Speakers:
Conor Murray, Chair of the Irish Cleanrooms Society
Main discussion topics:
ASEPTIC PROCESSSING
Contamination control system (CCS)
Annex applicability for low bioburden manufacturing areas
Sterilization of indirect product contact surfaces (as e.g. stopper bowls)
CCIT implementation
Pyrogen
“Cleanup” time during monitoring
Reside of disinfectants and related validation requirements
Smoke studies
Nonviable particle monitoring to ISO 14644-2:2015
IMPACT ON FACILITIES UPGRADE
Approach to upgrade existing facilities.
PUPSIT
Upgrading the zoning concept from Zone D to Zone C for “open isolators”?
Challenges to upgrade Traditional Viable EM (LIMS and Automatic Plate Counters)
Annex 1 and RABS vs Isolators
Exchange and alignment on CAPEX requirements