QT110: Cleanroom Training & Aseptic Processing

Clean Room and Aseptic Processing Training

We will Cover:

  • Basic Microbiology and Aseptic Technique
  • Aseptic Gowning and Clean room Behavior
  • General Facility Requirements
  • Environmental Monitoring



“…manufacturers should have a keen awareness of the public health implications of distributing a non-sterile product. Poor cGMP conditions at a manufacturing facility can ultimately pose a life-threatening health risk to a patient.”


What Will We Discuss?

Part 1

  • Understand why aseptic processing is necessary
  • Discover what leads to non-sterile conditions
  • Learn how contamination may occur
  • Gain knowledge of the methods that can be used to reduce the chances of contamination
  • Learn how an aseptic process can be achieved

Part 2
Aseptic Gowning and Clean Room Behaviors

  • Review general gowning and behavior requirements for aseptic areas
  • Discuss pre-gowning requirements to ensure proper aseptic technique can be achieved
  • Detail the required gowning materials
  • Outline pre-gowning activities that are performed just prior to gowning
  • Describe a standard procedure for aseptic gowning
  • Review required post-aseptic activities
  • Discuss common audit observations related to aseptic gowning

Part 3
Facility Requirements and Environmental Monitoring

  • Acceptable/desired site suitability parameters to control contamination & cross-contamination
  • Proper procedures for routine, scheduled, documented sanitization of an aseptic processing area
  • Environmental Monitoring including:
  • Air Particulates
  • Work Surfaces
  • Water Quality
  • Other Monitoring including: pressure, temperature, humidity, sterilization
♦ Attendees of this course will help their organization to avoid FDA observations during an audit.
♦ The ultimate goal is to protect the end user of the manufactured product (the patient).


Who Should Attend?

This very practical training course is a must for all personnel with assigned responsibilities for working in cleanrooms and other controlled environments (i.e., tissue recovery suites)


Download the Course Brochure