Sterilisation method

Abstract

Embodiments of the present disclosure relate to systems and methods for the application of vaporized chemicals in the sterilization of medical products. For example, embodiments of the present disclosure may relate to systems and methods for the terminal sterilization of medical products using vaporized hydrogen peroxide (VHP). Embodiments of the present disclosure may relate to, e.g., systems and methods for the terminal sterilization of medical products, such as pre-filled syringes (PFS).

1 - 39 . (canceled) 
     
     
         40 . A syringe including medicament, wherein the syringe is sterilized by a method comprising:
 creating a turbulent flow within a chamber containing a primary packaging component including the syringe; and   while maintaining the turbulent flow, performing a sterilization pulse comprising:
 introducing vaporized hydrogen peroxide (VHP) into the chamber; 
 removing the VHP from a lower interior of the chamber and re-introducing the VHP into an upper interior of the chamber; and 
 introducing dry gas into the chamber, wherein the dry gas has a dew point of −10° C. or lower; 
   wherein a condensation layer forms on the primary packaging component.   
     
     
         41 . The syringe of  claim 40 , wherein the medicament includes an antibody. 
     
     
         42 . The syringe of  claim 40 , wherein the primary packaging component includes a semi-permeable membrane. 
     
     
         43 . The syringe of  claim 40 , wherein the condensation layer includes a first portion in contact with the primary packaging component and a second portion not in contact with the primary packaging component; and a hydrogen peroxide concentration of the first portion is greater than a hydrogen peroxide concentration of the second portion. 
     
     
         44 . The syringe of  claim 40 , wherein the dry gas is introduced at least 5 minutes after the VHP is introduced. 
     
     
         45 . The syringe of  claim 44 , wherein the dry gas includes nitrogen. 
     
     
         46 . The syringe of  claim 40 , wherein the condensation layer comprises hydrogen peroxide and water. 
     
     
         47 . The syringe of  claim 40 , wherein the syringe is a first syringe of a plurality of syringes;
 during sterilization, the plurality of syringes are within the chamber; and   introducing VHP into the chamber includes introducing about 0.01 grams to about 0.10 grams of VHP per syringe in the chamber.   
     
     
         48 . A syringe including medicament, wherein after the medicament is loaded into the syringe, the syringe is sterilized by a method comprising:
 creating a turbulent flow within a chamber containing the syringe; and   while maintaining the turbulent flow, performing a sterilization pulse comprising:
 maintaining a sterilization pressure within the chamber for at least 5 minutes; 
 introducing vaporized hydrogen peroxide (VHP) into the chamber; 
 allowing the VHP to circulate within the chamber for at least 5 minutes, wherein allowing the VHP to circulate within the chamber includes removing the VHP from a lower interior of the chamber and re-introducing the VHP into an upper interior of the chamber; and 
 introducing dry gas into the chamber, wherein the dry gas has a dew point of −10° C. or lower. 
   
     
     
         49 . The syringe of  claim 48 , wherein the dry gas includes nitrogen. 
     
     
         50 . The syringe of  claim 48 , wherein the sterilization pressure is between about 400 millibars and about 800 millibars. 
     
     
         51 . The syringe of  claim 48 , wherein the sterilization pulse is a first sterilization pulse, and the sterilization method further comprises performing a second sterilization pulse. 
     
     
         52 . The syringe of  claim 48 , wherein introducing VHP into the chamber includes introducing about 0.2 grams to about 3.0 grams of VHP per cubic foot of volume of the chamber. 
     
     
         53 . The syringe of  claim 48 , wherein the dry gas is a first dry gas having a dew point of −10° C. or lower, and the sterilization method further includes performing an aeration pulse comprising:
 achieving a first aeration pressure of between about 400 millibars and about 800 millibars in the chamber; 
 increasing the pressure within the chamber to a second aeration pressure higher than the first aeration pressure; and 
 simultaneously exhausting the gas from the chamber while introducing room air, air having a dew point of −10° C. or lower, or a second dry gas having a dew point of −10° C. or lower, into the chamber. 
 
     
     
         54 . The syringe of  claim 48 , wherein, during the sterilization pulse, a condensation layer forms within the chamber. 
     
     
         55 . A syringe including medicament, wherein the syringe is sterilized by a method comprising:
 placing a primary packaging component including the syringe in a chamber;   creating a turbulent flow within the chamber; and   while maintaining the turbulent flow, performing a sterilization pulse comprising:
 maintaining a sterilization pressure within the chamber for at least 5 minutes; 
 introducing vaporized hydrogen peroxide (VHP) into the chamber; 
 allowing the VHP to circulate within the chamber for at least 5 minutes, wherein allowing the VHP to circulate within the chamber includes removing the VHP from a lower interior of the chamber and re-introducing the VHP into an upper interior of the chamber; and 
 introducing dry gas into the chamber, wherein the dry gas has a dew point of −10° C. or lower; 
 wherein, during the sterilization pulse, a condensation layer forms on a primary packaging component. 
   
     
     
         56 . The syringe of  claim 55 , wherein the sterilization method further comprises maintaining a temperature of between about 25° C. and about 60° C. within the chamber while performing the sterilization pulse. 
     
     
         57 . The syringe of  claim 55 , wherein the dry gas is a first dry gas having a dew point of
 −10° C. or lower, and the sterilization method further includes performing an aeration pulse comprising:
 achieving a first aeration pressure of between about 400 millibars and about 800 millibars in the chamber; 
 increasing the pressure within the chamber to a second aeration pressure higher than the first aeration pressure; and 
   simultaneously exhausting the gas from the chamber while introducing room air, air having a dew point of −10° C. or lower, or a second dry gas having a dew point of −10° C. or lower, into the chamber.   
     
     
         58 . The syringe of  claim 57 , wherein the first dry gas, the second dry gas, or both, includes nitrogen. 
     
     
         59 . The syringe of  claim 57 , wherein the sterilization pulse is the first sterilization pulse, the aeration pulse is a first aeration pulse, and the sterilization method further comprises performing a second sterilization pulse, performing a second aeration pulse, or both.