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  June 2014 Issue  (Digital Edition)


Not all cleanrooms are alike…
By MaryBeth DiDonna
…but they do have a lot in common. Obviously different facilities will house different equipment and personnel, class ratings will vary, and they will be used for different end purposes, but the main goal is the same: prevent contamination of the product.

Advances in Aerosol Benchtop Cleaning Improve Processes
By Mike Jones
Despite problems caused by inconsistent regulations, there is a three-step process engineers can use when searching for new strategies.

Microbial Testing and Monitoring of Compounding Pharmacies
By Anne Connors
As the compounding industry evolves, organizations can best prepare for changes by strengthening QC programs through microbiological testing and environmental monitoring in their facilities.

Prevention Instead of Decontamination
By Dr. Jasmin Grigat
Single-use filter units reduce contamination risk from filtration to incubation in microbiological quality control.

Instilling Science and Quality in Cleanroom Training
By Gerard Creaner
Early adopters look to video learning to achieve FDA vision and demonstrate how cleanroom procedures have real-world implications.

Microbial Monitoring Programs for Non-Sterile Operations
By Jan Eudy
It’s only natural that contamination control in today’s world of critical environments is in a constant state of evolution. 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.

The Applications Laboratory, Part 2
By
Barbara Kanegsberg and Ed Kanegsberg
 Knowing the rationale behind your cleanliness process requirements can improve the outcome when working with an applications lab. 

Testing Cleanrooms
By
Richard Bilodeau, PE
An overview of standards related to certification testing of controlled environments.

How It Works: Automated Viable Air Monitoring System
By Veltek Associates, Inc.

Monitoring and controlling all sampling points during manufacturing is a very daunting process. In addition, the available space inside the manufacturing area (especially inside RABS and isolators) presents a footprint problem for any viable monitoring system. Clean and controlled environments need to address the regulatory recommendation for continuous viable air monitoring and establish a viable monitoring system.

Cleanroom Tip: Contamination Control – Looking Toward the Future
By
Essentra Porous Technologies
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.


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