Workforce Continuing Education Course Catalog
- Gain familiarity with aseptic manufacturing practices and the controls used to provide and maintain the necessary environment for the manufacturing of parenteral products, including process simulations. Aseptic technique will be a primary focus.
- Perform aseptic process simulations within LAF's, BSC's and Barrier Isolators.
- Compare open-system to closed-system aseptic processes utilizing tube welder, aseptic connections and single-use disposable vessels.
- Gain hands-on experience by direct participation with the equipment and procedures used during an aseptic media fill process simulation.
- Participate in and develop an understanding of final product release testing.
- Demonstrate an understanding of endotoxins and methods used for testing of their presence in manufacturing operations.
- Be able to define the role water plays in parenteral drug manufacturing
- Conduct an investigation into aseptic processing issues and write a CAPA report based on observations.
- Day 1 -
a. Classroom: Aseptic Technique Review
b. Classroom: Microenvironments
c. Lab: Micropipetting / Automated Fill Line Demonstration
d. Lab: Aseptic Connections
e. Classroom: Product Release testing
f. Lab: Particulate Release Testing / Steritest
g. Classroom: Regulatory Aspects of Aseptic Processing
- Day 2 -
a. Classroom: Process Simulation and Media Fills
b. Lab: Media Fill Aseptic Simulation (Manual)
c. Lab: Cupric sulfate in Isolator / BSC Cell Culture Activity
- Day 3 -
a. Classroom: Discussion of Aseptic Technique / gowning from Day 2 Lab
b. Classroom: Biosafety Levels and Precautions
c. Classroom: Endotoxins
d. Video: Endotoxins--Charles River Laboratories
e. Lab: Endotoxins--PTS Unit
f. Classroom: Water Systems
g. Lab: Gram Stains / Serial Dilution of Media in an Isolator
- Day 4 -
a. Classroom: Discussion of Aseptic Technique from Day 3 Lab Activities
b. Classroom and Lab: Lyophilization / DSC / Freeze-drying microscopy
c. Classroom: History of Aseptic Processing
d. Classroom: Investigations Utilizing Fish-Bone Analysis
e. Review / Q&A
g. Final Written Test and Lab Practicum
- Attendance 90% or above
- Successful completion of lab practicum
- Aseptic Manufacturing Technicians
- Process Technicians
- QA personnel
- Quality Control Technicians
- Maintenance Engineers
- Aseptic Manufacturing Supervisors
- Aseptic Processing Level I - SEF-79964
- Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524