CleanRooms articles from June 2005

CleanRooms archives from June 2005

GlaxoSmithKline: manufacturing processes being addressed to correct drug defects.(CleanZone)
June 1, 2005... ROCKVILLE, MD. -- British pharmaceutical manufacturer GlaxoSmithKline (GSK; Brentford, U.K., www.gsk.com) says it has identified and is addressing unspecified manufacturing processes at its Cidra, Puerto Rico, facility that led to a March raid...

Single-wafer, mixed-fluid cleaning proposed for advanced processes.(NEWS)
June 1, 2005... AUSTIN, TEXAS -- The need for and difficulty of removing surface particles without damaging circuit features, and the increasing trend of mask cleaning borrowing from wafer-cleaning technologies, were key themes that emerged from the seventh...

Biosafety lab cited for three 'serious' health violations.(news)(Boston Medical Center Corp.)
June 1, 2005... BOSTON, MASS -- Detailing three procedural violations it deems as "serious," the Occupational Safety and Health Administration (OSHA; www.osha.gov) has fined Boston University and Boston Medical Center Corp. $8,100 as a result of researcher...

Why doesn't the food industry get it?(FROMtheEDITOR)
June 1, 2005... Four questions: 1) Are the latest contamination-control practices and technology being applied to food safety? [ILLUSTRATION OMITTED] 2) Does the food industry mandate the use of sterile packaging environments to ensure food...

Danish pharma plant named Facility of the Year.(NEWS)
June 1, 2005... Innovative products weren't the only things unveiled at Interphex 2005 this past April. A new "Facility of the Year" award, recognizing excellence in facility engineering, was also bestowed for the first time this year. The award, designed to...

Injectable technology to be manufactured in 14,000-square-foot cleanroom suites.(NEWS)
June 1, 2005... SAN DIEGO, CALIF. -- Artes Medical Inc. (www.artesmedical.com) has begun qualification runs of its injectable wrinkle-filler device, ArteFill, at its recently completed commercial cGMP manufacturing facility in San Diego. Once the product...

Analytical accreditation.(particles)(Brief Article)
June 1, 2005... CORBEIL-ESSONNES, France -- Air Liquide Balazs Analytical Services (www.airliquide.com) has received worldwide ISO/CEI 17025 accreditation for compliance with standards in more than 100 ultratrace analytical methods. Balazs's U.S. labs are...

Monitoring microorganisms.(particles)(BioSentry)(Brief Article)
June 1, 2005... SAN DIEGO, Calif. -- JMAR Technologies (www.jmar.com) is testing beta models of its BioSentry waterborne microorganism monitoring system with the Olivenhain (Calif.) Municipal Water District (OMWD), which will use three of the units to...

Cancer-chasing cleanroom.(particles)(Atomising Systems Ltd. )(Brief Article)
June 1, 2005... SHEFFIELD, U.K. -- Atomising Systems Ltd. (www.atomising.co.uk) has constructed a state-of-the-art cleanroom facility built to cGMP specifications for the manufacture of pSivida's (Perth, Australia) BrachySil cancer therapy. The cleanroom...

High-K handshake.(particles)(Vesta Technology Inc.)(ATDF )(Brief Article)
June 1, 2005... AUSTIN, Texas -- ATDF (www.atdf.com), a semiconductor research and development center, is partnering with VESTA Technology (San Jose, Calif.; www.vestatechnology.com) to establish an R & D and customer demonstration facility for its advanced...

Safe-handling label may move inside.(NEWS)(Brief Article)
June 1, 2005... ROCKVILLE, Md. -- At the request of the egg industry, the Food and Drug Administration (FDA; www.fda.gov) has proposed to amend its food-labeling regulations so that safe-handling statements may appear on the inside lid rather than on the front...

A glimpse at Interphex unveilings.(news)
June 1, 2005... Over 950 exhibitors from around the world gathered together this past April for the Interphex conference and exhibition at the Jacob K. Javits center in New York City. Walking the floor of the three-day pharmaceutical manufacturing...

Newly patented filtration technology enhances milk product purification.(NEWS)
June 1, 2005... APEX N.C. -- A filtration technology developed by NCSRT Inc. (www.ncsrt.com) has received three U.S. patents for superior dairy separation and purification of milk, whey and colostrum. The SmartFlow technology employs a process of cross-flow...

Infection inspection invention.(NEWS)
June 1, 2005... BIRMINGHAM, ALA. -- Medical IT company MedMined Inc. (www.medmined.com) has introduced the Nosocomial Infection Marker (NIM) to its Data Mining Surveillance technology. The company claims that infection-control professionals can now take...

Gas filter technology aims to extinguish pharma fire risk.(news)(Emflon CPFR )(Brief Article)
June 1, 2005... EAST HILLS, N.Y. -- Fire risk inherent with the production of certain protein-based drugs is the target of a new filtration technology developed by Pall Corp. (www.pall.com), which features specially designed PTFE (polytetrafluoroethylene)...

"Flexible" approach to contamination control meets goals.(news)
June 1, 2005... MT. PLEASANT, PA. -- At the Sony Technology Center-Pittsburgh (STC--P; Mt. Pleasant, Pa.), the liquid crystal display (LCD) rear projection televisions and plasma-based direct view televisions assembled there contain extremely precise...

Cassette-to-cassette system targets new semi processes.(news)(Omega i2L dry-etch system)(Brief Article)
June 1, 2005... NEWPORT, WALES -- Designed for 200-mm semiconductor processes, Trikon Technologies (www.trikon.com) began shipments in April for its Omega i2L dry-etch system, which combines the company's inline cassette-to-cassette handling subsystem with...

IEST updates and improves its recommended practice for testing ULPA filters.(setting the standard)(Institute of Environmental Sciences and Technologies)(Ultra Low Penetration Air)
June 1, 2005... The Institute of Environmental Sciences and Technologies (IEST) has long been a leader in the area of cleanroom filter definitions and performance testing. IEST maintains recommended practices (RP) for the following filter-related topics: ...

USP 797: microcleaning and the controlled environment--Part 1; Douglas Theobald continues his series on USP 797 with this two-part look at microcleaning.(LIFE SCIENCES)(United States Pharmacopeia)
June 1, 2005... Microcleaning is the process whereby the surfaces in a controlled environment are disinfected and sanitized with the elimination of microscopic-scale contaminants as the core objective. In USP general chapter 797, we are given a list of...

Cleanroom filters--requirements and markets.(your market analysis)
June 1, 2005... Demands for removal of smaller and smaller particles continue in the cleanroom industry. Purification of cleanroom air increasingly involves elimination of molecular contamination, and gas-phase contaminants are major problems for semiconductor...

Hybrid medical devices: clean, lean, drug-dispensing machines; Medical manufacturers are finding creative ways to make implantable drug-delivery devices that stand up to strict sterility guidelines and the volatile conditions of the human body.(special report)
June 1, 2005... Hundreds of thousands of hybrid medical devices are surgically implanted into patients every year. These devices, which include stents, medication pumps, and biosensing microchips, are changing the way patients live with many common diseases...

Evaluating robotics for pharmaceutical packaging: to determine if your cleanroom or contamination-controlled packaging line is ready for robotics, the overall benefits of automating must be understood.
June 1, 2005... Today's pharmaceutical manufacturers are challenged by strict contamination-control requirements, increased brand turnover and broader product lines in a range of formats and sizes. To speed time to market and accommodate an assortment of...

The importance of surface-cleaned micropowders for specialized uses in the ceramic industry: controlling the surface chemistry of micron and submicron particles is critical during the manufacturing process.
June 1, 2005... Engineers, designers, production managers and purchasing professionals should be informed of the processes used to manufacture the materials used in their respective applications. These applications include but are not limited to: **...

Gas/liquid delivery.(PRODUCTSPOTLIGHT)
June 1, 2005... Regardless of the classification level of the surrounding environment or cleanliness of the equipment, if the process gases or chemistry introduced into the process are contaminated, so will be the product. This month's product spotlight...

Adjustable armrests.(NEW PRODUCTS)
June 1, 2005... Adjustable armrests and additional controls for seat and/or backrest adjustment are now available as options on BioFit Class 10 (ISO Class 4) cleanroom chairs. The selection increases opportunities for customizing basic Class 10 (ISO Class 4)...

Hose identification.(NEW PRODUCTS)
June 1, 2005... These seven solutions for hose identification nearly double the number previously available. Imprinted, laseretched, electronically tagged and color-coded products create traceability, allow for instant recognition, identify capabilities or...

Purification kit.(NEW PRODUCTS)
June 1, 2005... The Vivapure 8- to 96-well cobalt-chelate kit, a complete system for simultaneous purification of multiple Histagged proteins, includes ready-to-use, membrane-based hardware for all steps of the purification process: lysate filtration, protein...

Run-to-run application.(NEW PRODUCTS)
June 1, 2005... The Run-to-Run (R2R) plug-in application for the Brooks Software's Advanced Process Control (APC) platform provides a development environment that lowers the cost of ownership by reducing model management activities through a unified modeling...

Thermal flow sensor.(NEW PRODUCTS)
June 1, 2005... The SS 20.60 FB enhanced air and gas flow sensors with integrated field bus interface deliver ready-prepared measuring values like Kg/hr or [m.sup.3]/min. The user has access to the sensor's status information and is informed by the PLC of any...

POC analyzer.(NEW PRODUCTS)
June 1, 2005... This analyzer effectively and continuously monitors photochemical organic contamination (POC), such as nonmethane hydrocarbons and siloxanes, and provides real-time contamination results. POCs have the potential of absorbing laser throughput,...

Spill sensor.(NEW PRODUCTS)
June 1, 2005... The new OS 250 detects spills and leaks before they cause a problem. As little as three drops of liquid will cause the OS 250 to react. The system consists of a moisture-sensing mat made of a material specially developed for detecting liquid...

Handheld airborne particle counters.(NEW PRODUCTS)
June 1, 2005... The APC and APC Plus stainless-steel handheld airborne particle counters are easier to decontaminate for entry into your critical environments and can simultaneously measure up to four particle size ranges. Additional features include a...

Dust collector cartridge filters.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... A new HemiPleat filter offers greatly extended service life and lower pressure drop compared to standard dust collector cartridge filters. The HemiPleat line includes filter elements to fit virtually all types of new and existing cartridge dust...

Microbial identification system.(NEW PRODUCTS)
June 1, 2005... The MicroSeq microbial identification system supports customers' in meeting U.S. FDA requirements for aseptic processing for the manufacture of sterile drug and biological products under current Good Manufacturing Practice (cGMP) regulations...

Reverse osmosis.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... The Osmotron Inject is a plant for the production of highly purified water (HPW) by means of two reverse osmosis stages and electrodeionization. The compact unit is entirely hot water-sanitizable and constitutes a safe, closed system. In the...

Stainless-steel cable containment system.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... HYCON is a modular, hygienic stainless-steel cable containment system. It is fully sealed and waterproof to European standard IP66 (power hose-proof). HYCON, constructed of 316 grade steel, uses new and patented technology. It is suitable for...

Leak detection instrument.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... Sensistor Technologies has introduced the H2000TM, which uses a safe, nonhazardous mixture of 5 percent hydrogen in 95 percent nitrogen to detect leaks. This method allows for nondestructive testing with short cycle times and reliable results,...

Clean bench.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... The Series 204 horizontal laminar flow clean benches include an internal motorized filter unit for full filter coverage and three-side access for easy cleaning. They come in several sizes ranging from 2 X 2 feet to 2 X 6 feet. They are designed...

Aerosol monitor.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... The AES-1000 aerosol monitor has an easy-to-read LED display that indicates the current air cleanliness level (equivalent to Class 100-Class 100,000/ISO Class 5-Class 8) by using a scale of one to ten. The monitor is extremely portable and can...

Dispensing system.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... The Acerta DS1 dispensing system is a single-head liquid-filling unit that uses a pre-assembled, sterile, disposable filling module. The system is designed for final sterile injectables and diagnostics in biotechnology and classical...

Oxygen analyzers.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... The Rapidox 2100 and 3100 oxygen analyzers allow for fast and accurate analysis of oxygen gas from under 1 ppm all the way up to 100 percent volume. These units were designed for a variety of applications from gas purity to vacuum leak...

Mass spectrometers.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... These two new mass spectrometers, the 3200 Q TRAP and the API 3200 LC/MS/MS systems with Turbo V source for added sensitivity, throughput, and cost-effectiveness in mass spectrometry-based workflows, are designed for food and beverage,...

Absolute humidity transmitter.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... A new transmitter design, Model AHT-200, uses thermal conductivity sensors to measure moisture content at elevated temperatures up to +200[degrees]C. The unit outperforms conventional capacitive/resistance humidity sensors in harsh environments...

Validation report.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... The Steam-Thru Connection (STC) validation report includes independent testing from NAMSA, Northview Laboratories and the University of Minnesota's Biotechnology Resource Center. The STC can be used in a range of applications, including media...

Flange-mounted impellers.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... New ECOFIT[R]-brand flange-mounted backward curved impellers provide optimal airflow and substantially lower installed cost for OEM customers. These new impellers are ideal for cleanrooms (fan filter units), fume hoods for factories,...

Particle size analyzer.(NEW PRODUCTS)(Buyers Guide)
June 1, 2005... Malvern Instruments has introduced the Insitec Voyager, a mobile, on-line particle size analyzer that can be attached to fixed sampling ports at a variety of points in a production line. It can also be used to sample from different production...

Disposable filter assembly.(Brief Article)
June 1, 2005... Meissner Filtration Products, Inc. announces the addition of an inline UltraCap[R] filter assembly to its existing line of T-style assemblies for disposable filtration in bio-manufacturing. The UltraCap assembly is an integrally sealed filter...

Calendar.(Calendar)
June 1, 2005... JUNE 6-9 ISPE Washington Conferences, including "BioProcess Pilot Plants: Balancing Cost, Flexibility and Compliance" and "Third Annual Process Analytical Technology (PAT) Symposium." Crystal Gateway Marriott, Arlington, Va. For more...