Patent Publication Number: US-2021186811-A1

Title: Hinged blinding shell for hanging a vial and related methods

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 62/952,682, filed Dec. 23, 2019, which is incorporated herein by specific reference. 
    
    
     BACKGROUND OF THE DISCLOSURE 
     1. The Field of the Disclosure 
     The present disclosure relates to blinding shells that can be used to cover vials during blinded studies of therapeutic drugs and to related methods. 
     2. The Relevant Technology 
     A large number of therapeutic drugs are provided in liquid form and are administered intravenously. Such drugs are commonly housed within a bag or vial. Dispensing of the drug intravenously typically requires that the bag or vial be suspended in an inverted orientation so that the port or septum through which the drug is accessed is facing downwardly. This orientation enables the drug to freely flow under the force of gravity when an IV line is coupled thereto. 
     Blinded testing of a drug during clinical trials requires that the drug be shielded so that the drug cannot be analyzed by the patient or the person administering the drug. Blinding shields are commonly used on vials where the vials are configured to receive a needle from a syringe to withdraw the therapeutic drug for administering. However, because of the complexity of vials that need to be suspended in an inverted orientation for intravenous delivery, blinding shells have not been developed for such vials. 
     Furthermore, a shortcoming of many conventional blinding shells is that different sized blinding shells are typically configured to house different sized vials. The problem is that if it is necessary to switch vial configurations or if it is necessary to concurrently send multiple vials for use on a patient, where the vials are different configurations, the patient and/or person administering may potentially notice the different configurations of blinding shells that are used to enclose the different sized vials. In turn, the patient and/or person administering may deduce that, because there are differences in the configurations of the blinding shells, the trial product contained therein has changed or has certain properties, thereby dimensioning the efficacy of the blinded trial. 
     Accordingly, what is needed are blinding shields and assemblies that overcome all or some of the above shortcomings and other problems known in the art. 
     SUMMARY OF THE DISCLOSURE 
     In a first independent aspect of the disclosure, a vial blinding assembly includes:
         a vial comprising:
           a bottle having a neck that bounds an inlet opening to a chamber of the bottle;   a stopper disposed on the bottle so as to cover the inlet opening, the stopper comprising a needle penetrable septum aligned within the inlet opening; and   a retainer securing the stopper to the bottle;   
           a blinding shell having an interior surface that bounds a cavity, the vial being disposed within the cavity, the blinding shell comprising:
           an encircling sidewall extending between a first end and an opposing second end;   a shield wall inwardly projecting from the first end of the sidewall and encircling an access opening, the access opening communicating with the cavity of the blinding shell and being aligned with the septum of the stopper, the shield wall at least partially covering the retainer or the stopper; and   a floor inwardly projecting from the second end of the sidewall so as to block access to the cavity at the second end;   
           wherein the blinding shell comprises a first shell portion and a second shell portion that are hingedly coupled together.       

     In one embodiment, the retainer includes an inwardly projecting flange that encircles an aperture that is aligned with the septum, the shield wall extending over at least a portion of the flange so that the access opening is aligned with the aperture. 
     In another embodiment, the flange has an outside face and the shield wall covers at least 80%, 85%, 90%, 95%, or 97% of the outside face of the flange. 
     In another embodiment, the blinding shell covers all of the vial except for the septum. 
     In another embodiment, the blinding shell covers all of the vial except for what can be seen through the access opening. 
     In another embodiment, the access opening has a maximum diameter that is less than 10 mm, 7 mm, 5 mm, or 3 mm. 
     In another embodiment, the access opening is circular. 
     Another embodiment includes means for securing the first shell portion to the second shell portion so that the vial is captured within the cavity of the blinding shell. 
     In another embodiment, the means for securing comprises a projection extending from the first shell portion that is press fit into a coupling hole formed on the second shell portion. 
     In another embodiment, the coupling hole comprise a blind pocket. 
     In another embodiment, the blinding shell is comprised of a plastic. 
     In another embodiment, the blinding shell is opaque. 
     In another embodiment, the blinding shell has an exterior surface, a distance between the interior surface and the exterior surface being less than 3 mm, 1 mm or 0.5 mm. 
     In another embodiment, the first shell portion and the second shell portion are hingedly coupled together by a hinge. 
     In another embodiment, the hinge comprises a living hinge that is integrally formed as a unitary member with the first shell portion and the second shell portion. 
     In another embodiment, a hanging tab outwardly projects from the floor, the hanging tab having a mounting hole laterally extending therethrough. 
     In another embodiment, the hanging tab outwardly projects along a central longitudinal axis of the cavity. 
     In another embodiment, the encircling sidewall comprises:
         an annular body extending between a first end and an opposing second end, the floor being disposed at the second end of the body: and   an annular neck inwardly constricting from the first end of the body to the shield wall.       

     In another embodiment, a flexible seal extends between the first shell portion and a second shell portion and is secured thereto by an adhesive. 
     Another embodiment further includes:
         a first closure tab outwardly projecting from a first side of the neck; and   a second closure tab outwardly projecting from a second side of the neck, the second side of the neck being opposite the first side.       

     In another embodiment, the first closure tab and the second closure tab are disposed within a common plane. 
     In another embodiment, the first closure tab comprises:
         a first closure tab portion projecting from the neck and forming a portion of the first shell portion; and   a second closure tab portion projecting from the neck and forming a portion of the second shell portion.       

     Another embodiment includes:
         a projection extending from the first closure tab portion; and   a coupling hole formed on the second closure tab portion, the projection being press fit into the coupling hole so as to form a secure friction fit therein.       

     Another embodiment includes a flexible seal extending between the first closure tab portion and the second closure tab portion and being secured thereto by an adhesive. 
     Another embodiment includes:
         the first shell portion comprising:
           a first body portion extending between a first end and an opposing second end, the first body portion being a portion of the body and bounding a portion of the cavity;   a first neck portion projecting from the first end of the first body portion, the first neck portion being a portion of the neck and bounding a portion of the cavity;   a first shield wall portion inwardly projecting from first neck portion, the first shield wall portion being a portion of the neck and bounding a portion of the cavity;   a first floor portion inwardly projecting from the second end of the first body portion, the first floor portion being a portion of the floor and bounding a portion of the cavity; and   a first closure tab portion outwardly projecting from the first neck portion.   
               

     In another embodiment, a hanging tab outwardly projects from the first floor portion, a mounting hole laterally extending through the hanging tab. 
     Another embodiment includes:
         the second shell portion comprising:
           a second body portion extending between a first end and an opposing second end, the second body portion being a portion of the body and bounding a portion of the cavity;   a second neck portion projecting from the first end of the second body portion, the second neck portion being a portion of the neck and bounding a portion of the cavity;   a second shield wall portion inwardly projecting from second neck portion, the second shield wall portion being a portion of the neck and bounding a portion of the cavity;   a second shield wall portion inwardly projecting from second neck portion, the second shield wall portion being a portion of the neck and bounding a portion of the cavity;   a second floor portion inwardly projecting from the second end of the second body portion, the second floor portion being a portion of the floor and bounding a portion of the cavity; and   a second closure tab portion outwardly projecting from the second neck portion and being disposed against the first closure tab.   
               

     Another embodiment includes
         a projection extending from the first closure tab portion or the second closure tab portion; and   a coupling hole formed on the other of the first closure tab portion or the second closure tab portion, the projection being press fit into the coupling hole so as to form a secure friction fit therein.       

     In a second independent aspect of the disclosure, a vial blinding assembly includes:
         a blinding shell having an interior surface that bounds a cavity, the cavity being configured to receive a vial, the blinding shell comprising:
           an encircling sidewall extending between a first and an opposing second end;   a shield wall inwardly projecting from the first end of the sidewall and encircling an access opening, the access opening communicating with the cavity of the blinding shell;   a floor inwardly projecting from the second end of the sidewall so as to block access to the cavity at the second end; and   a hanging tab outwardly projecting from the floor, the hanging tab having a mounting hole laterally extending therethrough;   
           wherein the blinding shell comprises a first shell portion and a second shell portion that are hingedly coupled together.       

     In another embodiment, the hanging tab outwardly projects along a central longitudinal axis of the cavity. 
     In another embodiment, the hanging tab is planar. 
     In another embodiment, the hanging tab extends between a first side of the sidewall and an opposing second side of the sidewall. 
     In another embodiment, the hanging tab comprises:
         a first hanging tab portion comprising a portion of the first shell portion, the mounting hole extending through the first hanging tab portion;   a second hanging tab port on comprising a portion of the second shell portion, the mounting hole extending though the second hanging tab portion, the second hanging tab portion being disposed against the first hanging tab portion.       

     In another embodiment, a vial is disposed within the cavity of the blinding shell. 
     In another embodiment, the blinding shell covers all of the vial except for what can be seen through the access opening. 
     In another embodiment, means are provided for securing the first shell portion to the second shell portion so that a vial can be captured within the cavity of the blinding shell. 
     In another embodiment, the first shell portion and the second shell portion are hingedly coupled together by a hinge, the hinge comprising a living hinge that is integrally formed as a unitary member with the first shell portion and the second shell portion. 
     A third independent aspect of the disclosure includes a method for using a vial blinding assembly, the method comprising:
         positioning a vial within a first cavity portion of a first shell portion, a second shell portion being hingedly coupled to the first shell portion, the vial comprising:
           a bottle having a neck that bounds an inlet opening to a chamber of the bottle;   a stopper disposed on the bottle so as to cover the inlet opening, the stopper comprising a needle penetrable septum aligned within the inlet opening; and   a retainer securing the stopper to the bottle; and   
           moving at least one of the first shell portion or the second shell portion so that the vial is captured between the first shell portion and the second shell portion, the first shell portion and the second shell portion at least partially covering the retainer or the stopper and bounding an access opening that communicates with the septum.       

     In another embodiment, moving at least one of the first shell portion or the second shell portion comprises a projection forming a portion of the first shell portion being press fit into a coupling hole formed on the second shell portion so that a secure friction fit connection is formed therebetween. 
     In another embodiment, the coupling hole expands as the projection is received therein. 
     In another embodiment, the first shell portion and the second shell portion cover all of the vial except for what can be seen through the access opening. 
     Another embodiment includes shipping the first shell portion and the second shell portion with the vial captured therebetween as part of a blinded study of a liquid trial product disposed within the vial. 
     In a fourth independent aspect of the disclosure, a method for a vial blinding assembly includes:
         positioning a vial within a first cavity portion of a first shell portion, a second shell portion being hingedly coupled to the first shell portion, the vial comprising:
           a bottle having a neck that bounds an inlet opening to a chamber of the bottle;   a stopper disposed on the bottle so as to cover the inlet opening, the stopper comprising a needle penetrable septum aligned within the inlet opening; and   a retainer securing the stopper to the bottle;   
           moving the second shell portion relative to the first shell portion so that the vial is captured between the first shell portion and the second shell portion, the first shell portion and the second shell portion forming at least a portion of a blinding shell, the blinding shell having a first end with an access opening that communicates with the septum and an opposing second end with an outwardly projecting hanging tab formed thereat, a lateral mounting hole passing through the hanging tab.       

     Another embodiment includes, suspending the blinding shell by the hanging tab so that the vial is inverted with the septum facing downward. 
     Another embodiment includes, coupling the hanging tab to an IV stand. 
     Another embodiment includes, passing a needle through the septum so that the needle communicates with a liquid trial product disposed within the vial, an IV line being fluid coupled with the needle. 
     Another embodiment includes, administering the liquid trial product to a patient intravenously as part of a blinded study of the liquid trial product. 
     Another embodiment includes, moving at least one of the first shell portion or the second shell portion comprises a projection forming a portion of the first shell portion being press fit into a coupling hole formed on the second shell portion so that a secure friction fit connection is formed therebetween. 
     In another embodiment, the blinding shell covers all of the vial except for what can be seen through the access opening. 
     In a fifth independent aspect of a disclosure, a kit includes:
         a first vial blinding assembly comprising:
           a first blinding shell having an interior surface that bounds a first cavity and an exterior surface, an access opening passing through the first blinding shell so as to communicate with the first cavity; and   a first vial having a chamber with a liquid trial product disposed therein, the chamber being sealed closed by a stopper having a needle penetrable septum, the first vial being disposed within the first cavity of the first blinding shell so that the septum of the first vial is aligned with the access opening of the first blinding shell;   
           a second vial blinding assembly comprising:
           a second blinding shell having an interior surface that bounds a second cavity and an exterior surface, an access opening passing through the second blinding shell so as to communicate with the second cavity; and   a second vial having a chamber with a liquid trial product disposed therein, the chamber being sealed closed by a stopper having a needle penetrable septum, the second vial being disposed within the second cavity of the second blinding shell so that the septum of the second vial is aligned with the access opening of the second blinding shell,   wherein the first cavity of the first blinding shell has a different configuration than the second cavity of the second blinding shell but the exterior surface of the first blinding shell has the same configuration as the exterior surface of the second blinding shell.   
               

     In another embodiment, the first vial has a different configuration than the second vial. 
     In another embodiment, the first blinding shell and the second blinding shell are opaque. 
     Another embodiment includes:
         the first blinding shell covers all of the first vial except for what can be seen through the access opening of the first blinding shell; and   the second blinding shell covers all of the second vial except for what can be seen through the access opening of the second blinding shell.       

     In a sixth independent aspect of the disclosure includes, a method includes:
         enclosing a first vial within a first cavity of a first blinding shell so that an access opening passing through the first blinding shell is aligned with a needle penetrable septum of the first vial, the first vial housing a liquid trial product; and   enclosing a second vial within a second cavity of a second blinding shell so that an access opening passing through the second blinding shell is aligned with a needle penetrable septum of the second vial, the second vial housing a liquid trial product, the first cavity of the first blinding shell having a different configuration than the second cavity of the second blinding shell but an exterior surface of the first blinding shell having the same configuration as an entire exterior surface of the second blinding shell.       

     In another embodiment, the first vial has a different configuration than the second vial. 
     In another embodiment, the first blinding shell and the second blinding shell are opaque. 
     In another embodiment:
         the first blinding shell covers all of the first vial except for what can be seen through the access opening of the first blinding shell; and   the second blinding shell covers all of the second vial except for what can be seen through the access opening of the second blinding shell.       

     Another embodiment includes, delivering the first blinding shell housing the first vial and the second blinding shell housing the second vial to a location for administering the liquid trial product in a blinded study. 
     Each of the above independent aspects may include any of the features, options and possibilities set out in this document, including those under each of the above independent aspects. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the present disclosure will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the disclosure and are therefore not to be considered limiting of its scope. 
         FIG. 1  is a perspective view of a vial blinding assembly coupled to an IV line; 
         FIG. 2  is a perspective top view of a blinding shell of the vial blinding assembly shown in  FIG. 1  in an open position; 
         FIG. 3  is a perspective bottom view of the blinding shell shown in  FIG. 2 ; 
         FIG. 4  is a perspective view of the blinding shell shown in  FIG. 2  having a vial disposed therein; 
         FIG. 5  is an elevated cross-sectional view of the vial shown in  FIG. 4 ; 
         FIG. 6  is a perspective view of the blinding shell shown in  FIG. 4  being moved to a closed position with the vial disposed therein; 
         FIG. 7  is an elevated front, cross sectional view of two adjacently disposed blinding shells having cavities of different configurations; 
         FIG. 8  is an elevated front view of the blinding shells shown in  FIG. 7 ; 
         FIG. 9  is an elevated front view of adjacently disposed vials having different configurations that are configured to be received within the cavities of the blinding shells shown in  FIG. 7 ; 
         FIG. 10  is a perspective view of an alternative embodiment of a blinding shell wherein the hanging tab has been removed; and 
         FIG. 11  is a perspective view of the blinding shell shown in  FIG. 10  in a closed position. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Before describing the present disclosure in detail, it is to be understood that this disclosure is not limited to parameters of the particularly exemplified systems, methods, apparatus, products, processes, compositions, and/or kits, which may, of course, vary. It is also to be understood that the terminology used herein is only for the purpose of describing particular embodiments of the present disclosure, and is not necessarily intended to limit the scope of the disclosure in any particular manner. Thus, while the present disclosure will be described in detail with reference to specific embodiments, features, aspects, configurations, etc., the descriptions are illustrative and are not to be construed as limiting the scope of the claimed invention. Various modifications can be made to the illustrated embodiments, features, aspects, configurations, etc. without departing from the spirit and scope of the invention as defined by the claims. Thus, while various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. While a number of methods and materials similar or equivalent to those described herein can be used in the practice of the present disclosure, only certain exemplary materials and methods are described herein. 
     Various aspects of the present disclosure, including devices, systems, methods, etc., may be illustrated with reference to one or more exemplary embodiments or implementations. As used herein, the terms “alternative embodiment” and/or “exemplary implementation” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments or implementations disclosed herein. In addition, reference to one or more embodiments is intended to provide illustrative examples without limiting the scope of the invention, which is indicated by the appended claims rather than by the following description. 
     It will be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to an “insert” includes one, two, or more inserts. As used throughout this application the words “can” and “may” are used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Additionally, the terms “including,” “having,” “involving,” “containing,” “characterized by,” variants thereof (e.g., “includes,” “has,” and “involves,” “contains,” etc.), and similar terms as used herein, including the claims, shall be inclusive and/or open-ended, shall have the same meaning as the word “comprising” and variants thereof (e.g., “comprise” and “comprises”), and do not exclude additional, un-recited elements or method steps, illustratively. 
     Various aspects of the present disclosure can be illustrated by describing components that are coupled, attached, connected, and/or joined together. As used herein, the terms “coupled”, “attached”, “connected,” and/or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being “directly coupled”, “directly attached”, “directly connected,” and/or “directly joined” to another component, no intervening elements are present or contemplated. Thus, as used herein, the terms “connection,” “connected,” and the like do not necessarily imply direct contact between the two or more elements. In addition, components that are coupled, attached, connected, and/or joined together are not necessarily (reversibly or permanently) secured to one another. 
     As used herein, directional and/or arbitrary terms, such as “top,” “bottom,” “front,” “back,” “left,” “right,” “up,” “down,” “upper,” “lower,” “inner,” “outer,” “internal,” “external,” “interior,” “exterior,” “proximal,” “distal” and the like can be used solely to indicate relative directions and/or orientations and may not otherwise be intended to limit the scope of the disclosure, including the specification, invention, and/or claims. 
     Where possible, like numbering of elements have been used in various figures. In addition, similar elements and/or elements having similar functions may be designated by similar numbering (e.g., element “10” and element “210.”) Furthermore, alternative configurations of a particular element may each include separate letters appended to the element number. Accordingly, an appended letter can be used to designate an alternative design, structure, function, implementation, and/or embodiment of an element or feature without an appended letter. Similarly, multiple instances of an element and or sub-elements of a parent element may each include separate letters appended to the element number. In each case, the element label may be used without an appended letter to generally refer to instances of the element or any one of the alternative elements. Element labels including an appended letter can be used to refer to a specific instance of the element or to distinguish or draw attention to multiple uses of the element. However, element labels including an appended letter are not meant to be limited to the specific and/or particular embodiment(s) in which they are illustrated. In other words, reference to a specific feature in relation to one embodiment should not be construed as being limited to applications only within said embodiment. 
     It will also be appreciated that where a range of values (e.g., less than, greater than, at least, and/or up to a certain value, and/or between two recited values) is disclosed or recited, any specific value or range of values falling within the disclosed range of values is likewise disclosed and contemplated herein. Thus, disclosure of an illustrative measurement or distance less than or equal to about 10 units or between 0 and 10 units includes, illustratively, a specific disclosure of: (i) a measurement of 9 units, 5 units, 1 units, or any other value between 0 and 10 units, including 0 units and/or 10 units; and/or (ii) a measurement between 9 units and 1 units, between 8 units and 2 units, between 6 units and 4 units, and/or any other range of values between 0 and 10 units. 
     It is also noted that systems, methods, apparatus, devices, products, processes, compositions, and/or kits, etc., according to certain embodiments of the present disclosure may include, incorporate, or otherwise comprise properties, features, aspects, steps, components, members, and/or elements described in other embodiments disclosed and/or described herein. Thus, reference to a specific feature, aspect, steps, component, member, element, etc. in relation to one embodiment should not be construed as being limited to applications only within said embodiment. In addition, reference to a specific benefit, advantage, problem, solution, method of use, etc. in relation to one embodiment should not be construed as being limited to applications only within said embodiment. 
     The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures. 
     The present disclosure is directed to vial blinding assemblies used in blinded studies of therapeutic drugs and related methods and kits. In general, the vial blinding assemblies include a vial holding a liquid trial product and a blinding shell that is opaque and selectively covers the vial. The blinding shell can be hinged and can include a mounting tab projecting from a floor thereof to enable the vial to be suspended in an inverted orientation, such as on an IV stand. By suspending the vial inverted, the liquid trial product can be administered to a patient intravenously under the force of gravity. The blinding shell functions to help preclude or limit those receiving or administering the liquid trial product from the vial from detecting any properties of the vial or the liquid trial product contained therein so that the fidelity and efficacy of the blinded study is maintained. 
     Depicted in  FIG. 1  is one embodiment of an inventive vial blinding assembly  10  incorporating features of the present disclosure. Vial blinding assembly  10  includes a blinding shell  12 A and a vial  14  ( FIG. 4 ) that is disposed therein. More specifically, with reference to  FIGS. 1 and 4 , blinding shell  12  has an interior surface  16  that bounds a cavity  18  and has an opposing exterior surface  20 . Cavity  18  has a central longitudinal axis  21  extending therethrough. During use, vial  14  is disposed within cavity  18 . 
     Described in further detail, blinding shell  12 A, as shown in  FIG. 1 , has an encircling sidewall  22  that extends between a first end  24  and an opposing second end  26 . As shown in  FIG. 6 , a shield wall  28  inwardly projects from first end  24  of sidewall  22  and centrally encircles an access opening  30  that communicates with cavity  18 . In the embodiment depicted, access opening  30  is circular and has a diameter being at least or less than 3 mm, 5 mm, 7 mm, 10 mm, 15 mm, or is in a range between any two of the foregoing. In other embodiments, access opening  30  can be elliptical, polygonal, irregular, or have other configurations. Shield wall  28  has an interior surface  29  ( FIG. 4 ) that bounds a portion of cavity  18  and an opposing exterior surface  31  ( FIG. 6 ) that is openly exposed. In the embodiment depicted, shield wall  28  and at least a portion interior surface  29  and exterior surface  31  are disposed in planes that orthogonally intersect with central longitudinal axis  21 . This configuration enables a close tolerance fit with vial  14  and simplifies production of blinding shell  12 A. However, other configurations can also be used. 
     Returning to  FIG. 1 , a floor  32  inwardly projects from second end  26  of sidewall  22  so as to completely block access to or otherwise cover cavity  18  at second end  26 . As depicted in  FIGS. 1 and 4 , floor  32  has an inside face  34  and an opposing outside face  35 . As will be discussed below in greater detail, the thickness of floor  32  extending between faces  34  and  35  can vary depending on the size of vial  14  being housed within cavity  18 . In the embodiment depicted, floor  32  and at least a portion of inside face  34  and outside face  35  are disposed in planes that orthogonally intersect with central longitudinal axis  21 . This configuration enables a close tolerance fit with vial  14  and simplifies production of blinding shell  12 A. However, other configurations can also be used. 
     As shown in  FIG. 1 , a hanging tab  36  outwardly projects from floor  32  and has a mounting hole  38  laterally extending therethrough More specifically, hanging tab  36  projects outward along the longitudinal direction of blinding shell  12 A and typically outwardly projects along central longitudinal axis  21  ( FIG. 4 ). Hanging tab  36  also extends laterally toward or to opposing sides of floor  32 . Although not required, in one embodiment, hanging tab  36  is planar and is disposed within a plane that is parallel to central longitudinal axis  21  and/or is orthogonal to floor  32 /outside face  35 . Hanging tab  36  has a height extending from floor  32  to a top edge  40 . To accommodate mounting hole  38 , the height of hanging tab  36  is typically at least 5 mm, 7 mm, 10 mm, 15 mm, or 20 mm or is in a range between any two of the foregoing values. Other dimensions can also be used. 
     Mounting hole  38  is configured to receive a hanger so as to enable suspending of vial blinding assembly  10 . For example, a hanger  42  can be attached to or be part of an IV stand for suspending vial blinding assembly  10  from the IV stand. Hanger  42  can be a hook, loop, strap, bar, rod, hanger or other structure that can be received within mounting hole  38 . Mounting hole  38  can be triangular, circular, polygonal or have other configurations. Commonly, mounting hole  38  will have a maximum diameter that is greater than 4 mm, 6 mm, 8 mm, 13 mm, or 18 mm or is in a range between any two of the foregoing values. Other dimensions can also be used. 
     Sidewall  22  can be further defined as comprising an annular body  44  that extends between a first end  47  and second end  26 . At least a portion of body  44  typically has a cylindrical configuration and bounds or encircles a portion of cavity  18 . Sidewall  22  also includes an annular neck  46  that inwardly constricts from first end  47  of body  44  to first end  24 /shield wall  28 . Neck  46  also bounds or encircles a portion of cavity  18 . Outwardly projecting from opposing sides of neck  46  is a first closure tab  48  and an opposing second closure tab  50 . Closure tabs  48  and  50  are typically planer and extend along the length of neck  46  from body  44  to shield wall  28 . However, it is not necessary that closure tabs  48  and  50  extend along the full length of neck  46 . Closure tabs  48  and  50  are typically disposed in a common plane and are typically disposed in a plane that is common with hanging tab  36  and/or passes through central longitudinal axis  21 . 
     As depicted in  FIG. 2 , blinding shell  12 A can also be described as comprising a first shell portion  54 A, a second shell portion  54 B, and a hinge  56  extending therebetween. Shell portion  54 A comprises a sidewall portion  22 A that extends between first end  24  and opposing second end  26  and extends between an outside edge  58 A and an inside edge  60 A. Sidewall portion  22 A partially bounds a cavity portion  18 A. Inwardly extending from first end  24  of sidewall portion  22 A is a shield wall portion  28 A partially bounding a notch  30 A. Shield wall portion  28 A also partially bounds cavity portion  18 A. A floor portion  32 A inwardly projects from second end  26  of sidewall portion  22 A so as to partially bound cavity portion  18 A thereat. A hanging tab portion  36 A outwardly projects from floor portion  32 A and has mounting hole  38  laterally passing therethrough. Hanging tab portion  36 A can be have the same configuration, orientation and dimensions as previously discussed with regard to hanging tab  36 . 
     Sidewall portion  22 A can also be defined as comprising a body portion  44 A that extends from first end  47  to second end  26  and that bounds a portion of cavity portion  18 A. A neck portion  46 A extends from first end  47  to shield wall portion  28 A and inwardly constricts as it extends therebetween. Outwardly projecting from opposing sides of neck portion  46 A is a closure tab portion  48 A and a closure tab portion  50 A. Closure tab portions  48 A and  50 A can be planar and disposed within a common plane. 
     Shell portion  54 B can have the same or substantially the same configuration as shell portion  54 A. As such, the same discussion and elements as discussed above with regard to shell portion  54 A are likewise applicable to shell portion  54 B. Furthermore, like elements between shell portion  54 A and  54 B are identified by like reference characters except that the reference characters of shell portion  54 B include the suffix “B.” In general, each of shell portions  54 A and  54 B form equal halves of blinding shell  12 A. Thus, when shell portions  54 A and  54 B are coupled together in a closed position, as discussed below in further detail, sidewall portions  22 A and  22 B combine to form sidewall  22 ; cavity portions  18 A and  18 B combine to form cavity  18 ; shield wall portions  28 A and  28 B combine to form shield wall  28 ; notches  30 A and  30 B combine to form access opening  30 ; floor portions  32 A and  32 B combine to form floor  32 ; hanging tab portions  36 A and  36 B combine to form hanging tab  36 ; body portions  44 A and  44 B combine to form body  44 ; neck portions  46 A and  46 B combine to form neck  46 ; closure tab portions  48 A and  48 B combine to form closure tab  48 ; and closure tab portions  50 A and  50 B combine to form closure tab  50 . Furthermore, because shell portions  54 A and  54 B form equal halves of blinding shell  12 A, the prior discussions with regard to sidewall  22 , cavity  18 , shield wall  28 , access opening  30 , floor  32 , hanging tab  36 , body  44 , neck  46 , closure tab  48 , and closure tab  50  is also applicant to their related portions unless self-evident otherwise. 
     Hinge  56  extends between inside edges  60 A and  60 B and enables shell portions  54 A and  54 B to move between an open position, as shown in  FIG. 2 , where vial  14  can be inserted into or removed from blinding shell  12 A, and a closed position, as shown in  FIG. 1 , wherein vial  14  is captured between shell portions  54 A and  54 B. In one embodiment, hinge  56  comprises a living hinge that is integrally formed as a single, continuation, unitary member with shell portions  54 A and  54 B. That is, in one embodiment, blinding shell  12 A is formed from a plastic material through a molding process, such as injection molding. Hinge  56  can be formed by producing the mold so that a thin, flexible piece of plastic extends between inside edges  60 A and  60 B. In an alternative embodiment, hinge  56  can be separately formed from shell portions  54 A and  54 B and then attached thereto, such as by welding, adhesive, crimping, or mechanical attachment. For example, hinge  56  can comprise a tape, adhesive strip, or a flexible sheet or film that is secured to and extends between inside edges  60 A and  60 B. In still other embodiments, hinge  56  can be eliminated and shell portions  54 A and  54 B can be formed as two separate and discrete members that are coupled together without the use of a hinge. 
     In one embodiment of the present disclosure, means are also provided for securing first shell portion  54 A to second shell portion  54 B in the closed position so that vial  14  is captured therebetween. By way of example and not by limitation, as depicted in  FIGS. 2 and 3 , closure tab portion  48 A has an interior surface  81 A and an opposing exterior surfaced  82 A. An enclosure  80 A outwardly projects from exterior surface  82 A. A coupling hole  84 A is formed on interior surface  81 A and projects into enclosure  80 A so as to be partially bounded by enclosure  80 A. Coupling hole  84 A is this bounded by an interior surface  85 A that is partially formed from closure tab portion  48 A and partially formed from enclosure  80 A. In this embodiment, coupling hole  84 A is in the form of a blind pocket. In other embodiments, however, coupling hole  84 A can pass all the way through enclosure  80 A and thus would not be blind. In the embodiment depicted, coupling hole  84 A has a square or rectangular transverse cross section. As discussed below in more detail, in other embodiments, the transverse cross section of coupling hole  84 A can have other configurations such as circular, polygonal or irregular. 
     Closure tab portion  48 B of second shell portion  54 B also has an interior surface  81 B and an opposing exterior surface  82 B. A projection  86 B outwardly projects from interior surface  81 B. In the embodiment depicted, projection  86 B has a cylindrical body  88 B that upstands from interior surface  81 B and extends to a rounded perimeter edge  90 B. Projection  86 B is configured so that when blinding shell  12 A is folded toward the closed position, projection  86 B aligns with coupling hole  84 A. Furthermore, projection  86 B is configured relative to coupling hole  84 A so that a manual press fit connection can be made between projection  86 B and coupling hole  84 A. Specifically, the maximum diameter of projection  86 B is slightly larger than the height and/or width of coupling hole  84 A. As such, as blinding shell  12 A is folded together toward the closed position so that projection  86 B aligned with coupling hole  84 A, projection  86 B can be manually press fit into coupling hole  84 A so as to move blinding shell  12 A into the fully closed position. Pressing projection  86 B into coupling hole  84 A forces interior surface  85 A of coupling hole  84 A to outwardly flex or bend so as to form a secure friction fit between projection  86 B and interior surface  85 A of coupling hole  84 A. Rounded perimeter edge  90 B of projection  86 B enables easy alignment and insertion of projection  86 B into coupling hole  84 A. 
     In the present embodiment, the connection of projection  86 B into coupling hole  84 A does not make a permanent connection. That is, projection  86 B can be removed from coupling hole  84 A by applying sufficient manual force. However, the press fit connection is sufficient to prevent unintended removal of projection  86 B from coupling hole  84 A, i.e., prevent unintended movement of blinding shell  12  from the closed position to the open position. However, in some embodiments, pressing projection  86 B into coupling hole  84 A can produce at least some plastic deformation of interior surface  85 A of coupling hole  84 A, thereby providing some permanent and visible indication of an initial closing. In other embodiments, the connection between projection  86 B and coupling hole  84 A can be a permanent connection, i.e., cannot be separated without some permanent deformation or destruction of a portion of blinding shell  12 A. For example, this can be accomplished by using an adhesive between projection  86 B and coupling hole  84 A. In other embodiments, a rib, barb, or other mechanical structure can be formed on projection  86 B that mates with a corresponding structure on coupling hole  84 A so as to produce a permanent connection between the two members. 
     It is appreciated that the corresponding sizes and shapes of projection  86 B and coupling hole  84 A can be modified into a variety of different configurations, i.e., sizes and shapes, that still produce the desired friction fit connection when projection  86 B is received within coupling hole  84 A. For example, coupling hole  84 A could have a circular transvers cross section while projection  86 B has a polygonal transverse cross section, such as octagonal with rounded perimeter edge  90 B, that is sized so that the desired friction fit connection is formed when the projection is received within the coupling hole. Other complementary configurations can also be used. Although not always required, projection  86 B is commonly formed as a solid member, i.e., no pockets or cavities formed thereon, so that projection  86 B does not collapse or expand while being pressed into coupling hole  84 A. 
     As depicted in  FIG. 2 , a plurality of spaced apart projections  86  can be used with corresponding coupling holes  84  to secure shell portion  54 A and  54 B together at opposing ends  24  and  26 . For example, closure tab portion  50 A has an interior surface  93 A and an opposing exterior surface  94 A. A projection  86 A 1  outwardly projects from interior surface  93 A. Likewise, closure tab portion  50 B has an enclosure  80 B 1  extending from exterior surface  94 B. A coupling hole  84 B 1  is formed on interior surface  93 B and projects into enclosure  80 B 1  so as to be partially bounded by enclosure  80 A. Projection  86 A 1  and coupling hole  84 B 1  function the same as projection  86 B and coupling hole  84 A discussed above. That is, as blinding shell  12 A is moved into the closed position, projection  86 A 1  can be pressed into coupling hole  84 B 1  so as to form a secure, friction tight, press fit connection between projection  86 A 1  and an interior surface  85 B 1  of coupling hole  84 B 1 . The alternatives and configurations discussed above with regard to projection  86 B and coupling hole  84 A are also applicable to projection  86 A 1  and coupling hole  84 B 1 , respectively. 
     Furthermore, hanging tab portion  36 A has an interior surface  93 A and an opposing exterior surface  94 A while hanging tab portion  36 B has an interior surface  93 B and an opposing exterior surface  94 B. A projection  86 A 2  outwardly projects from interior surface  93 A on one side of mounting hole  38  while a coupling hole  84 A 2  extends through interior surface  93 A an into an enclosure  80 A 2  on the opposing side of mounting hole  38 . Projection  86 A 2  and coupling hole  84 A 2  are configured to make the same press-fit connection with a coupling hole  84 B 2  and a projection  86 B 2  that are formed on interior surface  93 B of hanging tab portion  36 B on opposing sides of mounting hole  38  when shell portions  54 A and  54 B are moved to the closed position Again, all of the previously discussion alternatives with regard to the projections and coupling holes can be used. It is appreciated that shell portions  54 A and  54 B can be formed with 1, 2, 3, 4, 5, 6, or more combinations of spaced apart projections  86  and coupling holes  84 . The number of projections  86  and coupling holes  84  used is in part dependent upon the size of vial  14  and, in turn, the size of blinding shell  12 A. One goal is to have sufficient projections  86  and coupling holes  84  to ensure that there is no accidental separation between shell portions  54 A and  54 B and to help ensure that shell portions  54 A and  54 B cannot be easily flexed or bent to enable peeking at vial  14  between shell portions  54 A and  54 B. In other embodiments, each of projections  86  and coupling holes  84  can be switched between the different shell portions  54 A and  54 B or all of projection  86  can be formed on one shell portion  54  while all of the coupling holes are formed on the other shell portion  54 . 
     Once blinding shell  12 A is moved to the closed position and projections  86  are received within coupling holes  84 , one, two, three, or more seals  92 , as shown in  FIG. 1 , can be secured to blinding shell  12 A that extend between shell portions  54 A and  54 B. Seals  92  can comprise a piece of tape, sticker, or other flexible strip that can be secured by an adhesive. Seals  92  are preferably configured so that they cannot be removed without tearing. The one or more seals  92  can be spaced apart and ensure that once that once blinding shell  12 A has been moved to the closed position, it has not subsequently been moved to the open position. For example, in one embodiment, one or more seal  92  can be placed so as to extend between closure tab portions  48 A and  48 B and/or one or more seals  92  can be placed so as to extend between hanging tab portions  36 A and  36 B. Seals  92  can also prevent peeking between shell portions  54 A and  54 B. As such, seals  92  further ensuring the efficacy and fidelity of the blinded study. 
     In other alternative embodiments, a variety of other structures and techniques can be used for securing first shell portion  54 A to second shell portion  54 B in the closed position so that vial  14  is captured therebetween. By way of example and not by limitation, projections  86  and coupling holes  84  can be eliminated and be replaced with adhesive, adhesive strips, or other types of fasteners such as clamps, crimps, screws, or the like. 
     Turning to  FIG. 4 , with blinding shell  12 A in the open position, vial  14  can be positioned within one of cavity portions  18 A or  18 B As depicted in  FIG. 5 , vial  14  has an upper end  100  and an opposing lower end  102 . Vial  14  includes a bottle  104  having a stopper  106  disposed thereon Stopper  106  is secured in place by a retainer  108 . More specifically, bottle  104  bounds a chamber  110  that is configured to hold a liquid trial product  112 . As used herein, a “liquid trial product” refers to a liquid product being used in a blinded clinical trial and can include an active drug product that is under investigation, a related placebo product, a control product, or a comparator product. 
     Bottle  104  includes a body  114  having a circular floor  116  with cylindrical sidewall  118  upstanding therefrom. Bottle  60  also includes a neck  120  that is constricted relative to sidewall  118 . An annular shoulder  122  inwardly slopes from an upper end of sidewall  118  to neck  120 . Shoulder  122  inwardly slopes at an angle relative to a central longitudinal axis  124  of bottle  104 . Neck  120  terminates at an end face  126 . End face  126  encircles an inlet opening  128  that communicates with chamber  110 . An annular flange  130  radially outwardly projects from annular neck  120  adjacent to end face  126 . Bottle  104  is typically made of glass or serializable plastic and is commonly transparent. 
     With continued reference to  FIG. 5 , stopper  106  comprises an annular top  132  having a top surface  134  and an opposing bottom surface  136 . Opposing surfaces  134  and  136  can be planar and disposed in parallel alignment. However, some contours can also be disposed on one or both surfaces. Top  132  can further be defined as comprising an annular rim portion  137  that encircles a central septum  138 . Septum  138  has a top surface  140  and an opposing bottom surface  142  and is needle penetrable. Stopper  106  further comprises tubular stem  144  that projects from bottom surface  136  of top  132 . Tubular stem  144  has an exterior surface  146  and an opposing interior surface  148 . Interior surface  148  encircles bottom surface  142  of septum  138 . 
     Stopper  106  is typically formed a single, integral, unitary member, as opposed to two or more members connected together, and is typically made from a rubber or elastomeric material that can produced a liquid tight seal with bottle  104 . The material for stopper  106  is also selected so that a needle of a syringe can effectively pass through septum  138  for withdrawing a portion of liquid trial product  112  that is housed within bottle  104  and is self-sealing once the needle is withdrawn. 
     During assembly, stem  144  is advanced into inlet opening  128  until rim portion  137  comes to rest on top of end face  126  of neck  120 . In this configuration, exterior surface  146  of stem  144  sits against the interior surface of neck  120  to help effect a seal therebetween. Bottom surface  142  of septum  138  is aligned with and communicates with chamber  110 . 
     Stopper  106  is secured to bottle  104  by retainer  108 . Retainer  108  comprises a circular collar  150  having a first end  156  and an opposing second end  158 . Collar  150  encircles a cavity  152  that is configured to receive stopper  106  and at least a portion of neck  120  of bottle  104 . Retainer  108  further comprises an annular flange  154  that radially inwardly projects from second end  158  of collar  150 . Flange  154  terminates an inner face  160  that encircles an aperture  162 . Retainer  64  is generally formed from a bendable material, such as a metal, and is typically formed from aluminum. 
     During assembly, stopper  106  is positioned on bottle  104  so as to cover inlet opening  128 , as discussed above. Retainer  108  is then advanced over stopper  106 . Specifically, collar  150  is advanced over stopper  106  and over flange  130  of bottle  104  until flange  154  of retainer  108  rests on top of stopper  106  and first end  156  of collar  150  extends below flange  130  of bottle  104 . Retainer  108  is then crimped onto bottle  104  by radially inwardly bending first end  156  of collar  150  below flange  130  of bottle  104 . This crimping of retainer  108  functions to compress stopper  106  against end face  126  of bottle  104  to produce a liquid tight seal therebetween and also prevents manual separation of retainer  108  and stopper  106  from bottle  104  without the use of a tool or at least partial destruction of retainer  108 . The crimping of retainer  108  is typically achieved by a crimper that is passed over retainer  108  and then manipulated to radially inwardly compress first end  156  of collar  150 . Such crimpers are known in the art. 
     In the assembled configuration, top surface  140  of septum  138  is openly exposed through aperture  162  of retainer  108 . When it is desired to access liquid trial product  112  within vial  14 , a needle can be passed through septum  138  and into chamber  110  of bottle  104  to withdraw a portion of liquid trial product  112 . 
     It is appreciated that retainer  108  can have a variety of different configurations and can be used in a variety of different ways and still function to secure stopper  106  to bottle  104 . By way of example and not by limitation, in contrast to being crimped onto bottle  104 , retainer  108  could be formed to produce a snap-fit connection with bottle  104  or could be formed in two halves that are clamped together about neck  120 . In still other embodiments, the retainer could be attached by adhesive, press fit, or constriction under heating, e.g., shrink wrapping. It is also appreciated that stopper  106  and vial  14  can have different configurations, i.e., sizes and shapes. 
     As previously noted, in general, vial  14  is configured to fit within cavity  18  of blinding shell  12 A so that vial  14  is housed or captured within cavity  18  of blinding shell  12 A when blinding shell  12 A is moved into the closed position. More specifically, vial  14  typically has a configured that is generally complementary to cavity  18  so that there is minimal movement or play of vial  14  relative to blinding shell  12 A when blinding shell  12 A is in the closed position. For example, with reference to  FIG. 4 , when blinding shell  12 A is in the closed position, floor  116  of bottle  104  is typically disposed against or adjacent to floor  32  of blinding shell  12 A; body  114  of bottle  104  is typically disposed against or adjacent to the interior surface of body  44  of blinding shell  12 A; and neck of  120  of bottle  104  is typically disposed against or adjacent to the interior surface of neck  46  of blinding shell  12 A; and flange  154  of retainer  108  is typically disposed against or adjacent to interior surface  29  of shield wall  28 . Cavity  18  is typically sized relative to vial  14  so that when vial  14  is enclosed within blinding shell  12 A, vial  14  can only move longitudinally within cavity  18  by less than 10 mm and more commonly less than 7 mm, 5 mm or 3 mm. Furthermore, cavity  18  is typically sized relative to vial  14  so that when vial  14  is enclosed within blinding shell  12 A, retainer  108  and/or vial  14  can only move laterally within cavity  18  by less than 6 mm and more commonly less 4 mm or 2 mm. Where cavity  18  is larger than vial  14 , an insert can be positioned within cavity to occupy at least a portion of the open spaced within cavity  18 . For example, the insert could be in the form of a disk that is positioned between floor  116  of bottle  104  and floor  32  of blinding shell  12 A. In another embodiment, the insert could be in the form of a cup that receives lower end  102  of vial  14 . Other configurations of inserts can also be used. 
     As previously discussed, one of the objectives of blinding shell  12 A is to cover vial  14  as part of a blinded study so that the patient receiving the liquid trial product  112  and/or the person administering the liquid trial product  112  are unable to see vial  14  or liquid trial product  112 . The coving of vial  14  limits the ability of the patient and/or person administering to deduce or attempt to deduce any properties or changes in liquid trial product  112 , thereby improving the efficacy and fidelity of the blinded study. To that end blinding shell  12 A is opaque. This can be accomplished by either forming blinding shell  12 A from an opaque material or by applying an opaque coating or covering, such as a paint or printing, or an opaque layer, such as an adhesive sticker covering. Other approaches can also be used so that blinding shell  12 A is blacked out. In one embodiment, blinding shell  12 A is molded or otherwise formed from a plastic such as Acrylonitrile Butadiene Styrene (ABS). ABS is an opaque thermoplastic and amorphous polymer. Other plastics/polymers can also be used. In still other embodiments, blinding shell  12 A can be formed from a metal, fiberglass, composite or the like. 
     It is typically preferred that blinding shell  12 A cover as much of vial  14  as possible while still permitting withdrawal of liquid trial product  112  through septum  138 . Accordingly, as shown in  FIGS. 4 and 6 , in one embodiment blinding shell  12 A is configured so that when blinding shell  12 A is in the closed position with vial  14  disposed therein, the only portion of vial  14  that can be seen is that which can be seen through access opening  30  of blinding shell  12 A. For example, blinding shell  12 A is configured so that when blinding shell  12 A is in the closed position and vial  14  is captured therein, shield wall  28  extends over a portion of stopper  106  ( FIG. 5 ) and retainer  108 . More specifically, shield wall  28  extends over/covers a portion of flange  154  of retainer  108 . In another embodiment, flange  154  has an outside face  164 . Shield wall  28  extends over/covers all of outside face  164  of flange  154  or extends over/covers at least 80%, 85%, 90%, 95% or 97% of outside face  164  of flange  154  or extends over/cover a range between any two of the foregoing values. Furthermore, access opening  30  of shield wall  28  is aligned with septum  138  so that septum  138  can be accessed through access opening  30  when blinding shell  12 A is in the closed position. Shield wall  28  may cover none of septum  138  or may cover a portion of septum  138  but does not cover all of septum  138 . In another embodiment, blinding shell  12 A is configured so that when blinding shell  12 A is in the closed position within vial  14  disposed therein, the only portion of vial  14  that can be seen when shield wall  28  is viewed straight on is septum  138 , a portion of septum  138 , or septum  138  in combination with less than 10%, 5% or 2% of the surface area of outside face  164  of flange  154 . 
     To facilitate use of blinding shell  12 A in a blinded study, blinding shell  12 A is moved to the open position, as shown in  FIG. 4 , and vial  14  having liquid trial product  112  therein is positioned within one of cavity portions  18 A or  18 B or is otherwise disposed between the cavity portions  18 A and  18 B. Blinding shell  12 A is then moved to the closed position as shown in  FIG. 6 , and discussed above, so that vial  14  is captured within blinding shell  12 A with septum  138  or substantially only septum  138 , such as discussed above, being visible through access opening  30 . One or more seals  92  can then be positioned that extend between shell portions  54 A and  54 B so as to prevent opening blinding shell  12 A. In one embodiment, the blinding shells  12 A and vials  14  can be shipped to a medical facility or administering person, such as a physician or nurse, in a disassembled state. The medical facility or administering person can then enclose vials  14  within blinding shells  12 A prior to administering the liquid trial product  112  to the patient. In other embodiments, such as where it is desired that the administering person does not see vials  14 , the blinding shells  12 A and vials  14  can be preassembled into vial blinding assemblies  10  and then shipped or otherwise transported to a patient, medical facility, or administering person for subsequent administering. 
     During administering of liquid trial product  112 , vial blinding assembly  10 /blinding shell  12 /vial  14  can be suspended in an inverted position so that septum  138  of vial  14  and shield wall  28  are facing downward and hanging tab  36  is projecting upward. In one method of suspending, hanger  42  or some other structure is secured to hanging tab  36  by passing through mounting hole  38  and is then connected to a stand, such as an IV stand, or some other support structure. In other methods, a portion of the stand, such as an IV stand, or other support structure forms hanger  42  and is directly passed through mounting hole  38  to suspend vial blinding assembly  10 /blinding shell  12 /vial  14  in the inverted position. In yet other embodiments, clamps, clips, or other fasteners can be used to couple hanging tab  36 , with or without passing through mounting hole  38 , to a stand or other supporting structure. As such, in some embodiments, mounting hole  38  can be eliminated from hanging tab  36 . 
     Either prior to or after suspending blinding assembly  10 /blinding shell  12 /vial  14  in the inverted position, a needle  166  connected to an IV line  168  is passed through access opening  30  and exposed septum  138  so as to access liquid trial product  112 . The IV line  168  can then be fluid coupled to a patient using conventional methods for intravenous delivery of liquid trial product  112  to the patient under the force of gravity. 
     Although vial  14  is disposed within blinding shell  12  that is specifically adapted for suspending vial  14  in an inverted orientation, it is not necessary that liquid trial product  112  be delivered intravenously. For example, liquid trial product  112  can also be dispensed through a syringe by simply passing the needle of the syringe through septum  138 , drawing a portion of liquid trial product  112  into the syringe through the needle, withdrawing the needle from septum  138 , and then delivering the withdrawn liquid trial product  112  to the patient by either injecting the liquid trial product  112  into the patient using the syringe or using other conventional delivery methods. Where a syringe is being used, it is not necessary to suspend blinding assembly  10 /blinding shell  12 A; vial  14  in an inverted position. 
     In some situations, it may be necessary to administer liquid trial product  112  to a patient from vials having different configurations, i.e., different sizes and/or shapes. For example, different suppliers of liquid trial product  112  may use vials of different configurations, different types of liquid trial product  112  may be stored in vials of different configurations, or a single supplier may switch vial configurations between the production of different batches of liquid trial product  112 . Other causes may also exist for the need to administer liquid trial product  112  to a patient from vials of different configurations. Although the liquid trial product  112  may be administered to a patient from vials of different configurations, in some blinded studies it may be preferred that the patient and/or the administering person not be able to discern that the vials have different configurations. To this end, blinding shells can be formed that have internal cavities of different configurations, i.e., different sizes and/or shapes, to accommodate vials of different configurations, but have exterior surfaces with identical configurations. For example, depicted in  FIG. 7  is a cross sectional view of blinding shell  12 A in a closed position but with vial  14  removed. As shown in  FIG. 7 , blinding shell  12 A includes cavity  18 , hanging tab  36  and floor  32  that is disposed therebetween. Specifically, floor  32  extends between inside face  34  and outside face  35  ( FIG. 8 ). For purposes of clarity, outside face  35  of floor  32  is also shown in  FIG. 7  by dashed line. In the depicted embodiment, floor  32  extending between faces  34  and  35  is solid, i.e., no openings or pockets are formed therein. However, in other embodiments, one or more pockets or openings can be formed into floor  32  from inside face  34  so as to decrease material costs. 
     Also shown in  FIG. 7  is a cross sectional view of an alternative blinding shell  12 B in a closed position but with the vial removed therefrom Like elements between blinding shell  12 B and blinding shell  12 A are identified by like reference characters. Blinding shell  12 B is identical to blinding shell  12 A except that the length of cavity  18  of blinding shell  12 B has been lengthened relative to cavity  18  of binding shell  12 A by decreasing the thickness of floor  32 . That is, the length of cavity  18  of blinding shell  12 B has been lengthened by forming inside face  34  of floor  32  closer toward outside face  35  but not adjusting the position of outside face  35 . Because cavity  18  of blinding shell  12 B has been lengthened, the new cavity  18  can now receive a longer vial relative to what can be received within shell portion  54 A. For example, depicted in  FIG. 9  is vial  14  configured to be received within cavity  18  of blinding shell  12 A. Also shown in  FIG. 9  is a vial  14 A that is configured to be received within cavity  18  of blinding shell  12 B. Vial  14 A has a different configuration than vial  14 , i.e., vial  14 A is longer than vial  14 . 
     However, from the outside, as depicted in  FIG. 8 , blinding shells  12 A and  12 B have identical configurations and thus look identical. Thus, because the entire exterior surfaces of blinding shells  12 A and  12 B are identical, those administering and those receiving liquid trial product  112  from vials  14  and  14 A disposed within blinding shells  12 A and  12 B are unable to discern that vials  14  and  14 A have different configurations, thereby further helping to maintain the fidelity and efficacy of the blinded study. 
     Although  FIGS. 7 and 8  show adjusting the size of cavity  18  by adjusting the thickness of floor  32 , in other embodiments, the positioning of other interior surfaces or combination of surfaces can be adjusted, i.e., moved inward or outward or have a contour thereof modified, so as to modify the configuration of cavity  18  and especially to modify the diameter or width of cavity  18 . For example, the interior surface of shield wall  28 , body  44 , and/or neck  46  can be moved or adjusted to modify the configuration of the cavity without modifying the corresponding exterior surfaces of the blinding shell. In one specific example, if the diameter or width of vail  14 / 14 A is smaller than the diameter or width of cavity  18 , sidewall  22  can be thickened along the full height of cavity  18  so as to correspond to the configuration of vail  14 / 14 A. Alternatively, sidewall  22  can be thickened at two or more spaced apart locations along the height of cavity  18  so that vail  14 / 14 A is sufficiently supported within cavity  18 . 
     In view of the above, in one embodiment a kit can be provided that includes blinding shell  12 A having cavity  18  and vial  14  disposed therein and that also includes blinding shell  12 B having cavity  18  and vial  14 A disposed therein. In the kit, cavities  18  and vials  14  and  14 A of blinding shells  12 A and  12 B each have different configuration. However, the exteriors of blinding shells  12 A and  12 B are identical. The kit can also include at least 3, 4 or more additional blinding shells having a cavity with a vial disposed therein wherein the cavities and vials can be the same or different configurations. Again, however, the exteriors of each of the blinding shells are identical. The kit can be shipped or transported to a patient, medical facility or administering person for dispensing the liquid trial product  112  contained within the vials to a patient as part of a blinded study. Where the blinding shells and vials are being shipped in a disassembled state, the kit can comprise two or more blinding shells having cavities of different configurations and two or more vials having different configurations wherein the vials are configured to be received within the cavities of corresponding blinding shells and wherein the exterior of all of the blinding shells have the same configuration. 
     A method is also provided that includes inserting vial  14  within cavity  18  of blinding shell  12 A and inserting vial  14 A within cavity  18  of blinding shell  12 B where the cavities and vials are of different configurations. However, the exteriors of blinding shells  12 A and  12 B are identical. At least 3, 4, or more additional vials can be inserted within blinding shells where the cavities thereof and vials are of the same or different configurations. Again, however, the exteriors of each of the blinding shells are identical. In one method, the now assembled vial blinding assemblies can now be administered to a patient as part of a blinded study. In other methods, either in combination or sequentially, blinding shells  12 A and  12 B with vials  14  and  14 A therein can then be sent to a patient, medical facility, or administering person for dispensing the liquid trial product  112  contained within the vials to a patient as part of a blinded study. The blinding shells with vials can be sent to the same patient, medical facility or administering person or to different patients, medical facilities or administering persons. 
     Depicted in  FIGS. 10 and 11  is another alternative embodiment of a blinding shell  12 C incorporating features of the present disclosure. Like element between blinding shells  12 A and  12 C are identified by like reference characters. As previously discussed, in some embodiments, it is not necessary to administer liquid trial product  112  intravenously and thus it is not necessary that the blinding shell be configured to support vial  14  in an inverted position. Rather, it may be more desirable, such as for ease of packaging, storing and/or administering, that the blinding shell be configured to support vial  14  in an upstanding orientation. To that end, blinding shell  12 C is identical to blinding shell  12 A except that hanging tab  36  has been removed so that outside face  35  of floor  32  can rest directly on a support surface, i.e., table, counter, shelf, container, etc., so as to support vial  14  therein in an upstanding orientation. 
     Blinding shell  12 C also differs from blinding shell  12 A in that closure tab portions  48 A and  48 B have been replaced with modified closure tab portions  178 A and  178 B that combine to form a closure tab  178 . Closure tab portions  178 A and  178 B differ from closure tabs  48 A and  48 B by extending along the length of sidewall  22  and body  44  and also by extending outward beyond exterior surface  20  of body  44 . That is, with the removal of hanging tab  36 , there is no longer a mechanism for securing together second end  26  shell portions  54 A and  54 B of blinding shell  12 C. As such, closure tab portions  178 A and  178 B are added and configured so that projections  86  and coupling holes  84  can be formed thereon, respectively, at second end  26 . As such, as blinding shell  12 C is moved to the closed position so as to enclose a vial  14  therein, the opposing ends of blinding shell  12 C can be secured together using the press fit connections as previously discussed. As needed, any number of projections  86  and coupling holes  84  can be formed along the length of closure tab portions  178 A and  178 B. Again, once blinding shell  12 C is moved to the closed position, one or more seals  92  can be applied that extend between shell portions  54 A and  54 B, such as between closure tab portions  178 A and  178 B. All previously discussed alternatives for projections  86  and coupling holes  84  discussed above with regard to blinding shell  12 A are also applicable to blinding shells  12 B and  12 C. 
     It is appreciated that vial blinding assemblies and blinding shells, along the alternatives thereof and the components thereof, as discussed herein, have unique and beneficial advantages. For example, the blinding shells are easy and relatively inexpensive to produce and can be securely attached with minimal effort. Furthermore, the blinding shells are opaque and fully cover the vial, except for the septum and potentially a small adjacent area. As such, the blinding shells are highly effective in blinded studies in that they preclude any visual exposure of the liquid trial product being tested and substantially preclude visual expose of the vial. In particular, embodiments of the blinding shell are effective at covering the retainer that secures the stopper and, more particularly, the flange or terminal end face of the retainer that encircles the aperture through which the septum of the stopper is accessed. 
     Embodiments of the blinding shell are also unique in that they include a hanging tab which enables easy inverted suspension of the vial for intravenous delivery of the liquid trial product. Finally, embodiments of the blinding shells can be produced with cavities of different configurations for holding vials of different configurations but have identical exterior configurations. This design helps to ensure that patients and/or those who are administering are unable to detect whether vials of different configurations are being used and thus help to improve the fidelity and efficacy of the blinded studies. Other benefits and advantages also exist. 
     Various alterations and/or modifications of the inventive features illustrated herein, and additional applications of the principles illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, can be made to the illustrated embodiments without departing from the spirit and scope of the invention as defined by the claims, and are to be considered within the scope of this disclosure. Thus, while various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. While a number of methods and components similar or equivalent to those described herein can be used to practice embodiments of the present disclosure, only certain components and methods are described herein. 
     It will also be appreciated that systems, processes, and/or products according to certain embodiments of the present disclosure may include, incorporate, or otherwise comprise properties features (e.g., components, members, elements, parts, and/or portions) described in other embodiments disclosed and/or described herein. Accordingly, the various features of certain embodiments can be compatible with, combined with, included in, and/or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include said features without necessarily departing from the scope of the present disclosure. 
     Moreover, unless a feature is described as requiring another feature in combination therewith, any feature herein may be combined with any other feature of a same or different embodiment disclosed herein. Furthermore, various well-known aspects of illustrative systems, processes, products, and the like are not described herein in particular detail in order to avoid obscuring aspects of the example embodiments. Such aspects are, however, also contemplated herein. 
     The present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. While certain embodiments and details have been included herein and in the attached disclosure for purposes of illustrating embodiments of the present disclosure, it will be apparent to those skilled in the art that various changes in the methods, products, devices, and apparatus disclosed herein may be made without departing from the scope of the disclosure or of the invention, which is defined in the appended claims. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.