Page 235 - Assurance of Sterility for Sensitive Combination Products and Materials
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Developing new products 213
Yes Use sterile filtration, pre- sterilised containers and aseptic processing. Consider a terminal microbial reduction process
Use autoclaving at 121°C for 15 min Use moist heat with F o ³ 8 min Can a reduced terminal heat treatment be applied providing a terminal reduction of a possible bioburden?
No Use sterile filtration, pre-sterilised containers and aseptic processing
Yes
Can the product be sterilised by Moist heat at 121°C for 15 min? Yes Decision tree for sterilization choices for aqueous products. From EMA/CHMP/CVMP/QWP/850374/2015 Guideline on the steriliza-
Yes
Can the product be sterilised by moist heat with F o ³ 8 minutes achieving SAL of £ 10 –6 ? No Can the formulation be filtered through a microbial retentive filter? No Can a reduced terminal heat treatment be applied providing a terminal reduction of a possible bioburden?
No Yes Use pre-sterilised individual components, aseptic compounding and filling. Consider a terminal microbial reduction process tion of the medicinal product, active substance, excipient and primary container, April 2016, European Medicines Agency.
No Use pre-sterilised individual components and aseptic compounding and filling Fig. 8.1
