Tag Archives: Clean Rooms

JUNE 4, 2008 — /PRNewswire/ — MOORESVILLE, NC — Anpath Group, Inc. reports that its wholly owned subsidiary, EnviroSystems, Inc. (ESI), announced that the U.S. Environmental Protection Agency (EPA) accepted its submission to add additional claims to its disinfectant/sanitizer, EnviroTru(R) for use of the product as a sanitizer against the “superbug” MRSA (methicillin-resistant Staphylococcus aureus) and VRE (vancomycin-resistant Enterococcus faecalis). Having received approval from the EPA for these additional claims, the company has commenced the state registration process, which it believes should be completed with the majority of states within 30 days.

EnviroTru(R) is a multi-purpose disinfectant, sanitizer, and deodorizing cleaner, effective against numerous organisms, and also meets EPA requirements for Toxicity Category IV (no harmful dermal, ocular, inhalation, or ingestion effects). EnviroTru(R) does not require protective clothing, gloves, or special ventilation and has passed the AMS 1452A, AMS 1453, and Boeing D6-7127 specifications for non-corrosion and materials compatibility.

J. Lloyd Breedlove, president and CEO of Anpath Group, says, “We are confident these additional claims will add to the growing market demand for EnviroTru(R). The timeliness of this registration is noteworthy considering the increased incidence of MRSA cases reported in public settings, particularly schools.” Breedlove continues, “These claims are a small part of our aggressive development and testing program intended to expand our product offering. Moreover, while the ability to kill potentially harmful microorganisms is important, it is just as important that the biocide have a favorable profile for health and environmental effects. It is not acceptable to trade one problem for another by using potentially harmful chemicals to clean and disinfect. ESI has a single goal — reduce biological risks by destroying a wide range of disease-causing microorganisms with minimum risk to our customer, surfaces, and the environment.”

MRSA is a bacterium responsible for difficult-to-treat infections in humans. MRSA is a resistant variation of the common bacterium Staphylococcus aureus. It has evolved an ability to survive treatment with beta-lactam antibiotics, including penicillin, methicillin, and cephalosporins. MRSA was discovered in 1961 in the UK and it is now found worldwide, and is often referred to in the press as a “superbug.” In the past decade or so, the number of MRSA infections in the United States has increased significantly. At the same time, a growing number of cases were noted in schools around the nation, with many closing their doors to scrub down their facilities. After the death of a 17-year-old Virginia student, the school district closed all 21 schools for cleaning. A 2007 report in Emerging Infectious Diseases, a publication of the Centers for Disease Control and Prevention (CDC), estimated that the number of MRSA infections treated doubled nationwide, from approximately 127,000 in 1999 to 278,000 in 2005, while at the same time deaths increased from 11,000 to more than 17,000. Another study led by the CDC and published in the Oct. 17, 2007 issue of the Journal of the American Medical Association estimated that MRSA would have been responsible for 94,360 serious infections and associated with 18,650 hospital stay-related deaths in the United States in 2005. These figures suggest that MRSA infections are responsible for more deaths in the U.S. each year than AIDS.

Enterococci are bacteria that are normally present in the human intestines and in the urinary tract and are often found in the environment. These bacteria can sometimes cause infections. Vancomycin is an antibiotic that is often used to treat infections caused by Enterococci. In some instances, Enterococci have become resistant to this drug and thus are called vancomycin-resistant Enterococci faecalis (VRE).

About Anpath Group
Anpath Group, Inc., through its wholly owned subsidiary EnviroSystems, Inc., produces cleaning and disinfecting products that it believes will help prevent the spread of infectious microorganisms while minimizing the harmful effects to people, equipment or the environment.

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About EnviroSystems
EnviroSystems, Inc. is focused on safe infection prevention technologies that the company believes will position the company in the forefront of the industry at a time when there is rapidly growing awareness of the critical need to prevent biological risks — both natural and man-made.

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JUNE 6, 2008 — /FDA Digest/ — The U.S. Food and Drug Administration (FDA) today filed a complaint for permanent injunction against seafood processor Captain’s Select Seafood, Inc., Minneapolis, MN, and two of its top officers for violating the Federal Food, Drug and Cosmetic Act (FD&C Act).

FDA’s enforcement action follows the company’s extensive history of violating the FD&C Act and the agency’s Hazard Analysis Critical Control Point (HACCP) regulations. FDA’s HAACP regulations require that all seafood processors develop and implement adequate plans that identify all food safety hazards that are likely to occur for each kind of seafood product, and contain preventative measures that the processor can implement to control those hazards.

“We simply can’t allow a company to put the public’s health at risk by not having adequate procedures and plans to produce safe food,” says Margaret O’K. Glavin, associate commissioner for regulatory affairs. “Our warning letters should not be taken lightly. We will take action against companies and against their executives who violate the law and endanger public health.”

Captain’s Select Seafood makes a variety of fish and fishery products. The HACCP violations documented by the FDA pose a public health hazard because, without adequate controls, products made by Captain’s Select Seafood could harbor pathogenic bacteria, such as Staphylococcus aureus and Listeria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses in people who eat them.

The complaint was filed by the U.S. Department of Justice in the U.S. District Court for the District of Minnesota. This enforcement action follows a February 2006 warning letter and other violations dating back to April 2004. There are no reported illnesses associated with consuming Captain’s Select Seafood products. Consumers can call FDA’s toll-free Food Safety Hotline at 1-888-SAFEFOOD, should they have any food safety questions, and they can report any problems to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found online at www.fda.gov.

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JUNE 7, 2008 — /FDA Digest/ — The U.S. Food and Drug Administration (FDA) is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA recommends that consumers not eat raw red Roma, raw red plum, raw red round tomatoes, or products that contain these types of raw red tomatoes unless the tomatoes are from the sources listed below. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made. Consumers should continue to eat cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, or tomatoes grown at home.

On June 5, using traceback and other distribution pattern information, FDA published a list of states, territories, and countries where tomatoes are grown and harvested which have not been associated with this outbreak. This updated list includes: Arkansas, California, Georgia, Hawaii, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands, and Puerto Rico. The list is available at www.fda.gov. This list will be updated as more information becomes available.

FDA’s recommendation does not apply to the following tomatoes from any source: cherry, grape, and tomatoes sold with the vine still attached. FDA recommends that retailers, restaurateurs, and food service operators not offer for sale and service raw red Roma, raw red plum, and raw red round tomatoes unless they are from the sources listed above. Cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, may continue to be offered from any source.

Since mid-April, there have been 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Salmonella Saintpaul is an uncommon type of Salmonella.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that will be ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source of the tomatoes associated with the outbreak.

FDA is taking these actions while the agency continues to investigate this outbreak with state and federal partners. Such actions are a key component of FDA’s Food Protection Plan (see “Food safety plan emphasizes ‘effective action’ to prevent food supply contamination”), a scientific and risk-based approach to strengthen and protect the nation’s food supply. FDA will continue to issue updates as more specific information becomes available.

Information on safe handling of produce can be found at www.cfsan.fda.gov. Tomato consumer page can be found at www.fda.gov. Updates from the Centers for Disease Control and Prevention can be found at www.cdc.gov.

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JUNE 9, 2008 — /PRNewswire/ — NEW DELHI, INDIA — Honeywell announced today a multi-year distribution agreement with Loba Chemie, a global supplier of chemicals, laboratory supplies, and equipment, under which Loba Chemie will distribute Honeywell’s high-purity solvents to India’s growing pharmaceutical sector.

Marketed and sold under the Burdick & Jackson(R) brand name, Honeywell’s high-purity solvents are critical to the successful research, development, and approval cycle of pharmaceuticals. Terms of the agreement were not disclosed.

“India is an important market for us as the pharmaceutical industry continues to experience tremendous growth,” says Robert Tupker, commercial director for Honeywell’s Specialty Chemicals business in Europe, Middle East, Africa, and India. “This agreement will further help position us as a leader in providing a wide range of high-purity solvents for pharmaceutical companies worldwide.”

Vic Shah, director of international sales for Loba Chemie, says both companies aim to reach a new standard of success in the high-quality chemicals market in India. “We believe there are a lot of untapped opportunities to be explored, especially in the booming pharmaceutical industry,” says Shah.

The annual growth rate of India’s pharmaceutical market is estimated to be 8 to 9 percent, according to various industry reports.

Major applications for Honeywell’s solvents include analytical instrumental analysis, such as high-performance liquid chromatography (HPLC), as well as pilot- and full-scale production of pharmaceuticals. Honeywell also offers reagents for DNA and RNA synthesis.

Honeywell manufactures its solvents at the company’s Muskegon, MI, and Seelze, Germany sites. Loba Chemie, based in Mumbai, has more than 350 distributors throughout India.

About Honeywell
Honeywell Specialty Materials, based in Morristown, NJ, is a $4.9 billion, global leader in providing customers with high-performance specialty materials, including fluorine products; specialty films and additives; advanced fibers and composites; intermediates; specialty chemicals; electronic materials and chemicals; and technologies and materials for petroleum refining. Honeywell International is a $37 billion diversified technology and manufacturing leader, serving customers worldwide with aerospace products and services; control technologies for buildings, homes and industry; automotive products; turbochargers; and specialty materials. Based in Morris Township, NJ, Honeywell’s shares are traded on the New York, London, and Chicago Stock Exchanges.

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JUNE 2, 2008 — OMAHA, NE and PRINCETON, NJ — HDR Architecture, a leading health-care design firm, and CUH2A, a science and technology (S+T) design firm, have announced their intent to merge to create the most comprehensive S+T design firm in the world. The merged company will assemble a pool of design expertise across the entire spectrum of the rapidly converging fields of life sciences research, physical sciences research, and health care.

The combined companies will employ nearly 1,700 architecture, engineering, and planning (AEP) staff members in more than 40 locations worldwide. With complementary portfolios across the academic, government, and corporate S+T market sectors, HDR and CUH2A will deliver integrated AEP services to an array of specialty markets including biomedical R&D, academic research, biocontainment, nanotechnology, vivaria, cleanrooms, and forensics. The merged business practices will provide knowledge and perspective in the emerging field of translational research with its “bench to bedside” facilities that combine research with clinical care.

“CUH2A’s science and technology portfolio provides immediate growth and diversity to HDR’s practice, while allowing us to penetrate even further into the health care markets in the Northeastern and Southeastern U.S., as well as the Middle East and other critical global locations,” notes HDR Architecture president Merle Bachman. “Merging our shared commitments to innovation and integrated project delivery will broaden our reach in a global landscape flattened by faster communication, shared knowledge, and accelerated client expectations.”

CUH2A president Scott Butler adds, “HDR adds internationally recognized specialization in areas that round out our S+T practice, and its extensive network of offices establish a platform to deliver our combined expertise around the world.”

Reflecting on the R&D industry, Butler says, “The world of science is changing. Our clients are crossing global boundaries and working across disciplines to create the big breakthroughs in research. The CUH2A and HDR alliance puts us in the best position to enable these trends. We will bring together unmatched knowledge in every area of science research for every part of the world.”

The merger allows each company access to previously impenetrable markets and regions. As a result, HDR and CUH2A will each fastforward their company’s strategic development by at least 10 years and will enable the combined company to focus further on the shared vision of bettering the human condition globally. The two companies create sustainable facilities that help researchers to discover cures for insidious diseases, health care providers to deliver medical solutions to enrich people’s lives, and prestigious government agencies to defend communities against biothreats.

The union is expected to be completed by the end of June. Once the deal is completed, the science and technology groups of each company will merge into one business unit. Executives from HDR and CUH2A will form an integrated management team for the combined science and technology unit, which will be led by CUH2A’s Scott Butler.

About HDR
HDR Architecture is an operating company within HDR, Inc. with approximately 1,300 employees. The parent company, HDR, Inc. is an employee-owned architectural, engineering and consulting firm that excels at the design and management of complex projects. Approximately 7,000 professionals, in more than 160 locations worldwide, pool their strengths to provide solutions beyond the scope of traditional A/E/C firms. Well-known as an innovator in building design for science and technology research, HDR is also ranked as the No. 1 healthcare design firm by Modern Healthcare magazine in 2008, marking an unprecedented fifth consecutive year in the top spot. HDR was also named a “Best AEC Firm to Work For” by Building Design & Construction magazine in 2008.

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About CUH2A
With more than 400 employees, CUH2A architects, engineers and planners design the most advanced science and technology facilities in the world. Since its founding in 1962, CUH2A has designed over 60 million square feet of research and development space. The firm serves academic, corporate and government clients worldwide from offices in Atlanta, Dubai, London, New York, Princeton, San Francisco and Washington, DC.

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Semiconductor and power generation industries lead the pack in systems consumption

By Robert McIlvaine, The McIlvaine Co.

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Taking into consideration key factors in the electronics, pharmaceutical, and power generation industries, the worldwide sales of ultrapure water (UPW) equipment, chemicals, and services likely will reach US$4 billion this year. This figure is nearly twice the size of the market at the beginning of the decade.

Ultrapure water systems provide virtually contaminant-free water for use in human injectables, super-critical boiler steam systems, flat-panel display (FPD) production, and semiconductor fabrication. These four applications are the predominant drivers of sales of UPW-related products such as reverse osmosis membranes, ion exchange resins, ultra-filtration membranes, pumps, valves, and controls.

Key industries and drivers

Water reclamation: Across all industries, the practice of water reuse and reclamation is gaining momentum. By reclaiming water, rather than sending it into a wastewater stream, industries can dramatically reduce municipal water usage. Water reclamation/reuse systems are starting to represent a “sub-market” for additional tanks, pumps, and purification equipment.

Semiconductors: The semiconductor industry continues to be the largest consumer of UPW systems. Applications include chip washing, chemical vapor deposition, disk drive manufacturing, and immersion optical lithography. With 2008 projected revenues of $1.9 billion for UPW systems in this segment, the semiconductor industry represents approximately 50 percent of the world market.

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Power generation: Second to semiconductor fabrication applications, the power generation industry accounts for about 25 percent of the market. UPW system sales for power generation applications are expected to reach $1.1 billion this year.

Notably, there is a big transition in UPW installations in the power segment where sales of UPW systems for coal-fired boilers have been rapidly increasing. Sales of UPW systems for gas turbine combined cycle (GTCC) are slowly recovering after plummeting earlier in the decade. 2008 projections for sales into coal-fired plants are about $740 million compared to $53 million for gas turbine applications.

Pharmaceuticals: In the pharmaceutical industry, the highest growth sector for UPW system sales is in the biotechnology arena. While overall growth for UPW sales is maintaining an annual rate of about 7 percent, the demand for UPW systems in biotech applications is expected to be in line with growth of the biotech industry. Worldwide, UPW system sales in the pharma market will likely reach $268 million by the year’s end.

Flat-panel displays: FPDs have become the display of choice for electronic devices. As the demand for FPDs increases, so increases the demand for the ultrapure water required for FPD production. In terms of percentage growth, FPD fabrication is now the fastest growing market for UPW systems. Both liquid-crystal display (LCD) and thin-film transistor LCD (TFT-LCD) flat-panel fabrication technologies depend upon ultrapure water.

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2008 UPW system sales for FPD fabrication facilities are expected to reach $474 million. In 2005, UPW system sales were approximately $277 million. In three short years, sales of UPW systems into the FPD market have grown by more than 70 percent.

Asia: In 2005, Asia accounted for approximately 58 percent of UPW system revenues. In 2008, that percentage is expected to climb to 67 percent. Increases in semiconductor and FPD production as well as construction of new coal-fired power plants are driving increased UPW system sales in Asia.

Recent Asian activities affecting sales include the following:

  • Beijing-based BOE Technology has announced construction of a 4.5G TFT-LCD line in Chengdu, Sichuan Province.
  • Taiwan-based Innolux Display is building a 6G LCD panel fabrication facility in Chunan, Taiwan.
  • Hynix Semiconductor recently completed construction of a $1.2 billion wafer production line near Seoul, South Korea.
  • Taiwan Semiconductor Manufacturing Co. (TSMC) is investing $5 billion in development of 15-, 22-, and 32-nm technologies.
  • Chengdu Institute for Biological Products is building a production facility for Japanese encephalitis vaccines (to be located in Sichuan Province). Capacity will be 100 million doses per year.
  • The Shanghai CP Guojian Pharmaceutical Co. is building a new facility that will include the largest mammalian cell-culture system in Asia. The facility expects to begin production of monoclonal antibodies (mAb) in August 2008.

By tracking industry trends in power generation, electronics, and pharmaceutical production, it is possible to predict trends in sales of UPW systems. While there are no guarantees, the future for sales of UPW systems and services appears to be relatively strong, especially in Asia.

Robert McIlvaine is president and founder of The McIlvaine Co. in Northfield, IL. The company first published Cleanrooms: World Markets in 1984 and has since continued to publish market and technical information for the cleanroom industry. He can be reached at [email protected].

Particle Counters


July 1, 2008

Compiled by Carrie Meadows

Particle monitoring is an integral part of maintaining adequate cleanliness levels. Here’s a selection of the latest particle counting equipment available.

100 LPM airborne particle counter

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The Biotest APC M3 was the first portable airborne particle counter to sample at a rate of 100 LPM. Measuring 1 m3 of air in only 10 minutes, it cuts the time of particulate air monitoring for its users. When sampling a cubic meter of air, conventional 1.0 cfm (28.3 LPM) units take more than 35 minutes; 50 LPM units take 20 minutes. The APC M3’s higher flow rate reduces the time required to take samples by as much as 70 percent, thereby helping pharmaceutical manufacturers increase productivity and lower labor costs. The counter can also be used with Biotest’s APCOne11–21 CFR Part 11 compliant–Download Utility Software. The software securely transfers data to reduce operator error and meets FDA compliance for data protection. It also has an audit trail to log critical events, password protection features, and digital signature application for authentication of files.

Biotest Diagnostics Corp.
Denville, NJ
www.biotestusa.com

Lightweight counter with reduced emissions

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CLiMET offers 100 LPM sampling with the CI-1053. The airborne particle counter completes a full cubic meter sample in 10 minutes, achieved with a filtered external exhaust that significantly reduces particle emissions. The CI-1053 also incorporates communications capabilities via Ethernet Modbus, TCP/IP, and TELNET. The 14.25-lb particle counter is housed in a seamless stainless steel enclosure, with an internal battery that provides four hours of continuous sampling. The bright touchscreen provides a user-friendly interface. The standard two-year warranty underscores the design, performance, and quality of the CI-1053. This new family of particle counters is also available in similar products with flow rates of 1 cfm, 50 LPM, and 75 LPM. Contact CLiMET for a free demonstration at [email protected] or (909) 793-2788.

CLiMET Instruments
www.climet.com

Remote airborne particle counter for life sciences

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Hach Ultra’s latest MET ONE 6000 Series of remote airborne particle counters features the MET ONE 6015, offering accurate, reliable, continuous particle monitoring for the life science industry. Providing a sensitivity range of 0.5 to 10 µm at 1.0 cfm flow rate, the 6015 is designed to meet the specific needs of cleanroom operations with diagnostic features that provide reduced troubleshooting and downtime related costs. Featuring a wide choice of communication options such as RS-485 Serial Modbus, Ethernet, analog, pulse, and RS-232, the counter is easy to integrate with any facility monitoring system and enables future upgrading as communication needs change. An array of mechanical installation options also reduces downtime related to instrument removal and re-installation during routine calibration and preventative maintenance work. For the life science industry, the device installed with Hach Ultra recommended FMS software such as UVO or enVigil meets the necessary regulatory compliance needs for 21 CFR Part 11. The particle counter can also be integrated with the most commonly used industrial building management system and SCADA software with an OPC server. To request a brochure, send an email to [email protected] or call (541) 472-6500.

Hach Ultra Analytics
Grants Pass, OR
www.hachultra.com

Hybrid handheld particle counter

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Hal Technology (HalTech) has introduced what it says is the world’s first hybrid handheld particle counter, the HPC600 with built-in printer. The HPC600 measures six different particle size distributions simultaneously with sensitivity of 0.3

New Products


July 1, 2008

Compiled by Carrie Meadows

Aerosol photometer

DOP Solutions’ new SP200lite aerosol photometer, which has a digital readout, is easy to use and quick to set up. The instrument offers a unique damping system that ensures stable readings even when measuring highly variable concentrations. The photometer is fitted with a recorder output and fully adjustable audio alarm as standard. The software package available to use with the SP200 instrument range also encourages customers to report real HEPA filter test data in a certificate format and meet FDA, MHRA, and other regulatory requirements.

DOP Solutions
Letchworth, Hertfordshire, UK
www.dopsolutions.com

Rotary vane pumps

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Pfeiffer Vacuum introduces PentaLineTM rotary vane pumps with a new optimized drive system that provides a cost-effective, environmentally friendly vacuum for applications in the low and medium range of 10-3 mbar. Available in pumping speeds up to 35 m3/hour, the pump is designed for use in analytical instrumentation, research and development applications, and critical industrial and coating processes. The optimized drive system reduces power consumption by up to 50 percent, resulting in significantly lower operating costs. The new standby operating mode assures longer service life as well as cost savings in maintenance. The pumps are hermetically sealed, which prevents oil leaks, and incorporate a motor concept that makes them easy to deploy anywhere in the world. The pumps run cool with minimum vibration, ensuring a quieter work environment.

Pfeiffer Vacuum, Inc.
Nashua, NH
www.pfeiffer-vacuum.com

Disposable dosing system

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The Prevas disposable dosing system is designed for installation on liquid filling lines for vials, ampoules, and syringes. The system features a completely disposable product path and incorporates a bulk product bag, a positive displacement-rolling diaphragm pump, filling needles, and tubes into one assembly. The company says the Prevas system is the first completely pre-assembled, pre-sterilized, and pre-validated single-use system available for the pharmaceutical and biotech market. The product path assembly is attached to the filling system and connects to the product stream via sterile plug-and-use connections. This eliminates preparatory steps associated with stainless-steel construction, such as cleaning, assembly and disassembly, autoclaving and clean-in-place (CIP) or sterilize-in-place (SIP) operations, minimizing the costs and labor associated with these cleaning procedures. After the fill process is completed, the product path assembly is removed and replaced, with minimal downtime and increased productivity.

Bosch Packaging Technology
Waiblingen, Germany
www.boschpackaging.com

Recirculating lab faucet

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Designed to provide clean water at the point of use, GF Piping Systems has introduced the new Type 530 AquaTap™ recirculating laboratory faucet. Featuring a patented flow-through head design that eliminates dead-legs and optimizes flow, the faucet offers high recirculating capacity at a minimal pressure drop to the main water line with inline flow diverter (IFD) technology. Developed with water quality in mind, the new faucet is intended for laboratory dispensing applications in a variety of UPW markets, including life sciences, semiconductors, and food and beverages. The faucet eliminates the need for extensive water purging by providing continuous flow through the faucet head and preventing the formation of harmful bacteria.

GF Piping Systems
Tustin, CA
www.gfpiping.com

Tape sample kits

UltraTape Industries, a division of Delphon Industries and manufacturer of adhesive tapes for critical environments, has announced the availability of sample kits for purchase through its web site. There are currently five sample kits available, including those designed for general purpose cleanroom tapes, cleanroom construction tapes, ESD tapes, medical and pharmaceutical tapes, and wafer box sealing tapes. Each kit contains a variety of tape samples with different levels of adhesion, carrier films, and adhesive types that are appropriate for a particular application. UltraTape specializes in particle- and residue-free adhesive tapes that are required for semiconductor and medical applications.

UltraTape Industries
Salem, OR
www.cleanroomtape.com

Real-time gas analyzer

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Picarro has introduced what it says is the world’s most sensitive real-time gas analyzer for trace HF detection, capable of measuring down to 10 ppt (lower detection limit) in ambient air. In addition to its high sensitivity, the analyzer operates with no requirement for frequent calibration and with complete immunity to crosstalk from any other ambient gas component, including varying moisture levels. The simple-to-use analyzer can be operated remotely with sampling rates as fast 1 Hz, producing drift-free data with up to four digits of precision. Its high dynamic range means it can deliver a linear response for HF concentrations as high as parts per million, with an absolute accuracy better than 1 percent. The device is based on Picarro’s wavelength-scanned cavity ring-down spectroscopy technology (WS-CRDS), which measures near infrared absorption in a flow cell using an internal laser beam over an effective path length of up to 21 km. The HF analyzer is targeted for use in semiconductor fabrication facilities and cleanroom applications where ambient air must be rigorously monitored for HF.

Picarro, Inc.
Sunnyvale, CA
www.picarro.com

Gowning room furnishings

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Terra Universal manufactures a comprehensive line of gowning room furnishings, including laminar flow storage cabinets, stainless-steel benches, and garb and parts dispensers that help ensure organized, space-efficient, effective garbing procedures. Stainless or powder-coated steel garment cabinets come with adjustable shelving or garment rods and an optional fan/filter module that washes the materials with HEPA-filtered air to dislodge contaminants. Benches feature ultra-smooth, non-particulating surfaces that are easy to wipe down and disinfect, and solid, perforated, or rod tops, all in electropolished 304 stainless steel. Terra also provides hand and shoe cleaners, peel-off contamination mats, and convenient dispensers for organized storage of gloves, face masks, cleanroom coveralls, and other apparel.

Terra Universal
Fullerton, CA
www.terrauniversal.com

Process development and sample prep system

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The new Cogent® µScale tangential flow filtration (TFF) system for process development and low-volume sample preparation is an easy-to-use, semi-automated benchtop system that has been designed to fully support TFF process development at the “microscale” using up to three Pellicon® 3 88-cm2 cassettes (264 cm2). With a low minimum working volume, the ability to operate at feed pressures up to 80 psig (5.5 bar), and very low pulsation, the system fully supports both scaling studies and low-volume ultrafiltration and diafiltration (UF/DF) work using Pellicon 3 cassettes. The system can also be configured to process up to three Pellicon XL-50 TFF devices, and is well suited for purifying and concentrating monoclonal antibodies, recombinant proteins, vaccines, gene therapy constructs, blood serum products, and other cell derived components.

Millipore Corp.
Billerica, MA
www.millipore.com

Antimicrobial ergonomic pipette

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The Finnpipette F1 Series incorporates ergonomic features to effectively prevent the occurrence of repetitive strain injury (RSI) symptoms. The soft handle contours to the shape of the user’s hand, and the improved 120

By George Miller

At the opening of its vaccine-production plant in May, Novavax Inc. president and chief executive Rahul Singhvi, Sc.D., trumpeted not just the company’s new vaccine technology but also the environmental sustainability features of the production process and, hence, the facility.

“It incorporates new processes to increase production yields with significantly less infrastructure and capital cost compared to current approved vaccine facilities,” said Singhvi at the opening of the company’s 5,000-sq.-ft., $5 million pilot- and commercial-scale manufacturing showcase in Rockville, MD.

“Our production technology, combined with our use of disposable materials, offers the potential advantage of simple portability of production equipment to sites around the world, where vaccines may be urgently needed,” he continued.

Singhvi’s comparison to current vaccine facilities is a bit of an apples-to-oranges one, in that traditional facilities house the many eggs used to grow viruses for vaccine production (which require temperature-controlled storage space) as well as older-technology stainless-steel production gear. The relative savings, due to smaller size (the Novavax facility is about one-third the size of a traditional plant), plus elimination of egg storage and a manufacturing process that requires less heat removal, yields utility costs for heating, ventilation, and air conditioning of about 25% of those for a traditional facility, says Jim Robinson, vice president for manufacturing.

Eliminating egg logistics

The Novavax vaccine technology, based on the company’s virus-like particle (VLP) and Novasome adjuvant technologies, dispenses with the eggs and their storage requirements, and replaces more high-maintenance stainless-steel processing equipment with disposable plastic technology. The VLP technology yields vaccines that closely match the disease-causing viruses while lacking the genetic material to cause disease.

The new facility is, in fact, an operational form of a construction model that Novavax and partner GE Healthcare plan to use to showcase the process and facility setup that would enable health officials worldwide to produce their own vaccines, within their own borders–a big consideration given inevitable border closings during a pandemic.

In the meantime, the facility will be used to produce influenza vaccine for the company’s current clinical programs, with planned annual capacity of 10 million doses.

“It’s almost underwhelming from a manufacturing perspective, it’s so uncomplicated,” Robinson explains. “The disposable manufacturing platform allows you to manufacture in a much less elaborate facility. No clean-in-place (CIP) equipment is needed, and product contact is minimized due to the disposables.”

Shifting process responsibility

And the use of disposables–despite the necessity of disposing of them–is key to the environmental sustainability of the facility. “We’re trading one set of issues for another,” says Robinson, “shifting responsibility to the bag vendors to come up with processes that will not affect the product. We validate the process they use to sterilize bags. Then we connect the bags and run the process.”

Bag disposal remains a work in progress for the plastics and biotech industries. Because bags are made of multiple polymers in layers, they are a recycling challenge. “We will work with the county to see what can be done,” says Robinson. “Plus, the plastic bag industry is pursuing the conversion of used bags to fuel. That may be a solution.”


Novavax president and CEO Rahul Singhvi says that his company’s non-traditional vaccine production technology requires less infrastructure and uses disposable bioprocessing systems, aiding in environmental sustainability. Photo courtesy of Novavax.
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The manufacturing facility is built within what was previously a quality control lab that incorporated Class C (10,000 class) air handling, appropriate for the low-bioburden work, and one Class A (100 class) hood. Cell culture is also managed under Class A.

“The rest is under a totally closed system,” says Robinson. “That’s where disposables really help.” Novavax uses the GE Healthcare Wave bioreactor for cell culture. The system allows the culture medium and the cells to contact only a pre-sterilized, disposable chamber (the Cellbag), which sits on a rocking platform for mixing. The bioreactor requires no cleaning or sterilization, according to GE Healthcare documents.

The use of disposables provides other savings as well, he says. “We can build a facility that is less than a quarter of the cost of an egg-based facility, one-tenth the cost of cell culture facility for influenza. And we can use smaller-scale systems, so we don’t have to worry about big toxic spills.”

Cooperative design effort

Novavax engineers and manufacturing managers worked with Jacobs Engineering Group Inc. (Pasadena, CA) to design the facility. “We defined process, they designed the facility,” says Robinson.

GE Healthcare, manufacturing half of the disposable systems that Novavax uses today, is the majority supplier, as well as partner in the collaboration announced last December to develop and market a pandemic flu vaccine manufacturing solution for select international markets. The collaboration is aimed at health planners around the world who want to establish or increase manufacturing capacity and vaccine stockpiles to counter the threat of global avian influenza pandemic.

According to Novavax, the global demand for pandemic flu vaccines has been reported as possibly approaching 13 billion doses, with current world capacity at some 2.4 billion doses at best.

The Novavax VLP-based H5N1 pandemic flu vaccine is currently in clinical trials. The vaccine production system incorporates GE Healthcare’s ReadyToProcess disposable systems and devices for bioprocessing.

Regulator leads by example in sustainable design project

At the behest of the Department of Health and Human Services in its 2008 update of the Real Property Asset Management Plan, the U.S. Food and Drug Administration (FDA) has designated the Arkansas Regional Laboratory (ARL), a part of the Jefferson Laboratory Complex in Jefferson, AR, a sustainable design project. Such a project emphasizes design features including recycled building materials, energy conservation measures, and natural landscaping techniques to save resources.

The complex is a 500-acre campus comprising some 60 labs, office buildings, and outbuildings. The project came with a $400,000 budget request, part of the $5 million requested for new construction and repairs and improvements to existing facilities, according to FDA documents.

According to the HHS Sustainable Buildings Implementation Plan of March 2007, construction projects of $3 million or more require certification (either the Green Building Initiative’s Green Globes [www.greenglobes.com] or the U.S. Green Building Council’s LEED, for Leadership in Energy and Environmental Design [www.usgbc.org]).

Mandatory requirements, each of which is defined in the HHS document, include the following categories:

  • Integrated design including integrated project team, performance goals, and life cycle cost analysis
  • Commissioning
  • Energy performance
  • Water conservation
  • Ventilation and thermal control
  • Moisture control
  • Daylighting
  • Low-emitting materials
  • Indoor air quality during construction
  • Recyclable content
  • Biobased content
  • Construction waste
  • Ozone-depleting compounds

Mandatory goal categories for major renovations include the following:

  • Green certification for projects of $3 million or more
  • Integrated project team
  • Energy performance
  • Water conservation
  • Ventilation and thermal comfort
  • Moisture control
  • Indoor air quality during construction
  • Recycled content
  • Biobased content
  • Construction waste
  • Ozone-depleting compounds

By Carrie Meadows

As a first-time attendee at an Institute for Environmental Science and Technology (IEST) Working Group session, one probably doesn’t expect an animated crowd of participants sticking neon Post-It® notes on the walls. But at the inaugural meeting of proposed RP-CC044.1, “Vacuum Cleaning Systems for Cleanrooms,” at ESTECH in May, that is exactly what took place.

Roger Diener, chair of the new Working Group and contamination control engineer at Analog Devices (Wilmington, MA), took an unusual approach to the brainstorming session, one that has actually been in existence since the 1960s. Instead of soliciting feedback via the typical orderly roundtable discussion, Diener handed out the aforementioned brightly colored notepads to participants, instructing them to jot down any user-related aspect of cleanroom vacuum cleaners and stick them to any number of poster-sized papers on the walls, which were labeled with broad headings such as “general background,” “features,” “performance expectations,” “portable unit design considerations,” “design criteria,” and more. This technique, part of the K-J Method (or affinity diagram) invented by a Japanese anthropologist as a way to discover meaningful groups of ideas in a raw list, enabled the dynamic that produced an entire set of core expectations for the group’s attendees to fill in at a later date.

“I did it because a lot of people do have a different idea of what a Working Group meeting is,” says Diener. He notes that some attendees are reluctant to participate in a conventional setting, especially when they are new to the industry or RP process. The Working Group is composed of IEST members who design, manufacture, and use the systems for various cleanroom applications. “There are many different levels of experience to be incorporated into a well-rounded group. Some participants can be intimidated by that. This way gets all the questions and ideas out there, from basic to advanced, without putting anyone on the spot.”

Diener says that vacuum cleaning systems had been on the “short list” of topics that needed someone to rally for it in order to get the RP process rolling. Once it was identified as a need and he volunteered to chair the group, it was time to contact the manufacturing experts and get users to participate. During the Working Group session, Diener had pointed out that “a cleanroom is not just a ‘clean room’–it’s the largest piece of equipment [in your facility], and people need to act accordingly.” The Working Group is tasked with moving the proposed RP forward, keeping in mind the purpose of the vacuum cleaning system itself: to aid in the removal of large particles, fibers, and debris without becoming a risk to the surrounding environment.


IEST members brainstorm an initial draft of the proposed RP-CC044.1, “Vacuum Cleaning Systems for Cleanrooms.” Photo courtesy of IEST.
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“This document is intended to address the needs and issues you should understand when buying, specifying, and using a cleanroom vacuum cleaner,” he explains. “Let’s be clear: We’re not telling users, ‘This is how you should clean your cleanroom environment.’ With this RP, we’re recommending, ‘This is what you need to know about the [vacuum] equipment you’re bringing into the environment to keep contamination from becoming a problem.’”

The importance of these proposed guidelines lies in clearly outlining what is appropriate for a cleanroom vacuum cleaning system, agrees Ray McCarthy, a sales representative for industrial vacuum manufacturer Nilfisk CFM (Kingstown, RI) and a member of the Working Group. “I think it is important to note here that a vacuum is part of the whole cleaning process within a cleanroom environment. Each cleanroom is unique to whatever is being done within that cleanroom, whether it is a tableting process for the pharmaceutical industry or a fab within a semiconductor facility