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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

Selecting and Implementing a New Cleaning System

December 17, 2014 12:00 am | by Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

It is a good idea to put a PQ provision into the contract for a new cleaning system; make sure that the system is successfully cleaning your product in your plant before final payment is made. Think of it as “lemon” insurance. It is more than just a warranty that the equipment works—it works for the application for which it was chosen.


Cleanroom Gloves vs. Exam Gloves

December 17, 2014 12:00 am | by Dustin Deckrow | Angstrom Supply | Comments

What exactly is the difference between a cleanroom glove and an exam glove? What type of glove should you use in your facility? There is no short answer for this question and you are the best resource for making this decision. It is ultimately dependent on the size of particle or type of contamination that can cause failure in your process or product.


Developing an Effective Disinfectant Program

December 17, 2014 12:00 am | by Kathy Miscioscio and Chip Burnett | Contec, Inc. | Comments

To ensure the quality of the products they produce, pharmaceutical, biopharmaceutical, and medical device manufactures must disinfect as well as clean the cleanrooms in which their products are made. The choice of disinfectant and the frequency of disinfectant rotation, which includes a sporicidal agent, are based on an Environmental Monitoring Program. 


Monitoring a Controlled Environment: the Use of Contact Plates for Air Viable Particulate Testing

December 17, 2014 12:00 am | by Okwha Kim, Eric A. Binder, Nathan Storie, David Jones | Comments

Viable air sampling is a key part of an Environmental Monitoring program for controlled environments where aseptic products are manufactured. Both passive settle plate and active air sampling methods are used to ensure defined classification levels are met for each cleanroom.


Cleanroom Basics

December 17, 2014 12:00 am | by | DESCO | Comments

Contaminants can cause a variety of defects when assembling or packaging sophisticated products such as medical devices. If the cleanliness of the product is important, increasingly they are assembled and packaged in cleanrooms. The environment is controlled where particulates in airflow are filtered and the particulates analyzed by size and number, thus controlling the airborne particles to meet predetermined limits.


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.



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