Compounded sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. Most importantly, this activity is critical for the successful manufacture of safe and sterile therapeutics. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning. However, this technique is often overlooked by firms and staff leading to sloppy production caused – most often – by human error.
Since the sterility, safety, and efficacy of your products is paramount to success, especially in injectables and biologics, there is no room for mistakes. In addition, this course will review how quality systems help define requirements for aseptic technique/cleanrooms, 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 – keeping human error out of the equation
- Facility design and how it impacts the product – mitigating risks, reaping reward
- A review of proper environmental monitoring practices and systems used
- Aseptic technique & clean room behavior – the final word
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.