The long-awaited Annex 1 revision is imminent, and with consultations officially closed, and the proposed publication date looking set to be Q2 of 2021, it’s time to look at the key areas to prepare for. 

The ISPE Australasian Affiliate is excited to present a webinar panel discussion reviewing the hot topics and key changes ahead for sterile manufacturing. 

Delivered as a 2-hour interactive panel discussion featuring local SMEs, followed by a 30 minute Q&A session, this event will provide opportunities to participate and share an industry perspective on how to meet the new requirements.

Discussion topics will include:

  • Conveyer belt traveling between grades
  • PUPSIT (filter Integrity Testing)
  • Airflow smoke studies at rest and operation
  • Visual inspection of filled and individual units
  • Airlock containment
  • Vacuum testing over shelf life
  • Bioburden sampling immediately prior to filtration
  • Positive pressure hold
  • Monitoring at worst case locations
  • Advanced aseptic Filling (BFS, Isolators and RABS)
  • Contamination Control