Aseptic and Sterile Processing Fundamentals

Understanding Aseptic Operations and Cleanroom behaviors are essential requirements when evaluating your Sterility Assurance Program. Aseptic Operators are routinely observed during regulatory agency inspections to ensure human interaction with the process minimizes contamination risk. Due to the nature of the biopharmaceutical industry, sterility and contamination control are of the upmost importance in the manufacturing process. Many factors such as facility design, cleanroom design, equipment integration, ergonomics, operator training, and behavior must be considered when building and operating an aseptic processing facility. The discussion will review general requirements of aseptic manufacturing and cleanroom behavior as well as the systems which support and control cleanroom environments.


Paul Andrea
View LinkedIn profile

With over 25 years in BioPharma, Paul Andrea has experienced the significant development and transformation of the industry and specifically GMP Manufacturing. Paul began his career at Genentech.  In his 18 years there, he acquired technical and process expertise in Seed Train Operations, Equipment Preparation, Facility Management, Scheduling, Process Development, Formulation and Fill/Finish.  After departing from Genentech in 2012, Paul and his family moved to South Korea where he was part of the first expatriate hires for Samsung Biologics.  Paul led the Drug Product Organization from equipment qualification to Regulatory Approval. He also hired and trained over 100 Korean University Graduates with virtually no experience in GMP Manufacturing and more specifically, Aseptic Operations. His additional responsibilities included representing the Drug Product Department as the primary interface for the Business Development group, interacting with potential new clients, performing facility fit evaluation, facility design, new product introduction, and Quality and Compliance support for all components of Drug Product Manufacturing. After departing Samsung Biologics in 2017, Paul started TAF Group LLC.  His focus is to ensure the Manufacturing of Parenteral Drugs is performed in a safe and compliant manner following Global Regulatory requirements. Whether it is an audit of your Sterility Assurance Program, performing due diligence visits for potential CDMO selection, Regulatory Readiness, writing SOPs and protocols, or working side by side on the shop floor with the technical team, TAF Group LLC are ready to support your needs.


Next Date and Location

Thursday, November 17, 2022
9:00 a.m. - 4:30 p.m. Central Time
During EDUCON 2022
In-person or virtual
Hyatt Regency Chicago - Schaumburg
Schaumburg, Illinois
Registration information

Buy 3 Get 1 Free! Register three personnel from your company for the same course and receive a complimentary fourth registration. Contact IEST for details.