View the presentations from our first ever virtual event – the CleanRooms Worldwide eVent – at your leisure. Contamination control industry experts offer insights into facility design, electrical safety, cleaning and disinfection, and more.

Speaker Bios

Steven D. Cook, PE
Steven Cook is Vice President and Senior Program Manager for CH2M Hill's Electronics and Advanced Technology division. He is a specialist in advanced energy technologies, having produced or managed multiple projects and studies to develop strategies for energy reduction in advanced research and manufacturing facilities, including a major initiative to create cost-effective energy savings concepts for the latest generation of 300mm semiconductor wafer facilities. He is currently serving as Program Manager for major projects in the solar and semiconductor industries in Southeast Asia and Australia. Steven has a Bachelor of Science degree in Electrical Engineering from Oregon State University.

Dr. Udo Gommel
Dr. Udo Gommel is Director of the Department of UltraClean Technology and Micromanufacturing at the Fraunhofer Institute for Manufacturing Engineering and Automation (Fraunhofer IPA). Dr. Gommel joined Fraunhofer IPA as a scientist in 1996 where he has since spearheaded many of the Institute’s different competence fields including contamination control, international certification of production tools for clean applications, and served as Group Manager for Contamination Control & Clean Production Technologies. Udo holds a degree in physics and in 2006 was awarded a doctorate for research into assessment procedures for clean manufacturing materials. He is a member of the CleanRooms magazine editorial advisory board and the conference steering committee of the CleanRooms Europe Conference & Exhibition.

Tony Harrison
Tony Harrison is a qualified electrical & electronic engineer, with over twenty years’ involvement in control and monitoring systems for manufacturing industries. Tony represents the Pharmaceutical Healthcare Sciences Society (formerly known as the UK Parenteral Society) on the LBI/30 committee for the British Standards Institute, working on the revisions to the ISO14644 family of standards. LBI/30 also represents the UK interests on changes to EU GMP Annex 1. Tony is also one of the UK technical experts on ISO TC 209 WG1 working on the revisions to the cleanroom standard ISO 14644-1 & -2. The recently published guide to continuous particle monitoring to EU GMP Annex1 from the PHSS ‘Best Practice for Particle Monitoring in Pharmaceutical Facilities’ was produced by a working party of PHSS members chaired by Tony. In his role as Global Life Sciences Manager for Hach Ultra Analytics (part of the Danaher group of companies), working with colleagues on various standards groups in a world-wide network, he is responsible for interpreting and comparing the different regulatory and international standards for clean rooms and regulatory compliance issues. In recent years he has published papers on compliance issues relating to the life sciences industry, including most recently a paper in the European Journal of Parenteral & Pharmaceutical Sciences. He has also been responsible for creating validation best practice standard operating procedures (SOP) for regulatory compliance testing equipment.

Eric S. Kastango, MBA, Rph, FASP
Eric Kastango is the founder and President of the consulting company, Clinical IQ, LLC based in Florham Park, New Jersey. He received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences (1983) and an MBA from the University of Phoenix (2001). Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care). Eric is a Fellow of the American Society of Health-System Pharmacists (ASHP), has served on the ASHP’s Council of Education Affairs andas a pharmacy surveyor for the Accreditation Commission for Health Care, Inc. (ACHC). He is a member of the 2005-2010 USP Council of Experts, Sterile Compounding Committee and a member of the CleanRooms magazine Editorial Advisory Board.

Daryn Lewellyn
Daryn Lewellyn is the founder of electrical safety company, Lewellyn Technology. He has been teaching and developing training programs for over 18 years and spends most of his time now speaking on electrical safety at conferences, seminars, and corporate safety meetings, as well as consulting with clients in their facilities. He has had many articles published on topics such as Electrical Troubleshooting, NFPA 70E, and Arc Flash.

Mike Rataj
Mike Rataj is Chief of Quality Assurance at garment provider, Aramark Cleanroom Services. Prior to joining Aramark, he worked in various manufacturing and R&D roles for the pharmaceutical industry including Abbott Laboratories and Amoco Technology Company. He holds an MS in biology from the University of Illinois and an MBA in operations management from the Illinois Institute of Technology Stuart School of Business. He was also recently elected President of the Institute of Environmental Sciences and Technology (IEST) with term beginning in 2009.

Lisa Strickland
Lisa Strickland is a Research & Development Associate with Contec, Inc. specializing in contamination control issues in the life science markets. Lisa was previously a Project Chemist and has over 8 years experience in formulation. She joined Contec in 2004 and has spent the past 4 years focusing on cleaning, wiping, and mopping products and procedures. Her articles on proper cleaning techniques have been published in industry trade journals including CleanRooms magazine and the Italian Association for Contamination Control’s ASCCA News. Lisa represents Contec as a member of the American Society of Health-System Pharmacists (ASHP) and Parenteral Drug Association (PDA). She received her Bachelor of Science degree in Biology from the Franklin College of Arts and Sciences at the University of Georgia in Athens, GA (1995).

Assessing and Comparing Cleanroom Suitable Materials
Dr. Udo Gommel, Fraunhofer Institute
Most of the contamination found in clean manufacturing environments (particles, outgassing, ESD) originates from the production equipment utilized and thus mainly from the materials used to make them. For industry, the ability to objectively assess and compare the contamination potential of materials for use in clean environments is therefore an essential issue, but one in which there has been minimal research, up till now. This highly-informative talk summarizes the current research situation in the field of cleanliness-suitable materials and highlights new, sensitive assessment techniques. These works are driven by the members of the industrial alliance CSM (Cleanroom Suitable Materials).

Why You Absolutely Should Read the New Chapter on USP-797
Eric Kastango, Clinical IQ
USP Chapter 797, "Pharmaceutical Compounding: Sterile Preparations," is the first set of sterile compounding standards issued by the United States Pharmacopeia (USP). The Chapter sets forth standards, guidance, and examples for compounding sterile preparations, and in particular identifies the tools, protocols and specific environmental controls that must be in place to safely perform sterile compounding operations.

This timely presentation will examine the newly-revised US Pharmacopeia chapter 797 pointing out the critical new aspects of the chapter their benefits and ramifications, and what they mean for the requirements and validation of existing and planned sterile compounding operations.

New Approaches to Energy-Saving Facility Design
Steven Cook, CH2M Hill
Innovative approaches to energy-saving facility design can reduce operating costs and greenhouse gas emissions, increase reliability and productivity, and improve competitive advantage. Using selected project examples, this presentation will discuss how to implement energy-saving facility design techniques, including selecting equipment and systems to best match climatic conditions and load profile, utilizing innovative tools to assure systems are operated as efficiently as possible, and implementing sustainable design features and techniques into facility design and construction.

Successful Antimicrobial/Disinfection Strategies Begin With Proper Selection
Lisa Strickland, Contec Inc.
If there were only one type of disinfectant available to deal with all of the different microbial threats to aseptic production processes and healthcare environments, life would be a lot simpler. But that is far from the case. Deciding what type of disinfectant will provide the greatest efficacy for a particular application requires a back-to-basics approach. This presentation will examine the different options and how they are best suited to the task at hand in terms of chemical structure, effectiveness against particular organism types, personnel protection issues, regulatory issues, areas of application, and other factors.

Providing For Electrical Safety in the Cleanroom
Daryn Lewellyn and Mike Rataj, Aramark
Just in the U.S. alone, on average, approximately 5 to 10 arc flash explosions occur on the job every day. Arc flash is no less of a concern in cleanrooms and other controlled environments, in fact, it is more so. This important presentation will address electrical safety issues in the cleanroom including the National Fire Protection Association (NFPA) and OSHA perspectives on the subject. Topics discussed will include: safe electrical work practices, complying with the NFPA 70E "Standard for Electrical Safety in the Workplace" in a cleanroom environment, arc flash, and arc flash Personal Protective Equipment (PPE) and what types of cleanroom apparel are appropriate to provide protection in a controlled environment.

New Regulations Concerning Airborne Particle Counts (ISO 21501 and ISO 14644)
Tony Harrison, Hach Ultra
This detailed and highly-informative presentation discusses current standards and guidance in use for airborne particle monitoring in cleanrooms as well as verification standards and requirements. Emphasis is placed on FDA and EU GMP compliance monitoring requirements for aseptically processed pharmaceuticals including the new EU Annex 1 revision which becomes effective March 1, 2009 and expected revisions to ISO 14644-1 and -2. Also covered is the new ISO 21501 particle counter calibration standard.