Course
Aseptic Processing II
Name
BTC-3300E6
Available Classes
Not currently offered.
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. 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

    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

    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
NONE
Text and Supplies Needed
Micropipettes, Media, Culture, Faculty prepared presentations, Gram stain slides, biosafety cabinet, videos, gowning supplies, Laminar Air Flow Hood, Barrier Isolators, chemical and media supplies.
Clinical Site/Special Facilities
Capstone, or RTP cleanroom facility, labs, and classroom.
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
  3. Successful completion of lab practicum and final written test.
Accreditation/Special Approval Requirements
None
Intended Audience
Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel; persons desiring entry into the Biotechnology field
Specific Industry or Business Support Needs
Bioprocess Technician, Manufacturing Associate, QC & QA Validation, Lab technician, Gene Therapy Operation Specialist,
Wake County Need for Industry Positions
https://www.ncworks.gov/vosnet/jobbanks/jobdetails.aspx?enc=9B8/uT7EfbEIDLIMZ8rhowzqyZjsNU1dBVrIZPNl61aLdeYEgg50x36hjNUp+PGjUTRQrfSEaltBSklEYhGDVwQbUZDuzBO/cjtmJ5YS46zP599BKPtPTSimZIKHAGwW82qAEY0z6y6lpXcZRsqmRnldj1ChtPO5e9GgK8ASu/NSlo72Dr776c0HN06MTrPaNMzJ/INhNQkP+ZQbIANZzkPxDR2nLC4ip/keqmTVGQqRyFKOzTEt9ZgESjdDLpHlZcoYXcbA8gSCDPAUuhtl/cc2r/S29telVyiPs+C27d/f0QHnLJ8xbYmVyQjE+Vcb
Industry or Job Titles Related to training Outcomes for Employment
  • Bioprocess Technician
  • Manufacturing Associate
  • QC & QA Validation
  • Lab technician
  • Gene Therapy Operation Specialist
Related Courses
  • Biowork: Process Technician - BTC-3200A7
  • Aseptic Processing for the Incumbent Wor - BTC-3300C4
  • The Elements of Aseptic Manufacturing Level II - BTC-3300E4
Course Contact Information
Cynthia Lawrence
cllawrence1@waketech.edu
919-335-1037