Intro to Proper Aseptic Technique and Clean room Behaviour

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.

• Define aseptic processing and contrast it with terminal sterilization
• Follow proper personnel behavior in a cleanroom
• Apply correct cleaning and gowning practices
• Explain how facility design supports contamination control
• Describe environmental monitoring practices and systems
• Identify how quality systems set requirements for maintaining cleanrooms

• 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

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.
 

• Microbiology
• Aseptic Technique
• Environmental Monitoring
• Gowning
• FDA
• Clean Room
• ISO
• Classifications
• Contamination Control

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.