April 2010 Issue Modular Cleanrooms for Business Startups and New Product Development
By Kevin Weist
Regulations, cost, location, size, performance—how do you choose the right cleanroom?
The Microbial Bioburden of USP 797 Compliance
By Kimberly Kirkland, B.Sc., M.P.H, Deborah L. Jaeger, M.S
Simplifying environmental quality and control practices for pharmaceutical compounding
Meeting The Global Compliance Challenge
By Bikash Chatterjee
There can be no doubt that the last decade for the pharmaceutical and biotech industry has been full of extraordinary change.
Water Under The Bridge -- In Process Monitoring, Part 2
By Barbara Kanegsberg, Ed Kanegsberg
Manufacturing problems can lead to large costs of rework or can result in product becoming scrap. Immediate detection of problems is a key to increasing productivity and decreasing costs.
Back to Pre-Basics
By John B. Durkee, Ph.D., P.E.
The pre-basics are simply doing what one, or an organization, is expected to do. In other words, to stop doing “unthoughtful” things.
Modular, Safe, and Sterile
By Mary Williams
In this troubled economy biopharmaceutical companies are struggling to keep prices down, get new products to market faster, all while maintaining superior quality control, sterility, and safety.