Guideline to Aseptic Technique and Clean Room Behavior

Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination. Aseptic technique is being used to provide safety, efficacy and sterility to the products that are sterile in nature, especially when it comes to various patient injections.

This course will benefit those 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.

Cleaning, Gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are. 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.

Areas Covered in the Session : 

• Definition of Aseptic Processing (AP)
• Terminal Sterilization vs. AP
• Proper Personnel Behavior in a Cleanroom
• Facility Design and how it impacts the product
• A review of proper environmental monitoring practices and systems used
• Aseptic Technique & clean room behavior

Who Should Attend:

• Aseptic Operators
• Quality Assurance Departments
• Manufacturing Departments
• Microbiology Quality Control Departments

Course Director: 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 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.