March 2014 Issue  (Digital Edition)

Managing Cleanroom Operations for Today and Tomorrow
By Patrice Galvin
Putting out the fires and handling immediate, pressing issues are the mainstay of most management and operations roles. There are always responsibilities—both unexpected and routine—that can eat up time, energy, and keep you focused on the here and now.

2020 Pharma
By Barbara Kanegsberg and Ed Kanegsberg
A conversation with industry experts on the future of cleaning and validation.

Understanding Cleanroom Classifications
By Jeanne Moldenhauer
When using a classification system, be cognizant of the implications.

Container Closure Integrity Testing
By Louis Brasten, Barbara Jacobs, and Alicia Brydzinski
CCI testing is a viable alternative to sterility testing for vials and prefillable syringes, and may include a variety of test methods.

Practical Application of Rapid Microbiological Methods to the USP <1116> Contamination Recovery Rate Approach
By Peter Noverini
The past year has seen a change in the way pharmaceutical manufacturers monitor their aseptic environments with the most recent revision to the guidance chapter <1116> in USP 35/NF 30, now entitled “Microbiological Control and Monitoring of Aseptic Processing Environments.”

The Building Commissioning Maze, Part 1
Richard Bilodeau, PE
I’m now hearing a lot about “ongoing commissioning” and “continuous commissioning” of facilities. Can you clear up my understanding of the various types of commissioning and the role each plays in today’s built environments?

Document Management
By Jan Eudy
We are a medical device packaging start-up. Recently during our ISO 9001 pre-registration GAP audit, our auditor observed that we needed better document control of our records.