Workforce Continuing Education Course Catalog

Course
Aseptic Processing Level II
Name
SEF-79974
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
214095 BTEC BioNetwork Capstone Learning Center 11/18/2019 11/21/2019 J. Rajan $622.00 12/12
Description Course Outline Requirements Intended Audience More Details
Intended Audience
Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel; persons desiring entry into the Biotechnology field.
Description
Delve more deeply into the aseptic processing arena 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. Topics of classroom instruction include FDA regulations pertaining to process simulations, review of microbiology including endotoxins, biosafety levels and water system review.
Course Objectives
  1. 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.
  2. Perform aseptic process simulations within LAF's, BSC's and Barrier Isolators.
  3. Compare open-system to closed-system aseptic processes utilizing tube welder, aseptic connections and single-use disposable vessels.
  4. Gain hands-on experience by direct participation with the equipment and procedures used during an aseptic media fill process simulation.
  5. Participate in and develop an understanding of final product release testing.
  6. Demonstrate an understanding of endotoxins and methods used for testing of their presence in manufacturing operations.
  7. Be able to define the role water plays in parenteral drug manufacturing
  8. Conduct an investigation into aseptic processing issues and write a CAPA report based on observations.
Outline of Instruction
  1. 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
  2. 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
  3. 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
  4. 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
    f. Evaluations
    g. Final Written Test and Lab Practicum
Contact Hours
24
CEU's
2.4
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Lab notebooks, power point slides, aseptic suite and general lab equipment and supplies including peristaltic pumps, pipettors, Viable Air Monitors, Particulate Air Monitors, Steritest Units, Liquid Particulate Counting System, Filling Machines (both automated and manual), Filtration assemblies, pH meters, conductivity meters, Endotoxin Test systems, tube welder and aseptic connectors, lyophilizer, freeze-drying microscope and DSC unit.
Clinical Site/Special Facilities
Certified Aseptic Suite with ISO 5 Laminar Air Flow Cabinets, BSC's and Barrier Isolators. An autoclave and depyrogentaion oven are also required. A source of High Purity Water (HPW) or WFI is essential.
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
  3. Successful completion of lab practicum
Accreditation/Special Approval Requirements
Intended Audience
Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel; persons desiring entry into the Biotechnology field.
Specific Industry or Business Support Needs
Aseptic Manufacturing Technicians, Process Technicians, QA Personnel, Quality Control Technicians, Maintenance Engineers, Aseptic Manufacturing Supervisors
Industry or Job Titles Related to training Outcomes for Employment
  • Aseptic Manufacturing Technicians
  • Process Technicians
  • QA personnel
  • Quality Control Technicians
  • Maintenance Engineers
  • Aseptic Manufacturing Supervisors
Related Courses
  • Aseptic Processing Level I - SEF-79964
  • Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
Course Contact Information
Bionetwork Manager