Course
Maintenance Controls for Aseptic Operations
Name
SEF-148CL
Available Classes
Not currently offered.
Description
Learn the roles maintenance personnel perform in aseptic processing facilities. Through lecture and hands-on activities, we'll review proper aseptic techniques, sterility assurance, and cleanroom controls. Additional topics covered include regulatory requirements, cleanroom environments, basic microbiology, aseptic gowning, sterilization methods, and aseptic interventions.
Course Objectives
- Gain an overall view of maintenance responsibilities in aseptic processing
- Develop a basic understanding of cleanroom environments
- Have an understanding of basic microbiology
- Have knowledge of regulatory requirements controlling maintenance activities in aseptic processing
- Be able to identify the role of maintenance personnel in media fill process simulations
- Experience hands-on aseptic gowning for entry into cleanroom environments
- Gain hands-on experience with sterilization processes including steam sterilization, dry-heat sterilization, UV light and disinfectants
Outline of Instruction
- Day 1: Aseptic Control Elements for Maintenance Activities
- Introductions
- Lecture: Role of Maintenance in Aseptic Operations
- Lecture: Aseptic Process Qualification for Maintenance Personnel
- Lecture/Tour: Cleanrooms
- Lecture: Microbiology Basics
- Gowning Video
- Lab: Sterilization Processes-autoclaves, depryrogenation oven, UV light, disinfectants
- Lab: Media Fill Simulation with Routine and Non-routine Interventions - Day 2: Aseptic Control Elements for Maintenance Activities
- Lecture: Aseptic Critique
- Lecture: Aseptic Gowning
- Lecture: Equipment / System Qualification
- Lab: Sterilization Processes-autoclaves, depyrogenation oven,UV light, disinfectants
- Lab: Media Fill Simulation with Routine and Non-routine interventions
- Lab: Review and discuss all microbiological data
- Lecture: Aseptic Technique Critique
- BioJeopardy for Maintenance Engineers
- Lecture: Q&A, Final Quiz, Reviews
Contact Hours
16
CEU's
1.6
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 100%
- Participation
- Minimum score of 75% on final quiz. Students will be allowed two attempts.
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information
Bionetwork Manager
capstonecenter@waketech.edu