinets the safest and most reliable available. Delivering world-renowned service and support, our cabinets incorporate features designed to minimize cost of operation and maximize comfort for extended use applications.
www.thermoscientific.com
booth 15: Lighthouse Worldwide SolutionsLighthouse has the most complete line of particle counting and contamination monitoring solutions available. Including airborne particle counters, liquid particle counters, microbial samplers, facility monitoring systems. These solutions are now found in semiconductor, pharmaceutical, data storage, biotechnology, aerospace and defense industry facilities worldwide.
www.golighthouse.com
booth 16: EnVirofLo, inc.Custom Safety Enclosures For Lab Automation: enviroflo series enclosures are designed and manufactured to customer specifications as a highly versatile product line of laboratory automation enclosure systems. Developed for either table-top placement or as a free-standing structure, we enclose the most challenging equipment isolation requirements.
www.ntibio.com
booth 17: PathCon LaboratoriesPathCon Laboratories offers microbiological laboratory and consulting services in indoor air quality issues. We provide custom sampling protocols, sampling media, air sampler rental, bacterial and fungal counts and identifications, and data interpretation to assist pharmaceutical compounding facilities in evaluating microbial bioburden as described in USP 797.
www.pathcon.com
booth 10: TEC Services, inc.TEC Services was founded in 1994 and has since built a strong reputation in the controlled environment products, calibration, and service industry. TEC specializes in the production of aerosol photometers, aerosol generators, calibrations, as well as repair and service all within the field of HEPA filter testing and certification.
www.tecservicesinc.com
Booth 11: Evergreen Telemetry, LLCEvergreen Telemetry LLC develops and supplies wearable instruments and wireless sensing probes for measurements. It offers wireless sensors that transmit measurements to the Wrist Reporter, which displays a continuous stream of readings; sensing probes that are designed for placement upon diffusers, ducts, coils, pipes, fans, machines, and other locations of interest to technicians.
booth 12: Emd milliporeFor over 50 years, we have been providing unmatched application, validation, and engineering expertise to biotech and pharmaceutical companies around the globe. We recognize the need for quality, cost containment, and regulatory compliance at every stage of your process.
www.emdmillipore.com
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Exhibitor descriptions (continued)
booth 18: Esco Technologies, inc.Esco is introducing a new line of energy efficient, advanced safety, and ergonomic ECM-powered biosafety cabinets. We are one of the largest global manufacturers of biosafety cabinets, animal workstations, clean benches, isolators, and fume hoods. We are based in Philadelphia, PA, with products sold worldwide in more than 100 countries.
www.us.escoglobal.com
booth 19: nuAire inc.NuAire has been universally recognized as a leader for more than 40 years in providing laboratory professionals with reliable products such as biological safety cabinets, CO2 incubators, Laminar Airflow equipment, animal facility products, ultra-low temperature freez¬ers and centrifuges for the most demanding environments.
www.nuaire.com
booth 20: EmLab P&KEMLab P&K, a TestAmerica company, is one of the leading commercial IAQ laboratories in North America. EMLab P&K has over 90 service and drop-off locations throughout the United States. EMLab P&K specializes in microbial analysis including mold, bacteria, and USP <797> testing. More information about USP <797> services at
www.emlabpk.com/USP_797
booth 21: Airflotek, inc.Founded in 1982, Airflotek is a distributor of air filtration systems including fan & filter modules, HEPA/ULPA filters, terminal ducted modules, cleanroom ceilings & cleanroom lighting, softwall cleanrooms, air showers, pass-throughs, HEPA filtered vacuums, shoe cleaners, cleanroom furniture, laminar flow equipment & cleanroom construction.
www.airflotek.com
booth 22: Air Techniques internationalAir Techniques International (ATI) is the global leader in testing equipment for specialized air filters and masks. Since 1961, we’ve enabled our customers to improve product quality, ensure worker health and safety; complying with the most stringent testing standards and regulations. ATI is the trusted resource for government, military, nuclear, and commercial industries.
www.ATitest.com
Booth 23: American Biological Safety AssociationThe American Biological Safety Association (ABSA) was founded in 1984 to promote and expand biological safety expertise. To accomplish this core purpose, ABSA offers training opportunities, publications, networking, biosafety resources, and an annual biological safety conference for all biosafety professionals. To find out more, go to www.absa.org.
www.absa.org
Booth 24: Filtration Group LLC Filtration Group LLC is committed to product excellence, innovative solutions and customer service. We provide a full line of high quality filtration products for the HVAC, Turbine, Gas Phase, Cleanroom, Biosafety, along with their aftermarkets. Our extensive product line allows us to provide custom filtration solutions for a wide variety of challenging markets. Our service model has always been ‘Right Filter…Right Place…Right Time’.
www.filtrationgroup.com
booth 25: LabconcoSince 1925 Labconco Corporation has been a leader in laboratory equipment.
In 2013, the Purifier ® Logic+ is introduced as the most ergonomic and personally interactive biosafety cabinet ever invented. It’s color, touch screen display allows you to interact with the equipment more intuitively than ever.
www.labconco.com
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Exhibitor descriptions (continued)
booth 26: AAf internationalAAF International (American Air Filter) continues to provide innovative technology for its family of HEPA/ULPA filters, combining extremely low pressure drop and superior durability at the highest filtration levels. AAF offers a complete line of traditional HVAC, Cleanroom, and laminar flow filters, as well as custom design, small and large lot manufacturing.
www.aafintl.com
booth 27: drS Laboratories, inc.DRS Laboratories, Inc. is the Manufacturer of the MCS (Mini Chlorine dioxide System). Having explored alternative technologies to improve quality, timeliness, and cost of performing routine BSC decontaminations, DRS Labs has produced the first affordable, and portable device; including tools, procedures, and training. We also offer Decontamination Services in conjunction w/current certification contractors or independently.
www.drslaboratories.com
booth 28: Eagleson instituteCelebrating twenty-four years, the Eagleson Institute is a non-profit foundation with a mission to promote the principles and practices of laboratory safety. We value the role that certifiers play in the advancement of a safe work environment and look forward to supporting the industry’s future training needs.
www.eagleson.org
Booth 29: The Baker CompanyAs the world leader in the design and manufacture of biological safety cabinets, clean benches and fume hoods, Baker thrives on helping scientists and researchers achieve their mission in almost every kind of endeavor and a wide variety of industries, including biotech, pharmacy, governmental, clinical and medical education research.
www.bakerco.com
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Ed Balkovic – Genyzme, a Sanofi CompanyDr. Balkovic is a Principal Microbiologist in Contamination Control and Subject Matter Expert Microbiologist at Genzyme - a Sanofi company in Framingham, MA. His experience includes over 40 years in Microbiology & Virology; over 25 years in the Biologics Biopharmaceutical, & Biomedical industries; and over 15 years at Genzyme. He established the microbial identification laboratory serving Genzyme’s QC Microbiology testing labs. Dr. Balkovic now conducts investigations, assessments, special projects and training in the area of Pharmaceutical Microbiology, including numerous studies evaluating new and improved methods for microbial detection and identification.
He received his doctorate in Microbiology and Immunology in the Influenza Research Center at Baylor College of Medicine, Houston, TX. Prior to joining Genzyme, Dr. Balkovic has held various positions in Contamination Control, Technical Support, Quality Control, Quality Assurance, Regulatory Affairs and Research & Development at both emerging biotechnology and established biologics companies. He has extensive experience as a Clinical Virologist and Microbiologist. Previously, he supervised the National Virology Reference Lab serving all of the U.S. Veterans Administration’s Medical Centers. He was also the Senior Research Virologist at a major vaccine manufacturer - Connaught Labs (now Sanofi Pasteur).
He serves on the Program Planning Committee for the Parenteral Drug Association’s (PDA) Global Pharmaceutical Microbiology Conference and he served as the Conference Co-Chair in 2009 and 2010.
Eric Kastango – Clinical iQEric S. Kastango is the president of Clinical IQ LLC, a healthcare consulting firm based in Florham Park, NJ. He received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences and a MBA from the University of Phoenix. Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. Eric has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation.
He is an active member and Fellow of the American Society of Healthcare Pharmacists and served on the USP Sterile Compounding Committee from 2005-2010 and was recently re-elected to the 2010-2015 USP Council of Experts, Compounding Expert Committee. He is currently the Chairman of the USP Chapter <797> subcommittee.
Jim Wagner – Controlled Environment ConsultingMr. Wagner has been involved with certification and design of controlled environments since 1979. He serves on the NSF joint committee responsible for NSF standard 49 (Class II Biological Safety Cabinets), the Institute of Environmental Sciences and Technology working groups responsible for HEPA filters, laminar flow equipment, and cleanrooms, and the CETA working groups for the applications guides for certification of engineering controls used in sterile compounding.
Mr. Wagner serves on the 2005-2010 USP expert committee for sterile compounding. He has twice served as president of the Controlled Environment Testing association.
A frequent speaker at industry meetings and workshops on contamination control issues, Mr. Wagner is the primary instructor for the Eagleson Institute’s “Advanced Certification” class for certification of Biological Safety Cabinets. He is a co-developer and frequent presenter at the USP/Baxa training class “Aseptic Processing and Compliance Tools for USP <797>.
Jeanne moldenhauer – Excellent Pharma Consulting, inc.Jeanne Moldenhauer, Excellent Pharma Consulting has more than 25 years experience in the pharmaceutical industry. She chairs the Environmental Monitoring/Microbiology Interest Group of PDA, serves on the Scientific Advisory Board of PDA, founded the Rapid Microbiology User’s Group™, and is a member of ASQ and RAPS. She is the author of Steam Sterilization: A Practitioner’s Guide, Laboratory Validation: A Practitioner’s Guide, Environmental Monitoring: A Comprehensive Handbook, System’s Based Inspections for Pharmaceutical Manufacturers, co-author of Biological Indicators, and numerous publications.
Robert Westney, MS, RAC,CMQ/OE – Cryologics, Inc.Bob is President and Founder of Cryologics, Inc., which specializes in converting in-house microbial isolates into the format required for compendial testing. He is also Principal Consultant and Founder of Westney & Associates Consulting, LLC, which provides consulting services in the areas of cGMP compliance, contamination control, and environmental monitoring. In addition to authoring several trade journal articles and speaking at prominent industry trade group conference, he recently authored a chapter, “The Role of In-House Microbial Isolates in Contamination Control”, for an upcoming Parenteral Drug Association book on contamination control, due to be published the summer of 2013. He has 25 years of experience in the cGMP industry, including Quality Control Microbiology, Quality Assurance
Speaker bios
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and Regulatory Affairs. He has worked for biotechnology and pharmaceutical manufacturers, as well as for pharmaceutical, biotechnology, cosmetic, and food testing laboratories. He has played key roles in numerous U.S. and international regulatory inspections. He is currently Editor of the Pharmaceutical Microbiology Forum Newsletter, and a member of the Microbiology Network, a consortium of recognized industry microbiology experts.
Kiee garland – b&V TestingMs. Garland is responsible for oversight of B&V’s Environmental Sampling and Monitoring services to B&V’s pharmaceutical compounding and manufacturing clients with expertise in Environmental Sampling and Monitoring programs for USP <797> compliance. Ms. Garland has more than ten years of Microbiology experience (2001‐present) in USP and FDA‐regulated Pharmaceutical and Biotechnology industries, and is an expert in the design, development and execution of viable environmental sampling and monitoring programs for ISO classified drug production and compounding areas.
Kevin martin – Azzur groupMr. Martin has over 35 years of FDA regulated industry experience that includes management positions at Wyeth and McNeil Pharmaceutical. He is considered a subject matter expert on risk-based systems validation conducted within QA, IT, Manufacturing, Operations, Clinical and R&D in FDA regulated environments.
He was a member of the PhRMA Computer Systems Validation Sub-Committee, was the Core Team Secretary for the PDA Part II Task Group and is currently Chair of the GAMP Americas Steering Committee.
He received his Bachelors degree in Chemistry from Delaware Valley College of Science and Agriculture and his Master of Engineering from Penn State University.
Speaker bios (continued)
Louis diberardinis – director, Environment, Health and Safety OfficeMr. DiBerardinis received his Bachelor of Science Degree in Chemical Engineering from Northeastern University and a Master of Science Degree in Industrial Hygiene from Harvard University. He is a Certified Industrial Hygienist and Certified Safety Professional.
Mr. DiBerardinis is the Director, Environment, Health and Safety at MIT. Prior to that he was at Polaroid Corporation and Harvard University.
Mr. DiBerardinis is a visiting lecturer at Harvard University School of Public Health where he currently teaches in several graduate courses and continuing education programs. He is Adjunct Professor at the University of Massachusetts Lowell Campus in the Department of the Work Environment. He is the author of numerous technical publications and co-authored the text “Guidelines for Laboratory Design: Health and Safety Considerations” and is editor of the “Handbook of Occupational Safety and Health”, both published by John Wiley and Sons. He served as chair of the ANSI Z9.5 subcommittee on Laboratory Ventilation from 1984 to 2006.
Joe Gecsey – Hach Ultra AnalyticsCurrently the Life Science Application Manager at Hach (formerly Pacific Scientific Instruments), Joe has been involved with the particle counting industry since 1984. First joining Met One as an electronic design engineer, Joe has been involved in both airborne and liquid particle counter design, as well as multi-sensor systems for facility monitoring systems (FHS). He is part of the TC209 WG1 revision group on the main global cleanroom certification standard, ISO 14644-1 and -2, one of the two Americans on the committee. Joe has been involved in various standards involving particle counting in air and liquids, giving information seminars in Asia, Europe and South America on particle counting and associated topics. Joe was originally a native of southern California, receiving a B.S.E.E. (Electrical Engineering) from UC Santa Barbara in 1976. He has called southern Oregon home since 1981.
Dan Ghidoni – Northeast Scientific AssociatesDan has 24 years of experience in the contamination control industry, and is an Applications Engineer with the Baker Company’s New England sales representative Northeast Scientific Associates. He is responsible for providing equipment solutions to control laboratory contaminants, and was the engineering team leader for the company’s chemical fume hood and biological safety cabinet product lines. His extensive airflow knowledge assures proper integration of hoods with building HVAC systems. Dan is a member of ASHRAE and former chair of the laboratory committee. In addition, he is a member of the ASHRAE 110 committee responsible for updating the fume hood test standard. He teaches regularly at the Eagleson Institute and is a member of ABSA, AALAS, and AIHA. He holds a B.S. in Engineering from the University of Maine.
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deborah V. hirst – nioShDeborah V. Hirst, PhD, PE, is an environmental health engineer with NIOSH, part of the Centers for Disease Control and Prevention. She is a Lieutenant Commander in the U.S. Public Health Service. Dr. Hirst received a Bachelor of Science degree in civil and environmental engineering and a doctorate in environmental health engineering from the University of Alabama at Birmingham. Since joining NIOSH in 2007, she has researched and evaluated engineering control technology to reduce workers’ exposures to occupational safety and health hazards.
Ken mead, Phd, PE, CdC – nioShKenneth R. Mead (Ken) is a Senior Research Engineer assigned to the Centers for Disease Control and Prevention (CDC) – National Institute for Occupational Safety and Health (NIOSH) in Cincinnati, OH. Ken is a registered professional engineer (mechanical) with a BS from Wichita State University and both his MS and PhD in Industrial Hygiene from the University of Oklahoma. Ken was one of the original authors of the 2004 NIOSH Alert on Hazardous Drugs and has continued to stay involved in hazardous drug-related research. Ken is a member of several ASHRAE technical committees on ventilation, clean spaces and healthcare design and is a member of USP’s Expert Panel in developmental support of USP’s proposed Hazardous Drug Chapter.
Speaker bios (continued)
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CETA’s 22nd Annual ConferenceApril 11-15, 2013 • Hyatt Regency • Austin, Texas
