Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.


Course Details & Registration Information

Course
Aseptic Processing Concepts
Name
SEF-3001JV1
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
New and incumbent biomanufacturing employees
Description
Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure patient safety. Contamination of these drug products via the introduction of microorganisms, endotoxins, or particulates will lead to product failure, product destruction, and the potential for illness or death of patients and consumers. This course provides the foundational knowledge of aseptic practices required for processing sterile products and maintaining customer safety. In this course, students will be introduced to the regulatory requirements for sterile product manufacturing, the consequences of microbial contamination, and the best practices and behaviors in a cleanroom. Students will be introduced aseptic processing topics such as environmental monitoring, endotoxin testing, cleaning and disinfection, cleanroom design and controls, sterilization processes, aseptic gowning, formulation, and sterile filtration.
Course Objectives
  1. Explain the role aseptic processing plays in pharmaceutical manufacturing.
  2. Apply CGMP knowledge to cleanroom activities.
  3. Describe cleanroom operations in relation to manufacturing parenteral products.
  4. Evaluate sterile gowning needs in various aseptic processing environments.
  5. Discuss microbiology and bacterial endotoxins in the context of parenteral drug manufacturing.
  6. Identify microorganisms of concern to biopharmaceutical processing.
  7. Evaluate environmental monitoring oversight of aseptic processes.
  8. Describe environmental programs and techniques.
  9. Compare and contrast cleaning, disinfectant, and sanitizer components and materials.
  10. Develop an aseptic processing mindset.
Outline of Instruction
  1. The need for Aseptic Processing
  2. Current Good Manufacturing Practices (CGMP)
  3. Good Documentation Practices (GDP)
  4. Cleanroom Design and Control
  5. Microbiology Basics
  6. Endotoxins
  7. Micropipetting
  8. Environmental Monitoring
  9. Facility Cleaning and Disinfection
  10. Aseptic Gowning and Cleanroom Behaviors
  11. Component Preparation
  12. Solution Preparation and Filtration
  13. Sterilization Methods
Contact Hours
12
CEU's
1.2
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Online course - computer and internet connection required
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 100%
  2. Participation
  3. Students must complete all modules and module quizzes
  4. Students must complete the Course Assessment with 80% or higher to pass the course
Accreditation/Special Approval Requirements
Intended Audience
New and incumbent biomanufacturing employees
Specific Industry or Business Support Needs
Manufacturing Technicians, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, and Maintenance/Engineers with an Aseptic Emphasis
Wake County Need for Industry Positions
Biomanufacturers
Industry or Job Titles Related to training Outcomes for Employment
  • Manufacturing Technicians
  • Team Leaders and Supervisors
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Maintenance/Engineers with an Aseptic Emphasis
Related Courses
  • Aseptic Processing Level I - SEF-79964
  • Aseptic Processing Level II - SEF-79974
  • Cleanroom Gowning Certification - SEF-79244
Course Contact Information
Bionetwork Manager