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
Cleanroom Gowning Concepts
Name
SEF-3001JW1
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
New and incumbent biomanufacturing employees
Description
Aseptic gowning is a system of donning apparel to prevent the contamination of aseptic processing areas. The Cleanroom Gowning course will establish a framework and requirements for proper sterile gloving and aseptic gowning procedures. E-learning tools and videos, and discussions will be utilized. Additional topics include microbiology, environmental monitoring, personnel monitoring related to aseptic gowning, and key elements of developing an aseptic gowning qualification program.
Course Objectives
  1. Explain the need for aseptic gowning in aseptic processing.
  2. Describe the different stages of aseptic gowning.
  3. Understand the appropriate procedure for sterile gloving and aseptic gowning.
  4. Review the various aseptic gowning techniques used in industry.
  5. Convey proper and improper cleanroom behaviors.
  6. Discuss environmental and personnel monitoring and microbiology in the context of cleanroom gowning.
  7. Identify the phases for developing an aseptic gowning qualification program.
Outline of Instruction
  1. Gowning terminology
  2. Improper gowning citations and warning letters
  3. Sterile gloving
  4. Aseptic gowning
  5. Environmental and personnel monitoring
  6. Microbiology basics
  7. Phases to develop an aseptic gowning qualification program
  8. Current events: Personal protective equipment
Contact Hours
4
CEU's
0.4
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
None
Text and Supplies Needed
Computer and internet access - online course
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 100%
  2. Participation
  3. 100% Completion of 12 module assessments
  4. Must achieve at least 80% on final assessment to receive credit
Accreditation/Special Approval Requirements
Intended Audience
New and incumbent biomanufacturing employees
Specific Industry or Business Support Needs
Production Operators, Manufacturing Technicians, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance Personnel, Process Engineers, FDA Auditors
Wake County Need for Industry Positions
Biomanufacturers
Industry or Job Titles Related to training Outcomes for Employment
  • Production Operators
  • Manufacturing Technicians
  • Team Leaders and Supervisors
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Maintenance Personnel
  • Process Engineers
  • FDA Auditors
Related Courses
  • Aseptic Processing Level I - SEF-79964
  • Aseptic Processing Level II - SEF-79974
  • Cleanroom Gowning Certification - SEF-79244
  • Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
Course Contact Information
Bionetwork Manager