CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD
    41.
    发明申请
    CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD 有权
    控制非分类填充装置及方法

    公开(公告)号:US20140311617A1

    公开(公告)日:2014-10-23

    申请号:US14214890

    申请日:2014-03-15

    Inventor: Daniel Py

    Abstract: An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.

    Abstract translation: 注射构件穿过限定与隔膜流体连通的密封的空的无菌室的装置的弹性隔膜。 在穿透期间,在隔膜和注射构件之间形成环形界面,所述注射构件在与无菌室流体连通的隔膜的内表面上的穿透点和与注射构件接合的隔膜的外表面之间轴向延伸。 注射构件被(i)环形界面处的隔膜和注射构件之间的摩擦和(ii)在环形界面处的隔膜伸长而被去污染。 物质通过注射构件引入并进入装置的无菌室中,然后将注射构件从隔膜中取出,隔膜在所得到的穿透孔处重新吸收,并且在整个上述步骤中腔室保持无菌。

    Valve and Method
    42.
    发明申请

    公开(公告)号:US20240401716A1

    公开(公告)日:2024-12-05

    申请号:US18732311

    申请日:2024-06-03

    Inventor: Daniel Py

    Abstract: A valve having a valve body defining a flow passageway therethrough, first and second opposing valve chambers located on opposite sides of and intersecting the passageway, first and second valve members respectively movably received within the first and second valve chambers, each valve member defining a stem that engages the other, wherein the stem of the first valve member is movable between first and second positions, and the stem of the first valve member is movable between first and second positions, wherein in the first position of the first valve stem the valve is in an open position permitting passage of substance through the passageway, and in the second position of the first valve stem the valve is in a closed position preventing passage of substance through the passageway.

    CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD

    公开(公告)号:US20210292024A1

    公开(公告)日:2021-09-23

    申请号:US17217557

    申请日:2021-03-30

    Inventor: Daniel Py

    Abstract: An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.

    Self closing and opening filling needle, needle holder, filler and method

    公开(公告)号:US10850882B2

    公开(公告)日:2020-12-01

    申请号:US16030516

    申请日:2018-07-09

    Inventor: Daniel Py

    Abstract: An apparatus for filling a device having a penetrable septum and a sealed chamber. The apparatus includes a filling member engageable with the penetrable septum to penetrate the septum, port(s), and a closure. The closure and filling member are movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). The filling member and/or septum is movable relative to the other between (i) a first position wherein the filling member is spaced from the septum, and (ii) a second position wherein the filling member is penetrated through the septum and in communication with the sealed chamber. A locking device is movable between (i) a locked position locking the closure and/or filling member in the first position, and (ii) an unlocked position allowing movement of the closure and/or filling member relative to the other and into the second position.

    Septum that decontaminates by interaction with penetrating element

    公开(公告)号:US10688020B2

    公开(公告)日:2020-06-23

    申请号:US15944094

    申请日:2018-04-03

    Inventor: Daniel Py

    Abstract: A septum is penetrable by a needle for decontamination by physical interaction. The septum can include a peripheral portion, an exterior surface, and an interior surface. A penetration portion extends between the exterior and interior surfaces, is spaced inwardly of the peripheral portion, and is penetrable by the needle or other penetrating element. A flex portion is located between the penetration portion and the peripheral portion. A thicker portion extends between the flex portion and the penetration portion, and defines an increased thickness between the exterior and interior surfaces relative to the flex portion. The flex portion is flexible inwardly relative to the peripheral portion during penetration of the penetration portion by a needle or other penetrating element. The penetration portion physically interacts with and decontaminates the needle when it penetrates the septum. The septum may also reduce or prevent retrograde contamination when the needle is withdrawn.

    DEVICES AND METHODS FOR FORMULATION PROCESSING

    公开(公告)号:US20200062430A1

    公开(公告)日:2020-02-27

    申请号:US16559388

    申请日:2019-09-03

    Abstract: Apparatuses and methods for controlling transfer of substances to a formulation container to provide a predetermined formulation. A controller may utilize one or more of a flow time, flow rate or a volume of transfer of substance. Barcoded and RFID-containing components may be used to determine what connection or disconnection has been made, and/or time thereof. Process compliance may compare measured or determined flow or connection time, flow rate and/or the transfer volume to a predetermined time, flow rate and/or volume, and adjust one or more of the time, flow rate and/or the volume of the transfer. An optional holder or cradle is configured to receive therein a fluid transfer connector formed by the connection of first and second connector portions, each in fluid communication with a flow conduit or channel that delivers substance to or receives substance from its respective connector portion, only if the connector portions are properly connected together. One or more sensors may be used to determine identification information of the connector and/or flow rates of substance through the connector.

    Devices and methods for formulation processing

    公开(公告)号:US10399713B2

    公开(公告)日:2019-09-03

    申请号:US15410758

    申请日:2017-01-19

    Abstract: Apparatuses and methods for controlling transfer of substances to a formulation container to provide a predetermined formulation. A controller may utilize one or more of a flow time, flow rate or a volume of transfer of substance. Barcoded and RFID-containing components may be used to determine what connection or disconnection has been made, and/or time thereof. Process compliance may compare measured or determined flow or connection time, flow rate and/or the transfer volume to a predetermined time, flow rate and/or volume, and adjust one or more of the time, flow rate and/or the volume of the transfer. An optional holder or cradle is configured to receive therein a fluid transfer connector formed by the connection of first and second connector portions, each in fluid communication with a flow conduit or channel that delivers substance to or receives substance from its respective connector portion, only if the connector portions are properly connected together. One or more sensors may be used to determine identification information of the connector and/or flow rates of substance through the connector.

    SELF CLOSING AND OPENING FILLING NEEDLE, NEEDLE HOLDER, FILLER AND METHOD

    公开(公告)号:US20190009939A1

    公开(公告)日:2019-01-10

    申请号:US16030516

    申请日:2018-07-09

    Inventor: Daniel Py

    Abstract: An apparatus for filling a device having a penetrable septum and a sealed chamber. The apparatus includes a filling member engageable with the penetrable septum to penetrate the septum, port(s), and a closure. The closure and filling member are movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). The filling member and/or septum is movable relative to the other between (i) a first position wherein the filling member is spaced from the septum, and (ii) a second position wherein the filling member is penetrated through the septum and in communication with the sealed chamber. A locking device is movable between (i) a locked position locking the closure and/or filling member in the first position, and (ii) an unlocked position allowing movement of the closure and/or filling member relative to the other and into the second position.

    DEVICE FOR CONNECTING OR FILLING AND METHOD
    50.
    发明申请

    公开(公告)号:US20180363819A1

    公开(公告)日:2018-12-20

    申请号:US16000172

    申请日:2018-06-05

    Inventor: Daniel Py

    Abstract: A valve comprises a shell, a flexible valve member sealingly mounted within the shell, and a valve body mounted atop the flexible valve member within the shell. The flexible member is moveable between closed and open positions to allow the flow of fluid therethrough. The valve is engageable with a filling device having flow ports and a surrounding closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). Alternatively, the valve may comprise a portion of a female connector and the filling device may comprise a portion of a male connector to form an aseptic fluid connector for the aseptic transfer of fluid therethrough.

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