METHOD OF TERMINAL STEAM STERILIZATION

摘要

Disclosed is a method for terminal steam sterilization of a prefilled plastic syringe or a pre-filled plastic cartridge, said method comprising the steps of: maintaining a head space in the syringe or cartridge of less than about 10% volume; providing at least a 10% leeway for the plunger therein to slide in response to pressure differential; and sterilizing the syringe or cartridge at an autoclave pressure that is less than the internal pressure of the syringe or cartridge. Also disclosed is a method for terminal steam sterilization of a pre-filled glass syringe or pre-filled glass cartridge, said method comprising the steps of: maintaining a head space in the syringe or cartridge of less than about 10% volume; providing at least a 10% leeway for the plunger therein to slide in response to pressure differential; and sterilizing the glass syringe or glass cartridge at an autoclave pressure that is less than, equal to or greater than the internal pressure of the syringe or cartridge.