Aseptic Processing – Concepts and Controls


Lesson Code: ASP-1001 (PREMIUM LESSON). Explains why aseptic processing is used by providing an overview of microbial contamination and its effects on products. It 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.


  • Category: Aseptic Processing - Cleanroom GMP

Description

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.

Check out these screenshots from the e-Lesson:






Download the Product PDF here:

Europe:

EU_Aseptic Product Sheet.pdf

USA:

US_Aseptic Product Sheet.pdf