The successful implementation of a CIP system is determined by cost effectiveness, completion on schedule, and reliable cleaning
By Sally J. Rush, Seiberling Associates, Inc.
Regardless of the type of facility
Tag Archives: Clean Rooms
Isolators play an important role in reducing contamination through exposure to airborne particles and human contact. Developers of enclosed environment equipment must not only focus on the cleanliness of the internal atmosphere, but also keep in mind how the design will affect user experience and safety.
Compiled by Jason Andrukaitis
Built-to-order isolation equipment
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Clean Rooms International has been providing built-to-order isolation equipment since 1982 and has developed the expertise necessary to provide flexible solutions for customers. The company develops creative products for adding clean air, extracting contaminants, isolating major problem areas, and more. An isolator can mean many different things, so Clean Rooms International provides customization of isolation equipment. Customers produce the requirements, and the company will develop an approach that is unique to each business. For product questions, estimates, or to place an order call 616-452-8700 or e-mail sales@clean
roomsint.com.
Clean Rooms International
Grand Rapids, MI
www.cleanroomsint.com
Stent coating isolator
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EnGuard Systems, an established leader in the design and manufacture of isolators, has developed a stent coating isolator for use as an integral part of the safe and efficient development of coronary artery stents. In this custom application, the company’s ability to understand the process resulted in ergonomic integration of the process, the equipment, and the isolator. The stent coating isolator employs multiple safety devices and a process logic controller for the complex management of hazardous gases and interlock systems. EnGuard’s practical approach to isolation technology was developed from many years of hands-on pharmaceutical manufacturing experience. In addition to this application, the firm provides isolators for totally contained processing of potent compounds, aseptic applications, and parenteral products. EnGuard’s portable enclosures provide maximum interaction with the process while protecting the product and the personnel. EnGuard Systems provides complete isolator service from initial concept to validation support.
EnGuard Systems
Indianapolis, IN
www.enguardsystems.com
Controlled atmosphere gloveboxes
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Precise™ controlled atmosphere gloveboxes offer high-end construction and features at economical prices. These gloveboxes maintain a leak-tight, controlled condition environment for applications such as organometallic chemistry, alternative energy cells, and hydrophilic chemicals. The boxes are capable of maintaining low levels of oxygen (as low as 5 ppm) or moisture (as low as 50 ppm). Features include a one-piece molded, medium-density polyethylene shell, which is chemical-resistant and easy to clean; a viewing window of 1/4-inch thick laminated safety glass; and six manual valves for purging, filling, and drying train connections. Space-saving inner and outer transfer chamber doors that pivot upward are counterbalanced and equipped with quick-latches and pressure relief valve. The generous 13 ft3 interior of the main chamber meets Class 1 atmosphere conditions for leak rate per ISO 10648-2 test methods. The transfer chamber is 11 inches long and also features a pressure gauge with readings from 0 to
Compiled by Jason Andrukaitis
Wireless temperature monitoring system
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Accsense’s wireless monitoring system helps medical, pharmaceutical, and laboratory personnel keep track of temperatures, CO2 levels, humidity, and other measurements. The system works well with refrigerators, freezers, and incubators, keeping automated logs and sending alarm notifications via e-mail, phone, or pager. The system can be set up quickly with no additional hardware or software. An internet connection is all that is required to run the system. The device complies with USP 797, CLIA, JCAHO, FDA, AABB, and other industry regulations.
Accsense, Inc.
Santa Barbara, CA
www.accsense.com
Two-component mixing packages
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APS’s Meg-A-Pak™ is now available in 800-g packs for two-component reactive adhesives and sealants in flexible pouches. The package is simple, safe, and easy to use, and provides a combination packaging/mixing burst seal container for a variety of resin systems such as epoxies, acrylics, urethanes, silicones, conductives, polysulfides, adhesives, and other materials. For more information call 800-222-1117.
Adhesive Packaging Specialties, Inc.
Peabody, MA
www.adhesivepackaging.com
Stainless-steel overbraided PTFE hose
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AdvantaPure is now offering stainless-steel overbraided PTFE hose in six variations. Called APFOS, the hose offers the purity of PTFE fluoropolymer with the durability and enhanced pressure carrying capabilities of stainless steel. The hoses can be used for applications in the chemical, food and beverage, pharmaceutical, and other high-purity industries. The core provides non-restrictive flow and an inert surface to transport critical fluids. The hose handles temperatures ranging from
January 29, 2008 — /PRNewswire/ — CONCORD, CA AND EDEN PRAIRIE, MN — March Plasma Systems, a Nordson company (NASDAQ:NDSN), and Harland Medical Systems, Inc. continue to build on their joint business relationship. Harland Medical Systems has agreed to license March Plasma Systems application methods and surface materials for medical device markets.
The combination of March’s plasma enhanced surface treatment technologies with Harland’s biocompatible chemistries, application systems, and test methods provides medical device manufacturers with a total-solution approach that integrates all the materials, methods, machines, and manufacturing components required to create desirable biosurfaces on a variety of medical devices.
“Harland Medical Systems’ focus in the application and testing of specialized surface coatings compliments March’s strategy for applying surface modification techniques to medical devices. The alliance will further our success in the medical device market,” says Peter Bierhuis, president of March Plasma Systems.
“We are excited to add March Plasma’s extensive application knowledge and surface materials to the portfolio of surface modification methods and materials we offer to our medical device customers,” states Jon Anderson, CEO of Harland Medical Systems, Inc.
About March Plasma Systems
March Plasma Systems is the global leader in plasma processing technology for the medical device, life science, printed circuit board (PCB), semiconductor, and microelectronics industries. March has operations and support centers worldwide, including California, Florida, Europe, Singapore, China, Japan, Korea, and Taiwan. With over 20 years of continuous innovation, March designs and manufactures a complete line of award-winning and patented plasma processing systems. An expert staff of scientists and engineers is available to assist in the design of plasma processes that improve both product reliability and increase production yields.
Visit www.marchplasma.com
About Harland Medical Systems, Inc.
Harland Medical Systems offers chemistries, process development services, standard automation systems for applying and testing biosurfaces, and coating service capabilities to perform pilot and production medical device coating. Harland Medical Systems has operations and application laboratories in Eden Prairie and St. Paul, MN and provides sales and support on a worldwide basis.
Visit www.harlandmedical.com
January 29, 2008 — /ARLINGTON HEIGHTS, IL/ — The Institute of Environmental Sciences and Technology (IEST) announces that the virtual expo for ESTECH 2008, the 54th Annual Technical Meeting and Exposition, is now open. Learn about the ESTECH 2008 exhibitors before you step on the show floor.
ESTECH 2008 will be held at the Hilton Chicago/Indian Lakes Resort in Bloomingdale, IL, May 4-7, 2008. The venue offers a diverse array of tutorials, seminars, working group meetings, exhibits, and networking events.
ESTECH 2008 is an excellent opportunity for exhibitors and clients to meet and do business with key people in the international community of the environmental sciences. Exhibiting will allow companies to generate leads from key decision makers and promote their industry presence to current and potential customers. Exhibiting will show support for IEST and its goals of international standards development, technical advancement, and professional enrichment.
About IEST
Founded in 1953, IEST is an international not-for-profit technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards.
IEST is an ANSI-accredited standards-developing organization; secretariat of ISO/TC 209 cleanrooms and associated controlled environments; administrator of the ANSI-accredited US TAG to ISO/TC 209; administrator of the ANSI-accredited US TAG to ISO/TC 142 cleaning equipment for air and other gases; and a founding member of the ANSI-accredited US TAG to ISO/TC 229 nanotechnologies.
Visit www.iest.org
January 29, 2008 — LEUVEN, BELGIUM, AND HSINCHU, TAIWAN — Powerchip Semiconductor Corporation (PSC), a leading Taiwan-based memory semiconductor supplier offering dynamic random access memory chips (DRAMs) and flash memory chips, has entered into a partnership with IMEC, Europe’s leading independent nanoelectronics research center, to perform research and development for the sub-32 nm memory process generations.
As part of the agreement, PSC will collaborate within IMEC’s advanced lithography program addressing immersion, double patterning, and EUV lithography challenges. From March 2008 onwards, PSC researchers will reside at IMEC to closely collaborate with IMEC’s researchers in the abovementioned areas. In this way, they will build up fundamental understanding and develop robust solutions for the 32-nm and beyond memory process generations.
With this agreement, IMEC further enforces the unique strength of its consortium and program towards leading memory technologies. Before that, IMEC had already grouped the top five leading memory suppliers including Micron, Qimonda, Samsung, Elpida, and Hynix, to collaborate within IMEC’s global research platform striving to scale CMOS beyond the 32-nm node. The platform also unites world leading logic IDMs and foundries, including Intel, Panasonic, TSMC, Infineon, NXP, STMicroelectronics, and Texas Instruments. This “leading mix” of semiconductor market segments is proving to be a unique cross-fertilization platform strengthening state-of-the-art process R&D beyond 32-nm node and answering the needs of the whole semiconductor market.
Powerchip Semiconductor chairman Dr. Frank Huang expressed that, as photolithography technology approaches 32-nm, the industry has encountered physical limitations while at the same time development costs are increasing. Therefore, the trend of alliances and joint development will become more and more eminent in the industry. Semiconductor giants including Intel and TSMC as well as memory suppliers Samsung and Micron have already established long-term development collaboration with IMEC. As PSC continues to grow and technology continues to advance, in order to avoid being left behind on the development of next-generation advanced process technology, PSC has decided to sign an agreement with IMEC to participate in its global research network, in order to accelerate the advancement of process technology and to take a step further in increasing PSC’s high-efficiency production.
“We are excited that PSC has joined our research platform. Their growth in the memory business is impressive, and their know-how in memory scaling will be an important asset for our global research platform,” said Gilbert Declerck, president and CEO of IMEC. “PSC’s joining demonstrates our ambition to further expand our program with new leading partners, on the path to technologies below 32-nm. It emphasizes the increasing strength of our memory partner network, which is unique in the world. It also illustrates our commitment to further enforce our business in Taiwan, at the time when we’re opening IMEC Taiwan in the Hsinchu Science Park.”
About PSC
Powerchip Semiconductor was founded in December of 1994 in Hsinchu Science Park, Taiwan in order to focus on the production and marketing of DRAM chips. In 1998, Powerchip Semiconductor listed itself publicly on OTC market. Currently Powerchip Semiconductor has three 12-inch (300-mm) fabs, over 6,000 employees, and Capital of over 78.2 billion NTD.
PSC was established upon, and further developed its long term strategic relationships with, Japanese High-Tech firms. In 2006, PSC and Elpida jointly established Rexchip.
Visit www.psc.com.tw/english
About IMEC
IMEC is a world-leading independent research center in nanoelectronics and nanotechnology. Its research focuses on the next generations of chips and systems, and on the enabling technologies for ambient intelligence. IMEC’s research bridges the gap between fundamental research at universities and technology development in industry. Its unique balance of processing and system know-how, intellectual property portfolio, state-of-the-art infrastructure, and its strong network of companies, universities, and research institutes worldwide position IMEC as a key partner for shaping technologies for future systems.
IMEC vzw is headquartered in Leuven, Belgium, has a sister company in the Netherlands (IMEC-NL) concentrating on wireless autonomous transducer solutions, and has representatives in the US, China, and Japan. Its staff of more than 1,600 people includes more than 500 industrial residents and guest researchers. In 2007, its revenue (P&L) is estimated at about EUR 235 million.
Visit www.imec.be
January 29, 2008 — /PRNewswire/ — TOKYO, JAPAN — TAZMO Co., Ltd. and Silecs, Inc. today announced an extension of their existing partnership that allows them to co-market their respective solutions to mutual customers. Under the terms of the agreement, Silecs’ silicon-based materials and TAZMO’s coating equipment are now available as a mutually optimized solution to help manufacturers of semiconductors and liquid crystal displays (LCDs) accelerate the integration of these solutions into their advanced manufacturing processes. Silecs and TAZMO will jointly exhibit their products at this week’s SEMICON Korea trade show in Seoul, Korea.
The co-marketing agreement follows extensive collaboration between both companies on spin-coating and slit-coating process development for IC and LCD applications. In January 2007, TAZMO placed its spin-coating system at Silecs’ electronic materials production and demonstration facilities in Espoo, Finland to run wafer demos for both companies’ semiconductor customers.
“We are seeing strong demand for silicon-based materials in both semiconductor and LCD manufacturing, and we are pleased to be working with Silecs as a technology leader in this area,” says Takahiro Katayama, new business development manager of TAZMO. “Used together with advanced materials, our spin-coating and slit-coating equipment provide high-performance solutions to manufacturers of semiconductor devices and flat panel displays.”
“Our expanded collaboration with TAZMO will provide our mutual customers with a comprehensive solution set that combines the materials, tools, and processes they need to integrate these solutions into their devices,” says Jack Kokko, Silecs’ CEO. “The alliance with this leading supplier of semiconductor process equipment helps us to better support our microelectronics customers worldwide.”
About TAZMO Co., Ltd.
Established in 1972, TAZMO is headquartered in Ibara, Okayama Prefecture, Japan with 7 manufacturing facilities. The company is the manufacturer of the world’s best selling SOG, SOD coaters. In addition, TAZMO is an OEM contract manufacturer of EFEMs, process modules, wafer and substrate handling systems, and complete turn key assembly. Innovative wafer and substrate handling equipment includes our edge grip end effectors and edge hold aligner combined with a complete line of robots for high speed repeatable placement.
Visit www.tazmo.co.jp
About Silecs, Inc.
Headquartered in Mountain View, CA, Silecs, Inc. provides enabling materials for the microelectronics industry. Silecs’ products are used primarily in semiconductor and flat panel display manufacturing, giving customers improved performance, density, and yield for their devices, and reduced overall production costs. Silecs is committed to supplying high-purity materials that consistently meet customers’ stringent requirements. Silecs, Inc. is a privately held company backed by leading institutional investors.
Visit www.silecs.com
January 31, 2008 — /ATLANTA, GA/ –
January 28, 2008 — /NEW HOLLAND, PA/
January 28, 2008 — /FDA/ — The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of Heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc. of Angier, NC. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.
These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3-ml, 5-ml and 10-ml and syringe sizes of 6-ml and 12-ml.
Consumers and health care facilities with any of the recalled, pre-filled Heparin lock or normal saline IV flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.
The recall affects all lots of these products. The FDA received information that Heparin lock flush syringes from lot 070926H and normal saline IV syringes from lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened Heparin syringes.
Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.
The company voluntarily recalled these products on January 18 after confirming bacterial contamination in some user samples.
Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST.
Any adverse reactions experienced with the use of the products, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
Visit www.fda.gov