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September 2014 Issue  (Digital Edition)


Upping Your Game
By Patrice Galvin
Cleaning is the name of the game in this issue of Controlled Environments.

Develop Your Cleaning Scorecard
By Mike Jones
Playing the cleaning game means tallying up the costs and benefits.

Trends in the Biotechnology Industry
By Members of ISPE’s Biotechnology Community of Practice
Changing regulations and rising costs put pressure on cleanroom facilities.

Are Your Stainless Steel Surfaces Being Corroded by Repeated Bleach Use?
By Wendy Hollands and Jay Postlewaite, Ph.D.
Bleach is known to be corrosive to metals commonly found in pharmaceutical work environments. Two commonly used types of stainless steel coupons were exposed to household bleach and sodium dichloroisocyanurate solutions—the rate and degree of corrosion were compared.

Managing Data in Food Safety Cleanrooms
By Colin Thurston
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.

Immediate Benefits of Real-Time Microbial Monitoring
By Troy Tillman Sr.

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.

Selecting the Cleaning System
By Barbara Kanegsberg and Ed Kanegsberg

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.

Be Aware of Dangers Surrounding HPMs
By Richard Bilodeau, PE
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.


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