Fluid receiver fitting for aseptic fluid transfer and methods for making the same

Abstract

A fluid receiver fitting (FRF) for supporting aseptic fluid transfer between enclosures, as well as methods for forming the fluid receiver, is disclosed. The FRF includes a unitized seal section ( 226 ) and channel section ( 228 ) formed together by 2-shot injection molding, thereby eliminating or minimizing modes of fluid contamination where the seal section and channel section are separate members. The channel section may comprise one or more channels ( 286 ) for insertion of a needle (N) therein and a respective penetration zone ( 266 ) in a corresponding section of the seal section for the needle to a penetrate and thereby extract a fluid sample from a liquid stream against which a portion of the seal section is exposed. An angled interface ( 288 ) between each channel and its corresponding penetration zone provides a liquid stream pressure concentration zone which applies pressure to close a core (C) in the seal section formed by removal of the needle.

1 .- 24 . (canceled) 
     
     
         25 . A method of molding a fluid receiver fitting (FRF) for supporting aseptic transfer of a fluid, the method comprising:
 forming at least one channel in a channel section of the FRF, the at least one channel having a first end and a second end, the at least one channel section not being penetrable by a hypodermic needle when the at least one channel section is cooled; and   forming a seal section of the FRF, the seal section closing off the second end of the channel section and surrounding the at least one channel section except at the first end thereof, the seal section being penetrable by a hypodermic needle when the seal section is cooled, the seal section adhering to the channel section in a mold to form the FRF as a one-piece molded assembly.   
     
     
         26 . The method of  claim 25  further comprising:
 removing the one-piece molded assembly from the mold once the assembly has cooled; and 
 applying a sealing cover over the first end of the at least one channel via heat sealing to completely seal the at least one channel. 
 
     
     
         27 . The method of  claim 25  wherein the channel section is formed by injecting a shot of a first material into a cavity of the mold. 
     
     
         28 . The method of  claim 27  wherein the step of forming the channel section of the FRF by injecting a shot of the first material into the cavity of the mold comprises forming the second end to have an outward taper. 
     
     
         29 . The method of  claim 28  wherein the step of forming the second end of the at least one channel to have an outward taper comprises an angle θ, wherein 30°≤θ≤120°. 
     
     
         30 . The method of  claim 27  wherein the seal section is formed by injecting a shot of second material into the cavity. 
     
     
         31 . The method of  claim 30  wherein the second material is penetrable by a hypodermic needle when the second material is cooled. 
     
     
         32 . The method of  claim 31  wherein the step of forming the seal section of the FRF by injecting a shot of the second material into the cavity comprises forming a nub of the second material within the second end of the at least one channel. 
     
     
         33 . The method of  claim 31  wherein adhering the channel section and the seal section is completed by a weld defined by interface solidification of melted portions of the first material and the second material. 
     
     
         34 . The method of  claim 27  further comprising shuttling or rotating the mold after forming the at least one channel. 
     
     
         35 . The method of  claim 25  further comprising applying a sealing cover over the first end of the at least one channel via heat sealing to completely seal the at least one channel. 
     
     
         36 . The method of  claim 31  wherein the first material comprises one or more injection-moldable polymers selected from the group consisting of: nylon, polypropylene (PP), polyethylene (PE—high density, low density, LLD or VLLD), polyvinyl chloride (PVC), high impact polystyrene (HIPS), cyclic olefin co-polymer (COC), cyclic olefin polymer (COP), polyethylene vinyl acetate (EVA), polystyrene (PS), polycarbonate (PC), polyester terephthalate (PET), acetal copolymer or homopolymer resin, and liquid crystal polymer. 
     
     
         37 . The method of  claim 31  wherein the second material comprises thermoplastic elastomer (TPE). 
     
     
         38 . The method of  claim 35  wherein the sealing cover comprises polypropylene (PP). 
     
     
         39 . The method of  claim 25  wherein at least a portion of the seal section is located within the second end of the at least one channel. 
     
     
         40 . The method of  claim 25  wherein the second end of the at least one channel includes a tapered section extended at an angle different from an angle of the first end of the at least one channel. 
     
     
         41 . The method of  claim 25  wherein the channel section and the seal section are formed by multi-shot injection molding. 
     
     
         42 . The method of  claim 25  wherein the channel section and the seal section are adhered to form the FRF by overmolding. 
     
     
         43 . The method of  claim 25  wherein adhesive is not provided between the channel section and the seal section. 
     
     
         44 . A method of forming a fluid receiver fitting for supporting aseptic transfer of a fluid, the method comprising:
 forming a channel section having at least one channel, the channel section being formed of a first material that is not penetrable by a hypodermic needle, the at least one channel having a first end and a second end, the second end of the at least one channel having an outward taper an angle θ between 30°-120°; and   forming a seal section that closes off the second end of the at least one channel section and surrounds the at least one channel section except at the first end thereof, the seal section being formed of a second material that is penetrable by a hypodermic needle.   
     
     
         45 . The method of  claim 44  further comprising adhering the seal section and the channel section by a weld defined by interface solidification of melted portions of the seal section and the channel section to form a unitary element. 
     
     
         46 . The method of  claim 45  wherein the channel section is formed by injecting a shot of the first material into a cavity of a mold. 
     
     
         47 . The method of  claim 46  wherein the seal section is formed by injecting a shot of the second material into the cavity. 
     
     
         48 . The method of  claim 47  wherein forming the seal section by injecting a shot of the second material into the cavity comprises forming a nub of the second material within the second end of the at least one channel. 
     
     
         49 . The method of  claim 48  wherein the second material comprises thermoplastic elastomer (TPE). 
     
     
         50 . The method of  claim 44  wherein channel section is inserted into a mold and the seal section is overmolded about the channel section. 
     
     
         51 . The method of  claim 44  wherein at least a portion of the seal section is located within the second end of the at least one channel. 
     
     
         52 . The method of  claim 44  wherein adhesive is not provided between the channel section and the seal section. 
     
     
         53 . A method of forming a fluid receiver fitting for supporting aseptic transfer of a fluid, the method comprising:
 forming a channel section having at least one channel, the channel section being formed of a first material that is not penetrable by a hypodermic needle, the at least one channel having a first end and a second end; and   forming a seal section that closes off the second end of the at least one channel section and surrounds the at least one channel section except at the first end thereof, at least a portion of the seal section being located within the second end of the at least one channel, the seal section being formed of a second material that is penetrable by a hypodermic needle.   
     
     
         54 . The method of  claim 53  wherein the second end of the at least one channel has an outward taper at angle θ between 30°-120°. 
     
     
         55 . The method of  claim 53  wherein channel section is inserted into a mold and the seal section is overmolded about the channel section. 
     
     
         56 . The method of  claim 53  wherein the channel section is formed by injecting a shot of the first material into a cavity of a mold, and wherein the seal section is formed by injecting a shot of the second material into the cavity. 
     
     
         57 . The method of  claim 53  wherein the second material comprises thermoplastic elastomer (TPE). 
     
     
         58 . The method of  claim 53  wherein adhesive is not provided between the channel section and the seal section. 
     
     
         59 . The method of  claim 53  further comprising adhering the seal section and the channel section by a weld defined by interface solidification of melted portions of the seal section and the channel section to form a unitary element.