Page 237 - Assurance of Sterility for Sensitive Combination Products and Materials
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214 Assurance of sterility for sensitive combination products and materials
Use sterilisation at ³ 160°C for ³ 120 min Use dry heat with alternative combination of time and temperature to the standard cycle achieving an SAL of £10 –6 Use sterilisation with an absorbed minimum dose of ³ 25 kGy Use sterilisation by validated irradiation dose Can a reduced terminal heat treatment be applied providi
Yes Yes Yes Yes terminal reduction of a possible bioburden? No Use sterile filtration, pre- sterilised containers and aseptic processing
Can the product be sterilised by dry heat at 160°C for 120 min? Yes Decision tree for sterilization choices for nonaqueous liquid, semisolid, or dry powder products. From EMA/CHMP/CVMP/ QWP/850374/2015 Guideline on the sterilization of the medicinal product, active substance, excipient and primary container, April 2016,
Can the product be sterilised by dry heat with an alternative combination of time
and temperature to the standard cycle achieving an SAL of £ 10 –6 ?
No Yes Use pre-sterilised individual components, aseptic compounding and filling. Consider a terminal microbial reduction process
No Can the product be sterilised by ionising radiation with an absorbed minimum dose of ³ 25 kGy? No Can the product be sterilised using a validated lower irradiation dose (ref ISO 11137)? No Can the formulation be filtered through a sterilising filter? No Can a reduced terminal heat treatment be applied providing
