DEVICE AND METHOD FOR SIMULTANEOUS LYOPHILISATION OF A PLURALITY OF BIOLOGICAL SAMPLES

Abstract

The invention relates to a device and method for the simultaneous lyophilisation of a plurality of biological samples ensuring the traceability of said samples intended to be housed within coded containers (1); the device comprises a diffuser block (2) comprising a plurality of openings which define receptacles (21) to house the coded containers (1), wherein the diffuser block (2) further comprises a perimeter cavity (24) configured so that the alloy surrounding each receptacle (21) is similar in all the coded containers (1), enabling high thermal homogeneity, and the receptacles (21) have through openings defining an open bottom (23) to scan the coded containers (1). Likewise, the device further comprises a transfer lid (3) to ensure the position of each container (1) when it is transferred to the diffuser block (1) and back to the starting box (4).

Claims

1. A device for the simultaneous lyophilisation of a plurality of biological samples intended to be housed within coded containers (1), which comprises a diffuser block (2) made of a metal alloy with high thermal conductivity comprising a plurality of receptacles (21) to house the coded containers (1), characterised in that said diffuser block (2) further comprises: a perimeter cavity (22) enabling high thermal homogeneity, and the receptacles (21) have through-holes defining an open bottom (23).

2. The lyophilisation device according to claim 1, characterised in that the receptacles (21) have a matrix configuration with a plurality of rows and columns.

3. The lyophilisation device according to claim 1, characterised in that the receptacles (21) have a single row linear configuration.

4. The lyophilisation device according to claim 3, characterised in that the diffuser block (2) comprises a lateral cavity (25) intended to enable the coded containers (1) to be read by a scanner.

5. The lyophilisation device according to claim 4, characterised in that the receptacles (21) have a relief (26) configured to enable the coded containers (1) to fit in one position that enables scanning from the lateral cavity of the diffuser block (2).

6. The lyophilisation device according to claim 1, characterised in that it further comprises a transfer lid (3) which comprises a base (31) wherein a plurality of columns (32) configured in arrangement and quantity coinciding with the plurality of receptacles (21) of the diffuser block (2) to house the coded containers (1) protrude.

7. The lyophilisation device according to claim 6, characterised in that the transfer lid (3) comprises at least one tab (33) that exceeds the columns (32) in height and the diffuser block (2) comprises at least one transfer groove (24) adapted to house the flanges (33) of the transfer lid (3) to enable the transfer lid (3) and diffuser block (2) to be joined in a given unique position.

8. The lyophilisation device according to claim 6, characterised in that the transfer lid (3) is made of plastic.

9. The lyophilisation device according to claim 6, characterised in that the transfer lid (3) is made of a metal alloy.

10. The lyophilisation device according to claim 1, characterised in that the diffuser block (2) is a 7075 aluminium-zinc metal alloy.

11. An installation comprising the device described in any one of claims 1-10, comprising a starting box (4) wherein the coded containers (1), a lyophilisation device configured for freezing and vacuum drying the samples, a lyophiliser tray, a scanner (7), and vacuum sealing equipment are initially housed.

12. A method of using the installation of claim 11 for lyophilisation and traceability of biological samples, characterised in that it comprises: A. placing the transfer lid on top of the starting box (4) comprising the coded containers (1) forming a first assembly (5) which comprises the starting box (4) and the transfer lid (3), B. flipping the assembly (5) 180° so that the coded containers (1) enter between the columns (32) of the transfer lid and removing the starting box (4), C. placing the diffuser block (2) so that the flanges (33) of the transfer lid (3) fit into the grooves (24) of the diffuser block (2), forming a second assembly (6) of transfer lid (3) and diffuser block (2), D. flipping the second assembly (6) 180° so that the coded containers (1) are placed in the diffuser block (2), E. placing the oriented diffuser block (2) in the scanner (7), proceeding to read the codes of the coded containers and storing the generated information in a database, F. dispensing the biological sample and a lyophilisation matrix solution into each coded container (1), G. placing the diffuser block (2) in the lyophiliser tray and starting lyophilisation in the lyophiliser device.

13. The method of using the installation according to claim 12, characterised in that it comprises transferring the coded containers (1) with the biological samples and the lyophilisation matrix solution after lyophilisation to the starting box (4) following the reverse order of the steps of claim 12.

14. The method of using the installation according to claim 12, characterised in that it comprises vacuum sealing the starting box (4) with the coded containers with the lyophilised samples.

15. The method of using the installation according to any of claim 12 or 13, characterised in that at least one of the steps A-F is performed by a robotic arm.

16. The method of using the installation according to claim 12, characterised in that the biological samples comprise at least one product selected from: tissues, cells, blood, plasma, serum, cerebrospinal fluid, synovial fluid, amniotic fluid, vitreous humour, aqueous humour, tears, saliva, urine, faeces, sweat, semen, cells, exosomes, subcellular organelles, nucleic acids (for example, DNA and RNA), drugs, vaccines, toxins, vitamins, enzymes, cofactors, lipids, hormones, peptides, fluorochromes, cofactors, proteins, antibodies, antigens and cytokines.

17. The method of using the installation according to claim 12, characterised in that the lyophilisation matrix is an aqueous solution comprising sugars, surfactants, antioxidants, salts, or combinations thereof.

18. The method of using the installation according to claim 17, characterised in that the sugars are selected from the list comprising mannitol, sucrose, trehalose, glucose and combinations thereof; the surfactants are selected from the list comprising: Polysorbate 20, Polysorbate 80, or combinations thereof; the antioxidants comprise epigallocatechin gallate, and the salts are selected from the list comprising: TrisClH, sodium acetate, sodium phosphate, or combinations thereof.

Description

DESCRIPTION OF THE DRAWINGS

[0096] As a complement to the description provided and for the purpose of helping to make the features of the invention more readily understandable, in accordance with a practical preferred exemplary embodiment thereof, said description is accompanied by a set of drawings which, by way of illustration and not limitation, represent the following:

[0097] FIG. 1 shows three perspective views of a preferred embodiment of the diffuser block, wherein the perimeter cavity, the open bottom and the coded containers housed in the receptacles of the diffuser block are shown.

[0098] FIG. 2 shows three perspective views of the preferred embodiment of the transfer lid, wherein the columns of the transfer lid, as well as the tabs that enable the transfer lid and the diffuser block to be joined in a given unique position are shown.

[0099] FIG. 3 shows a perspective view of the diffuser block with the coded containers housed in the receptacles and their positioning in the scanner.

[0100] FIG. 4 shows a perspective view of a preferred embodiment, wherein some of the steps of the method to maintain the traceability of the samples are shown.

[0101] FIG. 5a shows a perspective view of a second alternative embodiment of the diffuser block, with a single row linear configuration wherein a view from the upper face is shown and the lateral cavity is represented.

[0102] FIG. 5b shows a perspective view of the second alternative embodiment, wherein the lower face is shown and the perimeter cavity, the open bottom and the relief of the receptacles are represented.

PREFERRED EMBODIMENT OF THE INVENTION

[0103] FIG. 1 clearly shows a preferred embodiment of a first aspect of the invention, wherein a diffuser block (2) is shown as a device for the simultaneous lyophilisation of a plurality of biological samples intended to be housed within coded containers (1).

[0104] FIG. 1 also shows that the diffuser block (2) has a plurality of openings which define receptacles (21) to house the coded containers (1) therein. Said diffuser block (2) in the described preferred embodiment is made of a metal alloy with high thermal conductivity and has a perimeter cavity (22) configured so that the alloy surrounding each receptacle (21) is similar in all the coded containers (1), enabling high thermal homogeneity. It also shows that the diffuser block (2) comprises an open bottom (23) since the receptacles (21) have through openings. In addition, it also shows that the diffuser block (2) comprises three transfer grooves (24), one on the narrower side of the diffuser block (2) and the other two remaining grooves on the longer side of the diffuser block (2).

[0105] The diffuser block (2) with the aforementioned features has high thermal conductivity to enable energy to be transferred to the sample containers during the vacuum sublimation phase of the lyophilisation process.

[0106] In addition, it shows great temperature homogeneity in all the coded containers (1), regardless of the position thereof in the starting plate (centred vs. lateral position), thanks to the perimeter groove and the open bottom.

[0107] Likewise, the open bottom enables the identification codes of each of the sample containers to be read without the need to remove them from the diffuser block, facilitating the identification thereof and ensuring the traceability of the same at all times.

[0108] FIG. 2 shows the described preferred embodiment wherein the device further comprises a transfer lid (3) which comprises a base (31) wherein a plurality of columns (32) configured in arrangement and quantity to the plurality of receptacles (21) of the diffuser block (2) and adapted to house the coded containers (1) protrude.

[0109] FIG. 2 also shows a tab (33) that exceeds the columns (32) in the transfer lid (3) in height. Said tabs (33) are adapted to be housed in the grooves (24) of the diffuser block to enable the transfer lid (3) and diffuser block (2) to be joined in a given unique position. In the preferred embodiment, the transfer lid (3) is made of plastic.

[0110] FIG. 3 shows a perspective view of the diffuser block (2) with the coded containers (1) in the receptacles (21), being scanned in a scanner (7), of a lyophilisation installation comprising a starting box (4) shown in FIG. 4, wherein the coded containers (1), a lyophilisation device (not shown) configured for freezing and vacuum drying the samples, a lyophiliser tray (not shown), a scanner (7), and vacuum sealing equipment (not shown) are initially housed.

[0111] FIG. 4 shows a perspective view of a second aspect of the present invention, wherein a method of using the device to ensure the traceability of the samples in a lyophilisation installation which improves the thermal homogeneity of the samples is shown.

[0112] The starting box (4) is initially shown with the coded containers (1), the transfer lid (3), and the diffuser block (2). In a first step of the described preferred embodiment, FIG. 4 shows that the transfer lid (3) must be placed on top of the starting box (4) which comprises the coded containers (1) forming an assembly (5) comprising the starting box (4) and the transfer lid (3).

[0113] Subsequently, the assembly (5) must be rotated 180° so that the coded containers (1) enter the columns (32) of the transfer lid (3) and the starting box (4) must be removed.

[0114] Next, it shows that the diffuser block (2) must be placed so that the tabs (33) of the transfer lid (3) fit into the grooves (24) of the diffuser block (2), forming a second assembly (6) of transfer lid (3) and diffuser block (2).

[0115] The next step is to flip the second assembly (6) 180° so that the coded containers are placed in the diffuser block (2). Next, the oriented diffuser block (2) is placed in the scanner (7), and the codes of the coded containers (1) are then read, enabling the generated information to be stored in a database.

[0116] In a preferred embodiment, the biological sample and a lyophilisation matrix solution are dispensed into each coded container (1) by a robotic arm.

[0117] Thus, the traceability of the samples has been ensured, and it is likewise ensured if the same process is performed in reverse order after lyophilisation. Consequently, the diffuser block (2) is placed in the lyophiliser tray and lyophilisation is started in the lyophiliser device. Once the samples have been lyophilised, the reverse order is followed to move the samples to the starting box (4) maintaining traceability at all times, therefore using the transfer lid (3) again.

[0118] Finally, the already lyophilised samples in the coded containers (1) in the starting box (4) are vacuum sealed in the starting box (4).