ARTICLES BY HAL BASEMAN
How Technology (And The People Who Use It) Will Reshape The Future Of Aseptic Processing
Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring.
Reimagining Aseptic Processing: What Must Change?
This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations.
Why Now Is The Time For An Aseptic Processing Revolution
This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.
5 Keys To Aseptic Processing Improvement & Efficiency
In recent years, we’ve seen a rise in regulatory concern over adequately determining the risk factors that challenge aseptic and sterile products processing. There needs to be a renewed emphasis on assurance and controls, including leveraging the best available technologies and conducting thorough, science-based risk assessments of processes.
Aseptic Processing Risk Management — Challenges & Common Misconceptions
Once a process is identified as “risky,” we tend to accept that risk and do little to try to uncover ways to reduce that risk and improve the process.