BioNetwork Training

The BioNetwork Capstone Center provides affordable, high-quality, hands-on training in biotechnology, biomanufacturing, and biopharmaceutical/pharmaceutical operations in a simulated industrial (cGMP) environment.

The Capstone Center is situated in the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University Centennial Campus. It provides a training environment that mirrors a biomanufacturing plant facility with state-of-the-art classrooms, industrial-grade equipment laboratories, and a certified cleanroom suite.

Industry-recognized credential: BioNetwork Capstone Certificates

Complete in: 12 months or less

For non-credit student support services or to see if you qualify for financial assistance, contact the Career Pathways Program & Student Resources. 

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Course Details & Registration Information

Course
Aseptic Processing Level I
Name
SEF-79964
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
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. Be familiar with an overview of cleanroom operations in relation to manufacturing parenteral products
  4. Develop an nderstanding cleaning and disinfection processes for aseptic manufacturing
  5. Gain knowledge of environmental monitoring controls of cleanroom activities
  6. Develop an understanding of the principle sterilization methods for aseptic manufacturing
  7. Become familiar with the fundamentals of gowning requirements for working in a cleanroom
  8. Gain hands-on experience with component preparation for aseptic operations
  9. Gain hands-on experience with environmental monitoring equipment and observations of microbial isolates
  10. Gain hands-on experience with cleaning and disinfection of aseptic processing areas
  11. Gain hands-on experience in aseptic gowning
  12. Gain hands-onexperience with solution preparation and sterile filtration of small-scale parenteral bulk product
Outline of Instruction
  1. Day 1: Microbiology and Cleanrooms
    - Introductions
    - Lecture: Microbiology Basics
    - Lecture: Why Aseptic Processing?
    - Lecture/Lab: Cleanroom Tour
    - Video: New England Compounding Pharmacy
    - Lab: Cleaning of Aseptic Areas
    - Aseptic Pipette and Pour Practice
  2. Day 2: Environmental Monitoring, Cleaning, Disinfection and Sterilization
    - Lecture: Environmental Monitoring
    - Labs: Environmental Monitoring (Finger Plates, Body Swabs, Contact Plates, Air Sampling for Viables, Air Sampling for Particulates)
    - Lecture: Cleaning and Disinfectants
    - Lecture: Sterilization Methods
    - Lab: Disinfectant Experiment
    - Lab: Component Preparation
    - Lab: Aseptic Pipette and Pour Practice
  3. Day 3: Compounding and Filtration
    - Lecture: Solution Preparation
    - Lecture: Aseptic Gowning and Cleanroom Behaviors
    - Video: Aseptic Gowning
    - Lecture: Sterile Filtration
    - Lab: Compounding and Filtration
    - Lab: Data Collection of Disinfectant Plates
    - Lab: Filter Integrity Test
  4. Day 4:
    - Lab and Lecture Review (Cleanroom Behaviors and Aseptic Technique Critique, Filtration Results, Gowning)
    - Lab: Aseptic Connections
    - Lab: Data Collection from EM Exercise
    - Lab: Review and Discuss Results of Microbiological Data
    - Q&A, Final Quiz
Contact Hours
22
CEU's
2.2
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 95% or above
  2. Participation
  3. Minimums score of 70% on final quiz in two attempts or fewer.
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
  • Aseptic Processing Level II - SEF-79974
Course Contact Information
Bionetwork Manager
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