Traininng.com LLC, Online
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination.
It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
Why should you Attend
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.
This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a clean room environment. This course is also a good refresher for those personnel that are familiar with the way to properly work in the clean room and why clean rooms are designed for proper contamination control.
Areas Covered in the Session
- In sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination
- It is providing sterility, safety, and efficacy to the sterile product, especially various injections for patients
- Cleaning, Gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are
- 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 Will Benefit
- 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
- Equipment needed to conduct Environmental Monitoring
- 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
||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.