Manufacturer’s Reducing The Burden Of Compliance
What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance to regulations. Every company which produces pharmaceutical products must guarantee a consistent quality which meets regulated specifications - for the entire product life cycle, from production to consumption. By Tara S. Hundley, Anton Paar USA
WHITE PAPERS & CASE STUDIES
The Challenges With Real-Time Viable Particle Counters
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
Risk Mitigation When Evaluating Cleanroom Construction Materials
Reducing the cost of goods sold has become a focus of pharmaceutical facility, cleanroom, and process design, especially as blockbuster patents have begun to expire and generic competition has intensified. The need to minimize manufacturing costs sparked a multitude of creative ideas. By Maik Jornitz, COO, G-Con
Flexible Production Platforms For Biopharmaceutical Manufacturing
A paradigm shift in flexible biopharmaceutical production sites and process designs has been recognized in multiple scientific publications and conferences.
Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software
Modular Does Not Always Mean Flexible For Pharmaceutical Facilities
Lately, the pharmaceutical industry has become increasingly interested in flexible facilities. By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing
Does Rheology Matter To Manufacturing
You bet it does, whether or not manufacturing realizes it. Rheology is the science that looks at how materials flow. Whether the product is a liquid, cream, paste, or solid, the manufacturing process must transfer raw ingredients through multiple stages to create the finished product. By Robert McGregor, Global Marketing and High End Product Manager, Brookfield Engineering Laboratories, Inc.