Aseptic Processing Overview and Validation is a conference that covers topics such as:
- 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
Aseptic Processing Overview and Validation brings together senior attendees involved or interested in:
- QC Micro
- Production
- Facilities / Maintenance
- Engineering & Validation
- Quality Assurance
