Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.
This environmental control in pharmaceutical industry webinar is a good refresher for those personnel that are familiar with the way to properly work in the clean room and why environmental control rooms are designed for proper contamination control.
In sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It is providing sterility, safety, and efficacy to the sterile product, especially various injections for patients.
Cleaning, Gowning and proper methods of contamination control will be reviewed keeping in mind FDA audit training, FDA CGMP compliance and FDA environmental monitoring, along with why clean rooms are designed the way they are.
- Definition of Aseptic Processing (AP)
- Terminal Sterilization vs. AP
- Proper Personnel Behavior in a Cleanroom
- Facility Design and how it impacts the product
- A review of proper environmental monitoring practices and systems used
- Aseptic Technique & clean room behavior
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 technique and clean rooms and how to properly maintain these environments.