Controlled Environments Magazine® E­Newsletter
Contamination Control for Life Sciences and Microelectronics
April 15, 2009 | Volume 3, Issue 15

Medical Device Manufacturers of U.S. Products in Mexico
By Rudy Pina
The Global Medical Device community has for several decades relied on Mexico, specifically the industrial community, for the manufacture of their medical products. This manufacturing process has evolved over the years to result in an industrial conglomerate that has paid off in dividends to the Original Equipment Manufacturers (OEM) as well as the contract manufacturing industry in Mexico.
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PRODUCT FOCUS
EasyClean™ 360 Isolator Cleaning System

The EasyClean™ 360 isolator cleaning system cleans LAFW, BSC, CAI, and other hard to reach surfaces to maintain the purity and quality of compounded products. The system includes a lightweight, maneuverable cleaning tool with two different length handles and cleanroom laundered polyester knit covers.
www.berkshire.com
CLEANROOM TIP OF THE WEEK

How To Succeed In The Search For Nothing:
Effective Swabbing Techniques For Cleaning Validation

Assuming the surface is free of visible residue (i.e., that the cleaning stage is done), the challenge is now to sample that surface in a reproducible manner so that any (invisible) residues, present in extremely small amounts, are collected and delivered to the instrument for measurement.
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MANAGEMENT TIP OF THE WEEK

Getting Your Point Across
When we're trying to get a point across to someone else we often think long and hard about what we want to say. That is the wrong way to go about it. Instead of focusing on what you want to say to get your point across, you should focus on what you want the other person to hear.
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INDUSTRY NEWS
  • Expansion Creates New Jobs in New York State, Extends Partnership
    A $150 million expansion at the University of Albany’s Nanotech Complex will create 450 new high-tech jobs in New York State by 2013. The expansion will also extend IBM’s R&D partnership with the University’s College of Nanoscale Science and Engineering (CNSE) through 2013.
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  • Ions Coldly go Through NIST Trap Junction
    Physicists at the National Institute of Standards and Technology (NIST) have demonstrated a new ion trap that enables ions to go through an intersection while keeping their cool. Ten million times cooler than in prior similar trips, in fact.
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  • Nano Changes Rise to Macro Importance in a Key Electronics Material
    By combining the results of a number of powerful techniques for studying material structure at the nanoscale, a team of researchers from the NIST, working with colleagues in other federal labs and abroad, believe they have settled a long-standing debate over the source of the unique electronic properties of a material with potentially great importance for wireless communications.
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  • Device Controls Electron Spin at Room Temperature
    In a breakthrough for applied physics, North Carolina State University researchers have developed a magnetic semiconductor memory device, using GaMnN thin films, which uses both the charge and spin of electrons at room temperature.
    read more

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Industry Calendar

April 20-24, 2009
PDA Annual Meeting
Las Vegas, NV

May 4-7, 2009
ESTECH 2009
Schaumburg, IL

May 11-12, 2009
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Berlin, Germany

May 12-13, 2009
Best Practices for an Effective Cleaning Validation Program
Costa Mesa, CA

May 20-22, 2009
SEMICON Singapore
Suntec, Singapore

May 26-27, 2009
Cleanroom Microbiology for the Non-Microbiologist
Berlin, Germany

June 2-4, 2009
SEMICON Russia
Moscow, Russia

June 8-10, 2009
European Supply Chain and Logistics Summit 2009
Düsseldorf, Germany

July 6-8, 2009
American Glovebox Society Annual Conference
San Diego, CA

July 16-17, 2009
Overview of FDA Regulatory Compliance for Medical Devices
Costa Mesa, CA

July 19-23, 2009
SEMICON West
San Francisco, CA

August 24-26, 2009
Active Pharmaceutical Ingredient (API) and Drug Product Specification
Costa Mesa, CA

September 2-4, 2009
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
Costa Mesa, CA

September 9-11, 2009 SEMICON Taiwan
Taipei, Taiwan

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