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Principles of Cleanroom Validation

November 6, 2011 7:00 pm | by David Muchemu | Comments

A cleanroom must be validated and certified to a particular class before operation.                              

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Are You a Manager or a Leader?

October 27, 2011 10:52 am | Comments

All leaders are managers but not all managers are leaders. Both managers and true leaders get things done through others, but managers do so by virtue of their specific position within their organizations, while true leaders— regardless of their official rank—do so by inspiring others.

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Advantages of Modular Cleanrooms

October 27, 2011 10:43 am | Comments

Modular, free-standing cleanrooms have many distinct advantages over their fixed wall counterparts. Using modular rooms greatly reduces design, engineering, and construction time, thereby reducing costs.

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A Bestiary of Difficult Employees

October 17, 2011 8:00 pm | Comments

Bestiaries, books that listed and described certain animals and their characteristics, were popular in the Middle Ages. Stories about each “beast” were designed to teach important moral lessons.

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Choosing the Right Cleanroom

October 17, 2011 8:00 pm | Comments

Regulations, cost, location, size, performance—how do you choose the right cleanroom? Selecting a cleanroom for a new business or product is not a difficult process. There are many considerations and options, but focusing first on requirements will help make the decision-making easier.

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The Cost of USP 797 Compliance

October 2, 2011 8:00 pm | Comments

The costs related to USP 797 compliance can vary greatly. Your specific needs will depend on your current compounding environment, as well as the types of CSPs being prepared. A key consideration, however, is the cost of non-compliance in the event that a contamination is tracked to your facility.

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The Myth of Work and Life Balance

October 2, 2011 8:00 pm | Comments

A recent survey of North American employees found that 87 percent of respondents say their work/life balance is negatively affecting their health. If you’ve been killing yourself trying to achieve daily work/life balance, it may be a pipe dream.

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Google is Not Enough

September 20, 2011 4:19 pm | by John B. Durkee, Ph.D., P.E. | BFK Solutions, LLC | Comments

Google can find targeted content in articles, books, and other material. I use it every day to answer specific questions, and to find specific references and information.                      

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Superfluous or Essential: Part I

September 20, 2011 4:16 pm | by Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

An art exhibit in London inspired us to ponder changing views about the definitions and implications of soil, residue, contamination, and especially the design and operation of controlled environments.                        

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I Don’t Mean to Be Critical

September 20, 2011 4:14 pm | by Bikash Chatterjee | Comments

The FDA guidance on process validation issued in January 2011 has turned the quality and product development worlds upside down.                       

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Establishing an Equipment Reliability Program

September 20, 2011 4:12 pm | by Richard Bilodeau, PE | SMRT - Architects and Engineers | Comments

How do I best establish an Equipment Reliability (ER) program?                                                 

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Water Filtration Snuffs Hazards of Industrial Dust

September 20, 2011 4:01 pm | by Ed Sullivan | Comments

Wet dust filters not only ensure regulatory compliance but can also improve worker comfort and production flow.                                         

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CO2 Snow-jet Cleaning in Micro-production

September 20, 2011 3:59 pm | by Doris Schulz | Comments

More than just surface-clean.                                              

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A Primer on Gloveboxes

September 20, 2011 3:54 pm | by Gary Roepke and Bob Applequist | Labconco Corporation | Comments

Determining the right glovebox for the right level of containment.                              

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Green House Gas Auditing – Is it Worth the Gamble?

September 20, 2011 3:48 pm | by Deborah Sweeney | Comments

The Green House Gas (GHG) audit industry is relatively new, and many are clamoring to enter this market before it becomes too costly to do so.                      

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