Maintenance Controls for Aseptic Operations

This course must be taught at a BioNetwork location.

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Maintenance Controls for Aseptic Operations
Level: Beginner
Lecture Hours: 4.00
Lab Hours: 4.00
Total Contact Hours: 8.00

Description

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.

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

Audience

This course equips professionals whose responsibilities depend on aseptic technique:

  • Maintenance Technicians
  • Team Leaders and Supervisors
  • Process Engineers
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