Aseptic Processing Overview and Validation

Topics

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

Who should Attend

Senior attendees involved or interested in:

• QC Micro
• Production
• Facilities / Maintenance
• Engineering & Validation
• Quality Assurance