WO2021019513A1

WO2021019513A1 - A supporting device and a casing assembly for a biopharmaceutical and medicinal package

Info

Publication number: WO2021019513A1
Application number: PCT/IB2020/057277
Authority: WO
Inventors: Navya ROSHAN; Roshan SANNAPPA; Minh Anh TRAN
Original assignee: Tavas Biosolutions Private Limited
Priority date: 2019-07-31
Filing date: 2020-07-31
Publication date: 2021-02-04

Abstract

A supporting device (200) for supporting a biopharmaceutical and medicinal package is disclosed. The supporting device (200) includes a base plate (3) defined with a receiving portion, a support member (1) disposed in the receiving portion of the base plate (3). The support member (1) is defined with a cutout (8) and plurality of grooves (2) to receive and accommodate the package. Further, the device has a barrier layer (4) fixed on the receiving portion of the base plate (3), to physically support and thermally engage the package accommodated in the support member (1)The barrier layer (4) acts as a thermal stable medium between the base plate (3) and the biopharmaceutical package during freezing and thawing process. The supporting device provides secured protection and eliminate bare handling of packages by operators during freezing and thawing process which may lead to damage or breakage of packages.

Description

TITLE:“A SUPPORTING DEVICE AND A CASING ASSEMBLY FOR A BIO PHARMACEUTICAL AND MEDICINAL PACKAGE”

TECHNICAL FIELD:

The present disclosure, in general, relates to packaging, storage and transportation of products. Particularly, but not exclusively, the present disclosure relates to a casing for protecting, storage and transportation of biopharmaceutical and medical packages and products. Further, embodiments of the present disclosure relates to a supporting device for the protective casing assembly to store, freeze, thaw and transport biopharmaceuticals and medicinal packages and products.

BACKGROUND OF THE DISCLOSURE:

Storage and transportation of packages, products or articles is an important aspect in the modem period. As communities and humans evolved, pharmaceutical and medicinal products have been inducted into the list of essential to be correctly stored, protected and/or transported. Moreover, in recent times, storage and transportation in the pharmaceutical sector is an important aspect, as there is a constant demand for an immediate requirement of materials including, but not limited to, drugs, biofluids, and any other therapeutic material that is not locally available in case of medical emergency.

With advent of technology, there has been significant growth in product development period and commercial manufacturing time of biopharmaceutical and medicinal products, where parameters such as, but not limited to, manufacturing flexibility, capacity, market demand for such products, and the like are rapidly increasing. To address such requirements on large scale, manufacturing and marketing of single-use systems or packages such as, bags, tubes, filters, connectors, and the like are on the rise. Conventionally, one of the biggest challenges faced in the biopharmaceutical or medical industry is requirement for protection and preservation of valuable biopharmaceutical and medicinal products including, but not limited to, vaccines, monoclonal antibodies, buffers, cell therapy intermediates, gene therapy products, media, buffers , drug substances, drug products, blood, semen, stem cells, bone marrow, and the like. Some of the challenges in protection and preservation of said biopharmaceutical and medicinal products include, transportation, storage, freeze-thaw process and/or sale period of such products. Conventionally, products being protected and preserved through the single-use systems may have contamination risks and loss of said product due to low-sustainability and/or endurance of such single-use systems. Also, conventionally manufactured single-use systems, such as plastic bags or other flexible and/or disposable containers, may often be subjected to damage either during storage or during transportation, resulting from volumetric expansion of the biopharmaceutical or medicinal products during freezing. Such expansion of the biopharmaceutical or medicinal products may generate excessive pressure in such containers, whereby leading to rupture or damage. Further, the thawing process of these frozen biopharmaceutical or medicinal products may involve removing the single-use systems from a freezer and placing in a surrounding having controlled room temperature . At this juncture, solid to liquid transition of the biopharmaceutical or medicinal products within the single-use system may again creates pressure on tubes, joints, or protuberances therein, which leads to potential damage or loss of said products.

Moreover, manual handling of such single-use systems (especially at higher volumes) may often result in damage to the products they contain due to several factors, where some of such factors may be including, but not limited to, shock, abrasions, impact or other mishandling events, that may arise from operator errors or inadequate protection provided by the single-use systems. Further, directly using the single-use systems in a freezing process may be a major concern in durability of the product, as direct freezing process may lead to potential breach of the single-use systems resulting in contamination and loss of product contained therein. To address such problems of single-use system, secondary and tertiary containment have been developed and implemented as a supplement to the single-use systems, to protect the valuable products.

In the recent past, preservation of the biopharmaceutical or medicinal products in the single use system often involve placing of such systems in a freezer and allowing such biopharmaceutical to freeze. Also, to ensure efficient use of available space inside the freezer, the single-use systems may be placed alongside one another and sometimes may be stacked into an array with varied spatial regularity, within the freezer. Under these conditions, cooling of the biopharmaceuticals may occur at different rates depending on exposure of each of the single-use systems to the surroundings and, may depend on an extent to which that single-use system may be shielded by neighboring single-use systems. In the recent times, to address some of deficient qualities in storing and transporting of the biopharmaceutical or medicinal products, container casings have been developed to accommodate and secure the single-use systems from breakage during storage, handling and/or transportation. Further, the conventional containers developed are not very efficient in freezing and thawing the single use bags and take up extended amount of time to achieve the required results, which would render in the biopharmaceuticals inside the single use bags getting damaged and unworthy for medicinal purpose.

The present disclosure is directed to overcome one or more limitations stated above or any other limitations associates with the conventional arts.

SUMMARY OF THE DISCLOSURE:

One or more shortcomings of the prior art are overcome by a device and an assembly as claimed and additional advantages are provided through the provision of the device as claimed in the present disclosure. Additional features and advantages are realized through the aspects and techniques of the present disclosure. Other embodiments and aspects of the disclosure are described in detail herein and are considered a part of the claimed disclosure.

In an exemplary embodiment of the present disclosure, a supporting device for supporting a biopharmaceutical and medicinal package is disclosed. The supporting device includes a base plate defined with a receiving portion and a support member disposed in the receiving portion of the base plate. The support member is defined with a cutout and a plurality of grooves to receive and accommodate the said package. Further, the supporting device consists of a barrier layer which is fixed on the receiving portion of the base plate, to physically support and thermally engage at least a portion of the said package accommodated in the support member. Additionally, the barrier layer is configured to act as a thermal stable medium between the base plate and the said package during freezing and thawing of the said package.

In an embodiment, the barrier layer is sandwiched between the base plate and the support member, to support and thermally engage at least a portion of the said package accommodated in the support member with the base plate.

In an embodiment, the plurality of grooves are defined adjacent to the cutout and are configured to accommodate accessories extending from the said packages. In an embodiment, the support member is made of foam.

In another non-limiting embodiment of the disclosure, a casing assembly for freezing, storing, thawing and transportation of biopharmaceutical packages is disclosed. The casing assembly consists of an enclosure having a closure portion and a base portion, where the closure portion is provisioned with a first protective layer and the base portion is provisioned with a second protective layer, and the closure portion is adapted to cover the base portion. Further, the casing assembly includes a supporting device disposed between the closure portion and the base portion of the enclosure . The supporting device consists of a base plate defined with a receiving portion and a support member disposed in the receiving portion of the base plate. The support member is defined with a cutout and plurality of grooves to receive and accommodate the said package. Further, the supporting device consists of a barrier layer which is fixed on the receiving portion of the base plate, to physically support and thermally engage at least a portion of the said package accommodated in the support member with the base plate. Additionally, the barrier layer is configured to act as a thermal stable medium between the base plate and the said package during freezing and thawing of the said package.

In an embodiment, the supporting device is positioned between the first protective layer and the second protective layer in the casing assembly.

In an embodiment, a locking mechanism is coupled with the enclosure and is configured to lock the supporting device within the casing assembly.

In an embodiment, the base plate is configured with at least one handle to maneuver and manipulate the supporting device.

In an embodiment, the first protective layer (6), the second protective layer (7) and the support member (1) are made of foam

It is to be understood that the aspects and embodiments of the disclosure described above may be used in any combination with each other. Several of the aspects and embodiments may be combined to form a further embodiment of the disclosure.

The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS:

The novel features and characteristics of the disclosure are set forth in the description. The disclosure itself, however, as well as a preferred mode of use, further advantages thereof, will best be understood by reference to the following description of an illustrative embodiment when read in conjunction with the accompanying drawings. One or more embodiments are now described, by way of example only, with reference to the accompanying drawings wherein like reference numerals represent like elements and in which:

FIG.1 illustrates a perspective view of a casing assembly for storage and transportation of a biopharmaceutical and medicinal package, in an open condition, in accordance with one embodiment of the present disclosure.

FIG.2 illustrates a front view of a support member for the casing assembly of FIG. 1, in accordance with one embodiment of the present disclosure.

FIG.3 illustrate a front view and a side view of a supporting device with the support member of FIG. 2.

FIG.4 illustrates a perspective view of the casing assembly in a closed state, in accordance with an embodiment of the present disclosure.

FIG. 5 illustrates an exploded perspective view of the enclosure of the casing assembly defined with holes, in accordance with an embodiment of the present disclosure.

The figures depict embodiments of the disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the mechanism and assembly illustrated herein may be employed without departing from the principles of the disclosure described herein.

DETAILED DESCRIPTION OF THE DISCLOSURE:

The foregoing has broadly outlined the features and technical advantages of the present disclosure in order that the detailed description of the disclosure that follows may be better understood. Additional features and advantages of the disclosure will be described hereinafter which form the subject of the claims of the disclosure. It should be appreciated by those skilled in the art that, the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other devices or assemblies for carrying out the same purposes of the present disclosure. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the scope of the disclosure as set forth in the appended claims. The novel features which are believed to be characteristic of the disclosure, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present disclosure.

The terms“comprises”,“comprising”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that an assembly, mechanism or method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or mechanism or assembly. In other words, one or more elements in a mechanism or assembly proceeded by“comprises ... a” does not, without more constraints, preclude the existence of other elements or additional elements in the mechanism or assembly.

Embodiments of the present disclosure relates to a casing assembly for storing and transporting biopharmaceutical and medicinal packages and also aids in freezing and thawing process without causing any damage to the packages. The casing assembly consists of a closure portion and a base portion that are coupled together to form an enclosure, where the closure portion is adapted to cover the base portion. The closure portion is provisioned with a first protective layer and the base portion is provisioned with a second protective layer. Further, the casing assembly includes a supporting device disposed between the closure portion and the base portion of the enclosure, such that the first protective layer and the second protective layer comes in contact with the supporting device when the enclosure is closed. Furthermore, the supporting device includes a base plate defined with a receiving portion and a support member disposed in the receiving portion of the base plate . The support member is defined with a cutout and plurality of grooves to receive and accommodate the biopharmaceutical package. Additionally, a barrier layer is fixed on the receiving portion of the base plate and is sandwiched between the base plate and the support member, to thermally engage and physically support at least a portion of the package accommodated in the support member with the base plate. Here, the barrier layer is configured to act as a thermal stable medium between the base plate and the biopharmaceutical package during freezing and thawing of the biopharmaceutical package. Thus, due to the above configuration of the casing assembly and the supporting device, the package can be stored and transported without any damage and the time required to freeze and thaw the biopharmaceutical packages within the supporting device or the casing remains very close to the time which is taken by the biopharmaceutical package when separately frozen or thawed.

In an embodiment, the term“package” may be referred to a covering, a housing, an enclosure, or any containment structure capable of receiving and storing substances, where the substance may either be in solid, liquid or gaseous form. Further, such package may be thermally stable in nature, for suitably maintaining contents therein at defined temperature and/or pressure. Also, the package may be capable of being handled by an operator or may be robotically handled, based on requirement.

In an embodiment, the phrase“the biopharmaceutical and medicinal packages” referred earlier and hereafter are to be treated as at least one of package used for storing or containing pharmaceutical, biopharmaceutical, medicinal, medical substance or a product in any form . Additionally, contents within the package may include, but may not be limited to, vaccines, monoclonal antibodies, buffers, cell therapy intermediates, gene therapy products, media, buffer, drug substances, drug products, stem cells, blood, semen, bone marrow, herbal extracts, animal extracts, and any other material that may require protective transportation.

Reference will now be made to the exemplary embodiments of the disclosure, as illustrated in the accompanying drawings. Wherever possible, same numerals will be used to refer to the same or like parts. The following paragraphs describe the present disclosure with reference to Figures 1 to 5.

FIG. l is an exemplary embodiment of the present disclosure which illustrates a casing assembly (100) for freezing, thawing, storage, and transportation of a biopharmaceuticals and/or medicinal packages or products [not shown in Figures]. In an embodiment, the biopharmaceutical and medicinal package [hereafter referred to as“the package”] may be a single-use package or a reusable package containing biopharmaceutical and/or medicinal materials, where the package may be capable of carrying such materials for freezing, thawing, and transportation based on requirement. The casing assembly (100) consists of a supporting device (200) which may be accommodated within the casing assembly (100). The supporting device (200) consists of a support member (1) that may be defined with a cutout (8). In an embodiment, the cut-out may be formed by missing a defined profile (8) resembling that of the package such that, the package may rigidly seat within the cutout (8) of the support member (1). Further, the supporting device (200) may include a base plate (3), where the support member (1) may be configured to be positioned within a receiving portion of the base plate (3). Furthermore, the supporting device (200) may include a barrier layer (4)fixed onto the receiving portion of the base plate (3). In an embodiment, the supporting device (200) may be configured such that the barrier layer (4) may be sandwiched between the base plate (3) and the support member (1).

The casing assembly (100) further includes an enclosure (5), that may be configured with a base portion and a closure portion. The base portion of the enclosure (5) may be configured to accommodate the supporting device (200). Additionally, the casing assembly (100) consists of a first protective layer (6) and a second protective layer (7) that may be provisioned in the closure portion and the base portion of the enclosure (5), respectively, to securely accommodate and enclose the supporting device (200), and in-tum the package, inside the enclosure (5) of the casing assembly (100).

The casing assembly (100) may be configured to securely accommodate the package and may be subjected to various process for preservation of biopharmaceutical and medicinal material within the package. For example, the casing assembly (100) or at least the supporting device (200) may be frozen and thawed in a controlled way along with the package for improving durability of the material contained within the package. The package may be securely accommodated in the supporting device (100) and the supporting device (100) may then be provisioned in the casing assembly (100). The supporting device (200) and the casing assembly (100)by nature of construction and configuration may prevent thermal exchange between the package and the surroundings and protect from physical damage to the biopharmaceutical and medicinal material within the package due to variation in pressure acting on the package, vibration, and the like. In an embodiment, the support member (1) may be manufactured based on dimensional and profile requirements applicable as that of the package. The package may be positioned within the cutout (8) defined in the support member (1), while the support member (1) may further be defined with plurality of grooves (2), extending from the cutout (8). The plurality of grooves (2) may be configured to accommodate extensions and/or accessories including, but not limited to, protuberances, wires, plugs, tubes, filters, connectors, clamps, and the like, extending from the package. Such extensions and/or accessories may be an integral part or may be add-on externally connected to the package, for purposes including, but not limited to, receiving or discharging material into and out from the package. The support member (1) may be fixed on the base plate (3) by suitable means, along with the barrier layer

(4) positioned in the receiving portion of the base plate (3). The cutout (8) defined in the support member (1) may allow the package to be positioned to contact the barrier layer (4). The barrier layer (4) may be manufactured using materials having high thermal stability so that, at least a portion of the package accommodated in the support member (1) may thermally engage with the base plate (3) and the material within the package may be effectively frozen or thawed, during storage and/or transportation. In an embodiment, the base plate (3) may be configured with at least one handle (9) [as best seen in FIG. 3] to maneuver and manipulate the base plate (3) and in-tum the supporting device(200) in or out of the enclosure (5) of the casing assembly (100), thereby eliminating any errors or mishaps that may occur during handling by an operator [or user] . The base plate (3) configured with the barrier layer (4) may enable to secure the package, during the freeze cycle within the freezer. This arrangement of the base plate (3) and the barrier layer (4) may avoid necessity for an operator to handle the package with bare hands to position the package directly within the freezer, thereby ensuring that the package may be protected from accidental incidents such as, but not limited to, breakage, leaks, spills etc.

Further, the casing assembly ( 100) includes a first protective layer (6) positioned at the closure portion of the enclosure (5) and a second protective layer (7) at the base portion of the enclosure

(5) such that, the base plate (3) and the support member (1) are placed therebetween. The first protective layer (6) and the second protective layer (7) may aid in enclosing and protecting the package from damages due to factors including, but not limited to, vibration, collision, temperature and pressure variation, foreign particles, and the like, during transporting and/or storing. In an embodiment, the casing assembly (100) also includes a locking mechanism (10) coupled on the enclosure (5), for hermetically locking of the package within the casing assembly (100). In an embodiment, the first protective layer (6) and the second protective layer (7) are made of foam, natural fibers, polymers, bubble raps, cardboard, and any other material that may thermally isolate the package from the surroundings. Also, the first protective layer

(6) and the second protective layer (7) may be an integral part of the closure portion and the base portion respectively or may be an externally provisioned to be removably fixed to the enclosure. Further, the first protective layer (6) and the second protective layer (7) may be fixed the closure portion and the base portion respectively by means including, but not limited to, fastening, adhesive bonding, clamping, snap fitting, and the like.

In an embodiment, the closure portion of the enclosure (5) may be defined with a cutout. Further, the first protective layer (6) positioned at the closure portion may also be defined with a cutout. The cutouts in the closure portion and the first protective layer may provide the necessary thermal concentration or relieving sections for suitably controlling the temperature of the package. Furthermore, the cutout in the closure portion and the first protective layer may allow the user to maneuver the package in and out of the casing assembly (100).

In an embodiment, the enclosure (5) may be a unitary structure capable of opening at a pivot point to form the closure portion and the base portion of the casing assembly (100). The enclosure (5) may also be formed as an assembly, where the base portion and the closure portion may be individually manufactured using similar or dissimilar materials and thereafter interlocked at a portion to accommodate and enclose the package.

Referring again FIG. 2, illustrates a schematic view of the support member (1), which may be configured to accommodate the package. The support member (1) may be defined with the cutout and the plurality of grooves (2) as can be seen in FIGs. 1 and 3. The cutout (8) may be machined with dimensional tolerances like dimensions of the package to be stored in the casing assembly (100), to rigidly secure the package. The plurality of grooves (2) may be configured to secure the accessories of the package, where such accessories may be rigidly held to avoid interference during storing and/or transportation of the package. For example, the package resembling a blood bag, which may include a plurality of tubes extending from a top portion of the blood bag. The plurality of grooves (2) in the support member (1) may be configured such that, the plurality of tubes [not shown in figs] extending from the blood bag may be housed and secured in the plurality of grooves (2) without being subjected to free movement that may cause damages during storage and transportation of the blood bag. In an embodiment, the package may be in the form of a bag or any type of container capable of storing either a solid or a liquid or a gas of biopharmaceutical and medicinal material based on the requirement. In an embodiment, vaccines, monoclonal antibodies, buffers, cell therapy intermediates, gene therapy products, drug substances ,drug products, media, feeds, stem cells, blood, semen, bone marrow, and the like can be stored, frozen, thawed and transported in the packages. Also, the cutout and the plurality of grooves defined in the support member (1) may be varied in order to accommodate multiple packages, either adjacent to one another or as stacks, based on requirement and capacity of the casing assembly (100).

In an embodiment, the support member (1) may be manufactured using specialized foam, which may be milled to a profde capable of holding the package. The support member (1) may be manufactured with materials having chemical composition such as, but not limited to, polyethylene, polypropylene, polyurethane and polyvinylidene fluoride, polystyrene, ethylene vinyl acetate and any other polymeric material having suitable properties. Also, the support member ( 1 ) may be made of natural fibers, fiber materials, foam, cardboard, paper, and the like . Further, the support member (1) may be manufactured using a polymer mixing process, which may be followed by a cross linking technology for extruding the support member (1). A high- pressure nitrogen gas process may be supplied during manufacturing the support member (1), to enhance strength, durability, and the temperature resistance by the support member (1). Further, for forming the support member (1), the extruded foam from polymer mixture may be subjected to high operating temperature ranges, that may enable the foam to be compressed or stretched without getting deformed. Hence, the foam used in the support member (1) may be used along with the package for a frozen storage applications, where the support member (1) can retain the original shape and physical properties including rigidity, flexibility and strength, during freeze-thaw cycles. Additionally, the foam used in manufacturing the support member (1) may possess uniform and controlled cell size, that enhances the mechanical and physical properties. The uniform and controlled cell size may enable the support member (1) to secure the package and its components within the cutout (8) and the grooves (2) and does not lead to disengagement of the package from its place during handling, storage or transport. In addition, as the foam is manufactured in the absence of any chemical agents/solvents, the support member (1) may be chemically and biologically inert when engaged with the package or during free-thaw cycles, thereby rendering the support member (1) usable in storage, transportation, freezing and thawing of medical, biopharmaceutical and pharmaceutical materials.

In an exemplary embodiment, a CNC milling process may be used to manufacture structure of the support member (1) as per the dimensions of the package and its accessories. Alternatively, the machining of the support member (1) may also be done by employing techniques such as, die cutting, thermo forming, vacuum forming, injection molding, punching and any other process which may be free from chemicals that may vary the characteristics of the foam from which the support member (1) is manufactured. The foam used for the support member (1), due to low weight, may tend to get displaced during operation of routing and milling processes, which may lead to error in internal dimensioning of the cutout and the plurality of grooves (2). To mitigate or avoid such errors during the machining process, vacuum pads may be provisioned to hold the foam firmly so that, when a machining tool moves across the foam, a vacuum suction force exerted by the vacuum pads may hold the foam firmly. This process ensures that the plurality of grooves (2) and/or the cutout (8) of support member (1) may be machined with minimal effort and tolerance range in comparison with that of the package. Furthermore, the uniform controlled cell size, water repellant nature and good thermal insulation properties of the foam used for manufacturing the support member (1) may be suitable to be used for a frozen bulk storage and transportation application. Further, the density of the foam used for the support member may range between 5 kg/m3 - 80 kg/m3. These densities of foam are ideal to provide the required strength and resistance to the packages against any shock, breakage or damage during storage, freezing or transportation. Furthermore, the thickness of the foam may range between 5mm - 300mm so as to accommodate the filled- up packages.

In an embodiment, the support member (1) may be an extension or protrusion extending from the base plate (3) which are according to the dimensional requirements of the package and the barrier layer (4) may be provisioned within these extensions or protrusions to increase the thermal properties of the base plate (3). Further, the support member (1) may also be formed by laying a material on the receiving portion of the base plate (3) such that the laid material resembles the boundaries in which the packages are to be accommodated. In an embodiment, the base plate (3) may be machined to create a depression in the receiving portion of the base plate (3) so that the barrier layer (4) can be provisioned within the depression and the packages are positioned over the barrier layer in the depression.

Referring now to FIG.3, which illustrates a schematic view of the supporting device (200) having the support member (1) positioned on the top surface or the receiving portion of the base plate (3). The base plate (3) may be manufactured by making use of a metal or a metal alloy as per requirement. In an embodiment, the base plate (3) may also be manufactured using, but not limited to polymers, fibers, glass, and any other material that may be thermally stable. The base plate (3) is configured such that it accommodates the support member (1) on its top surface or any other surface capable of receiving the support member (1) and the barrier layer (4). The barrier layer (4) may be positioned between the base plate (3) and the support member (1) so that, the barrier layer (4) is always in contact with the package when the package is positioned inside the cutout (8) of the support member (1). Further, the base plate (3) may be configured with at least one handle (9) at the ends of the base plate (3). In an embodiment, the at least one handle (9) may be configured to aid in lifting the supporting device (200) in and out of the casing assembly and also may be employed for positioning the supporting device (200) in and out of a freezer for freezing the package. In an embodiment, the barrier layer (4) may be a rigid layer fixed onto the base plate (3) capable of supporting the weight of the package during various cycles, namely, freezing cycle and thawing cycle without experiencing any stress or strain due to the varying temperature.

In an embodiment, the support member (1) may have tabs provisioned on the outer surface so as to lock into receiving portions defined in the base plate (3) to fix the support member ( 1) on the base plate (3). Further, the support member (1) can also be fixed onto the base plate (3) using suitable techniques which are not limited to fastening, adhesive bonding, clamping, etc.

In an embodiment, the supporting device (200) may consist of the support member (1) positioned over the barrier layer (4), where the barrier layer (4) is formed as a rigid layer which would act as the base plate (3).

In an embodiment, the barrier layer (4) provisioned between the base plate (3) and the support member (1) may be manufactured by using materials such as, but not limited to, Fluorinated ethylene -propylene (FEP), polytetrafluoroethylene (TFE), polyethylene chlorotrifluoroethylene (ECTFE), perfluoro alkoxy (PFA), polyethylene tetrafluoro ethylene (PTFE), Polyvinylidene fluoride, and the like. The barrier layer (4) is chemically inert and may be configured to withstand high and low temperature. Also, chemicals such as strong acids, strong alkali, salts, and solvents, may substantially not change the physical properties of the barrier layer (4). The barrier layer (4) may be made out of sheets, having thickness ranging from about 0.05mm to about 1mm, and may be used in the supporting device (200) to enable effective heat transfer during freezing onto the package . The barrier layer (4) may possess good thermal stability and may be capable of uniform thermal distribution. The barrier layer (4) in the casing assembly (100) aids in reducing the freezing time of the biopharmaceuticals inside the package. Thus, the barrier layer (4) on one hand supports the package during freezing and thawing operation, and at the same time also enables effective heat transfer or distribution process to optimize overall cycle time of freezing and thawing process. In an embodiment, the barrier layer (4) is configured on at least one surface of the base plate (3), for example, the barrier layer (4) may be provisioned over the top surface, the bottom surface and on side walls of the base plate (3). Further, the barrier layer (4) may be disposed within the base plate (3) and thereby enhancing the thermal properties of the base plate (3) and the barrier layer (4) may also be in the form of a liquid which can be inserted into the base plate (3) or just poured onto the receiving portion of the base plate (3).

In an embodiment, the barrier layer (4) may be punched at the comers to enable riveting of the barrier layer (4) with a plurality of L-Brackets (not shown in figure) onto the base plate (3) to produce a rigid structure on which the support member (1) of the supporting device (200) and the package rests. The barrier layer (4), however, may also be fixed to the base plate (3) be means including, but not limited to, fastening, adhesive bonding, clamping, and the like. In an embodiment, the barrier layer (4) may be fixed to the base plate (3) such that, there may be no air films or bubbles formed or trapped between the barrier layer (4) and the base plate (5). Further, the barrier layer (4) has a very even and a flat surface such that formation of air pockets or films between the barrier layer (4) and the package may be eliminated.

Moving on to FIG.4, illustrates a perspective view of the casing assembly (100) in a closed state. In this state the enclosure (5) of the casing assembly (100) may be closed and locked with the help of a locking mechanism (10) to securely lock the enclosure (5). The locking mechanism (10) may be externally coupled to the enclosure (5) of the casing assembly (100). The locking mechanism (10) ensures the safety of the package as well as prevents tampering and contamination of the contents in the packages. In an embodiment, the enclosure (5) of the casing assembly (100) may be made up of corrugated polypropylene and/or polyethylene sheets which may be flute type, injection molded type, bubble type, honey-comb type and the like. In another embodiment the enclosure (5) may also be made of a metallic alloy type material, wood, polymers, fiberglass, cardboard, and the like. In an embodiment, the enclosure (5) may be made from an opaque or translucent or transparent material based on the requirement so that a user may view the elements positioned inside the enclosure. Further, the first protective layer (6) and the second protective layer (7) may also be made of materials which are translucent or transparent in nature to enable viewing inside the enclosure (5).

In an embodiment, the enclosure (5) may be defined with plurality of recesses or holes (12) provisioned in the closure portion and the base portion [as best seen in Fig. 5] The plurality of holes (12) act as gripping means for handling the closure portion and the base portion during transportation. Further, the plurality of holes provide the necessary thermal concentration or relieving sections for suitably controlling the temperature of the package based on factors including, but not limited to, quantity of fluid in the package, thickness of the package, temperature at which package is required to be maintained, and the like. Furthermore, in an embodiment, sensors may be positioned in the plurality of holes to monitor various parameters within the casing assembly (100). The sensor may be one of, but not limited to temperature sensors, pressure sensors, proximity sensors, shock sensors and the like, for detecting parameters like temperature, pressure, movement of the package, etc., within the casing assembly (100).

In an embodiment, the method of assembling the casing assembly (100) may comprise of the following steps. Firstly, the first protective layer (6) and the second protective layer (7) are provisioned within the closure portion and the base portion. Next the closure portion and the base portion are coupled together to form the enclosure (5). The machined support member (1) may be then cleaned to remove any traces of foam particles that remain in the plurality of grooves (2). This cleaning process ensures that no foam particles stick onto the surface of the single use system when removed from the casing assembly (100). The next step includes coupling of the barrier layer (4) and the support member (1) with the receiving portion of the base plate (3) in a safe and secure manner to ensure that the barrier layer (4) and the support member (1) are locked onto the base plate (3) to form the supporting device (200) the (200). Lastly, supporting device (200) with the base plate (3), the barrier layer (4) and the support member (1) are inserted into or placed inside the enclosure (5), such that the first protective layer (6) and the second protective layer (7) serve as top and bottom protective for securing the supporting device (200) and in-tum the package in the casing assembly (100).

In an embodiment, the freezing of the package accommodated in the cutout (8) of the support member (1) may be achieved by positioning the supporting device (200) inside a freezer. Further, the casing assembly (100) having the package within may also be placed inside the freezer for freezing the package.

In an embodiment, the support member (1) may have a construction where the cutout (8) may be formed as a package/container into which the biopharmaceuticals are directly inserted for freezing, thawing, storing, and transporting. In an embodiment, the thickness of the first protective layer (6) and the second protective layer (7) may range between 1mm - 100mm to ensure additional support in the casing assembly (100) during storage or transportation of the package. In an embodiment, the casing assembly (100) may be provided with labels (11) for identification purposes that may be provided over the outer surface of the enclosure (5). The labels (11) may be provided so that the user can enter the details of the batch processed. These labels (11) may be half laminated to enable writing of details of the product or the batch stored in the casing assembly (100). The labels (11) may be configured to withstand temperature of freezing and thawing cycles and for long term use and storage in freezers.

Experiments have been conducted to test the performance of the supporting device with respect to freezing and thawing process. The freezing time and the thawing time of the package directly accommodated within the freezer and in room temperature have been recorded. Further, the freezing time and the thawing time of the package positioned within the supporting device when kept in the freezer and in room temperature are recorded. The recorded values are shown in the tables 1 to 3 below.

Experiment 1- Cooling plate of the freezer is in contact with only the bottom surface of the package:

Table 1

Experiment 2- Cooling plate of the freezer is in contact with the bottom and the top surface of the package:

Table 2

Experiment 3- Rate of thawing:

Table 3 The experimental results provided in the above tables show that the rate of freezing the bare package containing the biopharmaceuticals against use of the supporting device for accommodating the package show no substantial increase in freezing or thawing time. These results prove that the supporting device enables the package to be frozen or thawed, at a rate which is substantially equal to the rate of the bare package. Further, the tabulated results indicate that the package in contact with the barrier layer (4) in the supporting device (200) does not increase the freezing time, but rather aids in enhanced thermal stability within the supporting device (200) to effectively maintain temperature of the package and also enable effective heat transfer during the freezing process.

In an embodiment, the supporting device (200) and the casing assembly (100) provide secured protection and eliminate bare handling of packages and assemblies by operators during freezing and thawing process which may lead to damage or breakage of packages. Further, as there is no universal design of the casing assembly (100) or the supporting device (200) to hold the packages, any manufacturer or type of package of various manufacturers may be provided with a complete casing solution. Furthermore, the freezing time and the thawing time required by the packages within the supporting device (200) are almost identical to the freezing time and the thawing time of the package separately positioned. Hence, the supporting device (200) and the casing assembly (100) provide a secure and safe solution for freezing, thawing, storing, and transporting the packages.

Equivalents:

The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

Throughout this specification the word“comprise”, or variations such as“comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

The use of the expression“at least” or“at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.

Any discussion of documents, acts, materials, devices, articles and the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.

The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

While considerable emphasis has been placed herein on the particular features of this disclosure, it will be appreciated that various modifications can be made, and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other modifications in the nature of the disclosure or the preferred embodiments will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation. Referral Numerals:

Claims

We Claim:

1. A supporting device (200) for a biopharmaceutical and medicinal package, the supporting device (200) comprising:

a base plate (3), defined with a receiving portion;

a support member (1) disposed in the receiving portion of the base plate (3), the support member (1) is defined with a cutout (8) and a plurality of grooves (2) to receive and accommodate said package;

a barrier layer (4), fixed on the receiving portion of the base plate (3), to physically support and thermally engage at least a portion of the said package accommodated in the support member (1)

wherein, the barrier layer (4) is configured to act as a thermal stable medium between the base plate (3) and the said package during freezing and thawing of the said package.

2. The supporting device (200) as claimed in claim 1, wherein the barrier layer (4) is sandwiched between the base plate (3) and the support member (1), to support and thermally engage at least a portion of the said package accommodated in the support member (1) with the base plate (3).

3. The supporting device (200) as claimed in claim 1, wherein the plurality of grooves (2) are defined adjacent to the cutout (8) and are configured to accommodate accessories extending from said package.

4. The supporting device (200) as claimed in claim 1, wherein the support member (1) is made of foam.

5. A casing assembly (100) for freezing, storing, thawing and transportation of biopharmaceutical and medicinal package, the casing assembly (100) comprising: an enclosure (5) comprising a closure portion and a base portion, the closure portion is provisioned with a first protective layer (6) and the base portion is provisioned with a second protective layer (7), wherein the closure portion is adapted to cover the base portion;

a supporting device (200) disposed between the closure portion and the base portion of the enclosure (5), the supporting device (200) comprising: a base plate (3), defined with a receiving portion;

a support member (1) disposed in the receiving portion of the base plate (3), the support member (1) is defined with a cutout (8) and plurality of grooves (2) to receive and accommodate said package;

a barrier layer (4), fixed on the receiving portion of the base plate (3), to physically support and thermally engage at least a portion of the said package accommodated in the support member (1),

wherein, the barrier layer (4) is configured to act as a thermal stable medium between the base plate (3) and the said package during freezing and thawing of said package.

6. The casing assembly (100) as claimed in claim 5, wherein the supporting device (200) is positioned between the first protective layer (6) and the second protective layer (7) in the casing assembly (100).

7. The casing assembly (100) as claimed in claim 5 comprises a locking mechanism (10) coupled to the enclosure (5), wherein the locking mechanism (10) is configured to lock the supporting device(200) within the casing assembly (100).

8. The casing assembly (100) as claimed in claim 5, wherein the base plate (3) is configured with at least one handle (9) to maneuver and manipulate the supporting device (200).

9. The casing assembly (100) as claimed in claim 5, wherein the barrier layer (4) is sandwiched between the base plate (3) and the support member (1), to support and thermally engage at least a portion of the said package accommodated in the support member (1) with the base plate (3).

10. The casing assembly (100) as claimed in claim 5, wherein the first protective layer (6), the second protective layer (7) and the support member (1) are made of foam.