Freeze-drying apparatus and method
A process for freeze drying a material. The process has the steps of (a) placing material to be freeze-dried in a vessel, the vessel comprising a container having a base, and at least one wall defining an opening at one end; (b) applying a membrane to the at least one wall to thereby cover the opening, wherein the membrane comprises an aperture which, in use, is aligned with the opening; and (c) subjecting the vessel to a lyophilisation procedure, wherein the membrane is in place on the container during the lyophilisation procedure.
1 . A process for freeze drying a material, said process comprising:
(a) placing the material in a vessel, the vessel comprising a container having a base, and at least one wall defining an opening at one end;
(b) applying a membrane to the at least one wall to thereby cover the opening, wherein the membrane comprises an aperture which, in use, is aligned with the opening and wherein the membrane comprises a metal foil; and
(c) subjecting the vessel to a lyophilization procedure, wherein the membrane is in place on the container during the lyophilization procedure.
2 . A process according to claim 1 , wherein the aperture has an area of from about 2 mm 2 to about 13 mm 2 .
3 . A process according to claim 1 , wherein the step of applying the membrane to the at least one wall of the container comprises sealing the membrane to the at least one wall of the container.
4 . A process according to claim 3 , wherein sealing the membrane to the at least one wall of the container is selected from heat-sealing and adhesive sealing.
5 . A process according to claim 3 , wherein the membrane is reversibly sealed to the at least one wall of the container.
6 . A process according to claim 1 , comprising subjecting the vessel to a centrifugation process after step (b), wherein the membrane is in place on the container during the centrifugation process.
7 . A process according to claim 1 , further comprising (d) introducing inert gas into the vessel after the lyophilisation procedure, wherein the membrane is in place on the container during the introduction of the inert gas into the vessel.
8 . A process according to claim 7 , wherein the inert gas is selected from nitrogen gas, argon gas and dried air.
9 . A process according to claim 7 , wherein subjecting the vessel to a lyophilisation procedure further comprises subjecting the vessel to a lyophilisation procedure in a freeze-drying apparatus, and wherein the process further comprises (e) transferring the vessel containing the freeze-dried material and the inert gas from the freeze-drying apparatus to a dry cabinet, wherein the membrane is in place on the container during the transfer.
10 . A process according to claim 9 , wherein no additional closure covers the opening of the container during the (e) transferring.
11 . A process according to claim 9 , further comprising (f) in the dry cabinet, packaging the vessel into a non-porous receptacle with a desiccant and sealing the receptacle.
12 . A process according to claim 11 , wherein no additional closure covers the opening of the container when the vessel is packaged in the non-porous receptacle.
13 . A process according to claim 11 , wherein the non-porous receptacle comprises a metallized polymer that has a vapour transmission rate lower than the native polymer.
14 . A process according to claim 1 , wherein the material comprises one or more components that are required for carrying out a chemical or biochemical reaction.
15 . A process according to claim 14 , wherein the chemical or biochemical reaction is a nucleic acid amplification reaction.
16 . A process according to claim 15 , wherein the nucleic acid amplification reaction is a polymerase chain reaction or reverse-transcriptase polymerase chain reaction.
17 . A vessel for use in a freeze-drying procedure, the vessel comprising
a container having a base, and at least one wall defining an opening at one end; and
a membrane configured to cover the opening of the container, wherein the membrane is provided with an aperture which, in use, is aligned with the opening of the container, wherein the membrane comprises a metal foil.
18 . A vessel according to claim 17 , wherein the aperture has an area of from about 2 mm 2 to about 13 mm 2 .
19 . A vessel according to claim 17 , wherein the membrane is removably attachable to the container.
20 . A vessel according to claim 19 , wherein the membrane is attached to the container by a heat seal or by adhesive.
21 . A vessel according to claim 17 , comprising multiple containers, each of which is provided with a membrane or a portion of a membrane.
22 . A vessel according to claim 21 , wherein the multiple containers are joined together to form a single unit.
23 . A vessel according to claim 22 , wherein the multiple containers comprise individual or groups of multiple containers in separate units.
24 . A vessel according to claim 17 , wherein the membrane comprises at least one alignment feature to aid alignment in an analytical apparatus during a subsequent analysis procedure.
25 . A vessel according to claim 24 , comprising multiple containers and a single membrane, arranged such that a portion of the membrane covers an opening of each container in the vessel, and each portion of membrane is provided with an aperture, wherein each portion comprises a separate alignment feature.
26 . A vessel according to claim 17 , comprising a material which has been freeze-dried in situ in the container.
27 . A vessel according to claim 26 , comprising an inert gas in the container.
28 . A vessel according to claim 26 , wherein the material comprises reagents useful in a nucleic acid amplification reaction.
29 . A vessel for use in a freeze-drying procedure, the vessel comprising:
a container having a base, and at least one wall defining an opening at one end; and
a membrane configured to cover the opening of the container, wherein the membrane is provided with an aperture which, in use, is aligned with the opening of the container,
wherein a single membrane is provided for the multiple containers, arranged such that a portion of the membrane covers an opening of each container in the vessel, and each portion of the membrane is provided with an aperture and wherein the membrane comprises a metal foil.
30 . A vessel according to claim 29 , wherein a boundary between two adjacent portions of membrane is provided with an area of weakness to facilitate separating the portions of membrane.
31 . A vessel according to claim 30 , wherein the multiple containers comprise separate individual or groups of containers and wherein the boundary between two adjacent portions of membranes may be aligned with a boundary between adjacent separate individual or groups of containers.
32 . A system for use in a freeze-drying procedure, the system comprising:
two or more vessels, each of the vessel comprising:
one or more container, each of the container having at least one wall defining an opening at one end; and
a membrane, divided into membrane portions, each of the membrane portion being configured to cover the opening of a container, wherein each of the membrane portion is provided with an aperture which, in use, is aligned with the opening of the container and each of the membrane portion comprises a metal foil; and
a support for receiving the two or more vessels and being configured to retain the two more vessels in alignment with one another, the support having at least one alignment feature configured to engage with a corresponding alignment feature of the membrane to thereby align the membrane relative to the two or more vessels.
33 . A system according to claim 32 , wherein the alignment feature of the support comprises one or more male member and the corresponding alignment feature of the membrane comprises one or more female member.