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The Lead

Wearable Health Monitor Sticks to Your Skin

April 18, 2014 11:14 am | News | Comments

Wearing a fitness tracker on your wrist or clipped to your belt is so 2013. A major technological breakthrough out of Northwestern University wirelessly monitors the body with stretchable electronics. The patches could be used for everyday health tracking – wirelessly sending updates to your cellphone or computer – and could revolutionize clinical monitoring such as EKG and EEG testing – no bulky wires, pads, or tape needed.

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Controlled Environments

Why Feedback is Your Key to Winning

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


Pharma Lab Closing, Cutting 45 Jobs

April 17, 2014 11:15 am | News | Comments

An Albany-based pharmaceutical company that's part of a $250 million economic development project in Buffalo is shutting down its Syracuse-area research center, eliminating 45 jobs. Albany Molecular Research Inc. has announced that it will close its 12-year-old facility in Cicero on July 15.


Pharmaceutical Companies Merge in $5.6B Deal

April 17, 2014 10:50 am | News | Comments

Mallinckrodt plc and Questcor Pharmaceuticals Inc. have entered into a definitive merger agreement under which Mallinckrodt will acquire Questcor in a transaction valued at approximately $5.6 billion. Questcor commercial operations will function as a separate business unit within Mallinckrodt's Specialty Pharmaceuticals segment.


April 2014

April 16, 2014 11:47 am | Digital Editions | Comments

Articles from the April 2014 issue of Controlled Environments, plus our Digital Edition.


Understanding the Implications of the Classification System

April 16, 2014 11:27 am | by Jeanne Moldenhauer | Articles | Comments

Over the past few years there has been an increasing trend to change from previous classification systems used to the ISO classification systems in ISO 14644-1. However, many companies have continued to use the traditional Class 100, 10,000, 100,000 room classification system from Federal Standard 209-e. In Europe, the GMPs utilize another system—Grades A through D.


Measuring Airflow in the Cleanroom

April 16, 2014 11:17 am | by Patrice Galvin and MaryBeth DiDonna | Articles | Comments

Velocity can affect particle deposition in either a positive or negative way.                                                     


The Building Commissioning Maze, Part 2

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


Targeting Cancer with a Triple Threat

April 16, 2014 10:07 am | by Anne Trafton, MIT News Office | News | Comments

Delivering chemotherapy drugs in nanoparticle form could help reduce side effects by targeting the drugs directly to the tumors. Scientists have developed nanoparticles that deliver one or two chemotherapy drugs, but it has been difficult to design particles that can carry any more than that in a precise ratio. MIT chemists have devised a new way to build such nanoparticles, making it much easier to include three or more different drugs.


Labeling and Filing Firm Adds Class 100,000 Cleanroom

April 16, 2014 9:23 am | News | Comments

American Empire Manufacturing has added a Class 100,000 cleanroom to its Illinois manufacturing facility. The 10,000 sq. ft. clean suite allows the company to integrate additional liquid filling lines, a prototype lab, and three labeling machines. The cGMP/cGDP compliant facility has already been outfitted with energy efficient T-8 lighting, epoxy finish floors, and an ISO 8/Class 100,000 cleanroom.


Plastics and Packaging Companies Join Forces

April 16, 2014 9:11 am | News | Comments

The RKW Group has taken over 100% of the Belgian company, Hyplast NV. In the future, the company will operate under the name RKW Hyplast NV. RKW Group develops and produces film and nonwoven solutions for the hygiene and medical fields as well as the packaging industry (industrial and consumer packaging), technical films for the converting industry, and products for the agricultural and construction industries.


Selecting the Right Equipment For Your Cleanroom

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

It’s only natural that contamination control in today’s world of critical environments is in a constant state of evolution. After all, the complexities of facilities and processes flow from the increasing intricacies of end products. 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 | Articles | 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.


Routine Maintenance of Critical Cleaning Equipment

April 15, 2014 2:00 pm | Videos | Comments

Welcome to the Controlled Environments' audio series of cleanroom tips. In this tip, "Routine Maintenance of Critical Cleaning Equipment," it should go without saying that routine maintenance of equipment is essential. Developing a defined equipment maintenance audit can avoid process catastrophes.


Medical Device Manufacturing Shifts to Lifecycle

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

Increasing design complexities pose challenges for cleaning processes.                                                



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