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.
- 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
- Aseptic Operators
- Quality Assurance Departments
- Manufacturing Departments
- Microbiology Quality Control Departments