January 2010 Issue Containment of Hazardous Drugs: The New Paradigm
By Hank Rahe
Compared to pharmaceutical manufacturing, hazardous drugs have a narrow definition in the world of pharmacy. This article will compare and contrast the differences in the approach and knowledge base that exists in both worlds, in terms of defining and coping with the hazards these drugs represent.
Simulating Challenging Operational Environments
By Timothy J. Copeland
Simulating noise and vibration environments is key for successful product operation.
The Leaning of Thermal Validation
By Kevin Bull
Validation professionals spend extensive time validating temperature to ensure the integrity of controlled environments and to fulfill compliance requirements.
NIST Advanced Measurement Laboratory Complex
By Ahmad Soueid, AIA, LEED® AP
The Project that Broke New Ground in Nanoscale Research
Great Clean Manufacturing Bloopers of All Time, Act I
By John B. Durkee, Ph.D., P.E.
Some time ago, I participated in an article on unforgettable clean manufacturing stories. I was joined by contributors Ken Goldstein, Lise Laurin, and Scott Mackler who generously offered tales of mishaps and snafus they had witnessed over their careers.
Validation Readiness, Part I
By Barbara Kanegsberg, Ed Kanegsberg
Plan twice; validate once is a prudent variant of the adage. Cleaning validation is a hurdle in many applications, including aerospace, microelectronics, pharmaceuticals, and medical device manufacture.
The Un-dirty Dozen
By Patrice Galvin
In September 2009, Controlled Environments sent out our annual reader survey. Hundreds of people answered a variety of questions about the magazine, trade shows they attend during the year, and buying power, among others.