Understanding Proper Aseptic Technique and Cleanroom Behavior
Duration: 75 Minutes
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why cleanrooms are designed the way they are.
Objectives of the Presentation
- Definition of Aseptic Processing (AP)
- Terminal Sterilization vs. AP
- Proper personnel behavior in a cleanroom - keeping human error out of the equation
- Facility design and how it impacts the product - mitigating risks, reaping reward
- A review of proper environmental monitoring practices and systems used
- Aseptic technique and cleanroom behavior
In addition, this course will review how quality systems help define requirements for aseptic technique/cleanrooms, and how to properly maintain these environments.
Why Should you Attend
Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. Most importantly, this activity is critical for the successful manufacture of safe and sterile therapeutics. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.
This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a cleanroom environment. However, this technique is often overlooked by firms and staff leading to sloppy production caused most often by human error. This course is also a good refresher for those personnel that are familiar with the way to properly work in the cleanroom and why cleanrooms are designed for proper contamination control.
Who will Benefit
- Aseptic operators
- Aseptic sample handlers
- Personnel who work in a biological safety cabinet (BSC) and their management
- Quality assurance counterparts
- Proper facility design, personnel gowning, and the equipment needed to conduct environmental monitoring are highlighted to give context, so those responsible for these areas are encouraged to attend
- Manufacturing managers
- Microbiology Quality Control Professionals