In sterile combination, antiseptic technique is tributary to the bar of microbiological contamination. it’s providing sterility, safety, and effectivity to the sterile product, particularly varied injections for patients. Cleaning, Gowning and correct strategies of contamination management are reviewed along side why clean rooms square measure designed the manner they’re.
Why you have to Know:
Compounding sterile merchandise square measure created utilizing antiseptic technique. antiseptic technique could be a microbiological term concerning the interference of being contamination. The procedure involves the utilization of specialised instrumentation, sterile attire, meticulous process, and continuous improvement.
This course can review correct improvement, gowning and ways in which to avoid the common sources of contamination that exist in an exceedingly room setting. This course is additionally a decent refresher for those personnel that ar accustomed to the thanks to properly add the room and why clean rooms ar designed for correct contamination management.
Who will be benefit from this:
- 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
About the Instructor:
Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.