Chemical manufacturing, particularly pharmaceutical manufacturing, often requires aseptic sealing of the vessel within which the manufacturing process occurs and within the lines and conduits connected to said vessel. Aseptic sealing in such manufacturing typically requires the aseptic seal to withstand the pressures associated with the manufacturing process without leaking, breaking, or rupturing. A number of clamps, valves, connectors, and other fasteners have been developed to provide aseptic sealing of chemical manufacturing equipment in pressurized environments.
Recently, many chemical manufacturing processes have transitioned to single-use processing equipment as opposed to reusable processing systems which require stringent sterilization regimes using harsh chemicals and high temperature steam after each use. Single-use systems conduct the entire duration of the production process in a single batch, utilizing processing equipment that is transported off-site for sterilization using gamma, EtO, or x-ray sterilization methods. These methods provide greater assurance of sterility at a lower cost than steam sterilizing multi-use metal systems. The requirement of replacing the entire process assembly creates a need for products that assemble quickly and accurately.
Single-use processing equipment—in which the various components are typically manufactured of a polymer material as opposed to metals found in reusable processing systems—suffers from several flaws when compared to reusable processing systems. Most notably, an entire processing system must be assembled for each production batch. This process is time consuming and labor intensive—often conducted by hand by several individuals operating in a clean-room environment. In addition, the multitude of conduits and connections involved in any one single-use system increases the chances that any one connection may be assembled without maintaining aseptic sealing and/or without maintaining sealing capable of withstanding manufacturing pressures when the system is in operation without leaking, breaking, or rupturing.
The need exists, therefore, for improved equipment for assembling single-use aseptic pressurized chemical manufacturing systems which can be assembled quickly and easily by hand.
Disclosed herein is a clamp system comprising a first clamp, a second clamp, and a joining member. The first clamp comprising a first clamp first section and a first clamp second section. The second clamp comprising a second clamp first section and a second clamp second section.
The first clamp first section has a first semi-circular wall, a first wall first engagement member, and a first wall second engagement member. The first semi-circular wall has a first inner surface, a first outer surface, a first wall first end point, and a first wall second end point. The first wall first engagement member is attached to the first outer surface at the first wall first end point. The first wall second engagement member is attached to the first outer surface at the first wall second end point.
The first clamp second section has a second semi-circular wall, a second wall first engagement member, and a second wall second engagement member. The second semi-circular wall has a second inner surface, a second outer surface, a second wall first end point, and a second wall second end point. The second wall first engagement member is attached to the second outer surface at the second wall first end point. The second wall second engagement member is attached to the second outer surface at the second wall second end point.
The second clamp first section has a third semi-circular wall, a third wall first engagement member, and a third wall second engagement member. The third semi-circular wall has a third inner surface, a third outer surface, a third wall first end point, and a third wall second end point. The third wall first engagement member is attached to the third outer surface at the third wall first end point. The third wall second engagement member is attached to the third outer surface at the third wall second end point.
The second clamp second section has a fourth semi-circular wall, a fourth wall first engagement member, and a fourth wall second engagement member. The fourth semi-circular wall has a fourth inner surface, a fourth outer surface, a fourth wall first end point, and a fourth wall second end point. The fourth wall first engagement member is attached to the fourth outer surface at the fourth wall first end point. The fourth wall second engagement member is attached to the fourth outer surface at the fourth wall second end point.
The joining member comprises a cylindrical section, a first protrusion, and a second protrusion. The first protrusion is attached to and extends from a cylindrical section outer edge. The second protrusion is attached to and extends from the cylindrical section outer edge at a position approximately 180° apart from the first protrusion about a circumference of the cylindrical section.
The first wall first engagement member is configured to connect to a first portion of the first protrusion. The first wall second engagement member is configured to connect to a first portion of the second protrusion. The second wall first engagement member is configured to connect to a second portion of the first protrusion. The second wall second engagement member is configured to connect to a second portion of the second protrusion. The third wall first engagement member is configured to connect to a third portion of the first protrusion. The third wall second engagement member is configured to connect to a third portion of the second protrusion. The fourth wall first engagement member is configured to connect to a fourth portion of the first protrusion. The fourth wall second engagement member is configured to connect to a fourth portion of the second protrusion.
In some embodiments, the first wall first engagement member may comprise a first channel comprising a plurality of first channel teeth, the first wall second engagement member may comprise a second channel comprising a plurality of second teeth, the second wall first engagement member may comprise a third channel comprising a plurality of third channel teeth, and the second wall second engagement member may comprise a fourth channel comprising a plurality of fourth channel teeth. In such embodiments, the first protrusion may comprise a first protrusion first sidewall comprising a first plurality of teeth and a second plurality of teeth, and the second protrusion may comprise a second protrusion first sidewall comprising a third plurality of teeth and a fourth plurality of teeth. The first clamp first section may be configured to connect to the joining member by engaging the plurality of first channel teeth to the first plurality of teeth and the plurality of second channel teeth to third plurality of teeth. The first clamp second section may be configured to connect to the joining member by engaging the plurality of third channel teeth to the second plurality of teeth and the plurality of fourth channel teeth to the fourth plurality of teeth.
In certain embodiments, the plurality of first channel teeth may be arranged vertically along at least a portion of a first bottom wall of the first channel, the plurality of second channel teeth may be arranged vertically along at least a portion of a second bottom wall of the second channel, the plurality of third channel teeth may be arranged vertically along at least a portion of a third bottom wall of the third channel, and the plurality of fourth channel teeth may be arranged vertically along at least a portion of a fourth bottom wall of the fourth channel. In some embodiments, the first plurality of teeth may be arranged vertically along an upper portion of the first protrusion first sidewall, the second plurality of teeth may be arranged vertically along a lower portion of the first protrusion first sidewall, the third plurality of teeth may be arranged vertically along an upper portion of the second protrusion first sidewall, and the fourth plurality of teeth may be arranged vertically along a lower portion of the second protrusion first sidewall.
In some embodiments, the third wall first engagement member may comprise a fifth channel comprising a plurality of fifth channel teeth, the third wall second engagement member may comprise a sixth channel comprising a plurality of sixth channel teeth, the fourth wall first engagement member may comprise a seventh channel comprising a plurality of seventh channel teeth, and the fourth wall second engagement member may comprise an eighth channel comprising a plurality of eighth channel teeth. In such embodiments, the first protrusion may comprise a first protrusion second sidewall comprising a fifth plurality of teeth and a sixth plurality of teeth, and the second protrusion may comprise a second protrusion second sidewall comprising a seventh plurality of teeth and an eighth plurality of teeth. The second clamp first section may be configured to connect to the joining member by engaging the plurality of fifth channel teeth to the plurality of fifth teeth and engaging the plurality of sixth channel teeth to the seventh plurality of teeth. The second clamp second section may be configured to connect to the joining member by engaging the plurality of seventh channel teeth to the plurality of sixth teeth and engaging the plurality of eighth channel teeth to the eighth plurality of teeth.
In certain embodiments, the plurality of fifth channel teeth may be arranged vertically along at least a portion of a fifth bottom wall of the fifth channel, the plurality of sixth channel teeth may be arranged vertically along at least a portion of a sixth bottom wall of the sixth channel, the plurality of seventh channel teeth may be arranged vertically along at least a portion of a seventh bottom wall of the seventh channel, and the plurality of eight channel teeth may be arranged vertically along at least a portion of an eighth bottom wall of the eighth channel. In some embodiments, the fifth plurality of teeth may be arranged vertically along an upper portion of the first protrusion second sidewall, the sixth plurality of teeth may be arranged vertically along a lower portion of the first protrusion second sidewall, the seventh plurality of teeth may be arranged vertically along an upper portion of the second protrusion second sidewall, and the eighth plurality of teeth may be arranged vertically along a lower portion of the second protrusion second sidewall.
In some embodiments, the first protrusion may comprise a first protrusion channel located between the first protrusion first sidewall and the first protrusion second sidewall. In certain embodiments, the second protrusion may comprise a second protrusion channel located between the second protrusion first sidewall and the second protrusion second sidewall.
In certain embodiments, the first wall first engagement member may comprise a first hinge section and the first wall second engagement member may comprise a first plurality of inwardly facing teeth. In such embodiments, the second wall first engagement member may comprise a second hinge section and the second wall second engagement member may comprise a first plurality of outwardly facing teeth. The first clamp first section may be configured to connect to the first clamp second section by mating the first hinge section to the second hinge section and mating the first plurality of inwardly facing teeth to the first plurality of outwardly facing teeth.
In some embodiments, the first semi-circular wall may include a first clamping surface which is angled inwardly from the first inner surface towards the first outer surface. The second semi-circular wall may include a second clamping surface which is angled inwardly from the second inner surface towards the second outer surface.
In certain embodiments, the third semi-circular wall may include a third clamping surface which is angled inwardly from the third inner surface towards the third outer surface. The fourth semi-circular wall may include a fourth clamping surface which is angled inwardly from the fourth inner surface towards the fourth outer surface.
In some embodiments, the first clamp is comprised of a material selected from the group consisting of polymeric materials, glass filled polymer materials, and silicone materials. In certain embodiments, the second clamp is comprised of a material selected from the group consisting of polymeric materials, glass filled polymer materials, and silicone materials. In some embodiments, the joining member is comprised of a material selected from the group consisting of polymeric materials, glass filled polymer materials, and silicone materials.
Disclosed herein is a clamp system. The clamp system is described below with reference to the Figures. As described herein, the following numbers refer to the following structures as noted in the Figures.
Each of the first protrusion (320) and the second protrusion (330) may include a pair of opposing sidewalls. That is to say that the first protrusion may include a first protrusion first sidewall (321) and a first protrusion second sidewall (322) opposing the first protrusion first sidewall. Similarly, the second protrusion may include a second protrusion first sidewall (331) and a second protrusion second sidewall (332) opposing the first protrusion first sidewall.
The cylindrical section (310) may include an opening (312) substantially parallel with or parallel with a central axis thereof. The opening allows fluid from the first conduit section (400) to flow through the joining member (300) into the second conduit section (500) or vice versa.
Opposing faces (313 and 314) of the cylindrical section (310) may include one or more sealing members (315). These sealing members—which may take the form of a gasket, an o-ring, or the like—may be configured to engage a corresponding sealing structure—such as a flange face (420/520), an o-ring groove (430/530), or the like—of the first conduit section (400) and second conduit section (500) respectively to improve sealing between the clamp system (10) and the conduit sections.
In certain embodiments, such as shown in
As further shown in
Similarly, the first clamp second section (150) includes a second semi-circular wall (160). Attached to opposing end points ((163) and (164) as shown in
The second clamp (200) may be of similar or identical construction to the first clamp (100). As shown in
Similarly, the second clamp second section (250) includes a fourth semi-circular wall (260). Attached to opposing end points ((263) and (264) as shown in
As shown in
Preferably, the plurality of first channel teeth (132) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the first channel teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the first channel teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
The first wall second engagement member (140)—attached to the first outer surface (122) of the first semi-circular wall (120) at the first wall second end point (124)—may be of similar or identical construction to the first wall first engagement member (130). That is to say that, in the first wall second engagement member shown in
Preferably, the plurality of second channel teeth (142) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the second channel teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the second channel teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
Preferably, the plurality of third channel teeth (172) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the third channel teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the third channel teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
The second wall second engagement member (180)—attached to the second outer surface (162) of the second semi-circular wall (160) at the second wall second end point (164)—may be of similar or identical construction to the second wall first engagement member (170). That is to say that, in the second wall second engagement member shown in
Preferably, the plurality of fourth channel teeth (182) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the fourth channel teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the fourth channel teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
As shown in
Preferably, the first plurality of teeth (323), the second plurality of teeth (324), the third plurality of teeth (333) and the fourth plurality of teeth (334) are each individually fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
As shown in
While
As shown in
Preferably, the plurality of fifth channel teeth (232) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
The third wall second engagement member (240)—attached to the third outer surface (222) of the third semi-circular wall (220) at the third wall second end point (224)—may be of similar or identical construction to the third wall first engagement member (230). That is to say that, in the third wall second engagement member shown in
Preferably, the plurality of sixth channel teeth (242) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the sixth channel teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the sixth channel teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
Preferably, the plurality of seventh channel teeth (272) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the seventh channel teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the seventh channel teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
The fourth wall second engagement member (280)—attached to the fourth outer surface (262) of the fourth semi-circular wall (260) at the fourth wall second end point (264)—may be of similar or identical construction to the fourth wall first engagement member (270). That is to say that, in the fourth wall second engagement member shown in
Preferably, the plurality of eighth channel teeth (282) are fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the eighth channel teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the eighth channel teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
As shown in
Preferably, the fifth plurality of teeth (325), the sixth plurality of teeth (326), the seventh plurality of teeth (335) and the eighth plurality of teeth (336) are each independently fine teeth defined by having an integral tooth dimension of at least 1.02 mm and no greater than 1.78 mm. The integral tooth dimension of the teeth may also be at least 1.14 mm, or at least 1.27 mm. The integral tooth dimension of the teeth may also be no greater than 1.65 mm, no greater than 1.52 mm, or no greater than 1.40 mm. The integral tooth dimension may also be defined as a range selected from the group consisting of between 1.02 mm and 1.65 mm, between 1.02 mm and 1.52 mm, between 1.02 mm and 1.40 mm, between 1.14 mm and 1.78 mm, between 1.14 mm and 1.65 mm, between 1.14 mm and 1.52 mm, between 1.14 mm and 1.40 mm, between 1.27 mm and 1.78 mm, between 1.27 mm and 1.65 mm, between 1.27 mm and 1.52 mm, and between 1.27 mm and 1.40 mm.
As shown in
While the Figures show the clamp system connecting two conduit sections to one another, other uses may exist. For example, the clamp system may be utilized to connect a conduit section to a port in a bag (sometimes referred to as a bag port) thereby allowing the bag to be filled with material passing from the conduit section through the bag port. In such embodiments, the conduit section may be thought of as the first conduit section while the bag port may be thought of as the second conduit section.
While
Turning to
In
Finally, reverting to
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Like the embodiment shown in
In the embodiment shown in
Also shown in the embodiment in
In some embodiments, the first wall first second engagement member (140) and/or the second wall second engagement member (180) may include a thumb protrusion (referred to herein as a first thumb protrusion (145) and a second thumb protrusion (185) respectively). When present, the thumb protrusion(s) allow a user to easily pivot the first clamp first section (110) and the first clamp second section (150) about an axis formed by the first hinge section (134) and the second hinge section (174) to mate the first plurality of inwardly facing teeth (144) with the first plurality of outwardly facing teeth (184) during assembly of the first clamp (100).
The components of the clamp system disclosed herein—including the first clamp first section (110), the first clamp second section (150), the second clamp first section (210), the second clamp second section (250), and/or the joining member (300)—may be fabricated of any number of materials utilizing any number of manufacturing techniques. Non-limiting examples of such materials include polymeric materials, glass filled polymer materials—specifically glass filled nylon, and silicone materials. Non-limiting examples of such manufacturing techniques include injection molding and additive manufacturing (also referred to as 3D printing).
The clamp systems disclosed herein allow for assemblers to quickly and easily assemble single-use aseptic pressurized chemical manufacturing systems. The toothed engagements ensure that the user can quickly snap or click the clamp sections together to a position where they maintain aseptic sealing of conduit sections or other chemical manufacturing equipment. The teeth then prevent—or at least reduce the risk of—leaking breaking, or rupturing as the teeth cannot be pulled apart of disengaged once assembled without the use of an external tool such as the blade of a screw driver to physically pry the clamp sections apart. The clamp systems disclosed herein also allow for the clamp(s) and conduit section(s) to be provided to a user at least partially pre-assembled (following optional sterilization using gamma, EtO, or x-ray sterilization methods) which reduces the amount of user contact with the components during assembly and thereby reduces the risk of part contamination during assembly.
While the system has been described as having one or more exemplary designs, the present system may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the system using its general principles.
This Application claims priority from U.S. Provisional Application No. 63/588,793 filed on 9 Oct. 2023, the teachings of which are incorporated by reference herein in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63588793 | Oct 2023 | US |