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Solid State Technology
Re Processor Caught Betw
Re-processor caught between rock and two FDA offices
Although a re-processor of single-use medical devices has agreed to halt production, the president of the Lubbock, Texas-based company says the Food and Drug Administration's (FDA) claim that Adven Medical Inc. failed to properly validate cleaning, disinfecting and sterilization processes is "false and inflammatory."
Biotech Notebook Many Ma
Biotech notebook: Many making bids to stay alive, generate revenue
Britain's Xenova Group Plc. has agreed to buy rival KS Biomedix Holdings Plc., but analysts say the deal would do little to ensure the survival of two struggling biotech firms.
Iest Seeks Comments On G
IEST seeks comments on garment standard
The IEST, the Institute of Environmental Sciences and Technology, has released RP-CC003.3, Garment System Considerations for Cleanrooms and Other Controlled Environments, and is seeking comment on several other topics that were developed by the Contamination Control Division during ESTECH 2003 in May.
Microfluidic Device Quic
Microfluidic device quickly captures, releases proteins
The tiny line of gold fingers of a new microfluidic device are the piano keys that when tickled allow this new lab-on-chip to sing songs of particle analysis to the tunes of contamination control, drug discovery, homeland defense and lab chromatography.
China Promises To Whittl
China promises to whittle down tariffs on nonwovens
China will pare down its tariffs on a host of nonwoven roll goods from rates as high as 23 percent to 10 percent by 2005, but the world's most populous nation says it is not prepared to make additional cuts to industrial and agriculture levies.
Stage is set for CleanRooms China 2003 Dec. 12-13
With two new fabs breaking ground last quarter and eight fab projects currently underway in China, the stage is clearly set for CleanRooms China 2003 conference and exhibition to be held at the Shanghai International Convention Center on December 12-13—the second installment in this growing, annual event.
300 Mm Designs Boost Fab
300-mm designs boost fab construction, but cleanroom requirements relaxed
Despite hard times in the chip and microelectronics industries, a report from a firm that tracks wafer manufacturing says there are more than twice as many fabs under construction this year than in all of 2002.
Getting Amc Control On T
Getting AMC control on the right wavelength
When it comes to contamination control, even a light touch can cause problems.
Biotech Firm Picks Oklah
Biotech firm picks Oklahoma City
A unique Tax Increment Financing (TIF) package that would provide more than $7 million to construct a $12 million dollar office and production facility here was enough to get biotech start-up Cytovance Biologics to locate its company in the Presbyterian Health Foundation Research Park starting in 2005.
Sematech Gives Conveyors
Sematech gives conveyors a go in fab
International Sematech's latest offering looks a bit like cars racing in slow motion around a track, or perhaps a stately high tech waltz.
Cgmps Warmly Embraced By
cGMPs warmly embraced by third-party nutraceutical maker
A contract manufacturer of dietary supplements says implementing the same current good manufacturing practices (cGMPs) required for pharmaceutical aseptic processing will be a "seamless transition" once the proposal is mandated by the Food and Drug Administration.
What is the cost of non-involvement?
Everyone is feeling the weight of extra duties and it's fairly easy to understand why industry associations need to push harder than ever to elicit critical participation from membership at conferences, shows or board meetings.
Clean, green and cost effective: Considering sustainable lab design
For the past several years, heightened awareness of the effects of pollution, resource consumption and the interaction of the built and natural environments has inspired public- and private-sector organizations to adopt "green" or sustainable design criteria for many types of new and existing buildings.
Setting The Standard
A quick survey of the three mechanical filtration mechanisms
Filters are omnipotent in the practice of contamination control. We filter many things—cleanroom air, ultrapure water, process chemicals and high-purity gasses. We install filters at the outlets of our vacuum cleaners and we filter our process effluents.
Acceptable contamination limits: Full disclosure is imperative
How much contamination is acceptable? To answer this question we must define our goals as well as the consequences of not meeting them.
Relax, visualize airflow with party balloons
Last month's column touted computational modeling as a useful tool for predicting airflow patterns in a cleanroom. The complex geometries and boundary conditions of a real cleanroom, however, render this approach impractical.
On The Beat
Keystone compliance cops
The Food and Drug Administration's right hand doesn't know what the left is doing, and despite the validity, the bureaucracy-mired agency recoils when questions abound.
Cleanroom Garments Ask Q
Cleanroom garments: Ask questions, get what you need
Having recently reviewed articles pertaining to cleanroom garments and their associated programs, it appears that certain aspects of the selection and oversight process receive little if any attention.
Gamp The Essential Tool
GAMP: The essential tool for maintaining 21 CFR Part 11 compliance
Since its enforcement, starting in 1997, Title 21 of the U.S. Code of Federal Regulations (CFR) Part 11 has had a resounding impact in the biotechnology and pharmaceutical industries.
Squeezing every last drop of safety
It's a given that in today's healthcare climate, virtually any conversation about specific areas of operation begins—and often ends—with a discussion about money. Hospitals, especially, are under the gun. Some patients are rushed home to avoid the higher costs of a hospital stay, while others who do arrive for extended stays are arriving sicker than in years past.