GB2226873A

GB2226873A - A process to store and pack biomedical products and the container to be used as packing for said products

Info

Publication number: GB2226873A
Application number: GB8900142A
Authority: GB
Inventors: Vincent Donato
Original assignee: Scorpion BVI Ltd
Current assignee: Scorpion BVI Ltd
Priority date: 1989-01-05
Filing date: 1989-01-05
Publication date: 1990-07-11
Anticipated expiration: 2009-01-05
Also published as: GB2226873B; GB8900142D0

Abstract

It is described a process according to which a biomedical product 3 is submitted to a temperature checking to be then classified and stored in a first cold-storage room. The product is afterwards transferred from said room to a second cold- storage room in amounts which are each time previously fixed depending upon the foreseen daily requirements. From the second cold-storage room an amount of product to be packed is by turns withdrawn, which product is put into a containing element 2a made of polystyrene. Insulating material 5 and refrigerating elements 6, 7 according to predetermined amounts are also introduced into said containing element. The containing element after being closed with a polystyrene cover 2b is inserted into a paperboard box 9 which is afterward sealed with a strip of adhesive tape 10. <IMAGE>

Description

A PROCESS TO STORE AND PACK BIOMEDICAL PRODUCTS AND THE CONTAINER TO BE USED AS PACKING FOR SAID PRODUCTS The present invention relates to a process to store and pack biomedical products and to a container to be used as packing for said products.

It is known that particular preservation care is required for many types of biomedical products during the period going from their production to their use. More particularly, a great number of these products must be preserved at a controlled temperature, often within very restricted tolerance limits.

For example many biomedical products must absolutely be kept at a temperature ranging between 2 and 8c > C. Other biomedical products need a temperature lower than 2--C and still other products cannot bear temperatures higher than room temperature, that is about 20 0.

Should one of these products be maintained at temperatures higher or lower than those adapted to preserve them, an irreparable qualitative deterioration would occur, such that the product would become useless.

To meet the above mentioned requirements, the use of big containers made of paperboard is provided, each of them lending itself to hold a high amount of product packages during the period going from production and packaging of the product to its arrival at the destination place. The assembly consisting of the paperboard container and the product packages inserted therein is commonly called in the field "bulk".

The arrangement of the product in bulks allows the same to be shipped by airplane, ship or train or other means of transport without the use of insulated rooms or refrigerators, which would involve high costs.

This is due to the fact that it is generally provided the simultaneous dispatching of a number of bulks which being disposed adjacent one another give rise to an important mass having the right preservation temperature for the product. For the above reason the product can keep its preservation temperature for a sufficiently long time even if the surrounding atmosphere has a remarkably higher temperature. The maintaining of the appropriate temperature can be facilitated by interposing refrigerating elements between the different bulks, which elements consist of frozen low-heat-conductivity liquid hermetically closed in a containing envelope.

Once the product has reached its destination place, it can be stored in cold-storage rooms from which it will be removed at the moment of use.

It will be recognized that the above solution can be efficiently put into practice only when big amounts of biomedical products have to be shipped.

On the contrary, very serious problems arise when small amounts of biomedical products have to be dispatched. In fact if small amounts of these products are kept at room temperature, their temperature could change beyond the tolerance limits allowed within a short time.

Therefore the distribution of biomedical products to medical and/or research laboratories of small and medium size which do not use much of these products and in most cases do not have refrigerators or similar equipments at their disposal necessary to preserve big amounts of products, appears rather difficult and full ol inconveninces It is an object of the present invention to solve the above drawbacks by providing a process to store and pack biomedical products which is adapted to make the distribution of said products possible even in very small amounts.

The foregoing and further objects which will become more apparent in the course of the following description are substantially attained by a process to store and pack biomedical products which is characterized in that it comprises the following steps: -checking of the product temperature in a reception station; - classification of the product based on its deterioration hour and date and its preservation temperature; - storage of the product in a first cold-storage room; - transferring of the product to a second cold-storage room, said transfer being carried out in successive stages each of which is performed on a predetermined amount of product and is followed by the subsequent stage substantially after the predetermined amount of product has been submitted to the following steps;; - withdrawing of the product from tha second cold-storage room, said withdrawal being carried out in successive stages each of which is performed on a predetermined amount of product to be packed; - introduction of the amount of product to be packed into a low-heat-conductivity box-shaped envelope in which a layer of insulating material has been previously arranged; - introduction of at least a refrigerating element into the box-shaped envelope; - filling of the box-shaped envelope with insulating material; - closing of the envelope with a low-heat-conductivity cover; - introduction of the box-shaped envelope into a paperboard box; - sealing of the paperboard box.

In order to put the above process into practice it is advantageously provided the use of a container for packing biomedical products characterized in that it comprises a box-shaped envelope consisting of a containing element made of polystyrene and having walls the thickness of which is greater than 25 mm, and provided at the top with a polystyrene cover having a thickness greater than 25 mm, a predetermined amount of insulating material disposed at the inside of the box-shaped envelope in spaces comprised between the product arranged in the. box-shaped envelope, in a central region thereof, and the walls of the box-shaped envelope itself, and at least a refrigerating element substantially comprised of a frozen low-heat-conductivity liquid disposed in the interior of the box-shaped element, the latter being then engaged in a sealed paperboard box.

Further features and advantages of the invention will best be understood from the detailed description of a preferred embodiment of a process to store and pack biomedical products and a container to be used as packing for said products in accordance with the present invention, given hereinafter by way of non-limiting example with reference to the accompanying drawing, in which: - Fig. 1 is a block diagram in which the main step of the process of the invention are shown; - Fig. 2 is a perspective cross-sectiorbal view of a container in accordance with the present invention.

According to the example shown and hereinafter described, the process of the invention is provided to be carried out in a sorting station for biomedical products, where the products themselves arrive in form of bulks, sent from their production centres in a conventional manner.

As shown in Fig. 1, the process of the invention first provides a temperature-checking step tor the product in a reception station. This step is carried out by means of suitable termometers on delivery of the product and ains to ascertain whether the product has undergone temperature changes beyond the allowed limits during its transport from the production centre to the sorting station.

The checking step is followed by a step in which the product is classified on the basis of its deterioration hour and date, as well as its preservation temperature. During this classification step eac bulk or group of bulks substantially receives a code which is processed together with the above specified data, for the purposes to be clarified later.

There is then a step in which the product in bulk is transferred to a first cold-storage room in which the best temperature to preserve the product is constantly kept. Obviously the sorting station in which the process of the invention is carried out must be provided with a number of said first cold-storage rooms each of them being adapted to preserve a particular type of product which must be kept at a given specific temperature. The choice of the first cold-storage room in which the product must be introduced is carried out on the basis of all data collected during the previously described classification step.

Each bulk is designed to stay in the first cold-storage room substantially as far as all packages being part of the other bulks present in said cold-storage room and exhibiting an earlier deterioration date have been withdrawn from the cold-storage room to be submitted to all process steps hereinafter described. The rate at which the product is withdrawn from the cold-storage room is based on the daily requirements on the part of final users. These requirements too are communicated to the computer which is capable of indicating each time which is the bulk from which the product has to be withdrawn.

The withdrawal of the product from a bulk corresponds to a transferring step of the product itself to a second cold-storage room having a smaller capacity than the first cold-storage room and adapted to contain an amount of product packages substantially equal to the estimated amount that is daily required. So the transferring of the product of a bulk from the first to the second cold-storage room takes place in successive stages, each being carried out on a predetermined amount of product, and is followed by the subsequent stage only after said predetermined amount of product has been submitted to the process steps that will be described hereinafter.

The product packages disposed in the second cold-storage room are designed to be successively withdrawn therefrom. This withdrawal step toa is substantially carried out in successive stage, each being performed on a predetermined amount of product to be packed. The amount of product to be withdrawn in each stage is established on the basis of the requirements of the user to which the product must b sent.

Each amount of product to be packed, immediately after being withdrawn from the second cold-storage room, is packed in a container of the type shown in Fig. 2 and identified by reference numeral 1.

In said figure it is possible to see that the container 1 substantially comprises a box-shaped envelope 2 having a low heat conductivity and consisting of a containing element 2a with a cover 2b at the top. Both the containing element 2a and the cover 2b are made of polystyrene and have walls of a thickness greater than 25 mm. The amount of product to be packed, which in the example shown in Fig. 2 is represented by two proauct packages identified at 3, is preferably closed within a bag 4 and disposed in the interior of the box-shaped envelope 2, in a central region thereof.

Also disposed in the box-shaped envelope is an insulating flaked material 5 which substantially fills the spaces existing between the product. 3 and the walls of the box-shaped envelope 2.

There is also the presence of one or more refrigerating elements 6, 7 and 8 of known type and substantially consisting of a frozen low-heatconductivity liquid which is hermetically- closed in a containing envelope. Said refrigerating elements 6, 7 and 8 substantially have the function of maintaining an appropriate temperature for the product preservation in the interior of container 1. In this connection it could be important to fix the position of the refrigerating elements 6, 7 and 8 with respect to the product 3.

The positioning of said refrigerating elements can substantially take place in three different ways which are slightly different from one another. In fact the refrigerating elements can be disposed either between the product 3 and the insulating material 5, as in the case of the refrigerating element 6 shown in Fig. 2, or between an inner wall of the box-shaped envelope 2 and the insulating material 5, as in the case of the refrigerating element 7, or they can be plunged into the insulating material 5 in an intermediate position between the product 3 and the inner walls of the box-shaped envelope 2.

In Fig. 2 it is also shown that each refrigerating element can be disposed at a lower or higher position with respect to the product 3 located in the container 1 or even flush therewith.

Provision is then made for the box-shaped envelope 2 to be engaged in a paperboard box 9 preferably sealed by means of strips of adhesive tape 10.

In accordance with the process of the invention, for the packing of each amount of product withdrawn from the second cold-storage room it. is provided that the product itself should be introduced into the containing element 2a preferably after being enclosed in a bag 4 and after a layer of insulating material 5 has been disposed at the bottom of the containing element 2a. After the appropriate amount of product 3 has been introduced into the containing element 2a, the latter is filled with further insulating material 5.

There is then a further step in which at least a refrigerating element 6, 7 or 8 is introduced into the containing element 2a. Depending upon the ditterer,t cases, this step can be carried out either before o after the introduction of the product into the containing element 2a, simultaneously with the introduction of the insulating material 5 into the containing element 2a or after the introduction of said material. A different positioning of ' the refrigerating elements in the box-shaped envelope 2 is adopted for each of the above specified solutions. As shown in Fig. 2, when several refrigerating elements are present, each of said elements is provided to be introduced in accordance with one of the above specified solutions, so that the elements are suitably distributed around the packed product 3.The number and disposition of the refrigerating elements is established depending upon different factors such as for example the mass of the product to be packed, the expected travel length for the product to reach the final user, as well the room temperature to which the product is expected to be submitted during the travel.

Once the steps for introducing the insulating material 5 and the refrigerating elements 6, 7 and 8 are over, the containing element 2a is closed with its cover 2b. Cover 2b can be fastened to the containing element 2a for example by means of strips of adhesive tape not shown.

Then the box-shaped envelope 2 is inserted into the paperboard box 9 which is sealed with strips of adhesive tape 10. At this point the container 1 can be sent to the final user.

In order to ensure the qualitative integrity of the product to the final user it can advantageously be provided that the user should legally have the possibility of rejecting the product if the latter is not delivered within a fixed time after it has been withdrawn from the second cold-storage room or if a temperature checking by means of a termometer shows that the product temperature is higher or lower a, compared with the range of acceptable values for the preservation of the product itself.

The present invention attains the intended purposes.

In fact by the process and the container of the invention it is possible to carry out the distribution of small amounts of biomedical products being sure that the latter are not submitted to temperature raisings or lowerings beyond the allowed limits. All that is attained in a relatively inexpensive manner, because it is no longer necessary to have the availability of suitable means of transport provided with insulated rooms or refrigerators to keep the products at an appropriate temperature.

Obviously many modifications and variations can be made to the present invention, without departing from the scope of the inventive idea characterizing it.

Claims

CLA IMP

1. A process to store and pack biomedical products, characterized in that it comprises the following steps: -checking of the product temperature in a reception station; - classification of the product based on its deterioration hour and date and its preservation temperature; - storage of the product in a first cold-storage room; - transferring of the product to a second cold-storage room, said transfer being carried'out in successive stages each of which is performed on a predetermined amount of product and is followed by the subsequent stage substantially after the predetermined amount of product has been submitted to the following steps; - withdrawing of the product from the second cold-storage room, said withdrawal being carried out in successive stages each of which is performed on a predetermined amount of product to be packed;; - introduction of the amount of product to be packed into a low-heat-conductivity box-shaped envelope in which a layer of insulating material has been previously arranged; - introduction of at least a refrigerating element into the box-shaped envelope; - filling of the box-shaped envelope with insulating material; - closing of the envelope with a low heat-conductivity cover; - introduction of the box-shaped envelope into an outer box, preferably a paperboard box which is preferably subsequentiv sealed.

2. A process according to claim 1, ch:racterized in that the introduction of at least a refrigerating element into the box-shaped envelope is carried out before the introduction into the envelope of the amount of product to be packed.

3. A process according to claim 1, characterized in that the introduction of at least a refrigerating element into the box-shaped envelope is carried out during the filling of the latter with insulating material.

4. A process according to claim 1, characterized in that the introduction of at least a refrigerating element into the box-shaped envelope is carried out after the latter has been filled with insulating material.

5. A container to be used as packing for biomedical products, characterized in that it comprises: - a box-shaped envelope including of a containing element made of insulating (preferably polystyrene) and having walls the thickness of which is greater than 25 mm, and provided at the top with an insulating (preferably polystyrene) cover having a thickness greater than 25 mm;; - a predetermined amount of insulating material disposed at the inside of the box-shaped envelope in spaces comprised between the product arranged in the bo-shaped envelope, in a central region thereof, and the walls of the box-shaped envelope itself, - at least a refrigerating element, preferably substantially comprised of a frozen low-heat-conductivity liquid, disposed in the interior of the box-shaped element, the latter being then engaged in an outer box, preferably a sealed paperboard box.

6. A container according to claim 5, characterized in that said refrigerating element is located between the product and the insulating material.

7. A container according to claim 5, characterized in that the refrigerating element is plunged in an insulating material.

8. A container according to claim 5, characterized in that the refrigerating element is located between the insulating material and a wall of the box-shaped element.

9. A container according to claim 5, characterized in that the product is enclosed in a bag.

10. A container for the packing of biomedical products substantially as described herein with reference to Figure 2 of the accompanying drawings.

11. A process for storing and packing biomedical products according to claim 1, substantially as described herein.