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The Lead

See You Next Year!

October 27, 2014 | by Stefan Hocom | Comments

My clients love to see me ... go. It is one of the most interesting aspects of my job as a cleanroom certifier. Having been at this for decades now, I can honestly say that the happiness and relief that my clients convey post-certification is as consistent as the static environments in which I test.

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Controlled Environments

Insulated Wall Systems Reduce Particulate Contamination

November 19, 2014 11:35 am | Cleanrooms by United | Comments

Modular construction provides advantages that reduce facility down time and onsite debris generated by general “stick build” construction, while providing a cost-effective alternative to conventional construction without compromising quality, durability or efficiency.


What Every Employee Wants from You as a Leader

November 17, 2014 11:58 am | by DeEtta Jones | Comments

Do you ever feel overwhelmed as a manager? Being overburdened by the responsibility of having to figure out what others want and need of you is a familiar feeling shared among leaders. Fortunately, there is a “best practice” for obtaining just the kind of information needed to increase your leadership effectiveness—ask them what they want.


Cleaning Costs Checklist

October 28, 2014 12:11 pm | by Mike Jones | Comments

There are many factors to tabulate when selecting a new cleaning system. Production engineers need a cleaning process that is safe, sustainable, and affordable. This checklist can help plan your expenses.        


Some Thoughts on Healthcare Facilities

October 28, 2014 11:54 am | by Richard Bilodeau, PE | SMRT - Architects and Engineers | Comments

The five second rule on avoiding germs and infections is the subject of much light hearted banter, but the implications of healthcare associated infections are not. Healthcare facilities are fraught with bacteria, germs, infections, contaminated biological waste, bugs, superbugs, viruses, and any number of options to threaten our health. Hospitals, in their frontline role fighting disease, couldn’t have it any other way. 


How It Works: Eliminating Pitting and Corrosion of Stainless Steel Caused by Bleach

October 27, 2014 5:08 pm | Contec, Inc. | Comments

For years, bleach has been the standard sporicidal agent for killing bacteria and spores on stainless steel cleanroom surfaces. Although bleach is effective against killing various forms of microorganisms, it also leaves a residue which causes corrosion and pitting of stainless steel.


Breaking Down the Complex OSHA Requirements for Cleanrooms

October 27, 2014 4:25 pm | by Randall B. Charpentier, HEM | Comments

All employers must make every effort to ensure a safe and healthy workplace, free from recognized hazards. The common thread is that they must comply with applicable U.S. Department of Labor Occupational Safety and Health Administration regulations.       


Instantaneous Microbial Detection for Water

October 27, 2014 2:14 pm | by Allison Scott, Ph.D. | Azbil BioVigilant, Inc. | Comments

Water is utilized abundantly to process, formulate, and manufacture pharmaceutical products. Traditional culture-based methods used to ensure water quality, however, are ill-suited in providing a robust assessment of risk and control. Real-time bioburden monitoring promotes risk reduction and process control.


See You at the Show

October 27, 2014 12:47 pm | by MaryBeth DiDonna | Controlled Environments Magazine | Comments

Representatives from Controlled Environments regularly attend industry shows in order to find out what our readers want from us. We want to establish lasting relationships with our readers, and allow them to share their knowledge and capabilities with others in our field by authoring feature articles and suggesting topics.


Be Aware of Dangers Surrounding HPMs

September 22, 2014 3:44 pm | by Richard Bilodeau, PE | SMRT - Architects and Engineers | Comments

For a controlled environments facilities engineer, hazardous production materials are not the things that dreams are made of—but proper regulatory compliance and handling during the production process are cornerstones of the job. HPM management—and the plant maintenance that supports HPM—require constant attention.


Selecting the Cleaning System

September 19, 2014 4:34 pm | by Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

Your boss announces that you are in charge of selecting and implementing a new cleaning system. Now it is time to actually make a selection. It is a good idea to put a PQ provision into the contract for a system ... think of it as ‘lemon’ insurance.


Choosing the Right Cleanroom Shoe Covers

September 17, 2014 5:06 pm | Shoe Inn, LLC | Comments

Standard shoe covers come in a variety of materials; variations come in the form of different thicknesses, combinations, traction patterns, etc. With so many available options, how does a cleanroom/facility manager select the right shoe cover?    


Immediate Benefits of Real-Time Microbial Monitoring

September 17, 2014 4:48 pm | by Troy Tillman Sr. | TSI, Inc. | Comments

Real-time microbial monitoring provides instant information that leads to immediate benefits. Companies producing medicines and biotech products are concerned with airborne microbial contamination. They need to ensure that products and people are kept safe.


Implementing Gowning Guidelines For Proposed USP <800> Compliance

September 17, 2014 4:37 pm | by Peter Lojac and Kenneth Latta | Comments

Increasing concerns regarding the protection of healthcare workers, compounding pharmacists, and manufacturers handling hazardous drugs has bought about the proposed USP Chapter <800> – Hazardous Drugs – Handling in Healthcare Settings. Due to the harmful consequences of improper handling of these drugs, it is vital that a safe standard be set to ensure safety and efficiency.


Not All Gloves Are Created Equal

September 17, 2014 4:14 pm | by Derek Watts | Nitritex Canada Limited | Comments

When choosing gloves for your pharmaceutical manufacturing in an ISO Class 4, 5, or 6 cleanroom, why should you always choose cleanroom gloves and never surgical gloves? A common misconception is that gloves used in medical environments are sterile - but they are not necessarily clean.


Managing Data in Food Safety Cleanrooms

September 17, 2014 4:14 pm | by Colin Thurston | Comments

Cleanrooms play an important role in the prevention of contamination during the production of food and food supplements. They are most often built around food packaging processes, where there is a high potential for exposure of the finished food product to the atmosphere or people. A LIMS tracks real-time information about the cleanroom and offers the ability to demonstrate compliance.



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