April 2014 Issue  (Digital Edition)

Interphex 2014 Wrap-Up
By MaryBeth DiDonna
Shows such as Interphex give us the chance to learn about what’s new in the industry, such as updated standards, current trends, and exciting new products.

Cleanroom Garment Selection
By Jan Eudy
A primer on reusable and disposable cleanroom garments as well as garment testing and laundering.

Controlling Electrostatic Discharge in Cleanroom Packaging
By Michael Mills, Kathy Mills, Justin Mills, Laura Clark
What you need to know when packaging ESD-sensitive items.

FDA Tackles Broken Generic Drug Application Process
By Bikash Chatterjee
The spirit of this guidance is to speed access to generic medicines.

Medical Device Manufacturing Shifts to Lifecycle
By Barbara Kanegsberg and Ed Kanegsberg
Increasing design complexities pose challenges for cleaning processes.

The Building Commissioning Maze, Part 2
Richard Bilodeau, PE
I’m now hearing a lot about “ongoing commissioning” and “continuous commissioning” of facilities. How can I ensure that the commissioning process will be well-organized and deliver the best results?

Measuring Airflow in the Cleanroom
By Patrice Galvin and MaryBeth DiDonna
Velocity can affect particle deposition in either a positive or negative way.

Understanding the Implications of the Classification System
By Jeanne Moldenhauer
Over the past few years there has been an increasing trend to change from previous classification systems used to the ISO classification systems in ISO 14644-1. However, many companies have continued to use the traditional Class 100, 10,000, 100,000 room classification system from Federal Standard 209-e. In Europe, the GMPs utilize another system—Grades A through D.