CleanRooms Worldwide eVent
October 21, 2008 ??? 8:00 a.m.???6:00 p.m. Central Time
Virtual tradeshow???A first for the CleanRooms group of contamination control technology conferences and exhibitions
CleanRooms will premier its virtual trade show, the CleanRooms Worldwide eVent, on October 21. This online conference and exhibition uses leading-edge technology to bring contamination control professionals together with colleagues and suppliers, all from the convenience of the personal computer. For the first time, registrants can visit the tradeshow floor and chat with exhibitors, attend sessions with industry experts, and mingle in the virtual lounge, all without leaving the office.
For more information and for free registration, visit www.cleanrooms-worldwide.com.
Maximizing Benefits of Clean Manufacturing and Technical Cleaning Advancements in Automotive Production
Dr. Udo Gommel, Fraunhofer Institute
8:30 a.m.???9:00 CST
Consumer demand for ever more reliable and higher-quality vehicles continues to drive both automotive manufacturers and their subcontractors toward cleaner, more tightly controlled and monitored manufacturing processes and assembly areas. In addition, one of the most contamination-sensitive operations of automobile manufacturing, painting and finishing, is also one of the most energy-hungry. This presentation will examine current and future cleanliness specifications for automobile manufacturers and subcontractors, the clean process supply chain, energy-saving control systems, and adaptive measurement techniques for the clean areas employed by the automobile manufacturing industry.
Dr. Udo Gommel is director of the Department of UltraClean Technology and Micromanufacturing at the Fraunhofer Institute for Manufacturing Engineering and Automation (Fraunhofer IPA). Gommel 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
Why You Absolutely Should Read the New Chapter on USP <797>
Eric Kastango, Clinical IQ
11:00???11:30 a.m. CST
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 USP <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.
Eric Kastango, MBA, RPh, FASP, is the founder and president of the consulting company Clinical IQ, LLC (Florham Park, NJ). 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). 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.
New Approaches to Energy-Saving Facility Design
Steven Cook, CH2M HILL
1:00???1:30 p.m. CST
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 ensure systems are operated as efficiently as possible, and implementing sustainable design features and techniques into facility design and construction.
Steven D. Cook, PE, 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. Cook has a bachelor of science degree in electrical engineering from Oregon State University.
Successful Antimicrobial/Disinfection Strategies Begin with Proper Selection
Lisa Strickland, Contec Inc.
2:00???2:30 p.m CST
If there were only one type of disinfectant available to deal with all of the different microbial threats to aseptic production processes and health care 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.
Lisa Strickland is a research and development associate at Contec Inc.
Providing for Electrical Safety in the Cleanroom
Daryn Lewellyn and Mike Rataj, Aramark
Just in the United States 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 presentation will address electrical safety issues in the cleanroom, including the National Fire Protection Association (NFPA) and OSHA perspectives on the subject. Topics will include safe electrical work practices, complying with the NFPA 70E “Standard for Electrical Safety in the Workplace” in a cleanroom environment, arc flash, arc flash personal protective equipment (PPE), and what types of cleanroom apparel are appropriate to provide protection in a controlled environment.
Daryn Lewellyn is the founder of electrical safety company Lewellyn Technology. He has been teaching and developing training programs for more than 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.
Mike Rataj is chief of quality assurance at garment provider Aramark Cleanroom Services. 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.
Great Barrington, MA
Berkshire is a global company involved in the engineering and manufacturing of cleaning and contamination control products for cleanrooms and controlled environments. It offers a full line of sterile and autoclavable wipers (dry and pre-saturated), swabs, face masks, glove liners, mopping systems, and cleanroom paper. Berkshire introduces the EasyClean??? 360 isolator cleaning tool system. The ICT is made of smooth stainless steel and swivels 360?? for easy maneuverability. Elastic/padded covers accompany the ICT and are durable to a wide range of cleaning solutions. Visit the company’s web site or call (800) 742-7000 for more information.
Cleanroom Filters & Supplies
Lehigh Valley, PA
Cleanroom Filters & Supplies (CFS) is a national filter warehousing and distribution network. The company helps maintain an effective and sterile environment by supplying filters and cleanroom components necessary for day-to-day operations, ranging from shoe cleaners, glove/shoe covers, and wipes to pass-throughs, air showers, and softwall cleanrooms. The company’s warehouse stocks a variety of filters from Flanders, Airguard, and other top filter manufacturers. Type “C” HEPA filters are stocked to meet or exceed the strict requirements of the pharmaceutical and medical fields. Filters may also be ordered if unavailable from the company’s current stock. Whether the organization is a hospital, pharmaceutical company, or laboratory, CFS has the ability to provide all of the necessary products. Call toll free at (800) 523-9852 or visit the company’s web site.
Contec, Inc., an ISO 9001:2000 registered company, is a manufacturer of contamination control products for critical manufacturing environments worldwide. Contec products are used in various industries across the globe???biomedical, pharmaceutical, medical device, microelectronics, optics, semiconductor, data storage, automotive OEM, aerospace, and marine. The company’s extensive product line for cleanrooms includes knitted, woven, and nonwoven wipes; pre-saturated wipes; sterile and non-sterile wipes; mopping systems; wall washing systems; disinfectants; undergloves; sponges; and swabs. Many of its products are available validated sterile. ISO registration ensures customers receive consistent quality products???from development to delivery.
Grants Pass, OR
Monitoring airborne particles in clean zones is not just a regulatory issue; it is a question of quality. MET ONE brand remote particle sensors feature Long Life Laser?? technology to provide solutions for contamination control engineers around the world. Whether you are looking for handheld analyzers, portable units, or permanently installed facilities monitoring systems (FMS), Hach Ultra air particle counters provide dependability to monitor to cGMP and GMP standards and validate to ISO 14644 classifications; a flexible range of sensitivity and communication options for seamless integration into the customer’s system; and a complete software portfolio designed to meet regulatory and quality assurance needs. Visit the company’s presentation on ISO 21501 ??? A Standard Methodology to Optical Particle Counter Calibration and What It Means to Cleanroom Owners.
Kimberly-Clark Professional offers two innovative solutions for cleanroom control: Kimtech Pure G3 and G5 Sterling nitrile cleanroom gloves and Kimtech Pure A5 cleanroom apparel. The value-priced gloves, with environmentally friendly packaging, offer the comfort, sensitivity, and fit of latex with the protection of nitrile and are appropriate for Critical/Class 10 (G3) and Controlled/Class 100 cleanrooms (G5). The apparel features Clean-Don Technology???garment design features that make it easier to don the coveralls without compromising their sterility. The apparel’s Spunbond Meltblown Spunbond (SMS) material provides a cloth-like feel and is 25 times more breathable than flashspun, high-density polyethylene fabric. Visit www.kimtech.com for more information on these and other Kimtech products.