PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE

    公开(公告)号:US20230310681A1

    公开(公告)日:2023-10-05

    申请号:US18330083

    申请日:2023-06-06

    Abstract: A method of preparing a prefilled syringe (1), comprises (i) obtaining a syringe barrel (11) having an open end (111) and a tip (112) with an orifice (113) essentially opposite to the open end (111), and a needle adaptor cap (12) assembled on the tip (112) of the syringe barrel, wherein the needle adaptor cap (12) has a rubber element (121) tightly sealing the orifice (113) of the tip (112) of the syringe barrel (11) and the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) is sterilized by a first sterilizing comprising a main step of exposing the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 5 hours to about 60 hours at a relative humidity of about 40% to about 100% and at a temperature of about 30° C. to about 60° C.; (ii) filling a drug substance (14) through the open end (111) of the syringe barrel (11) into an interior of the syringe barrel; (iii) sealing the interior of the syringe barrel (11) by advancing a rubber stopper (13) through the open end (111) of the syringe barrel (11); (iv) packaging the syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11); and (v) second external surface sterilizing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11). The rubber element (121) of the needle adaptor cap (12) and the rubber stopper (13) are made of a rubber material having a comparably low oxygen transmission rate such as, at 1 atmosphere, of not more than 64 cubic centimeter per square meter and day. The second external surface sterilizing comprises a main step of exposing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 3 hours to about 30 hours at a relative humidity of about 40% to about 100% and at a temperature of about 25° C. to about 45° C. At least one of the duration, the relative humidity and the temperature of the second external surface sterilizing is essentially lower than the respective duration, relative humidity or temperature of the first sterilization.

    System for Integrating an Antibacterial-Element Receptacle into an Autoinjector Cap

    公开(公告)号:US20180264243A1

    公开(公告)日:2018-09-20

    申请号:US15925648

    申请日:2018-03-19

    Abstract: A system for integrating an antibacterial-element receptacle into an autoinjector cap facilitates the pre-injection treatment, the post-injection treatment, and prevents the accidental delivery of the injection. The system includes a cap assembly, an autoinjector body, and an antiseptic-soaked dressing. The cap assembly encloses the needle of the autoinjector and prevents the accidental trigger of the injection mechanism. The autoinjector body refers to the body of any conventional autoinjector. The antiseptic-soaked dressing is applied to the patient's skin prior to the delivery of the injection to disinfect and sterilize the injection area. The antiseptic-soaked dressing is housed in the cap assembly, between a receptacle and a removable cover. The removable is releasably mounted to the receptacle to allow access to the antiseptic-soaked dressing.

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