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Controlled Environments

What’s in a Name? Sometimes, Not So Much

July 11, 2012 10:20 pm | by Bob Applequist | Labconco Corporation | Comments

As the use of gloveboxes increases, facility managers use new terms to define applications.                                                   


New Weapon to Fight Falsified Drugs

July 11, 2012 9:33 pm | by Bikash Chatterjee | Comments

New European regulations detail responsibilities for falsified drugs, but do they go far enough?                                                         


Exposure Limits Resolved

July 11, 2012 8:00 pm | by John B. Durkee, Ph.D., P.E. | Comments

OSHA releases a long-awaited hazard communication standard, but questions remain.                                             


Documents Guide Cleaning Validation

July 11, 2012 8:00 pm | by John Broad, Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

As reusable medical device designs evolve, so too must validated cleaning processes.                                                           


Going Retro

July 11, 2012 8:00 pm | by Richard Bilodeau, PE | SMRT - Architects and Engineers | Comments

Existing facilities can gain a performance boost by conducting a retro-commissioning effort.                                            


Putting Cleaning Protocols to the Test

July 11, 2012 8:00 pm | by John Broad and Barbara Kanegsberg | BFK Solutions, LLC | Comments

Studies demonstrate reusable device cleaning validation using alternative markers.                                                        


Cleanroom Trash or Recycled Treasure?

July 11, 2012 5:29 pm | by Albe Zakes | Kimberly-Clark Professional | Comments

Cleanroom recycling programs offer eco-friendly waste solutions for garments.                                                          


Power: The Unregulated Utility

May 29, 2012 8:09 am | Comments

Pharmaceutical/Biotechnology companies are dependent on the quality of the power provided by the local utility. There are many issues regarding unconditioned power versus conditioned power provided by an Uninterruptible Power System (UPS).


Hazards Communicated!

May 24, 2012 1:44 pm | by John B. Durkee, Ph.D., P.E. | Comments

Where were you when the MSDS was “born,” nearly 30 years ago? Since that time, particularly over the last decade, various regional or national regulatory agencies have undertaken the task of classifying chemical hazards, rendering those classifications not only more important but also more consistent with others worldwide.


Read (and Write) the Fabulous Manual

May 24, 2012 1:41 pm | by John Broad, Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

Web-based translators are breaking barriers among geographically based tongues. A bigger problem is conveying the intended meaning behind the words even among people who speak the same "tongue."                                 


Site Selection for Clean Manufacturing Facilities

May 24, 2012 1:39 pm | by Richard Bilodeau, PE | SMRT - Architects and Engineers | Comments

Question: I expect to be involved in either selecting a site for new construction or a building for renovation in order to expand our manufacturing operations. Can you give me some advice?                               


Please help us determine the source of the silicone contamination.

May 24, 2012 1:36 pm | by Jan Eudy | Cintas Cleanroom Resources | Comments

Recently, our cleanroom became contaminated with silicone. Contamination with silicone is a very serious problem in our industry. Please help us determine the source of the silicone contamination.                             


Medical Device Manufacturing Environments - A commentary

May 24, 2012 1:32 pm | by Scott Mackler | Comments

For those concerned with developing requirements for aseptic processing or semiconductor wafer fab environmental specifications, the choices are easy: there essentially are none!                             


Customized Cleanroom Applications Meet Today’s Environmental Challenges

May 24, 2012 1:30 pm | by Michael Wetzel, PE | Air Innovations, Inc. | Comments

Customized environmental solutions can resolve unique cleanroom requirements.                                              


Mobile Technique Identifies Contamination Sources

May 24, 2012 1:28 pm | by Mark Berdovich and Thomas Pietrykowski | Particle Measuring Systems | Comments

The rapid detection of point-source contamination locations within the cleanroom can have significant benefits for defect reduction efforts.                                           



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