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Hybrid medical devices: Clean, lean, drug-dispensing machines

06/01/2005  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.

IEST updates and improves its Recommended Practice for testing ULPA filters

06/01/2005  The Institute of Environmental Sciences and Technologies (IEST) has long been a leader in the area of cleanroom filter definitions and performance testing.

Safe-handling label may move inside

06/01/2005  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 of egg cartons.

USP 797: Microcleaning and the controlled environment-Part 1

06/01/2005  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.

PRODUCT SPOTLIGHT

06/01/2005  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 examines some of the latest liquid and gas delivery system products, services and technologies available to prevent this from happening.

Gas filter technology aims to extinguish pharma fire risk

06/01/2005  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) materials.

Infection inspection invention

06/01/2005  BIRMINGHAM, ALA.— Medical IT company MedMined Inc. (www.medmined.com) has introduced the Nosocomial Infection Marker (NIM) to its Data Mining Surveillance technology.

Injectable technology to be manufactured in 14,000-square-foot cleanroom suites

06/01/2005  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.

A glimpse at Interphex unveilings

06/01/2005  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.

Newly patented filtration technology enhances milk product purification

06/01/2005  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.

Single-wafer, mixed-fluid cleaning proposed for advanced processes

06/01/2005  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 annual conference on surface preparation cleaning "Emerging Technologies in Semiconductor Surface Preparation," sponsored by SEMATECH(www.sematech.org).

Danish pharma plant named Facility of the Year

06/01/2005  Innovative products weren't the only things unveiled at Interphex 2005 this past April.

GlaxoSmithKline: Manufacturing processes being addressed to correct drug defects

06/01/2005  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 by the Food and Drug Administration (FDA; www.fda.gov, during which batches of defective medications were seized.

Your Market Analysis: Cleanroom filters — Requirements and markets

06/01/2005  Demands for removal of smaller and smaller particles continue in the cleanroom industry.

From the Editor: Why doesn’t the food industry get it?

06/01/2005  1) Are the latest contamination-control practices and technology being applied to food safety?

Evaluating robotics for pharmaceutical packaging

06/01/2005  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.

The importance of surface-cleaned micropowders for specialized uses in the ceramic industry

06/01/2005  Engineers, designers, production managers and purchasing professionals should be informed of the processes used to manufacture the materials used in their respective applications.

Biosafety lab cited for three ‘serious’ health violations

06/01/2005  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 exposure to the potentially lethal tularemia-causing bacterium in the spring of 2004.

Cassette-to-cassette system targets new semi processes

06/01/2005  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 Windows NT control software and process modules from the company's fxP series cluster tools.

"Flexible" approach to contamination control meets goals

06/01/2005  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 components the slightest speck of dust or dirt can wreak havoc.