Course
Maintenance Controls for Aseptic Operations
Name
SEF-148CL
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
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
  1. Gain an overall view of maintenance responsibilities in aseptic processing
  2. Develop a basic understanding of cleanroom environments
  3. Have an understanding of basic microbiology
  4. Have knowledge of regulatory requirements controlling maintenance activities in aseptic processing
  5. Be able to identify the role of maintenance personnel in media fill process simulations
  6. Experience hands-on aseptic gowning for entry into cleanroom environments
  7. Gain hands-on experience with sterilization processes including steam sterilization, dry-heat sterilization, UV light and disinfectants
Outline of Instruction
  1. 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
  2. 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
  1. Attendance 100%
  2. Participation
  3. 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