Intro to Proper Aseptic Technique and Clean room Behaviour
Learn the basics of aseptic technique and cleanroom behavior, including gowning, cleaning, contamination control, facility design and environmental monitoring.
Speaker
Danielle DeLucy
Pharmaceutical quality consultant · ASA Training and Consulting, LLC · MS
Overview
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.
Why attend: 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.
What’s covered
- Definition of aseptic processing
- Terminal sterilization vs aseptic processing
- Aseptic technique and cleanroom behavior
- Proper cleaning and gowning
- Common sources of contamination and how to avoid them
- Facility design and how it affects the product
- Environmental monitoring practices, systems and equipment
- How quality systems define requirements for aseptic technique and cleanrooms
Who should attend
What you get
About the speaker
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 has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
Ginette M. Collazo · 90 min