Device for storing, transporting and/or handling a liquid and method of handling a sterile or aseptic liquid

Abstract

A device for storing, transporting and/or handling a liquid or liquids and methods for using the device are described. The device is suitable for use with sterile or aseptic liquids, particularly with large liquid volumes such as 10-1000 liters or more, and avoids the need for bags, bins and carriers commonly used for storing and transporting large volumes of liquids. The device comprises a coiled tubing. The coiled tubing can be loaded onto a spool to support the coiled tubing. The tubing can be filled, sealed, stored and transported in a more robust manner than previously achieved with bags, bins and carriers.

Claims

1. A method of handling a sterile or aseptic liquid comprising: a) filling a coiled tubing with a sterile or aseptic liquid, wherein the coiled tubing has a size and length sufficient to contain a liquid volume of at least 10 liters to at least 1000 liters; b) sealing the ends of the coiled tubing; c) storing and/or shipping the coiled tubing filled with liquid; and d) dispensing some or all of the liquid from the coiled tubing, further comprising filtering the liquid simultaneously or sequentially with dispensing the liquid from the coiled tubing.

2. The method of claim 1 further comprising a spool for supporting the coiled tubing.

3. The method of claim 1, wherein the tubing comprises a gamma sterilization-stable, thermoplastic material and is gas-impermeable, caustic-stable, pressure-resistant, pH-stable, impact-resistant, particle-free, low-extractable, low-leachable, temperature-stable, or a combination thereof.

4. The method of claim 1, wherein the tubing comprises multiple lumens and one or more lumens is filled with a liquid.

5. The method of claim 1, wherein the tubing comprises at least one sterile connector at one end of the tubing or comprises a sterile connector at each end of the tubing.

6. The method of claim 1 further comprising recirculating the liquid within the tubing using a recirculating pump connected to the tubing.

7. The method of claim 1 further comprising dispensing the liquid from the coiled tubing by gravity flow, pumping, or introducing pressurized air.

8. The method of claim 1 further comprising monitoring the temperature, pH, pressure, gas content, flow rate, or a combination thereof, of the liquid in the coiled tubing using one or more sensors connected to the tubing.

9. The method of claim 1, wherein the tubing is composed of a single material or a composite of materials.

10. The method of claim 1, wherein the liquid comprises a pharmaceutical, buffer, media, nutrient, or a combination thereof.

11. The method of claim 1 further comprising raising, maintaining and/or lowering the temperature of one or more liquids in the tubing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The drawings are provided to illustrate one or more versions of the present invention and are not to be construed as limiting the scope of the claims.

(2) FIG. 1 illustrates a variety of cross-section profiles of tubing for both single lumen and multiple lumen tubing.

(3) FIGS. 2A-2B illustrate examples of the surface of the interior drum of a spool. FIG. 2A illustrates a grooved or indented surface of the interior drum. FIG. 2B illustrates a flat surface of the interior drum.

(4) FIGS. 3A-3C show a split ring spool sidewall, as well as an alignment feature for attaching or mating a sidewall to the interior drum of a spool. FIG. 3A shows a split ring configuration of one sidewall. The split ring can accommodate tubing ends, connectors, etc. FIG. 3B illustrates an optional concentric and radial alignment feature for attaching a sidewall to the interior drum of the spool. While shown with a split ring sidewall, the attachment features can be used with any form of sidewall. FIG. 3C illustrates the sidewall attached to the interior drum of the spool with the alignment feature shown in FIG. 3B.

(5) FIGS. 4A-4D illustrate examples of a sidewall configuration. FIG. 4A illustrates a sidewall having leg supports. Such legs can be spaced to facilitate use of forklift or pallet-jack to move the spools, with or without tubing. As shown in FIG. 4C, such legs can correspond to indents in a sidewall of a second spool to accommodate stacking of the spools as shown in FIG. 4D. Alternatively, a sidewall of a spool may comprise wheels or castors (see FIG. 4B). Additional spools may be stacked upon a spool having wheels or castors.

(6) FIGS. 5A-5B illustrate sidewalls comprising flanges and optional spool supports. Such flanges on the sidewalls are suitable for facilitating use of machinery, such as a forklift, to move the spools with or without tubing. Additionally, a spool may further comprise supports, such as rods (see FIG. 5A). The supports may be removable. These supports may be useful where additional stability is desired. The supports are compatible with stacking multiple spools (see FIG. 5B).

(7) FIGS. 6A-6B illustrates possible tubing connections. A tubing end 10 may be attached to a connector 12. Optionally, the connector can be connected to a further element 14, which may be a pump, filter, air line, valve, sensor, or other element, or a combination thereof. This further element may be attached to a further connector 16. Connector 12 and/or 16 can be any suitable type of connector, including single use sterile connectors, multiple use sterile connectors, compression fittings, snap-fit connections, welded connections, and the like. FIG. 6B demonstrates one example of tubing end connections. The tubing 10 is connected to a pump (such as a disposable pump, or a reuseable pump) 14, which is driven by a motor 18, and connected to a sterile connector 16.

(8) FIGS. 7A-7D illustrate examples of connector locations on a spool. One or more connectors can be located through the center of the spool (FIGS. 7A and 7C). One or more connectors may be located on an edge or side of a sidewall (FIG. 7B). One or more connectors can be located at one or more corners of a sidewall (FIG. 7D). The connectors may be nested in the sidewall or separate from the sidewall.

DETAILED DESCRIPTION

(9) The devices described herein comprise a coiled tubing that facilitates the storage, handling and transport of bulk liquids. The tubing is preferably a continuous structure without seams or joints, although it is contemplated that two or more tubing structures may be joined together using a suitable connector. The tubing can be rigid, flexible, or a mixture thereof. As used herein, flexible has its ordinary meaning as being capable of flexing or bending without rupture or breakage under normal conditions and use. Rigid has its ordinary meaning of being resistant to substantial shape change under normal conditions and use. For example, one or both ends of the tubing may be flexible and the central coiled tubing may be rigid. Alternatively, the entire tubing can be flexible, or the entire tubing can be rigid. The tubing may have a smooth or ridged exterior surface.

(10) The choice of tubing material may depend on the needs of the user. For example, the material may be gamma sterilization-stable, gas-impermeable, caustic-stable, pressure-resistant, pH-stable, impact-resistant, particle-free, low-extractable, low-leachable, temperature-stable, or a combination thereof. The tubing may comprise a single material, a composite material or blends, or layers of material, e.g., a laminate. Suitable materials include polymers, including thermoplastics. For example, polyethylene (PE), including low density or medium density polyethylene, linear low-density polyethylene (LLDPE), ultrahigh molecular weight polyethylene (UHMWPE), ethylene vinyl acetate (EVOH), polyethylene vinyl acetate ((P)EVA), ethylene vinyl acetate copolymers (EVA copolymers); polypropylene (PP); ethylene tetrafluoroethylene (ETFE); polyvinylidene fluoride (PVDF); fluoropolymer such as polytetrafluoroethylene (PTFE), Fluorinated ethylene propylene (FEP), perfluoroalkoxy alkane (PFA); silicone; rubber; and like materials. Typically, these tubing materials are medical grade and/or animal-free additive plastics. The tubing materials are generally sterilizable such as by steam, ethylene oxide, vaporized hydrogen peroxide, or radiation such as beta or gamma irradiation. Generally, the tubing is designed for single-use only and disposed of after use, although it is contemplated that the tubing can be reused after appropriate cleaning. In one aspect, the tubing is made from one layer of an extruded material or from multiple layers of co-extruded materials. Tubing can be commercially available tubing (e.g., from Saint-Gobain, Dow Corning, or AdvantaPure, etc.), or can be custom formulated to the user-defined application and shipping needs.

(11) The size and diameter of the tubing will be determined according to volume capacity needs. For example, larger volumes will use longer lengths of tubing and/or larger diameter of the tubing lumen to be filled. As will be readily apparent, the exact lumen diameter and wall thickness can vary according to the total liquid volume to be filled in the tubing, the tubing material, and use of the tubing. Larger volumes will tend to use larger lumen diameter tubing and larger wall thickness. Increased wall thickness may also be appropriate under such circumstances as long term storage, long distance shipping, under circumstances of potential shock exposure, or in combination with a pressurized use such as for dispensing liquid under pressure. The wall thickness of the tubing can also be chosen according to desired properties of the tubing (e.g., tensile strength, temperature stable, gas-impermeable, etc.) and may vary according to the material used to make the tubing. In the case of a multiple lumen tubing, the wall thickness of the exterior may be the same or different from the wall thickness between lumens. For illustrative purposes, the diameter of one or more lumens in the tubing can range between at least or about 0.125 inches to at least or about 1 inch. The wall thickness of the tubing may range from about 0.010 inches to about 0.25 inches. Furthermore, the wall thickness may be varied to facilitate winding the tubing onto a spool. For example, tubing can be made by extrusion with an offset mandrel such that one wall side has a thicker wall thickness (e.g., 0.1 inches) and the opposite wall thickness is thinner (e.g., 0.02 inches). As the tubing is extruded, it will naturally extrude in a coiled shape. Such tubing manufacturing is not limited to extrusion methods, but can also be achieved by injection molding, for example. In practice, the lumen diameter and tubing wall thickness will be dependent on the properties of the tubing material, as will be appreciated by those of skill in the art.

(12) While not intended to be limiting, examples of tubing cross-section profiles with a single or multiple lumens are illustrated in FIG. 1. Multiple lumens can be used to store, handle and/or transport multiple liquids. Additionally or alternatively, one or more lumens in a multiple lumen tubing can be unfilled with liquid (e.g., filled with air or another gas), which can allow for expansion of liquid in another lumen under freezing conditions. Such use of a multiple lumen tubing avoids potential rupture of the tubing due to liquid expansion upon freezing.

(13) Either or both ends of the tubing may further comprise one or more attachments. Such attachments include, for example, adapter, sterile connector, valve, sensor, recirculating pump, filter, or a combination thereof. Such attachments can permit the aseptic filling and/or dispensing of the liquid, monitor the liquid in the tubing (e.g., temperature, pH, gas content, flow rate etc.), recirculate the liquid in the tubing to keep any solids in suspension (e.g., this can be particularly suitable for vaccines that contain some solid or particulate materials), and/or filtering the liquid during filling and/or dispensing of the liquid from the tubing. For sterile or aseptic applications, sterile connectors may be used to connect these attachments to the tubing. For non-sterile applications, quick connect fittings would be suitable. Additionally, one or both ends of the tubing may be heat sealed.

(14) Since large volumes of liquid are contemplated to be stored and handled in the tubing described herein, it is advantageous to store the tubing coiled on a spool. A spool can help facilitate the handling, storage and shipment of large amounts of coiled tubing filed with liquid. In general, the spool comprises an interior drum and at least two sidewalls. The spool can be made of any suitable material so long as it is capable of being loaded with the coiled tubing. For example, the spool can comprise plastic, metal, alloys, glass, wood, foam, composite materials, or combinations thereof. The outer sidewalls of the spool and the interior drum can each comprise the same or different materials.

(15) In general, the spool dimensions can be standardized according to the size and quantity of tubing to be coiled onto the spool. It is preferable to have a diameter of the interior drum that minimizes or avoids kinking or collapse of the tubing once coiled onto the spool. For example, the diameter of the interior drum can range between at least or about 3 inches to at least or about 18 inches. The diameter of the sidewalls can range between at least or about 36 inches to at least or about 48 inches.

(16) The shape of the outer sidewalls of the spool can be any variety of shapes, including for example, symmetrical, asymmetrical, circular, square, rectangular, hexagonal, and the like. The shape of the outer sidewalls can vary according to whether the spool is stored and/or handled with the coiled tubing loaded horizontally or vertically. Examples of possible configurations are shown in the figures for illustrative purposes. The surface of the interior drum may be flat, or shaped, or a combination thereof. For example, the surface may have one or more grooves, indents, or the like. The grooves or indents may extend across the entire surface of the interior drum (such as shown in FIG. 2B), or the surface of the interior drum may only partially have grooves or indents. For example, a groove or indent may be located at the surface of the interior drum that is adjacent one or both sidewalls and the remaining surface of the interior drum is flat. Alternatively, the surface of the interior drum that is adjacent one or both sidewalls is flat and the remaining surface of the interior drum is grooved or indented. Optionally, these shapes may accommodate or the tubing when wound onto the spool and/or facilitate winding of the tubing onto the spool, avoid kinking of the tubing, etc. In a particular example, the surface of the interior drum adjacent to where tubing will be loaded or wound is matched to the shape of the tubing such that the tubing essentially fits into, or conforms with, the shape (such as a groove or indent) of the spool's interior drum.

(17) It is also contemplated that the spool can be assembled from, and/or disassembled into, at least two or more parts (e.g., FIG. 3). For example, each sidewall and the interior drum can be separate pieces. Alternatively, each sidewall may also comprise a portion of the interior drum such that assembly of both sidewalls forms a complete interior drum. Each part of the spool can feature a click-lock mechanism, threaded assembly, bolts, clamps, or use a tie rod or rods that extend through the drum and can be secured at each end with a nut, or other suitable mating mechanism. The unassembled or disassembled spool can be stored and shipped in less space than an assembled spool.

(18) The spool may additionally comprise other features. For example, the spool may further comprise legs, a stand, stabilizers, counterweights, crank handles, clamps, clips, notches, grooves, and/or carrying handles. Such features can facilitate the use of the spool and coiled tubing. For example, legs, stand, stabilizers and/or counterweights can assist in positioning of the spool. The clamps, clips or notches can be used for attaching the tubing to the spool. The crank handles can assist with winding and unwinding the tubing on the spool. Grooves can be used to guide the tubing during winding onto the spool. Additionally or alternatively, the spool may comprise a cover that at least partially or completely surrounds the spool and coiled tubing. This cover may further protect the coiled tubing (e.g., from impact), maintain an enclosed space for the coiled tubing (e.g., to control temperature, keep the tubing clean from dirt, dust, block light), etc. Furthermore, the spool may further comprise a sensor (e.g., to detect temperature, pressure, impact, moisture, radiation, and the like).

(19) The coiled tubing and/or the spool may further comprise a tracking device. Such devices include wireless devices like radio-frequency identification (RFID) with read or read/write capabilities. Such devices can record the date, time, location, user identification, serial number and other such information as may be useful to track during, for example, manufacture, transport, filling, storing, dispensing and disposal, etc.

(20) In general, the tubing is attached at one end to the spool and wound onto the spool until the desired amount of tubing is loaded onto the spool. Connectors can be attached to either or both ends of the tubing by any suitable means, e.g., compression fitting, quick connectors, snap fit connectors, push connect fittings, welding, adhesion bonding, etc.

(21) The devices described herein can be used in methods of handling a sterile or aseptic liquid. In general, the method comprises filling a coiled tubing as described above with a sterile or aseptic liquid. Optionally, more than one lumen in a multiple lumen coiled tubing can be filled with a liquid. Typically, the coiled tubing has a size and length sufficient to contain a liquid volume of at least or about 10 liters to at least or about 1000 liters. The ends of the coiled tubing are sealed, for example either or both ends of the tubing can be sealed with one or more sterile connectors, or one or more ends can be heat sealed, or a combination thereof where one end has a sterile connector and the other end is heat sealed. The liquid is now ready to be stored and/or shipped before dispensing from the coiled tubing.

(22) As described above, the tubing may further comprise a recirculation pump, filter, sensor, valve, connector for, or a connection to, a pressurized (preferably sterile) air source, or a combination thereof. The method may further comprise recirculating the liquid in the tubing; and/or monitoring one or more conditions such as temperature, pH, pressure, gas content, or a combination thereof; and/or filtering the liquid.

(23) Additionally, the method may further comprise raising, maintaining and/or lowering the temperature of one or more liquids in the tubing. For example, with a multi-lumen tubing, one or more lumens may be filled with a cold or frozen gas or liquid to maintain or lower the temperature. Similarly, one or more lumens may be filled with a warm or hot liquid or gas to maintain or raise the temperature. Such heated or cooled liquids or gases may be recirculated to maintain a constant temperature of the liquid in the tubing.

(24) The devices and methods described herein overcome and number of the disadvantages of the current devices and methods. These devices permit the handling, storage and shipping of large quantities of liquids without the same risk of leaks and contamination that are possible with large bags due to wrinkling and presence of seams. Furthermore, the tubing is readily integrity tested, unlike large volume bags and other containers. Additionally, the tubing can be adapted to any liquid volume and avoids unnecessary or undesirable air space kept with the liquid. For example, a rigid container will necessarily contain air in any volume not filled with liquid, leading to possible foaming and the associated problems such as protein denaturation in the liquid being handled, stored and/or shipped. This problem is avoided with the use of the coiled tubing as described herein since the tubing can be sealed to exclude any air pockets.

(25) While this invention has been particularly shown and described with reference to example embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims. It should also be appreciated that the various technical features of the described devices may be combined in various ways to produce alternative and additional embodiments.

(26) The teachings of all patents, published patent applications, and references cited herein are incorporated by reference in their entirety.