Aseptic technique is how sterile compounding prevents microbial contamination, protecting the sterility, safety and efficacy of products such as injections for patients. It relies on specialized equipment, sterile garments, careful processing and continuous cleaning.
This 60-minute introduction to aseptic technique and cleanroom behavior defines aseptic processing and compares it with terminal sterilization. You'll review proper cleaning, gowning and personnel behavior, the common sources of contamination in a cleanroom, and why cleanrooms are designed the way they are. The session also covers environmental monitoring practices and systems, and how quality systems define requirements for aseptic work and cleanroom upkeep.
WHY SHOULD YOU ATTEND?
Poor technique or behavior in the cleanroom puts product sterility at risk. This course shows new staff how to work correctly in a controlled environment and serves as a refresher for experienced personnel.
It suits aseptic operators, aseptic sample handlers, staff who work in a biological safety cabinet (BSC), and their managers and quality assurance counterparts.
AREA COVERED
- Definition of aseptic processing
- Terminal sterilization vs aseptic processing
- Aseptic technique and cleanroom behavior
- Proper cleaning and gowning
- Common sources of contamination and how to avoid them
- Facility design and how it affects the product
- Environmental monitoring practices, systems and equipment
- How quality systems define requirements for aseptic technique and cleanrooms
LEARNING OBJECTIVES
- Define aseptic processing and contrast it with terminal sterilization
- Follow proper personnel behavior in a cleanroom
- Apply correct cleaning and gowning practices
- Explain how facility design supports contamination control
- Describe environmental monitoring practices and systems
- Identify how quality systems set requirements for maintaining cleanrooms
WHO WILL BENEFIT?
This course will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC), and their management and Quality Assurance counterparts, in highlighting how to operate in a clean room environment, proper facility design, proper personnel gowning, and the equipment needed to conduct environmental monitoring. In addition, this course will review how Quality Systems help define requirements for aseptic techniques and clean rooms and how to properly maintain these environments.
- Microbiology
- Aseptic Technique
- Environmental Monitoring
- Gowning
- FDA
- Clean Room
- ISO
- Classifications
- Contamination Control
Poor technique or behavior in the cleanroom puts product sterility at risk. This course shows new staff how to work correctly in a controlled environment and serves as a refresher for experienced personnel.
It suits aseptic operators, aseptic sample handlers, staff who work in a biological safety cabinet (BSC), and their managers and quality assurance counterparts.
- Definition of aseptic processing
- Terminal sterilization vs aseptic processing
- Aseptic technique and cleanroom behavior
- Proper cleaning and gowning
- Common sources of contamination and how to avoid them
- Facility design and how it affects the product
- Environmental monitoring practices, systems and equipment
- How quality systems define requirements for aseptic technique and cleanrooms
- Define aseptic processing and contrast it with terminal sterilization
- Follow proper personnel behavior in a cleanroom
- Apply correct cleaning and gowning practices
- Explain how facility design supports contamination control
- Describe environmental monitoring practices and systems
- Identify how quality systems set requirements for maintaining cleanrooms
This course will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC), and their management and Quality Assurance counterparts, in highlighting how to operate in a clean room environment, proper facility design, proper personnel gowning, and the equipment needed to conduct environmental monitoring. In addition, this course will review how Quality Systems help define requirements for aseptic techniques and clean rooms and how to properly maintain these environments.
- Microbiology
- Aseptic Technique
- Environmental Monitoring
- Gowning
- FDA
- Clean Room
- ISO
- Classifications
- Contamination Control