CleanRooms articles from March 2005

CleanRooms archives from March 2005

IEST seeking recommendations for improving ISO cleanroom standard.(CleanZone)
March 1, 2005... ROLLING MEADOWS, ILL. -- Cleanroom users and administrators attending ESTECH 2005--the 51st annual meeting and exposition of the Institute of Environmental Sciences and Technology (IEST; www.iest.org)--May 1-4 in suburban Chicago, will be able...

FDA proposes new guidance for reporting drug impurities.(NEWS)(United States Food and Drug Administration)
March 1, 2005... ROCKVILLE, MD. -- The Food and Drug Administration (www.fda.gov) has announced a new draft, Guidance for Industry: ANDAs--Impurities in Drug Substances, that provides revised recommendations on what chemistry, manufacturing and controls (CMC)...

Limits loom for low-k semiconductor materials: new contamination control processes on the horizon?(NEWS)(low dielectric constant)
March 1, 2005... AUSTIN, TEXAS -- Citing consensus from an interconnection symposium, semiconductor research consortium Sematech (www.sematech.org) says the industry believes that low-k materials--those with a low dielectric constant--are reaching a practical...

Class 10,000 cleanroom provides more efficient, cleaner packaging suite.(NEWS)(Celliance Corp.)
March 1, 2005... ATLANTA, Ga. -- When Celliance Corporation, a Serologicals company headquartered in Atlanta, Ga. (www.serologicals.com), began performing environmental monitoring on their recombinant human insulin packaging suite, they immediately realized...

Looks like lab-on-a-chip latching on.(particles)(Brief Article)
March 1, 2005... SCOTTSDALE, Ariz. -- According to research conducted by In-Stat (www.in-stat.com), companies are increasingly developing lab-on-a-chip products despite increased competition and alternative technologies. In making inroads within the MEMS...

Pilot and production-scale purchase.(particles)(Euroflow)(Brief Article)
March 1, 2005... EAST HILLS, N.Y. -- Pall Corp. (www.pall.com) has acquired Euroflow (Stroud, U.K.), one of the world's leading manufacturers of pilot and production-scale chromatography columns for the biotechnology industry. Pall had held exclusive global...

ESD education.(particles)(ESD Association)(Brief Article)
March 1, 2005... ROME, N.Y. -- Courses for the ESD Association's (www.esda.org) Certified Professional-Program Manager and Certified Professional-Device/Design are now available. With more than 25 education opportunities this year, ESD says certification can be...

Worthwhile Web works.(particles)(National Environmental Balancing Bureau, www.nebb.org, www.ionics.com )(Brief Article)
March 1, 2005... GAITHERSBURG, Md. and WATERTOWN, Mass. -- The National Environmental Balancing Bureau (NEBB; www.nebb.org) sound and vibration committee has completed a new, suggested, long-form sound and vibration (S & V) specification that can be viewed and...

The future is now.(FROMtheEDITOR)
March 1, 2005... A lot can happen in ten years. Certainly 2005 seemed a long way off when I wrote the editorial for the December 1994 special forecast issue of CleanRooms. But now, as I look at the theme and the broad range of conference content at our...

Semi tester makes move to Class 10,000 environment.(NEWS)(InTEST Silicon Valley Corp.)(Brief Article)
March 1, 2005... SAN JOSE, Calif. -- An in-state move for semiconductor testing manufacturer inTEST TestDesign (www.intest.com) has resulted in more space for manufacturing and stockroom, plus a Class 10,000 cleanroom environment the company hopes will surpass...

President nominates acting commissioner to head FDA.(NEWS)(George W. Bush, Lester M. Crawford)(Brief Article)
March 1, 2005... ROCKVILLE, Md. -- Lester M. Crawford, DVM, acting commissioner of the Food and Drug Administration (www.fda.gov) since March 2004, has been nominated by President Bush to serve as the agency's next commissioner. Dr. Crawford has been an...

Contract-testing lab expands facility and services.(NEWS)
March 1, 2005... SALEM, N.H. -- Boston Analytical, Inc., an independent, cGMP-compliant, contract-testing lab in Salem, N.H. (www.bostonanalytical.com), has built a new 2,500-square-foot facility designated specifically for microbiological testing. Two...

Software system seeks to help pharma manufacturers meet cGMPs.(Datasweep Inc.)(Brief Article)
March 1, 2005... SAN JOSE, Calif. -- A software platform for pharmaceutical manufacturers promises to support FDA 21st Century cGMPs by letting companies span one or multiple manufacturing sites, tightly integrate quality management procedures with...

Hands-free technology addresses critical temperature measurements.(NEWS)
March 1, 2005... FREMONT, Calif. -- Two recently introduced, hands-free process optimization tools for semiconductor fabrication measure real-time, in situ temperature in solder reflow applications. The Process Probe 1935 thermocouple-instrumented wafer and...

Company retrofits manufacturing facility for proprietary antimicrobial development.(NEWS)(PURE Bioscience )(Brief Article)
March 1, 2005... EL CAJON, CALIF. -- PURE Bioscience (www.pure-bioscience.com) has begun conversion of part of its manufacturing space here to a dedicated, FDA-compliant, cGMP facility for production of pharmaceutical-grade silver dihydrogen citrate (SDC). ...

Evolution of an IEST Recommended Practice.(SETTING THE STANDARD)(Institute of Environmental Sciences and Technology)
March 1, 2005... INTRODUCTION The Institute of Environmental Sciences and Technology (IEST) is responsible for the origination, publishing, and revision of approximately 35 Recommended Practices (RPs) in topics of interest and value to the contamination...

USP 797: personnel training.(LIFE SCIENCES)
March 1, 2005... The single most critical element of the cleanroom, or any controlled environment, is the human element. In previous discussions, I have referenced the need to control not only the environment but the processes and access in and out of the room,...

Expanded role for life sciences cleanrooms.(YOUR MARKET ANALYSIS)
March 1, 2005... Cleanroom technology developed for traditional applications such as aseptic filling in pharmaceutical plants is increasingly being applied to distinctly 21st Century problems. The result is an expanded role for suppliers of rooms, filters,...

Moving toward automation: new aseptic processing technologies are advancing rapidly, but in the meantime, training and validation are more crucial than ever.(SPECIALREPORT)
March 1, 2005... During last fall's much-publicized case of flu vaccine contamination at Chiron Corp.'s Liverpool, U.K., manufacturing facility, the Food and Drug Administration's Center for Biologics Evaluation and Research (FDA CBER; www.fda.gov) issued a...

Relevant information for manufacturing quality control: a singular solution to a multi-industry problem.
March 1, 2005... Take a tour of manufacturing in the world today and you will encounter widely varying levels of sophistication across a broad spectrum of industries. From the nanometer-level geometries of semiconductor to the careful recipe and batch purity...

The ABCs of disinfectant validation: despite ambiguities inherent in the regulatory inspection process, a few absolute expectations should be met.
March 1, 2005... I recently attended a meeting with several members of the pharmaceutical, biotechnology and medical device industries. During our discussions of cleanroom decontamination, it quickly became apparent that the subject of disinfectant validation...

Process Analytical Technologies (PAT) and nonviable particle counting.
March 1, 2005... Pharmaceutical manufacturing environments have traditionally seen particle counting as a necessary evil to demonstrate compliance with a cleanroom standard. Now, however, Process Analytical Technologies (PAT) changes the focus to be on the...

The "quietest" lab: achieving vibration control and balanced design at NIST; Engineers, lab planners and scientists developed unique lab layouts with groundbreaking temperature and vibration controls.(National Institute of Standards and Technology)
March 1, 2005... In the world of nanoscience, as the size of the material for evaluation diminishes, the challenge to control ambient conditions increases. Therefore, you can imagine the tightly controlled environmental conditions required at the metrology...

Sensors/monitors.(PRODUCTSPOTLIGHT)
March 1, 2005... Whatever the level and type of contamination control required by your facility, implementing and integrating the right sensors and monitors will be crucial to ensuring that it is operating at peak efficiency and maintaining adequate cleanliness...

2005 approval guide.(NEW PRODUCTS)
March 1, 2005... This comprehensive CD-ROM is designed to help architects, consulting engineers, plant managers, contractors and product buyers select the right materials to address property threats and protect their facilities. The 2005 Approval Guide provides...

High containment system.(NEW PRODUCTS)
March 1, 2005... The company's ABSOLUT filtration/containment systems can filter fine dust particles and aerosols, bringing pharmaceutical processing contamination levels down well below the most stringent Occupational Exposure Limit. The system provides low...

Modular radiometer.(NEW PRODUCTS)
March 1, 2005... This modular radiometer system provides an affordable, versatile and reliable means for measuring output of ultraviolet-C (UVC) devices. The system includes a separate display, sensor and logic controller, allowing the use of some or all...

Dual EMI/RFI medical air filters.(NEW PRODUCTS)
March 1, 2005... These dual EMI/RFI honeycomb air filters for medical electronics enclosure applications incorporate the latest flame resistant coatings and antimicrobial additives. The filters provide air filtration and EMI shielding in a single, low-cost...

Reservoirs for liquid handling systems.(NEW PRODUCTS)
March 1, 2005... A variety of reagent reservoirs are available from Biotech Solutions featuring low binding polypropylene construction. The Deep Well and Low Profile reservoirs offer chemical and heat resistance for aggressive solvents. The Pyramid Bottoms...

Anaerobic/environmental systems.(NEW PRODUCTS)
March 1, 2005... The compact Bactron III has a small footprint and 300-plate incubator capacity. The unit includes the company's sliding air-lock shelf, independently controlled incubator, stainless-steel construction and patented gloveless design. The...

Glass fiber filter.(NEW PRODUCTS)
March 1, 2005... The Protec RF0.5 borosilicate glass fiber prefilter is 0.5 micron-rated to remove colloids, aggregated and nonproduct proteins, lipids and particles to protect membrane filters downstream. This filter provides high flow rates and high...

Molded silicone stoppers.(NEW PRODUCTS)
March 1, 2005... These molded silicone components for pharmaceutical, biopharmaceutical, sanitary process, and laboratory applications consist of stoppers and sealing systems for carboys and vessels, bottles, laboratory equipment and process and storage...

Portable counter for airborne particles.(NEW PRODUCTS)
March 1, 2005... The LASAIR II 310B counter for airborne particles provides complete monitoring features in a compact, convenient package that weighs 15.5 pounds. The 310B counts particles at 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 microns, making it ideal for...

Clean curtains.(NEW PRODUCTS)
March 1, 2005... This line of Curtain Walls was specially developed to give the protection and flexibility processors need. The "Clean Curtains" partition to fit in with the sanitation needs of processing environments. The curtains have a slick surface able to...

Non-spill couplings.(NEW PRODUCTS)
March 1, 2005... The NS4 ABS series non-spill coupling's acrylonitrile butadiene styrene (ABS) material enables medical device manufacturers to extend the benefits of non-spill functionality to applications requiring both medical-grade quality and gamma...

Disposable nitrile gloves.(NEW PRODUCTS)
March 1, 2005... Econwear's disposable nitrile gloves are ideal for individuals allergic to rubber latex. These stretch gloves offer superior fit, chemical resistance and are more puncture resistant than rubber and vinyl disposables. They reduce hand fatigue...

One-step cleaner.(NEW PRODUCTS)
March 1, 2005... DDDS, a concentrated one-step disinfectant, germicidal detergent and deodorant, offers a new list of updated EPA claims. DDDS is now effective against numerous bacteria (Staphylococcus aureus, Psuedomonas aeruginosa, Salmonella choleraesuis,...

Spectrometer software.(NEW PRODUCTS)
March 1, 2005... With its recently released version 3.0, PANalytical has improved the software for their range of MiniPal and MiniMate EDXRF benchtop spectrometers. New features in the software make it easier to use and enable more versatile analysis. The new...

Online filter life estimator.(NEW PRODUCTS)
March 1, 2005... The Filter Life Estimator, a Web-based tool, enables semiconductor fabricators using ASML lithography tools to plan filter maintenance schedules based on the contaminant mix in their particular operation. The estimator is available on the...

High-quality cleaning.(NEW PRODUCTS)
March 1, 2005... EnduroPower is a technology that makes it possible to reduce cleaning cost by saving time, water, energy and labor for the food, dairy and beverage industries. EnduroPower products use surfactants, which, in solution, form polar rod-shaped...

Fluoropolymer lay-flat bags.(NEW PRODUCTS)
March 1, 2005... These lay-flat fluoropolymer bags are chemically inert, nonwettable, and noncontaminating. They are able to withstand extreme temperatures from -400[degrees]F to +400[degrees]F; are impact- and tear-resistant; and remain unaffected by outdoor...

Air-purifying respirators.(NEW PRODUCTS)
March 1, 2005... The PeakFit air-purifying respirators are engineered to guarantee a superior fit that enhances users' comfort. The respirator is an NIOSH-approved N95 mask that features a large, contoured design that makes breathing easier and reduces workers'...

Cleanroom doors.(NEW PRODUCTS)
March 1, 2005... CleanSeal Cleanroom door systems from ASI Technologies are available with welded seamless window frames. The frames are easy to keep clean and provide a barrier to dirt and bacteria to maintain controlled conditions in stringent laboratory and...

Air-containment system.(NEW PRODUCTS)
March 1, 2005... The Protect Containment Systems line of building air-containment products offers protection against hazardous gases and chemical warfare agents. Products offered within the line include high-efficiency, single-pass activated carbon adsorbers...

Wireless data logging system.(NEW PRODUCTS)
March 1, 2005... The MicroLog Plus from Carltex Inc. enables wireless communications from up to 200 Remote Sensing Units monitoring temperature and humidity and transmitting the data to your PC. In addition to temperature and humidity, sensors are available for...

Dispensing system.(NEW PRODUCTS)
March 1, 2005... Millipore has announced the availability of its Acerta DS1 dispensing system, a single-head liquid filling unit that utilizes a pre-assembled, sterile, disposable filling module. The system is designed for final sterile injectables and...

Latex agglutination kit.(NEW PRODUCTS)
March 1, 2005... The E. coliPRO 0157 Latex Agglutination kit from Hardy Diagnostics offers definitive identification of E. coli 0157 from a single isolated colony. Rapid results are obtained in as little as two minutes at room temperature. E. coliPRO 0157 is...

SMACNA's second edition.(NEW LITERATURE)
March 1, 2005... The Sheet Metal and Air Conditioning Contractors' National Association (SMACNA) has published the second edition of its "Rectangular Industrial Duct Construction Standards." The updated 446-page manual expands the scope of the 1980 version,...

Nora flooring brochure.(NEW LITERATURE)
March 1, 2005... This 24-page color brochure highlights flooring solutions for healthcare facilities. It describes the ways in which nora products address the variety of demands healthcare facilities place on floor coverings, including hygiene requirements,...

Filtration selection guide.(NEW LITERATURE)
March 1, 2005... Millipore's Filtration Selection Guide summarizes key biopharmaceutical applications and provides recommendations on appropriate microfiltration, ultrafiltration, viral clearance, clarification, prefiltration and sterile filtration solutions....

Calendar.(Calendar)
March 1, 2005... MARCH 8-11 Antibody Production and Downstream Processing. Sheraton, San Diego, Calif. Sponsored by IBC Life Sciences. For more information: www.lifesciencesinfo.com/antibodyprod MARCH 14-16 Biomarker Pipeline. Hilton Logan...