Controlled Environments Newsletter

	Jun 2, 2010

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FEATURE ARTICLE

Changes Affecting EU GMP and the FDA's CGMP Non-Viable Particle Cleanliness

By Tony Harrison

What the revisions to ISO 14644 may mean to your cleanroom. EU GMP and the FDA’s cGMP set the target cleanliness levels for non-viable particles in pharmaceutical cleanrooms.

PRODUCT FOCUS

Portable Airborne Particle Counter

The MET ONE 3400 Series is available in 1 CFM, 50 LPM and now 100 LPM flow rates. The new 100 LPM MET ONE 3445 takes just ten minutes to collect 1 m3 samples required to certify Grade A areas per the EU GMP Annex 1 guidance.

• Long Life Laser

• Easiest to use and integrate

For additional information, visit www.hach.com

CLEANROOM TIP

Keep the Product Clean

Paperwork, raw materials for manufacturing the product, tools, and equipment must be successfully transferred to the cleanroom. The goal of a materials transfer program is to keep contamination from the outside world from entering the cleanroom.

MANAGEMENT TIP

How to Double Your Productivity—Leadership

Don’t underestimate the small things that will have a big impact. Leaders waste huge amounts of effort, money, and time doing things with little impact or results.

INDUSTRY NEWS

Pittcon 2011 Announces Call for Papers

The Pittcon Program Committee announced the Call for Papers for Pittcon 2011, which will be held March 13 - 18, 2011, in Atlanta, Georgia. Abstracts must be received by August 13, 2010. Abstracts may only be submitted electronically via the Technical Program link at www.pittcon.org.

Vibration and Shock Test Fixture Design Training

Practical knowledge about fixtures used in mechanical vibration and mechanical shock testing is the goal of the short course "Vibration and Shock Test - Fixture Design" meeting at NTS, October 12-14, 2010 in Plano, TX.

EPA Adds More Than 6,300 Chemicals and 3,800 Chemical Facilities to Public Database

As part of Administrator Lisa P. Jackson’s commitment to increase public access to information on chemicals, the U.S. Environmental Protection Agency (EPA) has added more than 6,300 chemicals and 3,800 chemical facilities regulated under the Toxic Substances Control Act (TSCA) to a public database called Envirofacts.

2011 PDA Annual Meeting-Call for Abstracts

The 2011 PDA Annual Meeting will be held April 11-15, 2011 in San Antonio, TX. The meeting will explore an area of immense importance to our industry. Harnessing the Power of Knowledge to Drive World Class Science and Technology, and the Program Planning Committee for this conference invites you to submit an abstract for presentation by July 30, 2010.