Course Image
Description
This course covers Why and When for aseptic processing, clean room behavior/Aseptic technique, sterile gowning and Batch Record review.
Contact Hours
Level
Beginner
Audience
- Beginners
Topics
- Sterile Gowning
- Finger touch plates and general facility surface plates
- Environmental Monitoring (static and dynamic testing) for viable/non-viable organisms
- Disinfectant Experiment
- Component preparation and sterilization
- Media Simulation Fills
- Steri-Test and Aseptic Connections
- Inspect disinfectants and collected plates for growth
Objectives
Attendees who have completed this course should be able to:
- Explain the need for aseptic processing in pharmaceutical manufacturing.
- Demonstrate how to don and doff sterile garments aseptically.
- Understand a Batch Record review process.
- How to perform Environmental Monitoring of air and surfaces.
- Prepare and sterilize components.
- Perform a disinfectant study.
- Participate in a Media Simulation Fill.
- Perform a finished product sterility test
- Inspect Disinfectant and EM plates for potential growth.
Delivery Options
Face-to-Face
Delivered in-person in a classroom or lab setting.
College Options
Request this Course
This course covers Why and When for aseptic processing, clean room behavior/Aseptic technique, sterile gowning and Batch Record review.
Level
Beginner
Audience
- Beginners
Topics
- Sterile Gowning
- Finger touch plates and general facility surface plates
- Environmental Monitoring (static and dynamic testing) for viable/non-viable organisms
- Disinfectant Experiment
- Component preparation and sterilization
- Media Simulation Fills
- Steri-Test and Aseptic Connections
- Inspect disinfectants and collected plates for growth
Objectives
Attendees who have completed this course should be able to:
- Explain the need for aseptic processing in pharmaceutical manufacturing.
- Demonstrate how to don and doff sterile garments aseptically.
- Understand a Batch Record review process.
- How to perform Environmental Monitoring of air and surfaces.
- Prepare and sterilize components.
- Perform a disinfectant study.
- Participate in a Media Simulation Fill.
- Perform a finished product sterility test
- Inspect Disinfectant and EM plates for potential growth.
Contact Hours
Delivery Options
Face-to-Face
Delivered in-person in a classroom or lab setting.
College Options
Request this Course