Join us at the virtual 2021 PDA Aseptic Processing of Biopharmaceutical Conference! This conference will focus on vaccine production and inspection challenges, as well as AI technologies in fill finish and container closure developments. Our Technical Services Senior Manager, Beth Kroeger is one of the distinguished speakers and will be sharing Important Considerations for Aseptic Technique.
Wednesday, October 20 | 3:50 - 4:20 p.m. GMT
Important Considerations for Aseptic Technique
Presented by: Beth Kroeger-Fahnestock
The objective of aseptic processing is to maintain sterility of a product, assembled from sterile components, under operating conditions to prevent microbial contamination. The goal is to keep microorganisms and particles out of manufactured products that are injected into humans, yet humans are the biggest contributors, and the impact of poor aseptic technique is not immediately evident. The speaker will draw upon PDA Technical Report 70, Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities and cover cleaning and disinfection best practices, regulations, SOP development, how to handle unplanned events, and techniques for working in ISO 5/Grade AB spaces.