Maintenance Controls for Aseptic Operations
Learn the various roles that maintenance personnel perform in aseptic processing facilities. Through lecture and hands-on activities, we'll review proper aseptic techniques, sterility assurance, and cleanroom controls. We will also cover topics such as regulatory requirements, cleanroom environments, basic microbiology, aseptic gowning, sterilization methods, and aseptic interventions.
Audience
This course equips professionals whose responsibilities depend on aseptic technique:
- Maintenance Technicians
- Team Leaders and Supervisors
- Process Engineers
Topics Include
This one-day, eight-hour course covers the following topics:
- Role of maintenance personnel in aseptic operations
- Aseptic process qualification for maintenance personnel
- Sterilization processes using autoclaves, depyrogenation ovens, UV light, and disinfectants
- Media fill simulation with routine and non-routine interventions
- Aseptic techniques and gowning
- Equipment and system qualification
- Review and discussion of all microbiological data
Learning Objectives
- Understand the fundamentals of cleanroom environments
- Recognize basic microbiological concepts
- Understand the regulatory requirements that control maintenance activities in aseptic processing
- Identify maintenance personnel's role in media fill process simulations
- Perform aseptic gowning for entry into cleanroom environments
- Understand sterilization processes including steam sterilization, dry-heat sterilization, UV light and disinfectants

Request this Course
Level: Beginner
Delivery Options

Customized course for 2019 Grifols Shutdown Training.

Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure... more

Aseptic gowning is a system of donning apparel to prevent the contamination of aseptic processing... more

Build on the foundation you constructed in Aseptic Processing Level I with this course, a hands-on... more
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