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Controlled Environments

Send It to the Lab...Then Wait

March 13, 2011 8:00 pm | Comments

An array of analytical methods can be used to detect surface contamination and to characterize attributes of processes. Many involve “sending a sample to the lab.” There are many quicker, even if less precise, methods of determining that the process is outside of control parameters.


Is the Peter Principle a Myth?

March 13, 2011 8:00 pm | Comments

The Peter Principle holds that “in a hierarchy, every employee tends to rise to his level of incompetence” and it is still quoted and blamed in many management situations today. Is it true? And if so, why does it persist?


New ISO Cleanroom Standards: What Will They Mean For Pharma?

March 6, 2011 7:00 pm | by Heidi Parsons | Comments

International experts have made significant changes to ISO’s airborne cleanliness classification standard — and now is the time for industry to comment.


Point of View: Contamination Control -- A Mindset?

March 6, 2011 7:00 pm | by Raymond K. Schneider, P.E. | Comments

Is there such a thing as a contamination control mindset? A quick web scan for the definition of “mindset” came up with a couple I thought interesting. Simply put, “a way of thinking about things” or, possibly more ominously, “a set of beliefs of a person (or perhaps a company) that affects the outcome of all their endeavors.”

Ask the Facilities Guy

March 6, 2011 7:00 pm | by Richard Bilodeau, PE | Comments

My company is planning to expand its manufacturing capacity. Any words of advice on how best to scope the budget for construction projects?

Ultrasonics: Sound or Fury?

March 6, 2011 7:00 pm | by Barbara KanegsbergEd Kanegsberg | Comments

“We know our ultrasonic system is working properly, because it’s making plenty of noise. Why is the cleaning process ineffective?” This recurring question has vexed manufacturers for decades.

Can There Be Life Without Exposure Limits?

March 6, 2011 7:00 pm | by John B. Durkee, Ph.D., P.E. | Comments

This column updates the May 2010 column, and January 2011 column in which I reported on a whipsaw (a lose-lose situation) faced by the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA).

Sources and Financial Impact of Microbial Contamination

March 6, 2011 7:00 pm | by Jeffrey I. Becker, CIHM | Comments

Organizations experiencing contamination issues know that contamination may cause serious financial risks to their bottom line.


Leadership Realities You Won't Learn in Management School

February 27, 2011 7:00 pm | Comments

In their book, Management? It's Not What You Think!, authors Henry Mintzberg, Bruce Ahlstrand and, Joseph Lampel offer “leadership realities” that are often overlooked or undervalued in organizations.


AMC the Silent Poison

February 27, 2011 7:00 pm | Comments

Poisons sap strength—including product quality and profits. Stop AMC at the source. Where is it in your process flow? Could AMC arise from the outside environment or prior processing in your supply chain? Is it being generated inside your facility?


The Credo of an Empowering Manager

February 13, 2011 7:00 pm | Comments

Your goal is to create a work environment in which people are empowered, productive, contributing, and happy. Don't hobble them by limiting their tools or information. Trust them to do the right thing, then get out of their way and watch them succeed.


Cleaning Strategies for Electronics Production

January 31, 2011 7:00 pm | by Doris Schulz | Comments

Obtaining requirements-oriented cleanliness in a cost-optimized way.

Point of View Matters

January 31, 2011 7:00 pm | by John B. Durkee, Ph.D., P.E. | Comments

Born without a right leg, Tony Robles is a champion college wrestler from Arizona State University. In 2011, his senior year, he may well win the NCAA collegiate championship.

"Tipping Point" Cleaning

January 31, 2011 7:00 pm | by Barbara KanegsbergEd Kanegsberg | Comments

The terms critical cleaning and precision cleaning are often used interchangeably.

New Sampling and Classification Methods Set in Revised ISO 14644 Cleanroom Standards

January 31, 2011 7:00 pm | by Roberta Burrows, CAEDiana Granitto | Comments

The highly anticipated revisions to the world’s bedrock cleanroom standards are now available from IEST, the Secretariat for ISO Technical Committee 209 (ISO/TC 209): Cleanrooms and associated controlled environments.


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