The sterility, safety, and efficacy of your products is paramount to success, especially in injectables and biologics, there simply is no room for mistakes.
Compounded sterile products utilize aseptic techniques that prevent microorganism contamination. This activity is critical for the successful manufacturing of safe, sterile therapeutics. The procedure involves using specialized equipment, sterile apparel, meticulous processing, and continuous cleaning. But often, this technique is overlooked by firms and staff, leading to sloppy production that is most often caused by human error.
During this interactive session, you will learn simple steps to improve your aseptic efforts and be able to:
- Define aseptic processing (AP)
- Stated the differences between terminal sterilization and AP
- Identify the proper personnel behavior in a cleanroom to keep human error out of the equation
- Describe facility design and how it impacts the product
- Explain proper environmental monitoring practices and systems used
Finally, this course reviews how quality systems help define requirements for aseptic technique/cleanrooms, and how to properly maintain these environments.