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Sterile Production
Part Three
● Sterilised by filtration
● Aseptic preparation
Others C C
● Air
● Surfaces
● Personnel
➤ records
➤ action taken
Module 13 Slide 24 of 48 WHO - EDM
Sterile Production
Processing
● Bio-burden determination
➤ raw materials
➤ in-process materials
– LVP : filtered immediately before sterilisation
– sealed vessels: pressure-released outlets
● Components, materials and containers
➤ fibre generation
➤ no re-contamination after cleaning
Part Three 17.44-47;
➤ stage identified 17.50-17.51
➤ sterilised when used in aseptic areas
● Gas through a sterilising filter
Module 13 Slide 25 of 48 WHO - EDM
Sterile Production
Processing
● Validation
➤ new processes
➤ re-validation: Periodic and after change
● Aseptic process: Sterile media fill (“broth fills”)
➤ simulate actual operation
➤ appropriate medium/media
➤ sufficient number of units
– acceptable limit
– investigations
Part Three 17.52, 17.40
➤ revalidation: periodic and after change
● Colour discs
Module 13 Slide 37 of 48 WHO - EDM
Sterile Production
Sterilization by Radiation
● Batch record
● Validation
➤ density of packages
● Mix-ups: Irradiated and non-irradiated materials
● Dose: Predetermined time span
● Environmental monitoring
● Sterility testing
● Endotoxin testing