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.
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.
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.
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.
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.
Danielle DeLucy
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 filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
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