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The Lead

The 5 Cs to Recruit, Engage and Retain Staff

April 1, 2014 | by Kim Seeling Smith | Comments

Technology and globalization have dramatically changed the way we work over the last 20 - 30 years. However, very little has changed in how we hire and manage staff – which has led to low employee engagement and productivity and high employee turnover.

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Controlled Environments

Why Feedback is Your Key to Winning

April 18, 2014 3:40 pm | by Barry Banther | Comments

There are 5 simple words that can spell doom for a leader – “If I had only known!”  These are the words you utter right after a major client cancels a contract, a customer stops ordering or an error occurs that will cost you thousands out of your own pocket. That’s why the best leaders and the most competent managers thrive on employee feedback.


The Building Commissioning Maze, Part 2

April 16, 2014 10:49 am | by Richard Bilodeau, PE | SMRT - Architects and Engineers | Comments

I’m now hearing a lot about “ongoing commissioning” and “continuous commissioning” of facilities. How can I ensure that the commissioning process will be well-organized and deliver the best results?                        


Selecting the Right Equipment For Your Cleanroom

April 15, 2014 3:18 pm | by Kathie Kalafatis | CleanAir Solutions, Inc. | Comments

There are many factors that must be considered before selecting equipment for your cleanroom or laboratory space.  Take the time to review the criteria with your co-workers and follow these five simple steps to ensure you order the right equipment for your next project.


Will Today’s Approach to Contamination Control Work Tomorrow?

April 15, 2014 2:58 pm | by Essentra Porous Technologies | Essentra Porous Technologies | Comments

It’s only natural that contamination control in today’s world of critical environments is in a constant state of evolution. And throughout the continued development of environmental monitoring programs, it pays dividends to recognize that what works today may not be the best solution for the future.


Upholding Compliance through Proper Maintenance

April 15, 2014 2:32 pm | by Kristyn Henke | Hutchins & Hutchins, Inc., Cleanroom Division | Comments

There are many factors to consider for the proper maintenance of your cleanroom and its equipment and supplies. Before any cleaning is done, make sure you are using the correct cleaning equipment, supplies, procedures, and knowledgeable staff. Each class of cleanroom has its own specific cleaning equipment and solvents.


Medical Device Manufacturing Shifts to Lifecycle

April 15, 2014 11:33 am | by Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

Increasing design complexities pose challenges for cleaning processes.                                                


FDA Tackles Broken Generic Drug Application Process

April 15, 2014 11:17 am | by Bikash Chatterjee | Comments

The spirit of this guidance is to speed access to generic medicines.                                                         


Controlling Electrostatic Discharge in Cleanroom Packaging

April 14, 2014 4:40 pm | by Michael Mills, Kathy Mills, Justin Mills, Laura Clark | Comments

What you need to know when packaging ESD-sensitive items.                                                        


Cleanroom Garment Selection

April 14, 2014 3:19 pm | by Jan Eudy | Comments

A primer on reusable and disposable cleanroom garments as well as garment testing and laundering.                                          


Interphex 2014 Wrap-Up

April 14, 2014 2:49 pm | Controlled Environments Magazine | Comments

Shows such as Interphex give us the chance to learn about what’s new in the industry, such as updated standards, current trends, and exciting new products. Meeting with our reader base in person also gives us the opportunity to discuss what they like about Controlled Environments and what they wish we’d cover more often.


3 Keys to Being an Irresistible Leader

April 4, 2014 4:19 pm | by Alesia Latson | Comments

Leadership is a tough job. Not only do you have to be adept at managing multiple priorities, but you also have to possess expert people skills. After all, regardless of industry, a leader is only as good as his or her team. Without the buy-in and respect of your employees, you’ll have a difficult time accomplishing the organization’s goals.


USP<797> and air velocity measuring

April 3, 2014 6:16 pm | by Cary Binder | Comments

There has been an enormous push to force compounding pharmacies to comply with USP <797>, and the niche certification industry (of which I have been part of for 35 years) is becoming an important part of guiding the pharmacy directors towards proper compliance with this standard. What is proper compliance?


Air Velocity Measurement

April 3, 2014 5:46 pm | by Koji Miyasaka and Bob Casale | Kanomax USA, Inc. | Comments

There are several ways to set up a ventilation system for a cleanroom or controlled environment, but regardless of which system is used the purpose is the same: to remove contaminates so the environment stays controlled. However, the methods used to check that the airflow is correct vary depending on the ventilation setup.


Wrong Water? Right Water?

March 31, 2014 5:29 pm | Comments

Water is the fluid most often used in cleaning, whether it is for personal, household, industrial, or the manufacture of high-value product. Water is the most abundant cleaning chemical. With appropriate additives, water-based cleaning has proven successful. However, particularly in critical manufacturing, the wrong water quality can derail the process and undermine product quality.


Document Management

March 24, 2014 4:57 pm | by Jan Eudy | Cintas Cleanroom Resources | Comments

We are a medical device packaging start-up. Recently during our ISO 9001 pre-registration GAP audit, our auditor observed that we needed better document control of our records.                             



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