This course delves more deeply into aseptic processing with intensive hands-on instruction of aseptic techniques in a simulated cGMP environment. Instruction includes process simulations of closed-system filtrations, hand filling, semi-automated filling, LAF cabinets, BSC's and barrier isolators, and release testing of a final product.
- Biopharmaceutical Technicians
- Biopharmaceutical Supervisors
- QA and QC Personnel
- Persons desiring entry into the Biotechnology field.
- FDA regulations pertaining to process simulations
- Review of microbiology including endotoxins, biosafety levels and water system review
By the end of the course, students will be able to:
- 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.
Delivered in-person in a classroom or lab setting.
This course delves more deeply into aseptic processing with intensive hands-on instruction of aseptic techniques in a simulated cGMP environment. Instruction includes process simulations of closed-system filtrations, hand filling, semi-automated filling, LAF cabinets, BSC's and barrier isolators, and release testing of a final product.
- Biopharmaceutical Technicians
- Biopharmaceutical Supervisors
- QA and QC Personnel
- Persons desiring entry into the Biotechnology field.
- FDA regulations pertaining to process simulations
- Review of microbiology including endotoxins, biosafety levels and water system review
By the end of the course, students will be able to:
- 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.
Delivered in-person in a classroom or lab setting.