Protective cap for container for transferring sterile components

Abstract

A container is configured for transferring a sterile component from the container into a sterile chamber through a transfer port. The container includes a flexible bag defining an interior cavity and a connection flange connected to the flexible bag. The connecting flange has an opening for access to the interior cavity of the flexible bag. An access door is connected to the connecting flange for sealing the opening. The container includes a protective cover removably connected to the connecting flange and at least partially covering the access door. The protective cover is transparent to permit viewing of the access door.

Description

Cross-references to related applications

[0001] This application claims priority to European application No. 23306439.3, filed on August 31, 2023, entitled “ProtectiveCover for Container for Transfer of Sterilized Components”, the disclosure of which is incorporated herein by reference in its entirety.

[0002] background This disclosure of the field This disclosure generally relates to the packaging and transfer of sterile components used in, for example, medical devices. More specifically, this disclosure relates to a protective cap for a channel lid or channel door of a container (i.e., a bag) used for transferring sterile components (e.g., a plunger stop).

[0003] Description of related technologies As is known in the art, transfer or storage devices (e.g., syringes) for delivering pharmaceuticals, drugs, or vaccines utilize a plunger stop that contacts the inner surface of a syringe barrel, which is typically tubular, to draw material into the device (or expel material from the device) via a plunger rod.

[0004] Currently, many such devices use automated filling machines for filling and assembly. These machines not only improve productivity and accuracy, but they also provide a substantially sterile and contamination-free filling environment to maintain an aseptic filling process. The various components of these devices (e.g., plunger stops, syringe barrels, etc.) are housed within the filling machine to enable at least a degree of automated assembly.

[0005] Typically, multiple plunger stops are initially placed in a generally flexible bag or similar container for retrieval by a filling machine prior to assembly. The bag usually has a passageway configured to connect to a transfer port of an automated filling machine. The bag and its contents are sterilized by, for example, gamma (γ) irradiation, steam, or the like. In this way, the plunger stops can be transferred directly from a first sterile environment (i.e., a sterile bag) to a second sterile environment (i.e., a sterile filling machine).

[0006] The passageway door of a transfer bag is typically protected by a protective cap to prevent contamination during transport and handling before connection to an aseptic filling machine. Generally, the protective cap is a fabric cap with an elastic band configured to fit around the flange of the passageway door. Several disadvantages exist associated with existing protective caps for transfer bags. The fabric material of the protective cap is opaque, thus hindering visual inspection of the integrity of the passageway door. To allow the user to inspect the integrity of the passageway door, the protective cap must be temporarily removed, exposing the passageway door to undesirable contamination. The elastic band of the protective cap can be installed in multiple positions relative to the passageway door, resulting in low repeatability of the preferred installation. Summary of the Invention

[0007] In view of the above, there is a need for an improved protective cover that is used in conjunction with a transfer bag to protect the passageway cover or door of the transfer bag during transport and storage. Ideally, this improved protective cover addresses the shortcomings of existing protective covers, allowing for visual inspection of the integrity of the passageway door and preferably offering high repeatability of installation.

[0008] According to some non-limiting embodiments or aspects of this disclosure, a container is provided configured to transfer sterile components from the container to a sterile chamber via a transfer port. The container may include a flexible bag defining an internal cavity and a connecting flange connected to the flexible bag. The connecting flange may have an opening for access to the internal cavity of the flexible bag. A passage door may be connected to the connecting flange to seal the opening, and a protective cap may be removably connected to the connecting flange to at least partially cover the passage door. The protective cap may be transparent.

[0009] According to some non-limiting embodiments or aspects of this disclosure, the connecting flange may include at least one radial recess extending radially inward from a peripheral surface of the connecting flange. The protective cover may include at least one locking tab configured to be received within the at least one radial recess. The at least one radial recess may be a plurality of radial recesses radially spaced apart with respect to the central axis of the connecting flange. The at least one locking tab may be a plurality of locking tabs radially spaced apart with respect to the central axis of the protective cover.

[0010] According to some non-limiting embodiments or aspects of this disclosure, the protective cover can rotate relative to the connecting flange between an unlocked position and a locked position. In the unlocked position, the at least one locking tab is radially aligned with the at least one radial recess such that the at least one locking tab is received within the at least one radial recess to allow the protective cover to be removed from the connecting flange. In the locked position, the at least one locking tab is radially offset relative to the at least one radial recess to prevent the protective cover from being removed from the connecting flange. At least one of the connecting flange and the protective cover may have a locking indicator configured to indicate the locked position of the protective cover.

[0011] According to some non-limiting embodiments or aspects of this disclosure, the protective cover may include an observation window located above the at least one locking tab. The observation window may be configured to allow visual presence of at least one radial recess on the connecting flange when the protective cover is in the unlocked position.

[0012] According to some non-limiting embodiments or aspects of this disclosure, the connecting flange may include a peripheral lip. The protective cover may have at least one clip configured to snap into the peripheral lip of the connecting flange. The protective cover may have at least one rib projecting from an inner surface toward the rigid collar and the passageway. The at least one rib may be configured to apply a constant pressure at the interface with at least one of the connecting flange and the passageway.

[0013] According to some non-limiting embodiments or aspects of this disclosure, the protective cover may include a seal configured to engage at least one of the connecting flange and the passageway door. A pressure control device may be configured to release excess pressure in the direction from the internal cavity of the flexible bag to the atmosphere.

[0014] According to some non-limiting embodiments or aspects of this disclosure, the container may include a tamper evident indicator located on the protective cover. The tamper evident indicator may be a tearable shrink sleeve or tab mounted around the periphery of the protective cover.

[0015] According to some non-limiting embodiments or aspects of this disclosure, the protective cover may be clear or tinted. The protective cover may be made of a rigid plastic material suitable for at least one of steam sterilization, gamma sterilization, and ethylene oxide sterilization.

[0016] According to some non-limiting embodiments or aspects of this disclosure, an assembly is provided for transferring sterile components from a container to a sterile chamber via a transfer port. The assembly may include a connecting flange having an opening, a channel door connected to the connecting flange for sealing the opening, and a protective cap removably connected to the connecting flange. The protective cap may be transparent.

[0017] Various other aspects of this disclosure are set forth in one or more of the following provisions: Article 1: A container configured to transfer sterile parts from the container to a sterile chamber via a transfer port, the container comprising: a flexible bag defining an internal cavity; a connecting flange connected to the flexible bag and having an opening for access to the internal cavity of the flexible bag; a passage door connected to the connecting flange for sealing the opening; and a protective cap removably connected to the connecting flange to at least partially cover the passage door, wherein the protective cap is at least partially transparent and / or translucent.

[0018] Article 2: The container according to Article 1, wherein the connecting flange includes at least one radial recess extending radially inward from the peripheral surface of the connecting flange, and wherein the protective cover includes at least one locking tab configured to be received within the at least one radial recess.

[0019] Article 3: The container according to Article 2, wherein the at least one radial recess is a plurality of radial recesses radially spaced apart about the central axis of the connecting flange, and wherein the at least one locking tab is a plurality of locking tabs radially spaced apart about the central axis of the protective cover.

[0020] Article 4: Container according to Article 2 or 3, wherein the protective cover is rotatable relative to the connecting flange between an unlocked position and a locked position, in the unlocked position, the at least one locking tab is radially aligned with the at least one radial recess such that the at least one locking tab is received by the at least one radial recess to allow the protective cover to be removed from the connecting flange, and in the locked position, the at least one locking tab is radially offset relative to the at least one radial recess to prevent the protective cover from being removed from the connecting flange.

[0021] Article 5: A container according to any one of Articles 2 to 4, wherein the protective cover includes an observation window located above the at least one locking tab, and wherein the observation window is configured to allow visual presentation of the at least one radial recess on the connecting flange when the protective cover is in the unlocked position.

[0022] Article 6: A container according to any one of Articles 2 to 5, wherein at least one of the connecting flange and the protective cover has a locking indicator configured to indicate the locked position of the protective cover.

[0023] Article 7: The container according to Article 1, wherein the connecting flange includes a peripheral lip, wherein the protective cover includes at least one clip, and wherein the at least one clip is configured to snap into the peripheral lip.

[0024] Article 8: A container according to any one of Articles 1 to 7, wherein the protective cover has at least one rib projecting from an inner surface toward a rigid collar and the passage door, wherein the connecting flange includes an annular seal, and wherein the at least one rib is configured to contact the annular seal when the protective cover is attached to the connecting flange.

[0025] Article 9: A container according to any one of Articles 1 to 8, wherein the protective cover includes a seal configured to engage at least one of the connecting flange and the passage door.

[0026] Article 10: The container according to any one of Articles 1 to 9 further includes a pressure control device configured to release excess pressure in the direction from the internal cavity of the flexible bag to the atmosphere.

[0027] Article 11: For containers pursuant to any of Articles 1 to 10, the container also includes a tamper-evident indicator located on the protective cover.

[0028] Article 12: Containers pursuant to Article 11, wherein the tamper indicator is a tearable shrink sleeve or tab mounted around the periphery of the protective cover.

[0029] Article 13: Containers according to any one of Articles 1 to 12, wherein the protective cover is clearly visible.

[0030] Article 14: Containers according to any one of Articles 1 to 12, wherein the protective cap is colored.

[0031] Article 15: A container according to any one of Articles 1 to 14, wherein the protective cover is made of a rigid plastic material suitable for at least one of steam sterilization, gamma sterilization and ethylene oxide sterilization.

[0032] Article 16: An assembly for transferring sterile parts from a container to a sterile chamber via a transfer port, the assembly comprising: a connecting flange having an opening; a channel door connected to the connecting flange for sealing the opening; and a protective cap removably connected to the connecting flange, wherein the protective cap is at least partially transparent and / or translucent.

[0033] Article 17: The component according to Article 16, wherein the connecting flange includes at least one radial recess extending radially inward from a peripheral surface of the connecting flange, and wherein the protective cover includes at least one locking tab configured to be received within the at least one radial recess.

[0034] Article 18: The component according to Article 17, wherein the at least one radial recess is a plurality of radial recesses radially spaced apart about the central axis of the connecting flange, and wherein the at least one locking tab is a plurality of locking tabs radially spaced apart about the central axis of the protective cover.

[0035] Article 19: Components according to Article 17 or 18, wherein the protective cover is rotatable relative to the connecting flange between an unlocked position and a locked position, in the unlocked position, the at least one locking tab is radially aligned with the at least one radial recess such that the at least one locking tab is received by the at least one radial recess to allow the protective cover to be removed from the connecting flange, and in the locked position, the at least one locking tab is radially offset relative to the at least one radial recess to prevent the protective cover from being removed from the connecting flange.

[0036] Article 20: Components according to any one of Articles 17 to 19, wherein the protective cover includes an observation window located above the at least one locking tab, and wherein the observation window is configured to allow visual presentation of the at least one radial recess on the connecting flange when the protective cover is in the unlocked position.

[0037] Article 21: Components according to any one of Articles 17 to 20, wherein at least one of the connecting flange and the protective cover has a locking indicator configured to indicate the locked position of the protective cover.

[0038] Article 22: The component according to Article 16, wherein the connecting flange includes a peripheral lip, wherein the protective cover includes at least one clip, and wherein the at least one clip is configured to snap into the peripheral lip.

[0039] Article 23: An assembly according to any one of Articles 16 to 22, wherein the protective cover has at least one rib projecting from an inner surface toward the rigid collar and the passage door, wherein the connecting flange includes an annular seal, and wherein the at least one rib is configured to contact the annular seal when the protective cover is attached to the connecting flange.

[0040] Article 24: An assembly according to any one of Articles 16 to 23, wherein the protective cover includes a first seal configured to engage at least one of the connecting flange and the passage door, or wherein the protective cover is configured to engage a second seal on at least one of the connecting flange and the passage door.

[0041] Article 25: The component according to any one of Articles 16 to 24 further includes a pressure control device configured to discharge excess pressure in the direction from the opening of the connecting flange to the atmosphere.

[0042] Article 26: The component according to any one of Articles 16 to 25 further includes a tamper indicator located on the protective cover.

[0043] Article 27: Components according to Article 26, wherein the tamper indicator is a tearable shrink sleeve or tab mounted around the periphery of the protective cover.

[0044] Article 28: Components according to any one of Articles 16 to 27, wherein the protective cover is clear.

[0045] Article 29: Components according to any one of Articles 16 to 27, wherein the protective cover is colored.

[0046] Article 30: Components according to any one of Articles 16 to 29, wherein the protective cover is made of a rigid plastic material suitable for at least one of steam sterilization, gamma sterilization and ethylene oxide sterilization.

[0047] Further details and advantages of this disclosure will be understood by reading the following detailed description in conjunction with the accompanying drawings. Attached Figure Description

[0048] Figure 1 This is an exploded view of a transfer bag with a passage door according to an embodiment or aspect of this disclosure, the passage door being combined with a protective cover; Figure 2 This is a perspective view of a protective cap for a transfer bag according to an embodiment or aspect of this disclosure; Figure 3 for Figure 2 A partial side cross-sectional view of the protective cover shown; Figure 4 This is a top perspective view of the connecting collar of a transfer bag according to an embodiment or aspect of this disclosure; Figure 5 A bottom view of the connecting collar and protective cover of a transfer bag according to an embodiment or aspect of this disclosure, wherein the protective cover is shown in the unlocked position; Figure 6A bottom view of the connecting collar and protective cap of a transfer bag according to an embodiment or aspect of this disclosure, wherein the protective cap is shown in the locked position; Figure 7 for Figure 6 The side view of the connecting collar and the side cross-sectional view of the protective cover are shown. Figure 8 for Figure 7 A magnified view of a portion; Figure 9 A side view of a connecting collar and a protective cap of a transfer bag according to an embodiment or aspect of this disclosure, wherein the protective cap is shown being removed from the connecting collar; Figure 10 for Figure 9 A side view of the connecting collar of the transfer bag, wherein the protective cover is shown as being connected to the connecting collar; Figure 11 A partial side cross-sectional view of a protective cap for a transfer bag according to an embodiment or aspect of this disclosure; and Figures 12A to 12C This is a bottom view of a protective cap for a transfer bag according to an additional embodiment or aspect of this disclosure. Detailed Implementation

[0049] The following description is provided to enable those skilled in the art to make and use the aspects contemplated for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0050] Unless the context clearly indicates otherwise, the singular forms “a,” “one,” and “the” used in this article include plural referents.

[0051] Spatial or directional terms (e.g., "left", "right", "inner", "outer", "above", "below", etc.) are related to the embodiments or aspects shown in the figures and should not be considered limiting, as these embodiments or aspects may take various alternative orientations.

[0052] All figures used in the specification and claims should be understood to be modified in all cases by the term "about". "About" means within 25 percent of the stated value, either positive or negative. However, this should not be considered a limitation on any numerical analysis under the principle of equivalence.

[0053] Unless otherwise stated, all ranges or ratios disclosed herein should be understood to encompass both the starting and ending values, as well as any and all subranges or subratios contained therein. For example, the stated range or ratio “1 to 10” should be considered to include any and all subranges or subratios between the minimum value of 1 and the maximum value of 10 (inclusive); that is, all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average of a particular range and / or ratio.

[0054] The terms “first”, “second”, etc., do not refer to any specific order or sequence, but rather to different conditions, characteristics, or elements.

[0055] All documents mentioned in this article are incorporated in full by reference.

[0056] The term "at least" is synonymous with "greater than or equal to".

[0057] As used herein, “at least one of…” is synonymous with “one or more of…”. For example, the phrase “at least one of A, B, or C” means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, “at least one of A, B, and C” includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.

[0058] The terms "comprising" and "including" do not exclude the presence of any elements or steps other than those listed in any claim or the entire specification. In this specification, "comprising" means "including," and "including" means "comprising."

[0059] As used herein, the term “parallel” or “substantially parallel” means that the relative angle between two objects (if extended to a theoretical intersection point) (e.g., elongated objects and including reference lines) is from 0° to 5°, or from 0° to 3°, or from 0° to 2°, or from 0° to 1°, or from 0° to 0.5°, or from 0° to 0.25°, or from 0° to 0.1° (inclusive).

[0060] As used herein, the terms “vertical,” “lateral,” “substantially vertical,” or “substantially lateral” mean that the relative angle between two objects at their actual or theoretical intersection is 85° to 90°, or 87° to 90°, or 88° to 90°, or 89° to 90°, or 89.5° to 90°, or 89.75° to 90°, or 89.9° to 90° (inclusive).

[0061] refer to Figure 1This illustration shows a component transfer container 50 according to an embodiment or aspect of the present disclosure. The transfer container 50 is configured to transfer sterile components from the transfer container 50 to a sterile chamber of a processing machine via a transfer port. The transfer container 50 includes a flexible master bag 52 having a distal end 54 and a proximal end 56 and defining an internal cavity 55. The distal end 54 is closed, while the proximal end 56 is open, preferably in the form of an annular opening. In some embodiments or aspects, the flexible master bag 52 may taper towards the proximal end 56, for example, in the form of a bottleneck. The flexible master bag 52 may be formed of any suitable flexible material suitable for steam sterilization, gamma sterilization, or ethylene oxide sterilization. Examples of such flexible materials may include, for example, polyethylene (PE), high-density polyethylene (HDPE), thermoplastic elastomer (TPE), polypropylene, polyvinylidene fluoride (PVDF), etc. In addition, the internal cavity 55 of the flexible master bag 52 is sized and configured to accommodate multiple sterile components 58, such as multiple plunger stops, multiple needle caps, multiple end caps, etc.

[0062] Still referencing Figure 1 The transfer container 50 also includes a connecting flange 60. The connecting flange 60 can be formed of any suitable rigid material suitable for steam sterilization, gamma sterilization, or ethylene oxide sterilization, such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyvinylidene fluoride (PVDF), polybutylene terephthalate (PBT), etc. The connecting flange 60 is configured to support a locking force against the door of the transfer inlet of the sterile chamber. In some embodiments or aspects, the connecting flange 60 includes a distal end 61 configured for a twist-lock connection to the transfer inlet. However, it should be understood that the connecting flange 60 can be configured for connection to the transfer inlet in other forms (e.g., magnetic connection). The distal end 61 may have an annular seal 67 projecting relative to the distal surface 69 of the distal end 61. As described herein, the annular seal 67 can be configured for sealing engagement with the protective cap.

[0063] like Figure 1As shown, the proximal end 63 of the connecting flange 60 includes an annular neck 62. The proximal end 56 of the flexible bag 52 is secured to the annular neck 62 by a rotation seal. Any suitable sealing method (e.g., heat sealing, adhesive sealing, etc.) can be used to form a rotation seal between the proximal end 56 and the annular neck 62. Thus, when the transfer container 50 is connected to the transfer port, the contents of the flexible bag 52 (i.e., component 58) can be collected through the opening 65 formed in the connecting flange 60.

[0064] Continue to refer to Figure 1 The transfer container 50 includes a passage door 66. The passage door 66 is removably connected to a connecting flange 60 to allow access to the internal cavity 55 of the transfer container 50. In some embodiments or aspects, the passage door 66 is configured to seal the transfer container 50 to maintain the sterility of the internal cavity 55 after sterilization. The passage door 66 can be completely removed from the connecting flange 60 to allow unobstructed access to the internal cavity 55. In some embodiments or aspects, the passage door 66 can remain connected to the connecting flange 60 and can move between an open position allowing access to the internal cavity 55 and a closed position sealing the connecting flange 60 and preventing access to the internal cavity 55. The passage door 66 has a sealing surface 68 configured for sealing engagement with the connecting flange 60. The sealing surface 68 may be an O-ring or a similar sealing structure configured to maintain the sterility of the internal cavity 55 by preventing external contaminants from entering the internal cavity 55.

[0065] The passageway door 66 may include one or more actuating features 69 to facilitate the connection or disconnection of the passageway door 66 from the connecting flange 60. For example, the one or more actuating features 69 may be one or more handles, one or more pull tabs, or one or more other structures. The passageway door 66 may be formed of any suitable rigid material suitable for steam sterilization, gamma sterilization, or ethylene oxide sterilization, such as polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polyvinylidene fluoride (PVDF), polybutylene terephthalate (PBT), etc.

[0066] Continue to refer to Figure 1 The transfer container 50 includes a protective cap 70 removably connected to a connecting flange 60. The protective cap 70 is configured to extend over a passage door 66 to protect the passage door 66 during transport and handling. The shape of the protective cap 70 is set to correspond to the external shape of the connecting flange 60. Together with the connecting flange 60 and the passage door 66, the protective cap 70 defines an assembly for transferring sterile parts 58 from the transfer container 50 into a sterile chamber.

[0067] As discussed herein, at least a portion of the protective cover 70 is preferably made of a transparent and / or translucent material to allow visual inspection of the condition of the passageway door 66. For example, at least a portion of the protective cover 70 may be formed of any suitable transparent and / or translucent rigid material suitable for steam sterilization, gamma sterilization, or ethylene oxide sterilization. In some embodiments or aspects, the protective cover 70 may be formed of a clearly transparent or clearly translucent material. In other embodiments or aspects, the protective cover 70 may be formed of a colored transparent or colored translucent material to provide visual contrast relative to the passageway door 66. In this way, the presence of the protective cover 70 can be easily checked by visually observing its color.

[0068] refer to Figure 2 The diagram illustrates a protective cover 70 according to one embodiment or aspect of the present disclosure. The protective cover 70 has a cover surface 74 configured to cover a connecting flange 60 and a passageway 66. In some embodiments or aspects, the shape of the cover surface 74 corresponds to the outer shape of the connecting flange 60. While the cover surface 74 can be substantially planar, other non-planar shapes are also possible. When the protective cover 70 is attached to the connecting flange 60, a portion of the inner surface of the cover surface 74 is configured to contact an annular seal 67 of the connecting flange 60. In this way, a sealing connection can be formed between the protective cover 70 and the connecting flange 60.

[0069] Continue to refer to Figure 2 The protective cover 70 has an annular edge 76 projecting from the cover surface 74. In some embodiments or aspects, the annular edge 76 has a first portion projecting away from the cover surface 74 in a direction substantially perpendicular to the plane defined by the cover surface 74, and a second portion projecting in a direction toward the central axis 79 of the protective cover 70.

[0070] Continue to refer to Figure 2 And refer to Figure 3 The annular edge 76 can be L-shaped, but other shapes are not excluded. The annular edge 76 can have a first end 76a connected to the cover surface 74 and a second free end 76b. The second free end 76b can have at least one locking tab 77, which protrudes toward the central axis 79 and is spaced apart from the cover surface 74 by a distance X. Figure 3 (As shown in the figure). At least one locking tab 77 may be a plurality of locking tabs 77 spaced apart from each other about the periphery of the cover surface 74 about a central axis 79. In some embodiments or aspects, these locking tabs 77 may have equal angular spacing from each other about the periphery of the cover surface 74. In other embodiments or aspects, these locking tabs 77 may have unequal angular spacing.

[0071] The annular edge 76 may be configured to interact with at least a portion of the connecting flange 60 to removably secure the protective cover 70 to the connecting flange 60. For example, the annular edge 76, including at least one locking tab 77, may be configured to interact with a corresponding locking feature on the connecting flange 60 to removably secure the protective cover 70 to the connecting flange 60.

[0072] refer to Figure 4 The connecting flange 60 may have at least one radial recess 78 extending radially inward from the peripheral surface 80 of the connecting flange 60. The shape of each radial recess 78 may correspond to the shape of a locking tab 77 on the protective cover 70. Each radial recess 78 is configured to receive a corresponding locking tab 77 when the protective cover 70 is aligned and connected with the connecting flange 60. The number and spacing of the radial recesses 78 on the connecting flange 60 correspond to the number and spacing of the locking tabs 77 on the protective cover 70. An annular seal 67 is positioned radially inward on the peripheral surface 80 and projects distally onto the peripheral surface.

[0073] In some embodiments or aspects, the protective cover 70 may be in an unlocked position relative to the connecting flange 60 around the central axis 79. Figure 5 ) and locked position ( Figure 6 In the unlocked position, each of the locking tabs 77 is radially aligned with the radial recess 78, such that the locking tab 77 is received by at least one radial recess 78 to allow the protective cover 70 to be removed from the connecting flange 60. In the locked position, each of the locking tabs 77 is radially offset relative to the radial recess 78 to prevent the protective cover 70 from being removed from the connecting flange 60. For example, the protective cover 70 can rotate about the central axis 79 in the direction of arrow A (as shown in the image). Figure 5 (As shown). In some embodiments or aspects, the protective cover 70 can be rotated in a first (e.g., clockwise) direction or a second (e.g., counterclockwise) direction to lock the protective cover 70 from an unlocked position to a locked position, or to unlock the protective cover 70 from a locked position to an unlocked position. In other embodiments or aspects, the protective cover 70 can be rotated in a single direction to lock the protective cover 70 and in the opposite direction to unlock the protective cover 70. For example, the protective cover 70 can be rotated in a first direction to lock the protective cover 70 from an unlocked position to a locked position, and in a second direction opposite to the first direction to unlock the protective cover 70 from a locked position to an unlocked position.

[0074] refer to Figures 7 to 8 Rotating the protective cover 70 to the locked position positions the locking tabs 77 of each protrusion 76 below the connecting flange 60 to prevent the protective cover 70 from being removed from the connecting flange 60. The distance X between the inner surface of the cover 74 and the locking tabs 77 (in...) Figure 3 (As shown in the diagram) can correspond to the thickness of the connecting flange 70. In some embodiments or aspects, such as Figure 8 As shown, the protective cover 70 has at least one rib 82 that projects from the inner surface 84 of the cover face 74 toward the connecting flange 60 and the access door 66. The at least one rib 82 may be an annular structure aligned with an annular seal 67 on the connecting flange 60. When the protective cover 70 is in the locked position, the at least one rib 82 is configured to apply a constant pressure to the annular seal 67 to seal the interface between the protective cover 70 and the connecting flange 60.

[0075] refer to Figure 2 The protective cover 70 may optionally include at least one viewing window 88 located above at least one protrusion 76. The viewing window 88 may extend through the cover surface 74 such that at least a portion of the protrusion 76 is visible through the viewing window 88. The viewing window 88 may be configured to allow visual confirmation of at least one radial recess 78 on the connecting flange 60 when the protective cover 70 is in the unlocked position. In this way, the viewing window aids in the correct alignment of the protective cover 70 relative to the connecting flange 60 during the initial connection of the protective cover 70 to the connecting flange 60.

[0076] At least one of the connecting flange 60 and the protective cover 70 may have a locking indicator configured to indicate the locked position of the protective cover 70. For example, see reference... Figures 5 to 6 The connecting flange 60 may have a first locking indicator 90, and the protective cover 70 may have a second locking indicator 92. In some embodiments or aspects, the first locking indicator 90 and the second locking indicator 92 may be a point, recess, protrusion, or other structure on the connecting flange 60 and the protective cover 70 that provides a visual indication of rotational alignment between the connecting flange 60 and the protective cover 70. For example, the first locking indicator 90 and the second locking indicator 92 may be rotationally aligned only when the protective cover 70 is in the locked position with the connecting flange 60.

[0077] refer to Figures 9 to 10 The diagram illustrates a protective cover 170 according to another embodiment or aspect of this disclosure. The connecting flange 60 includes a peripheral lip 71, and the protective cover 170 has at least one clip 172 configured for removable engagement with the peripheral lip 71 of the connecting flange 70. The at least one clip 172 may be a continuous clip extending around the entire periphery of the protective cover 170 to allow the protective cover 170 to snap onto the peripheral lip 71. In some embodiments or aspects, the at least one clip 172 may be a plurality of clips radially spaced apart from each other around the periphery of the protective cover 170. A tab 174 may be provided on an outer portion of the protective cover 170 to facilitate removal of the protective cover 170 from the connecting flange 60.

[0078] refer to Figure 11 The illustration shows a protective cover 270 according to another embodiment or aspect of this disclosure. The protective cover 270 has a seal 272 configured to engage the connecting flange 70 and the passageway 66. Figure 1 At least one of the following (shown in the diagram). Seal 272 may be disposed on the inner surface 274 of cover 276. In some embodiments or aspects, seal 272 may be an elastic O-ring.

[0079] Continue to refer to Figure 11 The protective cover 270 may have a pressure control device 278, which is configured to control the pressure from the transfer bag ( Figure 1 Excess pressure is discharged from the internal cavity (shown in the diagram) in the direction to the atmosphere. The pressure control device 278 may be a one-way valve.

[0080] Continue to refer to Figure 11 The protective cover 270 may have a tamper-evident indicator 280. The tamper-evident indicator 280 may be a tearable shrink sleeve or tab mounted around the periphery of the protective cover 270 (e.g., on at least one of the protrusions 286). The tamper-evident indicator 280 may prevent the protective cover 270 from being removed from the connecting flange 70 before the tamper-evident indicator 280 is removed.

[0081] refer to Figures 12A to 12C The protective cover 370 is shown according to an additional embodiment or aspect of this disclosure. Figures 12A to 12C The protective cover 370 shown may have the same features as those referenced herein. Figures 2 to 11 The features described in the embodiments or aspects shown are the same as those in the embodiments or aspects illustrated. In addition to the features of any one of these embodiments or aspects, Figures 12A to 12C The protective cover 370 shown also includes at least one reinforcing rib 380 extending beyond at least a portion of the cover surface 374 and configured to increase the structural rigidity of the protective cover 370. In some embodiments or aspects, the protective cover 370 may have three, four, six, or any other number of reinforcing ribs 380 projecting radially inward from the outer edge of the protective cover 370 along 382. These reinforcing ribs 380 may be spaced apart from each other about a central axis 379 around the periphery of the cover surface 374. In some embodiments or aspects, these reinforcing ribs 380 may have equal angular spacing from each other around the periphery of the cover surface 374. In other embodiments or aspects, these reinforcing ribs 380 may have unequal angular spacing. These reinforcing ribs 380 may be aligned with the locking tabs 377, for example, by positioning them between or inline with the locking tabs 377.

[0082] While several embodiments of the transfer container and protective cap arrangement are illustrated in the accompanying drawings and these embodiments have been described in detail above, other embodiments will be apparent to and readily made by those skilled in the art without departing from the scope of the invention. For example, it should be understood that this disclosure contemplates that one or more features of any embodiment may be combined with one or more features of any other embodiment to the extent possible. Therefore, the above description is intended to be illustrative and not restrictive.

Claims

1. A container configured to transfer sterile parts from the container to a sterile chamber via a transfer port, the container comprising: Flexible bag, the flexible bag defining an internal cavity; A connecting flange is connected to the flexible bag, and the connecting flange has an opening for access to the internal cavity of the flexible bag; A passageway door, which is connected to the connecting flange to seal the opening; as well as A protective cover, removably attached to the connecting flange to at least partially cover the passageway door. The protective cover is at least partially transparent and / or semi-transparent.

2. The container according to claim 1, wherein, The connecting flange includes at least one radial recess extending radially inward from the peripheral surface of the connecting flange, and wherein the protective cover includes at least one locking tab configured to be received within the at least one radial recess.

3. The container according to claim 2, wherein, The at least one radial recess is a plurality of radial recesses radially spaced apart about the central axis of the connecting flange, and wherein the at least one locking tab is a plurality of locking tabs radially spaced apart about the central axis of the protective cover.

4. The container according to claim 2 or 3, wherein, The protective cover is rotatable relative to the connecting flange between an unlocked position and a locked position. In the unlocked position, the at least one locking tab is radially aligned with the at least one radial recess such that the at least one locking tab is received by the at least one radial recess to allow the protective cover to be removed from the connecting flange. In the locked position, the at least one locking tab is radially offset relative to the at least one radial recess to prevent the protective cover from being removed from the connecting flange.

5. The container according to any one of claims 2 to 4, wherein, The protective cover includes an observation window located above the at least one locking tab, wherein the observation window is configured to allow visual presentation of the at least one radial recess on the connecting flange when the protective cover is in the unlocked position.

6. The container according to any one of claims 2 to 5, wherein, At least one of the connecting flange and the protective cover has a locking indicator configured to indicate the locked position of the protective cover.

7. The container according to claim 1, wherein, The connecting flange includes a peripheral lip, wherein the protective cover includes at least one clip, and wherein the at least one clip is configured to snap into the peripheral lip.

8. The container according to any one of claims 1 to 7, wherein, The protective cover has at least one rib projecting from the inner surface toward the rigid collar and the channel door, wherein the connecting flange includes an annular seal, and wherein the at least one rib is configured to contact the annular seal when the protective cover is connected to the connecting flange.

9. The container according to any one of claims 1 to 8, wherein, The protective cover includes a seal configured to engage at least one of the connecting flange and the passage door.

10. The container according to any one of claims 1 to 9, the container further comprising a pressure control device configured to release excess pressure in the direction from the internal cavity of the flexible bag to the atmosphere.

11. The container according to any one of claims 1 to 10, the container further comprising a tamper-evident indicator located on the protective cover.

12. The container according to claim 11, wherein, The tamper-evident indicator is a tearable shrink sleeve or tab installed around the periphery of the protective cover.

13. The container according to any one of claims 1 to 12, wherein, The protective cover is clearly visible.

14. The container according to any one of claims 1 to 12, wherein, The protective cover is colored.

15. The container according to any one of claims 1 to 14, wherein, The protective cover is made of a rigid plastic material suitable for at least one of steam sterilization, gamma sterilization, and ethylene oxide sterilization.

16. An assembly for transferring sterile parts from a container to a sterile chamber via a transfer port, the assembly comprising: A connecting flange having an opening; A passageway door, which is connected to the connecting flange to seal the opening; as well as A protective cover, removably attached to the connecting flange to at least partially cover the passageway door. The protective cover is at least partially transparent and / or semi-transparent.

17. The component of claim 16, wherein, The connecting flange includes at least one radial recess extending radially inward from the peripheral surface of the connecting flange, and wherein the protective cover includes at least one locking tab configured to be received within the at least one radial recess.

18. The component of claim 17, wherein, The at least one radial recess is a plurality of radial recesses radially spaced apart about the central axis of the connecting flange, and wherein the at least one locking tab is a plurality of locking tabs radially spaced apart about the central axis of the protective cover.

19. The component according to claim 17 or 18, wherein, The protective cover is rotatable relative to the connecting flange between an unlocked position and a locked position. In the unlocked position, the at least one locking tab is radially aligned with the at least one radial recess such that the at least one locking tab is received by the at least one radial recess to allow the protective cover to be removed from the connecting flange. In the locked position, the at least one locking tab is radially offset relative to the at least one radial recess to prevent the protective cover from being removed from the connecting flange.

20. The component according to any one of claims 17 to 19, wherein, The protective cover includes an observation window located above the at least one locking tab, and wherein the observation window is configured to contact the annular seal when the protective cover is connected to the connecting flange.

21. The component according to any one of claims 17 to 20, wherein, At least one of the connecting flange and the protective cover has a locking indicator configured to indicate the locked position of the protective cover.

22. The component of claim 16, wherein, The connecting flange includes a peripheral lip, wherein the protective cover includes at least one clip, and wherein the at least one clip is configured to snap into the peripheral lip.

23. The component according to any one of claims 16 to 22, wherein, The protective cover has at least one rib projecting from the inner surface toward the rigid collar and the passage door, wherein the connecting flange includes an annular seal, and wherein the at least one rib is configured to apply a constant pressure at the connection interface with at least one of the connecting flange and the passage door.

24. The component according to any one of claims 16 to 23, wherein, The protective cover includes a seal configured to engage at least one of the connecting flange and the passage door.

25. The component according to any one of claims 16 to 24, the component further comprising a pressure control device configured to discharge excess pressure in the direction from the opening of the connecting flange to the atmosphere.

26. The component according to any one of claims 16 to 25, the component further comprising a tamper-evident indicator located on the protective cover.

27. The component of claim 26, wherein, The tamper-evident indicator is a tearable shrink sleeve or tab installed around the periphery of the protective cover.

28. The component according to any one of claims 16 to 27, wherein, The protective cover is clearly visible.

29. The component according to any one of claims 16 to 27, wherein, The protective cover is colored.

30. The component according to any one of claims 16 to 29, wherein, The protective cover is made of a rigid plastic material suitable for at least one of steam sterilization, gamma sterilization, and ethylene oxide sterilization.

Images