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ASTM Medical Device Committees: Standards Evolution

January 26, 2012 7:00 pm | by Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

During the November, 2011 ASTM meetings in Tampa, FL, we observed a number of trends, particularly in the standards and guidance documents that impact medical device manufacture and maintenance.                                  

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Sacrificial Soils in Critical Cleaning

January 26, 2012 7:00 pm | by John B. Durkee, Ph.D., P.E. | Comments

Sacrificial soils are materials added to a soiled surface to help that surface become less soiled.                                          

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Keeping Your Team on Track

January 17, 2012 9:24 am | Comments

The Dale Carnegie blog offers practical advice on ways to build and maintain effective communication with your team/staff. These tips can put your team on the right track and help you stay there.

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Light Does Not Displace Heavy

January 16, 2012 7:00 pm | Comments

f all soil and cleaning agent components are soluble, rinsing is dilution.                               

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Failure Modes and Effects Analysis (FMEA)

January 10, 2012 10:37 pm | by Scott Mackler | Comments

One tool that we have found quite useful in supporting high facility on-stream time and process yield factors, as well as sustainability, is the equipment or hardware FMEA (Failure Modes and Effect Analysis). The FMEA exercise will provide the facilities team with a prioritized “risk burn-down” plan for ensuring readiness and can serve as a convenient basis for capital and operating expense budget creation and execution.

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Why Static-Control Flooring Is So Important - And How to Find Solutions to Keep You Grounded

January 2, 2012 7:00 pm | by Dave Long | Staticworx Flooring | Comments

Selecting the right kind of ESD (electrostatic discharge) flooring is always a challenge, and in controlled environments, the stakes are particularly high.                       

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Pharma Facility Quality Audits: A Primer for Design Teams

January 2, 2012 7:00 pm | by Scott Overton | Comments

Here is a familiar demand: “Show me where in the regulations it says to do that!” If you’ve spent any time in Quality, working on a facility or equipment project in the pharmaceutical industry, you have certainly had that put to you at some point.

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Nano is Big in North Carolina

January 2, 2012 7:00 pm | by Ahmad Soueid, AIA, LEED® AP | Comments

The Joint School of Nanoscience and Nanoengineering (JSNN) began with a simple but powerful idea: to create a facility where nanoscience and nanoengineering could be accessible to everyone.                                            

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How Do I Produce a Disaster Recovery Plan?

January 2, 2012 7:00 pm | by Richard Bilodeau, PE | SMRT - Architects and Engineers | Comments

Last month’s column laid the groundwork for developing a functional Disaster Recovery Plan. We reviewed key components of a disaster recovery plan and critical planning, discovery, and organizational steps one must take to develop a plan that functions beyond becoming a dust magnet on your bookshelf.

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Cosmetics and Cleanrooms

January 2, 2012 7:00 pm | by Barbara Kanegsberg, Dr. Kevina O’Donoghue and Ed Kanegsberg | BFK Solutions, LLC | Comments

Barbara Kanegsberg with special guest columnist Dr. Kevina O’Donoghue Reviewed by Ed Kanegsberg                                         

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Production before People or People before Production

January 2, 2012 7:00 pm | Comments

When asked about the most important factor in manufacturing, many employees put people ahead of production. It is important that our priorities are right on this one. Breaches in cleanroom protocol must not be allowed to result in an unsafe product. At the same time, skilled, educated cleanroom employees are essential for production of quality product.

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Isn't a meter always a meter?

January 2, 2012 7:00 pm | Comments

Unfortunately, no. There is no absolute truth in measurement. Measurement is really about probability. The percentages of times the measurement will be different are the uncertainties of that parameter.

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All the News That’s Fit to Print...

January 2, 2012 7:00 pm | by John B. Durkee, Ph.D., P.E. | Comments

This column reports on three unrelated outcomes about which you need know to manage critical cleaning work, and points out their significance.                                               

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Point of View: An Apple To Apple Comparison on Cleanroom Proposals

January 2, 2012 7:00 pm | by Kelly Barton | Comments

That’s a tough one, but for simple, relatively small cleanroom projects there are a few things that you can do to help ensure everyone bidding the job is “singing from the same song sheet.”                                

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Five Ideas to Increase Your Productivity at Work

December 19, 2011 7:00 pm | Comments

Finding it hard to carve out time to get important things done? Checking email, people at your office door, unexpected meetings can all fill time but may not be getting you any closer to getting your own work done or to move ahead on projects.

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