Aseptic Processing - Gowning

Lesson Code: ASP-1103 (PREMIUM LESSON). Describes the different gowning requirements typically used in aseptic manufacturing facilities to prevent contamination of products. It emphasizes the criticality of following correct gowning procedures for different cleanroom classes using ISO 5/6, ISO 7 and ISO 8 as examples.

  • Category: Aseptic Processing - Cleanroom GMP

Description

After completing this e-Lesson, you will be able to:

  • Define the term 'bioburden'
  • Explain why cleanrooms are classified
  • List the four ISO cleanroom classes commonly used in Aseptic Processing
  • Explain why different cleanroom classes have different gowning requirements
  • Provide examples of gowning equipment and procedures used for different cleanroom classes
  • Explain how airlocks prevent contamination of a cleanroom environment