Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production

Time: 9:35 am
day: Day Two


• Is the application of negative (HPAPI) or positive (Sterile) pressure cascades most appropriate?
• Design of engineering controls for sterile production and reduced cross contamination for quality assurance
• Revisions to Annex 1 and surrounding regulatory landscape
• Measuring product quality and operator safety in sterile HPAPI manufacturing