GB2382064A

GB2382064A - Pressure resistant packaging for biological samples

Info

Publication number: GB2382064A
Application number: GB0127480A
Authority: GB
Inventors: Peter Robert Moore; David Walsh
Original assignee: DGP
Current assignee: DGP
Priority date: 2001-11-14
Filing date: 2001-11-14
Publication date: 2003-05-21
Anticipated expiration: 2021-11-14
Also published as: GB0127480D0; GB2382064B

Abstract

In packaging of a biological sample 13, a leak-proof primary container 12 which can withstand high internal pressure of at least 95kPa is inserted on support means 6 into a sealable secondary container 10 which is in turn placed in a tertiary container 4. The primary container may be a specimen pot with a screw-cap with a torque of 0.1-3Nm, able to withstand drop tests and pressure tests at a temperature range of -100{C to 100{C. The support means consists of a plurality of slots 8 into which the container is placed, and has handles (24). The secondary container is a sealable bag and the tertiary container is a box made from a cardboard such as corrugated fibre-board. Cooling means 14 such as an ice-pack, cool pack or dry-ice pack is placed in the tertiary container around the secondary container, and insulation means 16 is inserted as a spacer between the cooling means and the tertiary container. The packaging includes tamper-evident means, and is disposable. Sampling tools such as an extraction scoop 18, scalpel 20 or forceps 22 are included in the packaging.

Description

Packaging The present invention relates to packaging and particularly, although not exclusively, relates to packaging for the shipment of dangerous materials, for example, biological material.

Shippers of infectious substances must comply with a specific set of stringent shipping safety regulations to ensure that shipments of substances are prepared and packaged in such a manner that they arrive at their destination in a good condition, and that they present no hazard to persons or animals during shipment. Shippers of diagnostic specimens where a relatively low probability exists that infectious substances are present, for example, diagnostic specimens being transported to undergo routine screening tests for the purpose of initial diagnosis, must also adhere to a specific set of packaging safety regulations. The safety regulations packaging specifications are based on the'United Nations Dangerous Goods Packaging Performance Tests'which have their individual modal (Air/Road/Sea) packaging instructions. The shipping regulations for diagnostic specimens (IATA/ADR Dangerous Goods Regulations, Packing Instruction 650) are less stringent than those for infectious substances (IATAJADR Dangerous Goods Regulations, Packing Instruction 602/620) however they must all be adhered to.

The regulations describe that infectious or diagnostic biological material must be packaged and shipped in primary receptacles, which in turn must be placed inside a secondary packaging, which in turn must be placed inside a tertiary outer packaging of sufficient strength for its capacity, weight and intended use.

Packaging systems currently used consist of plastic receptacles and packagings which are non-disposable. Hence, they must be washed out and re-used due to their expense.

Re-use of such non-disposable packaging systems with biological materials gives rise to the possibility of cross-contamination between samples and specimens stored therein. Furthermore, current packaging systems incorporate the shipment of primary receptacles inside secondary packagings, the latter of which have been pressure-tested

to meet the required regulation standards. A problem with such systems is that the shape and volume of the secondary packaging is under constraint due to current manufacturing procedures and results in increased costs. In addition, because the secondary packaging tends to be far larger than the primary receptacles contained therein, sealing mechanisms of the secondary containers are generally large and are open to the possibility of sample leakage. The system has also taken into account the functional processing of samples in laboratories insofar as it is an advantage to process samples presented contained in a disposable rack system. Unless the primary receptacle is designed to pass the leak-proof pressure tests this system would not have been legally compliant, in its stead a large unwieldy cylindrical secondary container would have to be used because of the necessity to achieve leak-prooffiess under pressurised conditions for either the secondary or primary receptacle. This test requires a thread and gasket sealing device embodied in cylindrical closure mechanisms.

It is one aim of the embodiments of the present invention to address the above problems and to provide a packaging for the safe packaging and shipment of diagnostic and/or infectious biological material.

According to a first aspect of the present invention, there is provided packaging for a biological material, the packaging comprising at least one primary container in which biological material is stored, the at least one primary container being insertable in to at least one secondary container, the at least one secondary container being insertable in to a tertiary container, wherein the at least one primary container is operable to withstand a pressure of at least 95kPa without leakage.

The biological material may comprise a diagnostic substance or an infectious substance. The biological material may comprise tissue or organ material from an animal. The animal may be a cow or sheep. The biological material may comprise animal brain material. The biological material may comprise Bovine Spongiform Encephalopathy (BSE). The biological material may comprise a prion protein.

Preferably, the at least one primary container is operable to withstand a pressure of at least 95kPa without leakage. Preferably, the at least one primary container is pressuretested. Advantageously, this alleviates the need for the at least one secondary container to be pressure tested whilst still enabling the packaging to conform with UN Dangerous Goods transport regulations.

Preferably, the primary container is operable to drop tests and leakproof pressure tests whilst withstanding temperatures in the range of-100 C to 100 C, more preferably-

80 C to 80 C and, most preferably,-50 C to 65 C. The at least one primary container may comprise a specimen pot, preferably a plurality of specimen pots. Preferably, the primary container comprises a screw closure cap, preferably a tin-plate/plastic screw closure cap. Preferably, the torque of the closure cap is in the region of 0. 1-3Nm, more preferably 0. 3-2Nm and, most preferably, 0. 6- INm.

The packaging may comprise support means. Preferably, the at least one primary container is supported in the support means prior to insertion in the at least one secondary container. The support means may comprise a plurality of slots or apertures formed therein and may comprise a rack. In a first embodiment, the support means may comprise at least 20 slots. In a first embodiment, the support means may comprise at least 40 slots. Preferably, the at least one primary container is supported in the plurality of slots in the support means.

The support means may comprise handle means preferably at least two handle means at either end thereof. Advantageously, the handle means facilitates the lifting of the support means in and out of the tertiary container.

Preferably, the at least one secondary container comprises leakproof bagging means, preferably a plastic bag. Preferably, the bagging means is salable and leakproof.

Preferably, the tertiary container comprises a box, preferably a cardboard box. In a preferred embodiment, the tertiary container comprises a corrugated fibreboard box preferably comprising a crash-lock base and tuck-in tabs.

The packaging may comprise cooling means. The cooling means may comprise at least one cool pack or ice pack or dry ice pack. Preferably, the cooling means is inserted around the secondary container when placed inside the tertiary container.

The packaging may comprise spacing means. The packaging may comprise insulation means. The spacing means may comprise the insulation means and is preferably inserted substantially in between the cooling means and the tertiary container. The packaging may comprise extraction means for the removal of the biological material from an animal. Said extraction means may comprise any or all of a scalpel, forceps or extraction scoop.

Preferably, any or all of the primary, secondary and tertiary containers are leak-proof and, preferably tamper-evident. Preferably, any or all of the primary, secondary and tertiary containers are disposable. Advantageously, the packaging does not need to be re-used thereby reducing the risk of cross-contamination occurring between biological samples stored in the primary container.

According to a second aspect of the present invention there is provided a method of packing biological storage for transportation thereof, said method comprising the steps of inserting biological material into at least one primary container, inserting the at least one primary container into at least one secondary container, and inserting the at least one secondary container into at least one tertiary container, wherein the primary container is operable to withstand a pressure of at least 95kPa.

All the features described herein may be combined with any of the above aspects, in any combination.

For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will be made, by way of example, to the accompanying drawings, in which :- Figure 1 shows a schematic perspective view of a packaging system ; Figure 2 shows a schematic view of a first embodiment of a specimen rack used in the packaging system shown in Figure 1; and Figure 3 shows a schematic view of a second embodiment of a specimen rack used in the packaging system shown in Figure 1.

Referring to Figure 1, there is shown an UN-approved disposable packaging system 2 for transporting biological specimens which are either infectious and/or diagnostic.

Suitable specimens include BSE brain stem samples. The packaging system 2 is'threetiered'and is made up of a number of different components which are described hereinafter.

The packaging system 2 consists of a specimen extraction tool 18, a scalpel 20 and forceps 22 with which an operator may cut and extract a biological specimen from an animal, for example, it's brain. Once removed from the animal, the specimen 13 is placed inside a specimen pot 12 fitted with a tinplate/plastic screw cap which is leakproof and tamper-evident. The torque of the closure of the cap on the pot 12 is 0. 8Nm.

The specimen pot 12 is termed a primary container and has been pressure-tested to conform with IATA Dangerous Goods Regulations. The pot 12 is able to withstand, without leakage, an internal pressure which produces a pressure differential of not less than 95kPa in the range of-40 C to 55 C. Once tightly sealed, the primary container 12 is placed in a slot 8 in a disposable fibre board rack 6.

Figures 2 and 3 show two embodiments of the rack 6 which, depending on the number of slots 8 therein, differ in shape and size. Hence, the number of slots 8 in the specimen rack 6 determine how many primary containers 12 may be stored and

shipped. Larger racks 6 as shown in Figure 2 have 40 slots 8, and smaller racks as shown in figure 3 have 20 slots each. All embodiments of the rack 6 have a handle 24 at either end thereof to assist their removal from the packaging system 2.

Referring to Figure 1, the specimen rack 6 is shown being inserted into a leak-proof, tamper-evident secondary bag 10 which is then tightly sealed with a self-adhesive closure. The secondary bag 10 is then placed inside an outer shipper 4. Figure 1 shows a packaging system 2 in which one large specimen rack 6, the embodiment of which is shown in Figure 2, is used for shipping samples. However, two smaller racks 6, as shown in Figure 3, may be used. Alternatively, racks 6 may be stacked up on top of one another depending on the size of an outer shipper. The largest outer shipper 4 accomodates 5 stacks of specimen rack 6. Therefore, the packaging system 2 can carry between 40 to 200 specimen pots 12 depending on the size of the racks.

The outer shipper 4 consists of a double wall corrugated E & B flute fibreboard box with FEFCO 0125 crash-lock base and tuck-in tabs 5. Once the secondary bag 10 and rack (s) 6 contained therein are in position inside the outer shipper 4, a cool pack 14, for example, Techni-ice, can be placed on top in order to maintain the specimens 13 at an appropriate shipping temperature. A spacer 16 is then placed on top of the cool pack 14 and the tuck-in tabs 5 of the outer shipper 4 are closed thereby sealing the complete packaging system 2. The packaging system 2 may then be bar-coded and sequentially numbered labels affixed thereto, and is then ready for shipment to a specific destination.

Advantages of the packaging system 2 reside in the fact that the primary container 12 conforms with the leakproof and pressure test requirements of UN/ADR/IATA Dangerous Goods regulations. Hence, they themselves may be stored in the secondary bag with does not have to be pressure-tested but has to be leakproof and, therefore, the shape and size of which does not need to be restricted to certain dimensions. Hence, the secondary bags may be packed into the outer shippers 4 which facilitates packing, storage and shipping thereof. Furthermore, all of the components of the packaging system 2 are cheap to manufacture and diposable. Therefore, there is no need to re-use

any part of the system 2 thereby effectively reducing the risk of cross-contamination occurring between biological samples.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment (s). The invention extend to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

CLAIMS:

1. Packaging for a biological material, the packaging comprising at least one primary container in which biological material is stored, the at least one primary container being insertable in to at least one secondary container, the at least one secondary container being insertable in to a tertiary container, wherein the at least one primary container is operable to withstand a pressure of at least 95kPa without leakage.

2. Packaging for a biological material as claimed in claim 1, wherein the biological material comprises a diagnostic substance or an infectious substance.

3. Packaging for a biological material as claimed in either claim 1 or claim 2, wherein the biological material comprises tissue or organ material from an animal.

4. Packaging for a biological material as claimed in claim 3, wherein the animal is a cow or sheep.

5. Packaging for a biological material as claimed in any preceding claim, wherein the biological material comprises animal brain material.

6. Packaging for a biological material as claimed in any preceding claim, wherein the biological material comprises Bovine Spongiform Encephalopathy (BSE).

7. Packaging for a biological material as claimed in any preceding claim, wherein the biological material comprises a prion protein.

8. Packaging for a biological material as claimed in any preceding claim, wherein the at least one primary container is pressure-tested.

9. Packaging for a biological material as claimed in any preceding claim, wherein the primary container is operable to drop tests and leakproof pressure tests whilst withstanding temperatures in the range of-100 C to 100 C.

10. Packaging for a biological material as claimed in any preceding claim, wherein the at least one primary container comprises a specimen pot.

11. Packaging for a biological material as claimed in any preceding claim, wherein the primary container comprises a screw closure cap.

12. Packaging for a biological material as claimed in claim 11, wherein the torque of the closure cap is in the region of 0.1-3Nm.

13. Packaging for a biological material as claimed in any preceding claim, wherein the packaging comprises support means.

14. Packaging for a biological material as claimed in claim 13, wherein the at least one primary container is supported in the support means prior to insertion in the at least one secondary container.

15. Packaging for a biological material as claimed in either claim 13 or claim 14, wherein the support means

comprises a plurality of slots or apertures formed therein.

16. Packaging for a biological material as claimed in any one of claims 13 to 15, wherein the support means comprises handle means at either end thereof.

17. Packaging for a biological material as claimed in any preceding claim, wherein the at least one secondary container comprises leakproof bagging means.

18. Packaging for a biological material as claimed in claim 17, wherein the bagging means is salable and leakproof.

19. Packaging for a biological material as claimed in any preceding claim, wherein the tertiary container comprises a box.

20. Packaging for a biological material as claimed in claim 19, wherein the tertiary container comprises a corrugated fibreboard box.

21. Packaging for a biological material as claimed in any preceding claim, wherein the packaging comprises cooling means.

22. Packaging for a biological material as claimed in claim 21, wherein the cooling means comprises at least one cool pack or ice pack or dry ice pack.

23. Packaging for a biological material as claimed in either claim 21 or claim 22, wherein the cooling means is

inserted around the secondary container when placed inside the tertiary container.

24. Packaging for a biological material as claimed in any preceding claim, wherein the packaging comprises spacing means.

25. Packaging for a biological material as claimed in any preceding claim, wherein the packaging comprises insulation means.

26. Packaging for a biological material as claimed in claim 25, wherein the spacing means comprises the insulation means and is inserted substantially in between the cooling means and the tertiary container.

27. Packaging for a biological material as claimed in any preceding claim, wherein the packaging comprises extraction means for the removal of the biological material from an animal.

28. Packaging for a biological material as claimed in claim 27, wherein said extraction means comprises any or all of a scalpel, forceps or extraction scoop.

29. Packaging for a biological material as claimed in any preceding claim, wherein any or all of the primary, secondary and tertiary containers are leak-proof and tamper-evident.

30. Packaging for a biological material as claimed in any preceding claim, wherein any or all of the primary, secondary and tertiary containers are disposable.

31. A method of packing biological storage for transportation thereof, said method comprising the steps of inserting biological material into at least one primary container, inserting the at least one primary container into at least one secondary container, and inserting the at least one secondary container into at least one tertiary container, wherein the primary container is operable to withstand a pressure of at least 95kPa.

32. Packaging substantially as herein described with reference to, and as illustrated by, the accompanying drawings.

33. A method substantially as herein described with reference to, and as illustrated by, the accompanying drawings.