This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 2
This chapter will present concepts related to the validation of aseptic processing
for the manufacture of sterile drug products. It will focus on those elements of
aseptic processing which affect product sterility. It will provide background into
the concepts and approach to aseptic process validation and will discuss in detail,
the planning and execution of aseptic process simulations.
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Format: Digital PDF (1 file - 243 KB)
About the Authors
Hal Baseman is
Chief Operating Officer and a Principal at ValSource LLC, a validation
consulting and service firm. He has over 30 years of experience in
pharmaceutical operations, validation and regulatory compliance. Hal has held
positions in executive, management, and technical operations at several drug
manufacturing and consulting firms. Hal is a long time member of the PDA and its
Training Research Institute faculty, as well as the ISPE. He is a frequent
presenter on subjects related to Quality Risk Management, Validation, and
Aseptic Processing. Hal has served as a member of the PDA Board of Directors,
Co-Chair of the PDA Science Advisory Board, Co-Leader of the PDA Validation
Interest Group, Co-Chair of the PDA Aseptic Process Simulation Technical Report
#22 Task Force on Aseptic Process Simulation, and Co-Chair of the PDA Risk
Management Task Force responsible for writing Technical Report #44 on Quality
Risk Management of Aseptic Processes. Hal co-chaired and led the 2009 PDA
response to the FDA on the draft Process Validation Guidance revision. He has
held positions on the ISPE Southeast Chapter and Suppliers Advisory Council, and
the Pharmaceutical Blow Fill Seal International Operator`s Association (BFSIOA).
Hal holds an MBA in Management from LaSalle University and a B.S. in Biology
from Ursinus College.