ARTICLES BY HAL BASEMAN

  • How Technology (And The People Who Use It) Will Reshape The Future Of Aseptic Processing
    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?
    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
    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
    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
    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.

Hal Baseman

Hal Baseman

Hal Baseman, COO and a principal at ValSource, LLC, has over 40 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several drug manufacturing and consulting firms. He is the former chair of the PDA Board of Directors, former chair of the PDA Science Advisory Board, former co-leader of the PDA Process Validation Interest Group, and co-leader of the PDA Aseptic Processing Points to Consider and Annex 1 Commenting Task Forces, as well as a long-time member of the PDA Training Research Institute faculty. Baseman holds an MBA in management from LaSalle University and a B.S. in biology from Ursinus College. He can be reached at hbaseman@valsource.com.