News snippets from the world of contamination control
Hanford issues nation wide recall of Cefazolin
Hanford Pharmaceuticals, Inc., of Syracuse, New York, is voluntarily recalling four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials, an antibiotic used in a hospital environment. Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus), which may pose a serious or life-threatening risk for some patients. Cefazolin for Injection, USP is used to treat skin and skin structure, respiratory, and other infections.
DA issues draft guidance for fresh-cut fruits and vegetables
To minimize microbial food-safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers in a ready-to-eat form, the FDA today published a draft guidance document for producers of fresh-cut produce titled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables.”
“Fresh cut produce is the fastest growing sector of the fresh produce industry. This document should help to improve safety by providing clearer guidance on how to reduce health hazards that are potentially introduced during the production process,” said acting FDA commissioner Dr. Andrew von Eschenbach.
Processing produce into fresh-cut produce increases the risk of bacterial contamination and growth by breaking the natural exterior barrier of the produce by peeling, slicing, coring, trimming, or mashing with or without washing or other treatment before being packaged for consumption. Examples of fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled baby carrots, broccoli florets, cauliflower florets, cut celery stalks, shredded cabbage, cut melons, sliced pineapple, and sectioned grapefruit.
UVDI acquires Sparks Technology Inc.
UltraViolet Devices, Inc. (UVDI; Valencia, Calif.), a leading manufacturer of UV products for air and water treatment recently acquired Sparks Technology, Inc (STI) of Batavia, Illinois. Sparks Technology has been a leading OEM supplier to many industries including microelectronics, medical, and specialty applications related to air and water purification, and is the exclusive patented license holder of the Bonded Particulate Structure (BPS), a process in which activated carbon is bonded into a monolithic form that still maintains a significant level of open pore structure that provides major advantages over existing filtration technologies.
Dan Goetz, president of UVDI, said, “I am extremely energized about the acquisition of Sparks Technology, Inc. This combination brings proprietary bonded carbon technology to UVDI which, when combined with UVDI’s industry-leading UV technology, will enable the creation of products to address indoor air quality (IAQ) problems with complete system solutions for commercial and residential applications.”
New PDA facility to offer state-of-the-art training and education
The Parenteral Drug Association (Bethesda, Md.; www.pda.org) plans to consolidate operations to offer enhanced pharmaceutical and biotechnology training and education from a centralized facility.
The new headquarters will occupy the first and second floors of the Bethesda Towers in Bethesda, Maryland, putting PDA within close proximity to many of the state’s pharmaceutical and biotechnology companies, as well as regulatory groups with which PDA regularly interacts.
According to Robert Myers, PDA president, “This consolidation will allow us to improve our unique training and education facility.” The new laboratory will feature PDA’s industry-standard, hands-on aseptic processing laboratory course, and the facility’s new cleanroom will be a state-of-the-art sterile manufacturing operation.
The PDA headquarters is scheduled to move to the new location in Q3 2006. The Training and Research Institute will follow in Q1 2007.
Construction underway for DuPont’s second direct bonding production line in China
DuPont has begun construction on a second production line for liquid crystal display (LCD) direct bonding in Shenzhen, China. The new line will more than double the company’s direct bonding production capacity and cleanroom space in the region.
DuPont’s direct bonding technology increases a display’s durability and readability, particularly outdoors in bright sunlight, by over 300 percent. It also eliminates the condensation that occurs when a glass coverplate is used, and improves the display’s resistance to scratching, stains and dirt.
Direct bonding, mainly reserved for avionics and military applications, has been considered too costly to use in consumer products. The DuPont facility in Shenzhen, however, has made direct bonding a viable option for consumer applications and available for widespread adoption of the technology.
The first DuPont direct bonding production line, which opened in Shenzhen in 2005, was the first of its kind in Asia. The second line will be located at the same facility and will more than double the company’s regional direct bonding capabilities. It’s scheduled for start-up in Q4 2006.
Balazs Analytical Services, a division of Air Liquide Electronics U.S. LP (www.airliquide.com), has introduced PPQ Analysis, a new analytical technique for accurate quantification of ultratrace metal concentrations in water and process chemicals down to part per quadrillion (ppq) levels.
According to Alex Tremblot, general manager of Balazs, “As the industry moves to 90nm production and more advanced technology nodes, it is experiencing problems not observed before. Understanding contamination in ultrapure water and high-purity cleaning chemistries is becoming critical. Balazs has developed true quantitative techniques to identify contaminants at ppq levels. PPQ Analysis has already been used to quantify low-level Ni and Ca contamination to help resolve yield issues.”
To perform PPQ Analysis, a self-cleaning sampling device is used to take point-of-use samples, which are then prepared and analyzed. The samples also undergo ICP-MS analysis to lower matrix effects. Spike recoveries are performed at ppq concentrations resulting in the 90 to 100 percent range, confirming that the data is indeed valid.
Zentox announces expansion
Zentox (Newport News, Va.; www.zentox.com), a leader in innovative air purification and industrial water services technologies, will expand its facility in Newport News, Va., to increase the company’s current square footage by approximately 50 percent. Sixty percent of the new space is planned for the manufacturing of Photox units.
Photox is an advanced air purification system for the reduction of indoor airborne microbiological and volatile organic compound (VOC) contaminants. Based on photocatalytic oxidation technology (PCO), Photox is designed to remove noxious odors, toxic vapors and infectious organisms from the indoor environment.
The remainder of the new space will be used for a Photox showroom and walk-in store.
Hydrophilic coating process patented
Tulip BioMed, Inc. (San Diego, Calif.; ), a developer of medical devices and patented technologies for the living tissue markets, has filed for a provisional patent on its hydrophilic coating process, which affects the manufacturing and use of cannulae.
Cannulae are devices inserted through the skin, a duct, vein, or cavity in order to harvest tissue, drain away fluids, or insert tissue or other material. The patent covers a key differentiation between Tulip’s disposable cannulae and standard reusable cannulae. Tulip BioMed has developed stable, coated disposable cannulae that are designed to eliminate cross-contamination resulting from an inability to properly clean the instruments. The company manufactures its cannulae with needle stems that have finely polished inner and outer surfaces coated with a hydrophilic coating.
The cannulae are processed inside and out with a hydrophilic coating designed to absorb body fluids and create a slick surface so that cells can pass through the cannula without collecting tissue or being damaged, causing less trauma to the surrounding tissue and increasing the viability of the living cells removed for harvesting or re-injection.
According to Darin Andersen, president and COO of Tulip BioMed, “This technology is another big step toward securing Tulip BioMed’s future as a dominant player in Living Tissue Management as well as stem cell technologies. Tulip BioMed is showing its vision in promoting disposable devices. Recent incidents involving infection risks are continuing to surface, and the need for one-time use devices is becoming more apparent.”
Major milestones achieved in high-k metal gate technology
In two key presentations at the 2006 Symposium on VLSI Technology, SEMATECH engineers shared technical details on metal electrode materials that can be used to build low threshold voltage (Vt) nMOS transistors with high-k dielectric, and also unveiled a new approach for creating advanced, low standby power transistors for the 45 nm technology generation.
Husam Alshareef, project engineer in SEMATECH’s Advanced Gate Stack program, outlined the details of the first achievement involving nMOSFETs with metal electrodes showing an effective workfunction of ~4.0eV. The three-year project, which involved nearly 40 engineers at SEMATECH and collaborating universities and suppliers, resulting in the identification of nMOS metal gate electrode materials represents a major milestone in the quest to fabricate working CMOS devices using metal gate and high-k dielectric stacks.
In a second VLSI presentation, S.C. Song, Material Evaluation Test Structure project manager at SEMATECH, described a dual high-k, dual metal gate (DHDMG) process for CMOS field-effect transistors (FETs) that offers several advantages over previously reported dual metal gate integration approaches. The result is a highly manufacturable flow that can meet industry and ITRS targets for low stand-by power (LSTP) 45 nm technology generation.
The DHDMG process, developed by SEMATECH engineers in its R&D wafer fab, allows high-k dielectric materials and their associated metal gates to be optimized in separate processing steps, eliminating the integration problems that characterize more conventional methodologies.
The Institute of Environmental Sciences and Technology (IEST) will present a two-part educational series titles “Maintaining the Integrity of the Cleanroom.” Part one will take place Wednesday, September 20, 2006, at 11:00 AM (CDT), and part two will take place the following Wednesday, September 27, 2006, at 11:00 AM (CDT). The courses can be taken together or as stand-alone classes, and will be led by Jan Eudy, corporate quality assurance manager for Cintas Corporation. The per-site fee has no limit on the number of students who may participate at each location.
Each one-hour online course addresses compliance to the ISO 14644-5 Standard, Cleanrooms and associated controlled environments - Operations. It will cover the essentials of the ISO 14644-5 document and how it can be applied to cleanroom management. Attendees will become knowledgeable in the application of IEST recommended practices to achieve compliance with international cleanroom management fundamentals.
The online series is appropriate for QA/QC personnel, production personnel, technical support personnel, sales personnel, and training personnel in contamination control industries, as well as cleanroom cleaning companies, and manufacturers of equipment for cleanrooms.