Articles from the May/June 2017 edition of Controlled Environments, and the winners of our third annual Readers’ Choice Awards.
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The Importance of Monitoring
MaryBeth DiDonna, Editor, Controlled Environments
Health and lives could be endangered if cleanroom environments are allowed to fall below required standards of cleanliness and sanitation.
Understanding What Cleanroom Classifications Mean
MaryBeth DiDonna, Editor, Controlled Environments
There is no one-size-fits-all answer for determining the classification level of cleanrooms.
Setting Appropriate Alarm Limits in Sterile Manufacturing Processes
Jason Kelly, Lighthouse Worldwide Solutions
Setting inappropriate Alert and Action alarms on your Environmental Monitoring System (EMS) could be a big contributor to lost revenue, longer downtimes, and a lot of discarded product.
Choosing the Cleanroom’s Most Suitable Particle Sample Points
Gilberto Dalmaso, PhD, and Mark Hallworth, Particle Measuring Systems
Environmental system designers decide where to place sample points for particle monitoring. However, the process is not always straightforward.
Electronic Transfer of Regulatory Information
Bikash Chatterjee, Pharmatech Associates
As the deadline looms for drug master files, the FDA moves toward e-filing.
Wet Processing Parameters for Nano Manufacturing
Ed Sullivan
As the market for nanotechnology (nano) and MEMS (Micro-Electro-Mechanical Systems) solutions continues to ramp up, the rate of organizations seeking to get involved with this sector is also burgeoning. Yet there are still significant challenges that are, in many cases, posing difficulties in entering this market.
Right-Sizing Isolation for Superior Experimental Results
Jeff Elliott
Optimizing workspaces to match requirements leads to improved equipment.
Pilot Programs
Barbara Kanegsberg and Ed Kanegsberg, BFK Solutions LLC
Managing a pilot program involves many cleaning and contamination control challenges.
HVAC Design for Cleanrooms
David Arrouart, Mecart
The HVAC system is at the heart of the cleanroom. Although many clients are unenthusiastic when broaching the subject, the HVAC system should not be overlooked given its central role.
Readers’ Choice Awards Winners Announced
In its third year, the Readers’ Choice Awards highlight the cleanroom equipment and supplies that readers judge most effective and trusted in their work.
How It Works: Continuous Air Monitoring for Non-Viable Particle Testing
Particle Measuring Systems
Continuous monitoring is a worldwide-accepted standard for non-viable particle testing, and can now be applied to viable air monitoring.
Cleanroom Tip: Finding Hidden Sources of Contamination, Part II
Jennifer Nunes, UltraTape
The objective of a controlled cleanroom is to provide a contamination-free space in which to test or manufacture contamination-free products. Here are some more hidden causes of contamination, continued from our last issue.