Aseptic Processing – Concepts and Controls
This lesson introduces the concept of aseptic processing and how it differs from sterilization.
It explains why aseptic controls are needed by providing an overview of microbial contamination and its effects on products. It then describes how this contamination can be prevented by using controls and procedures that minimize bioburden in the manufacturing environment such as cleanrooms, gowning, appropriate behavior of personnel, and environmental monitoring.
These topics are described at an overview level with more in-depth treatment provided in other lessons in the aseptic processing suite.
The goal of the lesson is to communicate and reinforce the criticality of avoiding product contamination in aseptic manufacturing operations and how personal responsibility is essential to the ultimate aim of producing safe and effective products.
Prerequisites: A basic knowledge of GMP is assumed.
Download the Product PDF here:
EU_Aseptic Product Sheet.pdf
US_Aseptic Product Sheet.pdf