Course
Aseptic Processing I
Name
BTC-3300D6
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
Through lecture and hands-on activities, practice the basics of aseptic operations in a simulated CGMP environment. Topics include microbiology, cleanroom design and control, environmental monitoring, cleaning and disinfection, aseptic gowning, component preparation, solution preparation, sterile filtration, sterilization methods and cleanroom behavior. Topics are correlated to regulatory guidelines.
Course Objectives
  1. Develop an understanding of the role aseptic processing plays in the manufacture of pharmaceuticals.
  2. Gain a basic understanding of microbiology in the context of parenteral drug manufacturing.
  3. Gain hands-on experience with cleaning and disinfection of aseptic processing areas.
  4. Develop an understanding of the principal sterilization methods for aseptic manufacturing.
  5. Gain hands-on experience in aseptic gowning.
Outline of Instruction
  1. Day 1: Microbiology and Cleanrooms

    a. Introductions
    b. Lecture: Why Aseptic Processing?
    c. Overview of CGMPs and GDPs
    d. Cleanroom designs and controls (Tour)

    e. Lab: Cleaning of Aseptic Areas- Facility cleaning and selected slides (Lecture)

    f. Lab- Cleaning the cleanroom/ BSCs

    Day 2: Environmental Monitoring
    a. Lecture: Microbiology Basics
    b. Lecture: Environmental Monitoring
    c. Lecture: Microbiology Basics

    d. Labs: Environmental Monitoring (Finger Plates, Body Swabs, Contact Plates, Air Sampling for Viables, Air Sampling for Particulates)

    e. Lab: Disinfectant Experiment

    f. Lab: Component Preparation

    Day 3: Sterile product equipment and component preparation sterilization section

    a. Lecture: Aseptic Gowning and Cleanroom Behaviors

    b. Video: Aseptic Gowning


    c. Lab: Filtration in cleanroom

    d. Lab: Read Disinfectant plates
    Day 4: Lab and Lecture Review (Cleanroom Behaviors and Aseptic Technique Critique, Filtration Results, Gowning)
    a. Lab: Solution preparation lecture
    b. Lecture: principles of filtration
    1 Lab: Review and Discuss Results of Microbiological Data
    2 Q&A for AP I
    3 Course Evaluations
    4 Final Quiz and Course Wrap-up
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
Gowning materials, lecture materials, disinfectants, agar plates (finger plates, body swabs, contact plates) Air sampler (viable, and particulate sampling).
Clinical Site/Special Facilities
Capstone or RTP cleanroom facility
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
  3. Minimum score of 80% on final quiz in two attempts or fewer.
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 Processing Technician, Bioprocess Technician, Gene Therapy Operation Specialist, Lab Technician, QC or QA personnel.
Wake County Need for Industry Positions
https://www.ncworks.gov/vosnet/jobbanks/jobdetails.aspx?enc=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
Industry or Job Titles Related to training Outcomes for Employment
  • Bioprocess Technician
  • Lab Technician
  • Gene Therapy Operation Specialist
  • Manufacturing Associate
Related Courses
  • Aseptic Processing for the Incumbent Wor - BTC-3300C4
  • Biowork: Process Technician - BTC-3200A7
Course Contact Information
Cynthia Lawrence
cllawrence1@waketech.edu
919-335-1037