2019 - Aseptic Processing Overview and Validation

Topic 1: Basic Micro Review
The role of environmental monitoring
Types & sources of microorganisms
The impact of microorganisms on product and patient health and safety
Topic 2: Review Aseptic Processing Basics
Cleanliness classifications
Process differences between aseptically produced and terminally sterilized product
Relation of manufacturing and handling procedures to sources of product contamination
The differences between and the purposes of cleaning, disinfection and sanitization
Proper cleaning techniques
The role of isolator technology
Topic 3: Review Clean Area Behaviors
Personnel gowning requirements
Good clean area behaviors/practices
Practices to avoid – and why
Review site-specific EM/aseptic behavior observations/risks & ask attendees to brainstorm ways to change/improve/eliminate these behaviors & risks
Topic 4: Aseptic Validation
The purpose of media fills, and elements critical to their success