| CPC A61J 1/2096 (2013.01) [A61J 1/1406 (2013.01); A61J 1/1443 (2013.01); A61J 1/2003 (2015.05); A61J 1/2006 (2015.05); A61J 1/2037 (2015.05); A61J 1/2075 (2015.05)] | 7 Claims |
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7. A method for sterilizing a unit for closed transfer of liquids comprised of a syringe or an airtight device for closed transfer of liquids connected to a connector section, the connector section comprising: an outer body having a proximal end adapted to be attached to the syringe or the airtight device for closed transfer of liquids and an open distal end; at least one hollow needle fixedly attached to the proximal end of the body of the connector section, the needle having at least one port at a lower end thereof adjacent to pointed distal tip thereof that allows fluid communication between the exterior and the hollow interior of the needle; and a septum holder located inside of the outer body of the connector section, the septum holder comprising at least two parts, wherein the at least two parts of the septum holder comprise a septum support comprising a septum seat having a septum attached thereto, and a body part that are moveable towards and away from each other; the septum support comprising opening to accommodate an insert comprising at least one bore that forms a seat of a needle valve; wherein the body part and the septum support comprise components configured to releasably hold the septum holder in an unblocked configuration in which the at least one port is outside of the bore in the insert allowing fluid to flow through the hollow needle and to allow the septum support and the body part to be moved towards each other and to be locked in a blocked configuration in which the at least one port is inside of the bore in the insert blocking the flow of fluid through the hollow needle and the septum is closest to the body part;
the method comprising:
a) arranging the septum holder in the unblocked configuration;
b) sealing the unit in a pack suitable for gas sterilization;
c) placing the pack in a closed container or room;
d) introducing sterilizing gas into the closed container or room;
e) leaving the pack exposed to the sterilizing gas for a period long enough for the gas to enter the pack and enter the inside of the syringe and connector section through the ports adjacent to the pointed distal tip of the needles, thereby sterilizing the syringe and connector section;
f) evacuating the sterilizing gas out of the container or room to draw the sterilizing gas out of the packs and the inside of the syringe and connector section;
g) introducing air to replace the sterilizing gas into the container or room and the packs and the inside of the syringe and connector section wherein the air inside the pack is sterile; and
h) repeating if necessary steps d through g until reaching a satisfactory level of sterility;
wherein, connecting the unit to a second member of a closed system for transfer of liquids by inserting a proximal end of the second member into the open distal end of the body of the connector section causes the septum holder to move within the connector section moving the septum support and the body part towards each other, and locking the septum holder in the blocked configuration.
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