Hands-on Aseptic Processing Program

Who Should Attend?
Individuals that are responsible for aseptic fulfillment, including filling operators, QA/QC, microbiology, trainers, facility/HVAC maintenance/design, at all levels.

Course Description
This two-week comprehensive training program, taught by ten industry-leading experts in their fields, with over 200 years of combined experience, will give you and your personnel the training and information needed to properly evaluate and improve your aseptic processes to reduce the risk of contamination. The first week will cover the fundamentals of aseptic processing, including facility design, velocity testing and airflow studies, basic microbiology, cleaning and sanitization techniques, environmental monitoring, personnel qualification (including proper gowning techniques and aseptic technique evaluations). The second week will incorporate the information from the first week, but with more hands-on experience performing and evaluating media fills, product formulation, rapid microbiological identification, lyophilization, CIP systems, final product testing, good documentation practices and root-cause analysis during investigations. With over 50 hours of hands-on lab time, this is the most complete and innovative aseptic processing training program available.

Pharmaceutical Microbiology for the Non-Microbiologist

Who Should Attend?
Individuals that are responsible for activities that impact operations in a pharmaceutical manufacturing environment, including cell processing operators, QA/QC personnel, trainers, facility/HVAC maintenance/design technicians and engineers, at all levels.

Course Description
This program will offer a clear understanding of the importance of why all pharmaceutical manufacturing areas (not just filling suites) are labeled cleanrooms, and will also address the understanding of "How do we maintain the required cleanliness level and what do we do if we are presented with a microbial challenge."

Specifically, our program will help you to identify microorganisms found in your processing environment; what microorganisms to look for; what it means when a certain type of microorganism is recovered; what are common water system contaminants and why; the uses of biological indicators; what is required to "qualify" a cleaning/sanitization program; understand filtration validation; understand the components of microbial risk assessment.

How to Conduct Meaningful Airflow Studies

Who Should Attend?
Individuals that are responsible for activities that impact operations in a pharmaceutical manufacturing environment, including cell processing operators, QA/QC personnel, trainers, facility/HVAC maintenance/design technicians and engineers, at all levels.

Course Description
This program will offer a clear understanding of the importance of airflow studies. You will learn how to identify the rationale, frequency and expectations for perofrming airflow visualization evaluations. Hands-on training using various types of "fog generators" - learn the benefits and disadvantages of each. Learn what facility requirements must be met prior to conducting an airflow study and what steps should be taken after an airflow study prior to manufacturing. Our program will show you how using airflows studies can help you to define your manufacturing process.

More Information
Questions? Please contact Grace Gardner at ggardner@aseptictraining or 949.716.8414.