WO2005103589A2 - Appareil et methode pour maintenir des temperatures basses dans des materiaux biologiques pendant leur irradiation - Google Patents

Appareil et methode pour maintenir des temperatures basses dans des materiaux biologiques pendant leur irradiation Download PDF

Info

Publication number
WO2005103589A2
WO2005103589A2 PCT/US2005/014103 US2005014103W WO2005103589A2 WO 2005103589 A2 WO2005103589 A2 WO 2005103589A2 US 2005014103 W US2005014103 W US 2005014103W WO 2005103589 A2 WO2005103589 A2 WO 2005103589A2
Authority
WO
WIPO (PCT)
Prior art keywords
vessel
container
chamber
recess
dry ice
Prior art date
Application number
PCT/US2005/014103
Other languages
English (en)
Other versions
WO2005103589A3 (fr
Inventor
Steven J. Burns
Original Assignee
Clearant Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Clearant Inc. filed Critical Clearant Inc.
Publication of WO2005103589A2 publication Critical patent/WO2005103589A2/fr
Publication of WO2005103589A3 publication Critical patent/WO2005103589A3/fr

Links

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D3/00—Devices using other cold materials; Devices using cold-storage bodies
    • F25D3/12—Devices using other cold materials; Devices using cold-storage bodies using solidified gases, e.g. carbon-dioxide snow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • A61J1/165—Cooled holders, e.g. for medications, insulin, blood, plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029—Radiation
    • A61L2/0035—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L7/00—Heating or cooling apparatus; Heat insulating devices
    • B01L7/02—Water baths; Sand baths; Air baths
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2303/00—Details of devices using other cold materials; Details of devices using cold-storage bodies
    • F25D2303/08—Devices using cold storage material, i.e. ice or other freezable liquid
    • F25D2303/082—Devices using cold storage material, i.e. ice or other freezable liquid disposed in a cold storage element not forming part of a container for products to be cooled, e.g. ice pack or gel accumulator
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2303/00—Details of devices using other cold materials; Details of devices using cold-storage bodies
    • F25D2303/08—Devices using cold storage material, i.e. ice or other freezable liquid
    • F25D2303/084—Position of the cold storage material in relationship to a product to be cooled
    • F25D2303/0843—Position of the cold storage material in relationship to a product to be cooled on the side of the product

Definitions

  • the present invention relates to an apparatus and method for maintaining low temperatures in biological materials exposed to an irradiation field. More precisely, it relates to a container and a method of irradiation using a container for reducing the variation in delivered gamma dose to biological materials contained in vessels surrounded by dry ice.
  • the container prevents attenuation of the main gamma field during irradiation by keeping dry ice out of the path of the main gamma field.
  • Irradiation technology has long been used in medical sterilization.
  • biological products have validated specifications for inactivation treatment by gamma radiation.
  • the biological products are irradiated on dry ice in containers, for example polyfoam containers, to protect product integrity.
  • the polyfoam containers insulate the product and the commonly used pellet or riced dry ice maintain temperatures at or below an acceptable range. Considerable amounts of energy and thus heat are generated during the irradiation process, temperatures typically exceed 10°C to 15°C above ambient. This temperature range can be deleterious to the biological product.
  • the most common radioactive source for sterilization by radiation is gamma rays.
  • gamma rays are used to inactivate viruses, bacteria, yeasts, molds, mycoplasmas, and parasites as described in U.S. Patent 5,362,442.
  • the sterilizing gamma rays are often produced by sources containing Cobalt 60, but may be provided by other sources.
  • multiple containers can be loaded into an irradiation carrier for conveying the containers to a radiation source for simultaneous exposure and sterilization.
  • the carrier can be configured to hold, for example, fifteen containers, depending on the size of the individual containers.
  • the carrier is then attached to a conveyor system which brings the carrier into a room containing a gamma radiation source.
  • the carrier can be any device which will hold a number of containers, for example, a metal structure dimensioned and configured for carrying several containers.
  • the conveyor of the irradiation system is used to transport carriers to the radiation source and can be any means by which the carriers are brought to and from the radiation source.
  • the conveyor system in the previously described irradiation system can be configured so as to bring the carrier holding the containers to the radiation source in an orientation where a first side of the containers receives radioactivity.
  • the conveyor can be further configured so as to bring the carrier to the radiation source in another orientation where a second side, for example a side 90° relative to the first side, receives radioactivity.
  • the conveyor can move the carrier to any one of several positions necessary for irradiating the containers.
  • the conveyor can also include means for varying the time at which the carriers are held at each of the positions so as to hold any one of the several positions for a specified time.
  • the means for varying time at which a carrier is held in position is used to control the length of exposure to the radiation source and to reduce variability in exposure. This shifting within the containers makes it impossible to accurately control or determine the dose of radiation being received by the biological materials due to varied attenuation of the irradiation field depending on the final arrangement of the vessels and dry ice.
  • the present invention is a process for using, and design of, an insulated container for maintaining low temperatures during irradiation of vessels of biological materials.
  • a container is designed to hold vessels of biological materials and dry ice or other cooling element used to achieve and maintain low temperatures in those vessels of biological materials.
  • the container may have channel or other shaped constraints for restricting motion of the vessels and the blocks of dry ice or other cooling element.
  • the biological material is a liquid stored in a container, such as serum (including fetal bovine serum), plasma, plasma fractions, etc.
  • the liquid contains one or more pathogens such as a virus or a bacteria.
  • viruses include, but are not limited to, human immunodeficiency virus, herpes virus, filovirus, circovirus, paramyxovirus, cytomegalovirus, hepatitis virus (A, B, C, and D), pox virus, toga virus, Ebstein-Barr virus and parvovirus and any combination thereof.
  • the shaped constraints within the container may hold the vessels between blocks of dry ice or other cooling elements such that as the dry ice sublimates, gravity maintains the dry ice in contact with the outer walls of the vessels.
  • the shaped constraints in combination with gravity also maintain a fixed angular relationship between the source of the gamma field and the vessels and prevent attenuation of the radiation source by dry ice obstructing the path of the gamma rays.
  • One embodiment of the invention is a container to maintain a low temperature in a material within a vessel when exposed to an irradiation field.
  • the container contains a thermally deformable cooling element having a substantially planar surface, and an interior surface defining a chamber having a vertical axis and a horizontal axis to house the vessel and cooling element.
  • the surface of the cooling element engages the vessel such that thermally deforming the cooling element causes a displacement of the vessel within the chamber.
  • the interior surface has at least one recess to engage at least a portion of the vessel. The recess limits the displacement of the vessel to a direction substantially along the vertical axis.
  • Another embodiment of the invention is a container for maintaining a low temperature in an assembly of at least two vertically stacked vessels of biological material when exposed to an irradiation field.
  • the container comprises an interior surface defining a chamber to house the assembly and at least two blocks of dry ice located on either side of the assembly of vessels.
  • the interior of the container has at least one recess that engages the assembly of vessels to keep the assembly substantially in the irradiation field and the at least two blocks of dry located such that they do not attenuate the irradiation field as it irradiates the assembly of vessels.
  • the irradiation field is propagated substantially horizontally.
  • the at least one recess is configured so as to permit the assembly to be displaced substantially only in a vertical direction within the chamber upon sublimation of the dry ice.
  • Yet another embodiment of the invention is an irradiation system comprising a biological material having a pathogen; at least one vessel to hold the biological material, the at least one vessel having a neck portion.
  • the irradiation source includes at least one irradiation field to irradiate the biological material; a first thermally deformable cooling element having a substantially planar surface; and at least one container having an interior surface defining a chamber to house the vessel and cooling element. The surface of the cooling element is engaged with the vessel such that thermally deforming the cooling element causes a displacement of the vessel in the chamber.
  • the interior surface of the container has a recess to engage the neck portion of the vessel so as to locate the at least one vessel substantially inside the at least one irradiation field and prevent the first cooling element from attenuating the irradiation field being received by the vessel.
  • the recess is configured to permit the assembly to be displaced substantially only in the vertical direction within the chamber upon thermally deforming the first cooling element.
  • Another embodiment of the invention is a method of irradiating a biological material in a gamma irradiation field providing a vessel of biological material at a temperature ranging from about -80° C to about -50°C.
  • the method includes forming a stacked assembly comprising a first substantially planar block of dry ice, a second substantially planar block of dry ice, with the vessel disposed between with the first and second blocks of dry ice to remove heat from the biological material during the irradiation.
  • the stacked assembly is located in an insulated container.
  • the insulated container has an interior surface defining a chamber house the stacked assembly such that the first and second blocks of dry ice are located above and below the vessel.
  • the interior surface of the container has at least one recess that engages at least a portion of the vessel.
  • the container is located in the irradiating field so that the field propagates along the horizontal axis so as to substantially intersect the vessel and irradiate the biological material and the first and second blocks of ice are located such that they do not attenuate the irradiation at the vessel.
  • the irradiating field irradiates the container so as to sublimate the first and second blocks of dry ice in a direction substantially along the vertical axis and causing translation of the vessel within the chamber, the recess limiting the translation to the direction of sublimation and maintaining the first and second blocks of ice substantially outside the irradiating field.
  • Still another embodiment of the invention is a container for maintaining a vessel of biological material at a low temperature during irradiation comprising providing a stacked assembly comprising a first substantially planar block of dry ice, a second substantially planar block of dry ice, and at least one vessel containing the biological material at a temperature ranging from about -80°C to about
  • the vessel is located between the first and second blocks of dry ice, with the vessel and dry ice being located within a container having an interior surface defining a chamber to house the stacked assembly.
  • the interior surface defines a recess.
  • the stacked assembly is located within the chamber and the recess on the interior surface engages a portion of the vessel with the to define a first position of the vessel within the chamber.
  • the container is irradiated so as to sublimate the first and second blocks of dry ice.
  • the sublimation of the dry ice translates the vessel to a second position within the chamber with the recess limiting the vessel to moving along the vertical axis, maintaining the vessel engaged with the first and second blocks of dry ice to maintain the biological material at a low temperature.
  • the biological material is a liquid containing one or more pathogens.
  • FIG. 1A is a side section view of a container including vessels and dry ice according to the present invention.
  • FIG. IB is a side section view of the container of FIG, 1A after sublimation of a portion of the dry ice.
  • FIG. 1C is a plot of experimental test results for the temporal changes in temperature for various vessels disposed within a container according to the present invention exposed to a gamma radiation source.
  • FIG. 2 is a front section view of the container of FIG. 1A.
  • FIG. 3 is a side view of a vessel for containing biological materials within the container of FIG. 1A according to the present invention.
  • FIG. 4 is a top section view of the container of FIG. 1A.
  • FIG. 5 is a side section view of stacked containers including vessels and dry ice according to the present invention.
  • FIG. 1A is a side section view and FIG. 2 is a front section view of an illustrative embodiment of a container 10 comprising a walled portion 11 and a cover 12.
  • Container 10 can be dimensioned and configured to hold at least two vessels 20 in a vertically stacked arrangement. Alternatively, the two vessels may be horizontally next to one another.
  • the container 10 can be configured to hold twelve vessels 20 for containing materials stacked in three groups of four vessels each, each group of four vessels arranged in a configuration two bottles wide and two bottles high.
  • Container 10 can be configured to hold cooling elements for cooling the biological material in vessels 20.
  • container 10 is configured such that an upper block of dry ice 32 rests on top of the upper row vessels of each group of four vessels 20, while each group of four vessels 20 rests on top of a lower block of dry ice 34.
  • the lower blocks of dry ice 34 in turn rest on bottom wall 111 of walled portion 11 of container 10.
  • side blocks of dry ice 36 may be located between left and right walls 112, 113 of walled portion 11 of container 10.
  • the blocks of dry ice 32, 34, 36 may have approximately planar surfaces in their initial state as installed within the container 10.
  • the vessels 20 may also have approximately planar surfaces, providing for good contact between the blocks of dry ice 32, 34, 36 and the container 10 and facilitating stacking of the vessels 20.
  • the shown system is preferably configured to reduce initial fluid temperatures to and maintains those fluid temperatures in a range of about -80°C to -40°C, and more preferably in a range of about -80°C to about -50°C, and even more preferably in a range of about -80°C to about -70°C.
  • the system employed with block dry ice may effectively remove heat from the vessels of biological materials exposed to doses of radiation as high as about 100 Kgy during the irradiation process.
  • Shown in FIG. 1C is a plot of experimental test results for the temporal changes in temperature for the various vessels 20 disposed within a container 10 exposed to a gamma radiation source.
  • a container 10 As indicated, in a forty-eight hour period of radiation exposure, a container 10, as described above, maintained vessel temperatures at less than about -70°C. Shown in FIG. 3 is an illustrative embodiment of vessel 20.
  • Vessel 20 comprises a main body 21 and a neck 22, and can be roughly "milk bottle” shaped. Lid 221 may be located on neck 22 to retain the materials within vessel 20.
  • the vessels 20 can have substantially planar wall surfaces, providing for good contact between the blocks of dry ice 32, 34 and the wall surfaces of the vessels 20. While the invention may be appropriate for use with standard 250 ml, 500 ml and one liter bottles, the system is not limited to such bottles being used as vessels 20.
  • the vessel 20 can contain any biological fluid which may contain one or more pathogens.
  • biological fluids include, but are not limited to, those fluids containing recombinant proteins, blood components, blood proteins, physiological buffers (e.g., saline).
  • blood components is intended to mean one or more of the components that may be separated from whole blood and include, but are not limited to, the following: serum, cellular blood components, such as red blood cells, white blood cells, and platelets; blood proteins, such as blood clotting factors, enzymes, albumin, plasminogen, fibrinogen, and immunoglobulins; and liquid blood components, such as plasma, plasma protein fraction (PPF), cryoprecipitate, plasma fractions, and plasma- containing compositions.
  • PPF plasma protein fraction
  • blood protein is intended to mean one or more of the proteins that are normally found in whole blood.
  • blood proteins found in mammals include, but are not limited to, the following: coagulation proteins, both vitamin K-dependent, such as Factor VII and Factor DC, and non-vitamin K-dependent, such as Factor VIII and von Willebrands factor; albumin; lipoproteins, including high density lipoproteins (HDL), low density lipoproteins (LDL), and very low density lipoproteins (VLDL); complement proteins; globulins, such as immunoglobulins IgA, IgM, IgG and IgE; digestive enzymes such as trypsin and the like.
  • coagulation proteins both vitamin K-dependent, such as Factor VII and Factor DC, and non-vitamin K-dependent, such as Factor VIII and von Willebrands factor
  • albumin lipoproteins, including high density lipoproteins (HDL), low density lipoproteins (LDL), and very low density lipoproteins (VLDL);
  • Another group of blood proteins includes Factor I (fibrinogen), Factor II (prothrombin), Factor III (tissue factor), Factor V (proaccelerin), Factor VI (accelerin), Factor VII (proconvertin, serum prothrombin conversion), Factor VIII (antihemophiliac factor A), Factor DC (antihemophiliac factor B), Factor X (Stuart-Prower factor), Factor XI (plasma thromboplastin antecedent), Factor XII (Hageman factor), Factor XIII (protransglutamidase), von Willebrands factor (vWF), Factor la, Factor Ila, Factor Ilia, Factor Va, Factor Via, Factor Vila, Factor Villa, Factor DCa, Factor Xa, Factor XIa, Factor Xlla, and Factor XHIa.
  • Yet another group of blood proteins includes proteins found inside red blood cells, such as hemoglobin and various growth factors, and derivative
  • the walled portion 11 of container 10 can form a rectangular shaped box with a back wall 115 surrounded by bottom, left, right, and top walls 111, 112, 113, and 114, respectively.
  • container 10 may be circular cylindrical in shape or any other geometry that may, for example, facilitate stacking within carrier 50.
  • Back wall 115 can define a vertical direction along axis L — LA and bottom wall 11 can define a horizontal axis IB — LB.
  • Container 10 may be composed of an expanded polyurethane or polystyrene, providing an excellent insulation layer.
  • container 12 may be composed of other relatively rigid insulating material, or a less rigid insulating material (including air) or vacuum enclosed in rigid walls of any material well-known in the art for its ability to withstand large amounts of radiation and low temperatures.
  • the insulating material and or the rigid walls may be any material appropriate for such purposes that is well-known in the art.
  • the bottom and top walls 111, 115 define a chamber having a preferably rectangular cross- section although other geometric configurations are possible.
  • the inner sides of bottom and top walls 111, 115 may have ribbing 116.
  • ribbing 116 may provide a surface on which lower blocks of dry ice 34 rest. More specifically, ribbing 116 may be spaced relative to one another so as to minimize physical contact between the dry ice 34 and wall 111 thereby minimizing heat transfer between dry ice 34 and container 10.
  • the ribbing 116 may have a further raised portion 117 spaced relative to one another so as to impede lateral movement of the upper and lower blocks of dry ice 32, 34 substantially along the horizontal axis IB — IB.
  • cover 12 conforms to the size and shape of the opening in the walled portion 11 of container 10.
  • the cover 12 may have a stepped portion 121 to match and fit within stepped portion 118 at the opening of walled portion 11 of container 10.
  • the cover 12 may be attached to the walled portion 11 by any means well-known in the art including, but not limited to, bolting, screwing, an interference fit, taping, velcro, and strapping.
  • the inner surface of the back wall 115 of the walled portion 11 of container 10 may be configured so as to define vertical channels or recesses 119 for impeding lateral movement of vessels 20 and possibly also further impeding lateral movement of upper and lower blocks of dry ice 32, 34.
  • the cover 12 may have vertical channels or recesses 122 with which necks 22 of vessels 20 engage.
  • the vertical channels 122 impede lateral movement of vessels 20 along the axis IB — LB shown in FLG. 2.
  • channels 122 are preferably configured so as to define a substantially elongate oval cross-sectional area although other geometries are possible, for example rectangular.
  • the depth of the vertical channels 119 and 122 may be used together or individually to impede lateral movement of vessels 20 within container 10. Protrusions may be built into the cover 12 or the walled portion 11 of container 10 to serve the same purpose as the vertical channels or recesses 122 and 119, respectively.
  • the vertical channels 119 can also allow a user to locate the vessels 20 in their proper locations as they are loaded into walled portion 11 of container 10 prior to irradiation. As shown in FIG. 2, vessels 20 are preferably loaded into container 10, the upper, lower, and side blocks of dry ice 32, 34, 36 are placed around the vessels 20.
  • Container 10 can be preferably top loaded with vessels 20 and blocks of dry ice 32, 34, 36 such that back wall 115 may be located in the horizontal plane, and the opening of walled portion 11 facing upward to receive the vessels 20 and blocks of dry ice 32, 34, 36.
  • the vertical channels may be included in detachable walls that may be attached to the interior of the walled portion 11 and/or the cover 12. Alternatively, detachable ribbing may be selectively located within the chamber so as to form channels of variable dimensions.
  • the detachable walls offer the advantage of allowing variations in the sizes of vessels 20 and may be attached to the interior of the walled portion 11 and/or the cover 12 by any mechanical means well known in the art including, but not limited to, screwing, bolting, quick connect, and velcro.
  • the cover 12 may be installed onto the opening of the walled portion 11.
  • container 10 may then be rotated 90° and placed within stacks of other containers 10 in a carrier 50.
  • the vessels 20 on the lower rows rest on the lower blocks of dry ice 34, while the upper blocks of dry ice 32 rest on the upper rows of vessels 20.
  • This arrangement provides large areas of contact between the blocks of dry ice 32, 34 and the vessels 20, providing improved heat transfer compared to pelleted or riced dry ice packed around the vessels 20.
  • the stacked containers 10 may be exposed to a radiation field or fields 40, with rays entering from the direction of the cover 12 and/or the back wall of walled portion 11.
  • the radiation field 40 generates heat within the containers 10.
  • heat generated in vessels 20 is transferred to ice 32, 34 and 36.
  • This heat along with the ambient heat absorbed by the containers, causes the blocks of dry ice 32, 34, 36 to sublimate.
  • the blocks of dry ice 32, 34 sublimate they become smaller, as shown in FIG. IB.
  • the upper surface of the ice becomes lower, resulting in the vessels 20 resting upon blocks 34 following to lower elevations as the blocks 34 sublimate.
  • Vertical channels 119 and/or 122 guide the vessels 20 as their elevation changes, maintaining physical contact between vessels 20 and blocks of dry ice 32, 34.
  • vessels 20 maintain the same angular relationship to the radiation sources due to the vertical channels 119 and/or 122 impeding movement of the vessels 20 in any direction other than vertical.
  • the blocks of dry ice 32, 34 are also maintained above and below the vessels, respectively, such that they do not interfere with the radiation source. This allows for a relatively constant irradiation of the vessels 20.
  • Ribbing 116, 117 may further facilitate heat transfer between vessels 20 and ice 32, 34 and 36 by providing an interstice to which hot sublimated gases may escape away from the vessels 20 and ice 32, 34, and 36.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Combustion & Propulsion (AREA)
  • Physics & Mathematics (AREA)
  • Mechanical Engineering (AREA)
  • Thermal Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Pretreatment Of Seeds And Plants (AREA)

Abstract

Ce conteneur isolé pour maintenir des températures basses pendant l'irradiation de vaisseaux de matériaux biologiques contient les vaisseaux de matériaux biologiques et de la glace carbonique ou un autre élément de refroidissement utilisé pour établir et maintenir des températures basses dans ces vaisseaux de matériaux biologiques. Le conteneur peut comprendre des cavités, des conduits ou d'autres moulages de retenue pour empêcher les vaisseaux et les blocs de glace carbonique ou autre élément de refroidissement de se déplacer.
PCT/US2005/014103 2004-04-23 2005-04-25 Appareil et methode pour maintenir des temperatures basses dans des materiaux biologiques pendant leur irradiation WO2005103589A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US56465104P 2004-04-23 2004-04-23
US60/564,651 2004-04-23

Publications (2)

Publication Number Publication Date
WO2005103589A2 true WO2005103589A2 (fr) 2005-11-03
WO2005103589A3 WO2005103589A3 (fr) 2006-01-12

Family

ID=35197577

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/014103 WO2005103589A2 (fr) 2004-04-23 2005-04-25 Appareil et methode pour maintenir des temperatures basses dans des materiaux biologiques pendant leur irradiation

Country Status (1)

Country Link
WO (1) WO2005103589A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11919181B2 (en) 2019-01-22 2024-03-05 Koninklijke Philips N.V. Double-sided comb for a hair-cutting device

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4250998A (en) * 1979-08-06 1981-02-17 Frank Taylor Diabetic travel kit
US4446705A (en) * 1982-05-12 1984-05-08 Environmental Testing & Certif. Corp. Shipping container
US6079404A (en) * 1996-06-12 2000-06-27 The University Of Dayton Article for thermal energy storage
US6216487B1 (en) * 1999-09-30 2001-04-17 Gano, Iii John Henry Re-freezable beverage cooler
US6361746B1 (en) * 1998-11-16 2002-03-26 Julie Ann Wlodarski Medical specimen tote
US6609392B1 (en) * 2002-03-25 2003-08-26 G. C. Hanford Manufacturing Co. Apparatus and method for a temperature protected container

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4250998A (en) * 1979-08-06 1981-02-17 Frank Taylor Diabetic travel kit
US4446705A (en) * 1982-05-12 1984-05-08 Environmental Testing & Certif. Corp. Shipping container
US6079404A (en) * 1996-06-12 2000-06-27 The University Of Dayton Article for thermal energy storage
US6361746B1 (en) * 1998-11-16 2002-03-26 Julie Ann Wlodarski Medical specimen tote
US6216487B1 (en) * 1999-09-30 2001-04-17 Gano, Iii John Henry Re-freezable beverage cooler
US6609392B1 (en) * 2002-03-25 2003-08-26 G. C. Hanford Manufacturing Co. Apparatus and method for a temperature protected container

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11919181B2 (en) 2019-01-22 2024-03-05 Koninklijke Philips N.V. Double-sided comb for a hair-cutting device

Also Published As

Publication number Publication date
WO2005103589A3 (fr) 2006-01-12

Similar Documents

Publication Publication Date Title
US4321232A (en) Package and sterilizing process for same
EP0269073A1 (fr) Procédé de stérilisation au moyen de radiation de micro-ondes
US3494724A (en) Method and apparatus for controlling microorganisms and enzymes
WO2006013360A1 (fr) Appareil de séchage par lyiophilisation
KR100842015B1 (ko) 살균 제품 또는 살균되어야 하는 제품을 위한 다목적 포장용기
US9139350B2 (en) Anti-static package for medical containers
KR101338511B1 (ko) 자외선으로 유연성 용기 내의 혈소판 농축물을 조사하는방법
KR101504466B1 (ko) 회전 드럼 냉동 건조기를 위한 가열 장치
US20050226763A1 (en) Packaging for sterile objects or objects to be sterilized
KR20150071680A (ko) 의학적, 약제학적 또는 화장품 용례를 위한 다수개의 컨테이너를 수용하기 위한 운반 및 포장 컨테이너 및 그 방법 및 용도
US10792602B2 (en) Sterilizing method and apparatus
US20020083717A1 (en) Containment system for samples of dangerous goods stored at cryogenic temperatures
KR20120034103A (ko) 이차 포장 내의 사전충전된 용기의 표면 오염제거 방법
KR20170081167A (ko) 멸균 용기, 멸균 방법 및 멸균 장치
US20030190272A1 (en) Sterilization containers and methods for radiation sterilization of liquid products
EP1140219B1 (fr) Attenuation biotherapeuthique de virus au moyen de l'energie de micro-ondes a frequence variable
WO2005103589A2 (fr) Appareil et methode pour maintenir des temperatures basses dans des materiaux biologiques pendant leur irradiation
US20210275709A1 (en) Arrangement for the Contamination-Free Introduction of a Sterile Object from a Container into a Containment and Method Therefor
KR20160016615A (ko) 과채의 살균방법 및 그 장치
EP1361900B1 (fr) Dispositif de transport et de support utilise pour des pieces
JP2000238728A (ja) 食品加工装置
JP2020130911A (ja) 凍結輸送容器及び該凍結輸送容器に収容できる凍結輸送容器用収容容器
JP5652740B1 (ja) 搬送箱
US12013177B2 (en) Container for cryopreservation and transportation
US20230173118A1 (en) Pulsed ultraviolet in-line sterilization system for primary drug containers

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KM KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SM SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase in:

Ref country code: DE

WWW Wipo information: withdrawn in national office

Country of ref document: DE

122 Ep: pct application non-entry in european phase