Compounding sterile products are made utilizing aseptic technique. 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.
Join this session by expert speaker Danielle DeLucy, where she will review how Quality Systems help define requirements for aseptic technique and clean rooms and how to properly maintain these environments.
Session Highlights:
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
Why You Should Attend:
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.
Who Should Attend:
Operations employees who are required to enter controlled environments as part of their job function – includes some or all of the employees in the following departments:
Production
QC Micro
Engineering & Validation
Facilities / Maintenance
Quality Assurance
*You may ask your Question directly to our expert during the Q&A session.
** You can buy On-Demand and view it as per your convenience.
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 17 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.