January 2014 Issue  (Digital Edition)

Continuous Improvement

By Tim Studt
Letter from the editor

Modern Approaches to Pharma Cleanroom Design
By Tim Sandle, PhD
The challenges of cleanroom design, construction, and certification focus on minimizing contamination risks.

ESD Control Flooring in Clean Environments
By Erik S. Van Anglen
The selection of an ESD floor covering begins with an evaluation of the activities to be performed in the space but doesn’t end there.

Reducing Contaminants at the Threshold
By Kurt Angermeier
A case study of a food processing plant highlights how doors can help shut out pathogens.

Cleanroom Initiative Meets Growing Needs of Medical Device Customers
By Empire Precision Plastics
An expansion that includes portable and micro-cleanrooms creates flexible and economical space for a precision molding facility.

4D Processes
By Barbara Kanegsberg and Ed Kanegsberg
Successful high-performance cleaning processes benefit from following a well-designed plan.

FDA’s Proposed Change in Generic Drug Labeling
By Bikash Chatterjee
Generics make up more than 80% of drugs dispensed in the U.S. The proposed change strives for greater patient safety.

Cleanroom Tip: Checklists Help Process For Internal Compliance Audits
Internal audits should not be an annual event but timed around work schedules and focused on critical areas.