Compounding sterile products are made by utilizing certain aseptic techniques. 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. In sterile compounding, aseptic technique contributes towards the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients.
Join this 60 minutes session by expert speaker Danielle DeLucy, MS where she will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a cleanroom environment. This course is also a good refresher for the personnel who are familiar with the right way to properly work in the cleanroom and understand why cleanrooms are designed for proper contamination control. Danielle will also review proper methods of contamination control and explain why cleanrooms are designed the way they are. In addition, she will explain how quality systems help define requirements for aseptic technique and cleanrooms, and how to properly maintain these environments.
Here is what you'll learn:
Who should attend?
Aseptic Operators, Aseptic Sample Handlers, Personnel who work in a Biological Safety Cabinet (BSC) and their Management and Quality Assurance Counterparts
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 15 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...
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