Course
Cleanroom Gowning Certification
Name
SEF-79244
Available Classes
Not currently offered.
Description
In the course's classroom component, students will learn about regulatory requirements and aseptic gowning techniques. Students will then learn aseptic behaviors related to gowning and how to gown in aseptic settings. After this formal training, students must successfully complete three consecutive gowning trials to earn the certification. Successful gowning attempts are determined by the results of environmental monitoring, ensuring that the gown remains sterile.
Course Objectives
- Demonstrate the ability to gown aseptically without critical technique failures.
- Illustrate that they are able to meet the microbial contamination limits while gowning.
Outline of Instruction
- Aseptic gowning
- Sterile gloving
- Environmental monitoring and microbial detection
- Gowning and environmental monitoring
Contact Hours
8
CEU's
0.8
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
- Attendance 95% or above
- Participation
- Successful gowning attempt (gown remains sterile) as determined by environmental monitoring.
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
- Manufacturing Associate
- Process Development Associate
- Biomanufacturing Associate
Related Courses
- Aseptic Processing Level I - SEF-79964
- Aseptic Processing Level II - SEF-79974
- Biowork: Process Technician - BTC-3200A7
- Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
- Fundamentals of Validation - SEF-165CL
- Good Documentation Practices and Data Integrity - SEF-211CL
Course Contact Information
Gina Driver
gfdriver@waketech.edu