Lyophilization system and related method

Abstract

A SYSTEM relating to the freeze-drying of basic substances (Sb) contained within basic vials (Fb) comprises: a freeze-drying chamber (400 / 500); FIRST detection means (400. M1 / 500.M1); SECOND detection means (400.M2. / 500. M2); power supply means (420 / 520); switching means (430 / 530); receiving means (440 / 540); control means (450 / 550). A related method.

Description

[0001] TITLE

[0002] Lyophilization System and Related Method

[0003] DESCRIPTION

[0004] Field of Invention

[0005] _The present invention concerns systems and related methods relating to freeze- drying.

[0006] _More particularly, the present invention concerns a system for monitoring the freeze-drying process in relation to the freeze-drying of substances contained in one or more freeze-drying vials and a related method.

[0007] Background to the Invention

[0008] _Freeze-drying is a process by which substances can be preserved in a dehydrated form.

[0009] _This process involves freezing the water contained in the substance being freeze-dried, and then removing the ice by sublimation under partial vacuum, using gentle heating (primary drying).

[0010] _The non-freezable water remaining from primary drying is then removed by heating at high temperatures (secondary drying).

[0011] _The end point (so-called set-point) of the freeze-drying process is defined by the achievement of a desired optimal degree of humidity in the substance being freeze- dried.

[0012] _In relation to said optimal humidity level, if the substance to be freeze-dried, at the end of the freeze-drying process, has a higher humidity level or a lower humidity level than said optimal humidity level, said substance must be discarded.

[0013] _In fact, in summary:

[0014] >_if the substance, at the end of the freeze-drying process, has a higher humidity level than the said optimal humidity level, this excessive humidity may cause rapid deterioration of the product and, therefore, not fulfil the requirements relating to the shelf life that the freeze-dried product must have;

[0015] >_If the substance, at the end of freeze-drying, has a lower humidity level than the said optimal humidity level, this excessive drying may cause, for example, changes in the molecular structure of the substance, or may cause problems for its future use, such as, for example, not having certain characteristics relating to solubility and, therefore, creating problems when the freeze-dried product must be dissolved in a liquid substance for the so-called "reconstruction" before use. and, furthermore

[0016] >_if the substance, during the freeze-drying process, undergoes a drying process that is too rapid, this too rapid drying may cause problems, such as, for example, changes in the molecular structure of the substance and / or the formation of lumps and / or other undesirable effects and, therefore, the resulting freeze-dried product must be discarded;

[0017] >_if the substance, during the freeze-drying process, undergoes a drying process that is too slow, this too slow drying can cause problems, such as, for example, changes in the molecular structure of the substance and / or unwanted chemical reactions and / or other unwanted effects due, mainly, to the presence of water in the substance for too long a period of time.

[0018] 1st Known System

[0019] _A first known system relating to the freeze-drying of a substance contained in a plurality of vials, consists in inserting, in each vial, a probe in contact with the substance, in order to detect the degree of humidity in the same substance, wherein said probe is equipped with wireless or other types of transmitting means, in order to be able to insert said complex comprising vial with substance with probe with transmission means, into a freeze-drying chamber and, therefore, activated the freeze-drying process, monitoring the degree of humidity of the substance which will gradually decrease, to then determine the end of the freeze-drying when a certain degree of humidity is detected for said substance during freeze-drying.

[0020] _This system has a series of drawbacks.

[0021] _A first drawback is due to the fact that the probe is in contact with the substance being freeze-dried and this contact can cause unwanted contamination of the substance itself.

[0022] _A second drawback is due to the fact that this system is very expensive, since, mainly, it involves the use of a plurality of probes that must be associated with each vial, as well as a huge amount of work for the preparation of the vials that must be equipped with a probe and transmission means.

[0023] 2nd Known System

[0024] _A second known system, relating to freeze-drying, consists in theoretically predetermining, "at the table", what the optimal freeze-drying procedure would be, such as, for example, the process methods with relative temperatures and times, in order to obtain, at the end of the freeze-drying process, a substance presumably free from defects and having a desired specific degree of humidity, without inserting probes inside the substance.

[0025] _Said second system has a series of drawbacks.

[0026] _A first drawback is due to the fact that these theoretical, "at the table", estimates regarding the freeze-drying procedure to be adopted and the relative freeze-drying times are not reliable and / or optimal and, therefore, sometimes, non-optimal freeze- drying procedures are carried out in which, for example, in order to avoid the extraction of the vials from the freeze-drying chamber with a substance that is still too wet, it is preferable to extend the freeze-drying time beyond that estimated “at the table", with the risk of drying the substance too much and / or with a reduction in the production capacity for the relative freeze-drying machine, since the working times for each freeze-drying session are unnecessarily extended. _I n fact, for example, these estimates, "at the table", are very difficult and / or impossible to formulate with precision:

[0027] >_since they must be formulated in correlation with the initial humidity level of a given substance, which is sometimes not available, where said initial humidity level is not always the same for each freeze-drying session;

[0028] >_since they must be formulated in correlation with the type of vial containing the substance to be freeze-dried, more particularly, for example, in correlation with the shape and / or thickness and / or material of the vial body of the individual vials containing the substance, where said type of vial is not always the same for each freeze-dried session;

[0029] >_since they must be formulated in correlation with the molecular composition of the substance to be freeze-dried, where said molecular composition is not always the same for each freeze-drying session; and, consequently, sometimes incorrect and / or non-optimal freeze-drying procedures are adopted, which generate a defective freeze-dried product that must be discarded, or the need to extend the freeze-drying times beyond necessary, with the related consequences already mentioned above.

[0030] _These “at the table" estimates are impossible to formulate when regard a substance that has never been used before in terms of composition or water content, or when one has to work with vials that have never been used before.

[0031] Exposition of the Invention

[0032] _The purpose of the present invention is therefore to resolve the above-mentioned drawbacks.

[0033] _The invention, which is characterized by the claims, solves the problem of creating a SYSTEM relating to the freeze-drying of basic substances contained within basic vials, wherein said system is characterized by the fact of comprising: a freeze-drying chamber; FIRST detection means, positioned within said freeze- drying chamber, capable of detecting a first electrical characteristic in relation to at least one FIRST vial; SECOND detection means, positioned within said freeze- drying chamber, capable of detecting said first electrical characteristic in relation to at least one SECOND vial; power supply means, capable of powering said first detection means and said second detection means; switching means, capable of switching the activation between said FIRST detection means and said SECOND detection means; receiving means, capable of receiving FIRST signals from said first detection means and capable of receiving SECOND signals from said second detection means; control means for controlling said power supply means and / or said switching means and / or for receiving and processing the signals received from said receiving means.

[0034] _The invention, which is characterized by the claims, solves the problem of creating a METHOD relating to the freeze-drying of basic substances contained within basic vials using the previous system, wherein said METHOD is characterized by the fact that it comprises the following operations: 1.1)_preparing one or more open basic vials, wherein each basic vial has a basic vial body, wherein each basic vial contains a basic substance, wherein said basic substance is a substance to be freeze-dried; 1.2) -preparing at least one first open vial, wherein said first vial comprises a respective first vial body equal to said basic vial body, wherein said first vial contains a first substance, wherein said first substance is equal to said basic substance; 1.3)_prepare at least one second closed vial, wherein said second vial comprises a respective second vial body equal to said base vial body and equal to said first vial body, wherein said second vial contains a second substance, wherein said second substance corresponds to a freeze-dried form of the base substance contained in each base vial, wherein said second substance has a degree of humidity equal to the degree of humidity that is desired to be obtained at the end of freeze-drying in relation to the base substance to be freeze-dried; 1.4) place within said freeze-drying chamber a plurality of said base vials as prepared in point 1.1) above; 1.5)_place in the first detection means at least one first vial as prepared in above point 1.2); 1.6)_place in the second detection means at least one second vial as prepared in above point 1.3); 1.7)_start the freeze-drying process in said freeze-drying chamber; 1.8)_detect during said freeze-drying process the values pertaining to a first electrical characteristic in relation to said first vial, in order to obtain first electrical values; 1.9)_detect during the freeze-drying process the values pertaining to said first electrical characteristic in relation to the second vial, in order to obtain second electrical values; 1.10)_carry out, during said freeze-drying process, comparisons between said first electrical values and said second electrical values.

[0035] Brief Description of the attached illustrations

[0036] -Further features and advantages of the present invention will be made more evident from the following description of some of its preferred practical embodiments, given here purely by way of example and not of limitation, made with reference to the figures of the attached drawings in which:

[0037] >_Figures 1 , 1 A, 1 B are illustrations of a basic vial;

[0038] >_Figures 2, 2A and 2B are illustrations of a first vial;

[0039] >_Figures 3, 3Aand 3B are illustrations of a second vial;

[0040] >_Figure 4 is a schematic illustration of a first embodiment of a freeze-drying system;

[0041] >_Figure 5 is a schematic illustration of a second embodiment of a freeze-drying system. Preferred Example Forms of Practical Realization

[0042] With reference to the attached figures, the present invention concerns a system relating to freeze-drying for carrying out a freeze-drying process suitable for freeze- drying a basic substance Sb contained in one or more vials of basic Fb, wherein this freeze-drying takes place inside a freeze-drying chamber 400 / 500 of a freeze- drying machine.

[0043] More particularly, the present invention concerns a system of the aforementioned type capable of monitoring, as an estimate, the freeze-drying process in relation to the basic substance Sb contained in the basic vials Fb, such as, for example, capable of estimating, in real time, when this basic substance Sb has reached a certain degree of humidity, such as, for example, a desired degree of humidity that the basic substance Sb must have as a final freeze-drying.

[0044] _With reference to figures 1_1A_1B, 2 2A 2B, 3_3A_3B, the system which is the object of the present invention, as will be better understood below, preferably, provides for the use of three types of vials and, more particularly, one or more basic vials Fb, one or more first vials F1 and one or more second vials F2, in which each vial extends along a respective vertical axis, Fb.y, F1.y, F2.y and along a respective transverse axis, Fb.x, F1.x, F2.x.

[0045] _With reference to figures 1_1A_1B, each basic vial Fb can be a vial without a cap, therefore open, see fig. 1, or a vial Fb equipped with a cap T.Fb, see fig. 1A and 1 B, in which said cap T.Fb includes transfer ports for the escape of gases and / or vapours and / or other substances, in which said cap T.Fb can assume a raised position, see fig. 1A, in order to configure an open basic vial Fb, or a lowered position, see fig. 1B, in order to configure a closed basic vial Fb.

[0046] _With reference to figures 2 2A 2B, each first vial F1 can be a vial without a cap, therefore open, see fig. 2, or a first vial F1 equipped with a cap T.F1 , see fig. 2A and 2B, in which said cap T.F1 includes transfer ports for the escape of gases and / or vapours and / or other substances, in which said cap T.F1 can assume a raised position, see fig. 2A, in order to configure an open first vial F1 , or a lowered position, see fig. 2B, in order to configure a closed first vial F1.

[0047] _With reference to figures 3_3A_3B, each second vial F2 can be a vial without a cap, therefore open, see fig. 3, or a vial F2 equipped with a cap T.F2, see fig. 3A and 3B, in which said cap T.F2 includes transfer ports for the escape of gases and / or vapours and / or other substances, in which said cap T.F2 can assume a raised position, see fig. 3A, in order to configure a second open vial F2, or a lowered position, see fig. 3B, in order to configure a second closed vial F2.

[0048] -Preferably, said three vial bodies C.Fb C.F1 C.F2, or said basic vial body C.FB and said first vial body C.F1, are vial bodies which are equal to each other as regards technical characteristics relating to heat transmission, i.e. equal in relation to the transmission of calories and refrigeration with respect to a substance contained in them, when said vial bodies are subjected to the same environmental conditions and / or to the same changes in said environmental conditions.

[0049] -Always preferably, said three vial bodies C.Fb C.F1 C.F2, or said basic vial body C.FB and said first vial body C.F1 , are vial bodies that are identical to each other as regards the functional characteristic relating to the release of water from said vials in the various state during the freeze-drying process, such as, for example, the same characteristics in relation to the size and / or the conformation and / or the position of the openings for the release of water in the various state.

[0050] _Still preferably but not limited to, said three vial bodies C.Fb C.F1 C.F2, or said basic vial body C.FB and said first vial body C.F1, may be vial bodies identical to each other and having, optionally, identical closing caps.

[0051] _More particularly, still preferably, said three vial bodies C.Fb C.F1 C.F2, or said basic vial body C.FB and said first vial body C.F1, are vial bodies which are equal to each other, where said equality is such as to obtain, in relation to the respective substances contained therein, the same treatment during a freeze-drying cycle, when said vial bodies are subjected to the same environmental conditions and / or to the same changes in said environmental conditions.

[0052] _Wrth reference to the following description, the system which is the object of the present invention, in the various embodiments specified below, can be used to monitor, as an estimate, the freeze-drying progress process in relation to the Sb substance contained in the base vials Fb, or, to estimate, in real time, when the substance Sb contained in the base vials Fb has reached the end-of-freeze-drying humidity level, or, to carry out other operations and / or estimates, as better understood below. _Again with reference to the system which is the object of the present invention, in the various embodiments specified below, it can also be used and / or adopted in existing freeze-drying machines, as an "after-market" application.

[0053] _With reference to the following description, the reference placed before the T if it starts with the number “4" (i.e. 4...) refers to the embodiment of figure 4, and the reference placed after the T if it starts with foe number “5” (i.e. 5...) refers to the embodiment of figure 5.

[0054] _Wifo particular reference to figure 4 , the SYSTEM which is the subject of foe present invention, relating to the freeze-drying of basic substances Sb contained within basic vials Fb, comprises: _a freeze-drying chamber 400; -FIRST detection means 400.M1, positioned within said freeze-drying chamber 400, suitable for detecting a first electrical characteristic in relation to at least one FIRST vial F1, for example positioned above a tray 410 positioned within said freeze-drying chamber 400; >_SECOND detection means 400.M2, positioned within said freeze-drying chamber 400, suitable for detecting said first electrical characteristic in relation to at least one SECOND vial F2, for example positioned above a tray 410 positioned within said freeze-drying chamber 400; .power supply means 420, adapted to power said first detection means 400.M1 and said second detection means 400.M2; -Switching means 430, adapted to switch foe activation between said FIRST detection means 400.M1 and said SECOND detection means 400.M2; .receiving means 440, adapted to receive FIRST signals from said first detection means 400.M1 and adapted to receive SECOND signals from said second detection means 400.M2; .control means 450, such as for example a microprocessor, adapted to control said power supply means 420 and / or said switching means 430 and / or said receiving means 440.

[0055] .With particular reference to figure 5 , the SYSTEM which is foe subject of the present invention, relating to foe freeze-drying of basic substances Sb contained within basic vials Fb, comprises: _a freeze-drying chamber 500; .FIRST detection means 500.M1, positioned within said freeze-drying chamber 500, suitable for detecting a first electrical characteristic in relation to a plurality of first vials F1_F1_F1, for example positioned above a tray 510 positioned within said freeze- drying chamber 500; .SECOND detection means 500.M2, positioned within said freeze-drying chamber 500, suitable for detecting said first electrical characteristic in relation to a plurality of second vials F2_F2_F2, for example positioned above a tray 510 positioned within said freeze-drying chamber 500; .power supply means 520, adapted to power said first detection means 500.M1 and said second detection means 500.M2; .switching means 530, adapted to switch the activation between said FIRST detection means 500.M1 and said SECOND detection means 500.M2; .receiving means 540, adapted to receive FIRST signals from said first detection means 500.M1 and adapted to receive SECOND signals from said second detection means 500.M2; .control means 550, such as for example a microprocessor, adapted to control said power supply means 520 and / or said switching means 530 and / or said receiving means 540.

[0056] .Therefore, summarizing, as a common feature, with figure.4 / figure.5, the SYSTEM object of the present invention, pertaining to the freeze-drying of basic substances Sb contained inside basic vials Fb, comprises: _a freeze-drying chamber 400 / 500; .FIRST detection means 400.M1 / 500.M1, positioned within said freeze-drying chamber 400 / 500, suitable for detecting a first electrical characteristic in relation to at least one FIRST vial F1 , for example positioned above a tray 410 / 510 positioned within said freeze-drying chamber 400 / 500; .SECOND detection means 400.M2. / 500. M2, positioned within said freeze-drying chamber 400 / 500, suitable for detecting said first electrical characteristic in relation to at least one SECOND vial F2, for example positioned above a tray 410 / 510 positioned within said freeze-drying chamber 400 / 500; .power supply means 420 / 520, suitable for powering said first detection means 400.M1 / 500.M1 and said second detection means 400.M2 / 500. M2; .switching means 430 / 530, suitable for switching the activation between said FIRST detection means 400.M1 / 500.M1 and said SECOND detection means 400.M2 / 500.M2; .receiving means 440 / 540, adapted to receive FIRST signals from said first detection means 400.M1 / 500.M1 and adapted to receive SECOND signals from said second detection means 400.M2 / 500. M2; .control means 450 / 550, such as for example a microprocessor, adapted to control said power supply means 420 / 520 and / or said switching means 430 / 530 and / or said receiving means 440 / 540.

[0057] .Preferably, with reference to figure 4, said switching means 430 are positioned within said freeze-drying chamber 400, for example above a tray 410 positioned within said freeze-drying chamber 400 and, always preferably, also said feeding means 420 and said receiving means 440 are positioned within said freeze-drying chamber 400 and, for example, also positioned above the same tray 410 lying within said freeze-drying chamber 400, or positioned in another location.

[0058] -Again preferably, with reference to figure 5, said switching means 530 are positioned within said freeze-drying chamber 500, for example above a tray 510 positioned within said freeze-drying chamber 510 and, again preferably, also said feeding means 520 and said receiving means 540 are positioned within said freeze- drying chamber 500 and, for example, also positioned above the same tray 510 lying within said freeze-drying chamber 500, or positioned in another location.

[0059] -Therefore, to summarize, as a common feature, with particular reference to figure.4 / fyure.5, preferably, said switching means 430 / 530 are positioned within said freeze-drying chamber 400 / 500, for example above a tray 410 / 510 positioned within said freeze-drying chamber 410 / 510 and, always preferably, also said feeder means 420 / 520 and said receiver means 440 / 540 are positioned within said freeze-drying chamber 400 / 500 and, for example, also positioned above the same tray 410 / 510 lying within said freeze-drying chamber 400 / 500, or positioned in another place.

[0060] -According to a preferred embodiment, said system can be configured to determine first electrical values and second electrical values pertaining to at least the same first electrical characteristic, such as, for example:

[0061] >_with reference to Figure 4

[0062] >_on the basis of said first signals, relating to said first detection means 400.M1, determine the value relating to the electrical permittivity and / or electrical capacity and / or other electrical characteristic relating to at least one first row F1 positioned in said first detection means 400.M1; and

[0063] >_on the basis of said second signals, relating to said second detection means 400.M2, determine the value relating to the electrical permittivity and / or electrical capacity and / or other electrical characteristic relating to at least a second row F2 positioned in said second detection means 400.M2; >_or, with reference to figure 5

[0064] >_on the basis of said first signals, relating to said first detection means 500.M1, determine the value relating to the electrical permittivity and / or electrical capacity and / or other electrical characteristic relating to a plurality of first rows F1_F1_F1 positioned in said first detection means 500.M1; and

[0065] >_on the basis of said second signals, relating to said second detection means 500. M2, determine the value relating to the electrical permittivity and / or electrical capacity and / or other electrical characteristic relating to at least a plurality of second rows F2_F2_F2 positioned in said second detection means 500. M2. as better understood later

[0066] _With reference to figure 4 , said FIRST detection means 400.M1 and said SECOND detection means 400.M2 are preferably identical to each other, as well as, preferably, positioned within the freeze-drying chamber 400, for example, as mentioned above, on a tray 410 lying in said freeze-drying chamber 400, in such a way that the methods and / or parameters for the detection of one or more electrical characteristics, pertaining to the respective vials F1 and F2, will be identical to each other, also assuming identical effects of parasitic electrical elements associated with the chain of the detection means, i.e. assuming an identical permittivity for both detection means 400.M1 and 400.M2, as well as a permittivity that changes identically in relation to the variations in temperature and / or to the variation in environmental conditions to which said detection means 400. M1 and 400.M2 will always be subjected during the freeze-drying operations, freeze-drying which takes place within said freeze-drying chamber 400.

[0067] J / Vith reference to figure 5 , said FIRST detection means 500.M1 and said SECOND detection means 500. M2 are preferably identical to each other, as well as preferably positioned within the freeze-drying chamber 500, for example, as mentioned above, on a tray 510 of said freeze-drying chamber, in such a way that the methods and / or parameters for detecting one or more electrical characteristics, pertaining to the plurality of first vials F1_F1_F1 and the plurality of second vials F2.F2.F2 will be identical to each other, assuming that the effects of parasitic electrical elements associated with the chain of the detection means are also identical, i.e. assuming an identical permittivity for both detection means 500.M1 and 500.M2, as well as a permittivity that changes identically in relation to variations in temperature and / or variations in environmental conditions to which said detection means 500.M1 and 500.M2 will always be subjected during the freeze-drying operations which take place within said freeze-drying chamber 500.

[0068] _With reference to figure 4, according to a preferred embodiment, the power supply means 420 are suitable for powering and activating first detection means 400.M1 , in order to obtain FIRST signals which are then transmitted to the receiving means 440, and suitable for powering and activating second detection means 400. M2, in order to obtain SECOND signals which are then transmitted to the receiving means 440, as will be better understood below.

[0069] With reference to figure 5, according to a preferred embodiment, the power supply means 520 are suitable for powering and activating first detection means 500.M1 , in order to obtain FIRST signals which are then transmitted to the receiving means 540, and suitable for powering and activating second detection means 500. M2, in order to obtain SECOND signals which are then transmitted to tiie receiving means 540.

[0070] _So, to summarize, as a common feature, with reference to Fig.4 / Fig.5, the power supply means 420 / 520 are suitable for powering and activating first detection means 400.M1 / 500.M1 , in order to obtain FIRST signals which are then transmitted to the receiving means 440 / 540, and suitable for powering and activating second detection means 400.M2 / 5002.M2, in order to obtain SECOND signals which are also then transmitted to the receiving means 440 / 540.

[0071] _Said power supply means 420 / 520 are preferably positioned within said freeze- drying chamber 400 / 500 and in proximity to the switching means 430 / 530.

[0072] .With reference to figure 4 , according to a preferred embodiment, the receiving means 440 are able to receive FIRST signals received from first detecting means 400.M1 and SECOND signals received from second detecting means 400.M2, to then transmit them to the control means 450 and therefore obtain said FIRST electrical values and said SECOND electrical values. f desirable, the receiving means 440 may condition said FIRST signals and said SECOND signals, then transmit the corresponding conditioned signals to the control means 450 and thereby obtain said FIRST electrical values and said SECOND electrical values. _I f desired, the receiving means 440 may process said FIRST signals and said SECOND signals, then transmit the processed signals to the control means 450 as aforesaid and thereby obtain said FIRST electrical values and said SECOND electrical values.

[0073] _With reference to figure 5 , according to a preferred embodiment, the receiving means 540 are able to receive FIRST signals received from first detecting means 500.M1 and SECOND signals received from second detecting means 500.M2, to then transmit them to the control means 550 and therefore obtain said FIRST electrical values and said SECOND electrical values. _I f desirable, the receiving means 540 may condition said FIRST signals and said SECOND signals, then transmit the related conditioned signals to the control means 550 and thereby obtain said FIRST electrical values and said SECOND electrical values.

[0074] _Even if desirable, the receiving means 540 can process said FIRST signals and said SECOND signals, then transmit the related processed signals to the control means 550 and thus obtain said FIRST electrical values and said SECOND electrical values.

[0075] _So, to summarize, as a common feature among the embodiments of Fig.4 / Fig.5, the receiving means 440 / 540 are able to receive FIRST signals from the first detecting means 400.M1 / 500.M1 and SECOND signals from the second detecting means 400.M2 / 500.M2, to then transmit them to the control means 450 / 550 and, therefore, obtain said FIRST electrical values and said SECOND electrical values.

[0076] _lf desirable, as a common feature pertaining to the embodiments of fig.4 / fig.5, the receiver means 440 / 540 can condition said FIRST signals and said SECOND signals, to then transmit the related conditioned signals to the control means 452 / 550 and therefore obtain said FIRST electrical values and said SECOND electrical values.

[0077] -Again if desirable, as a common feature in relation to the embodiments of fig.4 / fig.5, the receiver means 440 / 540 can process said FIRST signals and said SECOND signals, to then transmit the related processed signals to the control means 4502 / 550 and therefore obtain said FIRST electrical values and said SECOND electrical values.

[0078] _Said receiving means 440 / 540 are preferably positioned within said freeze- drying chamber 400 / 500 and in proximity to the switching means 430 / 530.

[0079] _With reference to figure 4 , according to a preferred embodiment, the control means 440 are adapted to control the power supply means 420, adapted to control the switching means 430 and adapted to receive and process and / or compare and / or show (via display) the signals received from the receiving means 440.

[0080] _The control means 440 may be positioned within the freeze-drying chamber 400, such as positioned above the tray 410, or positioned externally to the freeze-drying chamber 400 and connected to the feeder means 420 and the receiver means 440 in any manner, such as by wires or by wireless connections.

[0081] _ln this context, other embodiments able to perform similar functions in order to obtain similar results are also protected by the present invention.

[0082] _With reference to figure 5 , according to a preferred embodiment, the control means 550 are adapted to control the power supply means 520, adapted to control the switching means 530 and adapted to receive and / or process and / or compare and / or show (via display) the signals received from the receiving means 540.

[0083] _The control means 550 may be positioned within the freeze-drying chamber 500, such as positioned above the tray 510, or positioned externally to the freeze-drying chamber 500 and connected to the feeder means 520 and the receiver means 540 in any manner, such as by wires or by wireless connections. _I n this context, other embodiments able to perform similar functions in order to obtain similar results are also protected by the present invention.

[0084] _So, to summarize, with reference to Fig.4 / Fig.5, the control means 450 / 550 are adapted to control the power supply means 420 / 520, adapted to control the switching means 430 / 530, and adapted to receive, process and / or compare the signals received from the receiving means 440 / 540.

[0085] _The control means 450 / 550 may be positioned within the freeze-drying chamber 400 / 500, such as positioned above the tray 410 / 510, or positioned externally to the freeze-drying chamber 400 / 500 and connected to the feeder means 420 / 520 and the receiver means 440 / 540 in any manner, such as by wires or by wireless connections.

[0086] _Said counter means 450 / 550 preferably comprise a microprocessor.

[0087] _Wrth reference to Figure 4, according to a first embodiment, said FIRST detection means 400.M1 comprise at least one FIRST electrode 400.M1.a and at least one SECOND electrode 400.M1.b; wherein said FIRST electrode 400.M1.a and said SECOND electrode 4OO.M1.b are spaced apart 400.D.M1 by a given amount; wherein said FIRST electrode 4OO.M1a and said SECOND electrode 400.M1 b form a capacitive coupling between them; wherein at least a first portion of the field lines of the capacitive coupling obtained by said FIRST electrode 4OO.M1a and said SECOND electrode 4OO.M1.b affects at least one first vial F1, when said first vial F1 is positioned in said first detection means 400.M1.

[0088] _Again with reference to Figure 4, always according to this first embodiment, said SECOND detection means 400.M2 comprise at least a THIRD electrode 4OO.M2.a and at least a FOURTH electrode 4OO.M2.b; wherein said THIRD electrode 4OO.M2.a and said FOURTH electrode 4OO.M2.b are spaced apart 400.D.M2 by a given amount; wherein said THIRD electrode 4OO.M2a and said FOURTH electrode 4OO.M2.b form a capacitive coupling between them; wherein at least a first portion of the electric field lines of the capacitive coupling obtained by said THIRD electrode 400.M2a and said FOURTH electrode 4OO.M2.b affects at least a second vial F2, when said second vial F2 is positioned in the second detection means 400.M2.

[0089] _More specifically, by way of example, again with reference to figure 4, a first vial F1 is positioned as a dielectric medium between the two electrodes 4OO.M1.a and 4OO.M1.b of the first detection means 400.M1 and a second vial F2 is positioned as a dielectric medium between the two electrodes 4OO.M2.a and 4OO.M2.b of the second detection means 400.M2.

[0090] -Therefore, always with reference to the exemplary form illustrated in figure 4, said first detection means 400.M1 and said second detection means 400.M2 configure, respectively,

[0091] >_a first capacitor 400.C1 comprising the two plates 4OO.M1.a and 400.M1.b and a first dielectric formed by said first vial body C.F1 and the relative substance S1 contained therein;

[0092] >_a second capacitor 400.C2 comprising the two plates 4OO.M2.a and 4OO.M2.b and a dielectric formed by said second vial body C.F2 and the relative substance S2 contained therein; by which it is possible to detect the values of the relative capacity and / or the values of the electrical permittivity of the dielectric medium (the vials) placed between the plates, but, in this context, also other embodiments relating to said detection means, suitable for detecting one or more electrical characteristics in relation to the respective vials F1 and F2 positioned therein, can be adopted, without departing from the inventive concepts protected by the present invention.

[0093] .Preferably, with reference to the system which is the object of the present invention illustrated in Figure 4, the value of the electrical permittivity and / or of the electrical capacity and / or of another electrical characteristic relating to at least said FIRST vial F1 is detected and considered as FIRST electrical values, and / or the value of the electrical permittivity and / or of the electrical capacity and / or of another electrical characteristic relating to at least said SECOND vial F2 is detected and considered as SECOND electrical values.

[0094] .With reference to the above, by means of this first embodiment illustrated in Figure 4, said system can be configured to perform the following operations: ..▻.obtain FIRST electrical values, such as for example the value of the electrical permittivity and / or the electrical capacity and / or other electrical characteristic, pertaining to at least said FIRST vial F1 , using first signals received from said first detection means 400. M1 ;

[0095] ..▻.obtain SECOND electrical values, such as for example the value of the electrical permittivity and / or the electrical capacity and / or other electrical characteristic, pertaining to at least said SECOND vial F2, using second signals received from said second detection means 400.M2 and, therefore,

[0096] ..▻.process and / or compare said first electrical values with said second electrical values, pertaining to the same electrical characteristic, in order to carry out various control or verification operations or other types of operations, such as, for example, the operations specified above, or other operations as better understood below.

[0097] _With reference to figure 5, according to a second embodiment, said FIRST detection means 500.M1 comprise a FIRST plurality of electrodes 500.M1.a1_500.M1.a2_500.M1.a3 and a SECOND plurality of electrodes 500.M1.b1_500.M1.b2_500.M1.b3; wherein said FIRST plurality of electrodes 500.M1.a1_500.M1.a2_500.M1.a3 and said SECOND plurality of electrodes 500.M1.b1_500.M1.b2_500.M1 b3 are spaced apart 500.D.M1 by a given measure; wherein said FIRST plurality of electrodes 500.M1.a1_500.M1.a2_500.M1.a3 and said SECOND plurality of electrodes 500.M1.b1_500.M1.b2_500.M1.b3 form a capacitive coupling between them; wherein said FIRST plurality of electrodes 500.M1.a1_500.M1.a2_500.M1.a3 and said SECOND plurality of electrodes 500.M1.b1_500.M1.b2_500.M1 b3 are positioned in proximity to a plurality of FIRST vials F1_F1_F1 positioned in said first detection means 500.M1; wherein at least a first portion of the field lines of the capacitive coupling obtained by said FIRST plurality of electrodes 500.M1.a1_500.M1.a2_500.M1.a3 and said SECOND plurality of electrodes 500.M1.b1_500.M1.b2_500.M1.b3 affects said plurality of FIRST vials F1_F1_F1 positioned in the FIRST detection means 500.M1.

[0098] _Again with reference to Figure 5, always according to this second embodiment, said SECOND detection means 500.M2 comprise a THIRD plurality of electrodes 500.M2.a1_500.M2.a2_500.M2.a3 and a FOURTH plurality of electrodes 500.M2.b1_500.M2.b2_500.M2.b3; wherein said THIRD plurality of electrodes 500.M2.a1_500.M2.a2_500.M2.a3 and said FOURTH plurality of electrodes 500.M2.b1_500.M2.b2_500.M2.b3 are spaced 500.D.M2 from each other by a certain measurement; wherein said THIRD plurality of electrodes 500.M2.a1_500.M2.a2_500.M2.a3 and said FOURTH plurality of electrodes 500.M2.b1_500.M2.b2_500.M2.b3 form a capacitive coupling between them; wherein said THIRD plurality of electrodes 500.M2.a1_500.M2.a2_500.M2.a3 and said FOURTH plurality of electrodes 500.M2.b1_500.M2.b2_500.M2.b3 are positioned in proximity to a plurality of SECOND vials F2_F2_F2 positioned in said second detection means 500.M2; wherein at least a first portion of the electric field lines of the capacitive coupling obtained by said THIRD plurality of electrodes 500.M2.a1_500.M2.a2_500.M2.a3 and said FOURTH plurality of electrodes 500.M2.b1_500.M2.b2_500.M2.b3 involves at least said plurality of SECOND vials F2_F2_F2 positioned in the SECOND detection means 500.M2.

[0099] More particularly, by way of example, again with reference to figure 5, a FIRST plurality of vials F1_F1_F1 is positioned as a dielectric medium between the FIRST plurality of electrodes 500.M1.a1_500.M1.a2_500.M1.a3 and the SECOND plurality of electrodes 500.M1.b1_500.M1.b2_500.M1.b3 of the first detection means 500.M1, and a SECOND plurality of vials F2_F2_F2 is positioned as a dielectric medium between the THIRD plurality of electrodes 500.M2.a1_500.M2.a2_500.M2.a3 and the FOURTH plurality of electrodes 500.M2.b1_500.M2.b2_500.M2.b3 of the second detection means 500.M1.

[0100] Therefore, with reference to the exemplary form illustrated in figure 5, said first detection means 500.M1 and said second detection means 500.M2 configure, respectively,

[0101] >_a first capacitor 500.C1 comprising the two plates 5OO.M1.a1 / .a2 / .a3 and 5OO.M1.b1 / .b2 / .b3 and a dielectric formed by a plurality of first vial bodies C.F1_C.F1_C.F1 and related substances S1_S1_S1 contained therein;

[0102] >_a second capacitor 500.C2 comprising the two plates 5OO.M2.a1 / .a2 / .a3 and 5OO.M2.b1 / .b2 / .b3 and a dielectric formed by a plurality of second vial bodies C.F2_C.F2_C.F2 and related substances S2_S2_S2 contained therein; by which it is possible to detect the values of the relative capacity and / or the values of the electrical permittivity of the dielectric medium (the vials) interposed between the two armatures, but, in this context, also other embodiments relating to said detection means 500.M1 and 500.2, suitable for detecting one or more electrical characteristics in relation to the plurality of first vials F1_F1_F1 and to the plurality of second vials F2JF2JF2, can be adopted without departing from the inventive concepts protected by the present invention.

[0103] -Preferably, with reference to the system which is the object of the present invention illustrated in Figure 5, the value of the electrical permittivity and / or of the electrical capacity and / or of another electrical characteristic relating to said FIRST plurality of vials F1_:F1_F1 is detected and considered, as FIRST electrical values, and / or the value of the electrical permittivity and / or of the electrical capacity and / or of another electrical characteristic relating to said SECOND plurality of vials F2 is detected and considered, as SECOND electrical values.

[0104] _With reference to the above, by means of this second embodiment illustrated in Figure S, said system can be configured to perform the following operations: ..>_obtain FIRST electrical values, such as for example the value of the electrical permittivity and / or the electrical capacity and / or other electrical characteristic, pertaining to said FIRST plurality of vials F1__F1_F1 , using first signals received from said first detection means 500.M1;

[0105] ..>_obtain SECOND electrical values, such as for example the value of the electrical permittivity and / or the electrical capacity and / or other electrical characteristic, pertaining to said SECOND plurality of vials F2_F_F2, using second signals received from said second detection means 500. M2 and, therefore,

[0106] ..>_process and / or compare said first electrical values with said second electrical values, pertaining to the same electrical characteristic, in order to carry out various control or verification operations or other types of operations, such as, for example, the operations specified above, or other operations as better understood below.

[0107] _With reference to the system which is the object of the present invention, said FIRST vial F1 comprises a first vial body C.F1 and said SECOND vial F2 comprises a second vial body C.F2 and, preferably, said first vial body C.F1 has a first electrical characteristic equal to that of the second vial body C.F2 when said Iwo vial bodies C.F1 and C.F2b are subjected to the same environmental conditions (e.g. same temperature), such as, for example, the same electrical permittivity value if these two vial bodies C.F1 and C.F2 are subjected to the same environmental conditions (e.g. same temperature) and, furthermore, always preferably, said first electrical characteristic, therefore for example said quantity relating to electrical permittivity, changes in the same manner when the same temperature values vary and / or when the same environmental conditions vary for these two vial bodies C.F1 and C.F2. _I n this context, preferably, said first vial body C.F1 and said second vial body C.F2 are two vial bodies C.F1 C.F2 identical to each other, or, always preferably, said first vial body C.F1 said second vial body C.F2 and said base row body C.Fb are three vial bodies C.F1 C.F2 C.Fb identical to each other.

[0108] _V\fith reference to the above description, preferably, the base vials Fb are positioned in a vertical position above the tray, 410 / 510, with the bottom of each vial Fb in contact with the bottom panel of said tray 410 / 510, the first detection means 400.M1 / 500.M1 also provide for positioning one or more first vials F1 with the bottom of each first vial F1 in contact with the bottom panel of the same tray 410 / 510, in such a way as to obtain the same heat transmission by thermal conduction between the tray and said vials Fb and F1 and, therefore, obtain the same thermal effects for the two vials Fb and F1 and / or for the two vial bodies C.Fb and C.F1 , as well as the same thermal effects in relation to the relative substances Sb and S1 contained in the same vials Fb and F1 during the freeze-drying process.

[0109] _With reference to this configuration, preferably, also the second detection means 400.M2 / 500.M2 provide for positioning one or more second vials F2 with the bottom of each second vial F2 in contact with the bottom panel of the same tray 410 / 510, in order to obtain the same thermal effects at least in relation to the two vials F1 and F2 and / or for the two respective vial bodies C.F1 and C.F2 during the freeze-drying process.

[0110] Method

[0111] _With reference to the above description, the present invention also concerns a METHOD relating to the freeze-drying of basic substances Sb contained inside basic vials Fb, using the system above described, wherein said METHOD comprises the following operations: 1.1)_preparing one or more open basic vials Fb, wherein each basic vial Fb has a basic vial body C.Fb, wherein each basic vial Fb contains a basic substance Sb, wherein said basic substance Sb is a substance to be freeze-dried; 1.2) preparing at least one first open vial F1 , wherein said first vial F1 comprises a respective first vial body C.F1 equal to said basic vial body C.Fb, wherein said first vial F1 contains a first substance S1 , wherein said first substance S1 is equal to said basic substance Sb; 1.3)_prepare at least one second closed vial F2, wherein said second vial F2 comprises a respective second vial body C.F2 equal to said basic vial body C.Fb and equal to said first vial body C.F1, wherein said second vial F2 contains a second substance S2, wherein said second substance S2 corresponds to a freeze-dried form of the basic substance Sb contained in each basic vial Fb, wherein said second row F2 has a known humidity level, for example predetermined, such as, for example, a humidity level equal to the humidity level that is desired to be obtained by freeze-drying for said basic substance Sb to be freeze-dried, i.e. in the freeze-drying cycle; 1.4)_place within said freeze-drying chamber 400 / 500 a plurality of said base vials Fb as set up in point 1.1 ) above, for example place said base vials Fb on a tray 410 / 510 positioned within said freeze-drying chamber 400 / 500; 1.5)_place in the first detection means 400.M1 / 500.M1 at least one first vial F1 as set up in point 1.2) above, for example place said vial F1 on a tray 410 / 510 positioned within said freeze-drying chamber 400 / 500; 1.6)_place in the second detection means 400.M2 / 500. M2 at least one second vial F2 as set up in point 1.3) above, for example, place said vial F2 on a tray 410 / 510 positioned within said freeze-drying chamber 400 / 500; 1.7)_start the freeze-drying process in said freeze-drying chamber 400 / 500 as set up in the previous points; 1.8)_detect during said freeze-drying process the values relating to a first electrical characteristic in relation to said first vial F1 , in order to obtain first electrical values, such as, for example, first values relating to the electrical permittivity and / or electrical capacity and / or other electrical characteristic in relation to the first vial F1 positioned in the first detection means 400.M1 ; 1.9)_detect during the freeze-drying process the values pertaining to said first electrical characteristic in relation to said second vial F2, in order to obtain second electrical values, such as, for example, second values pertaining to the electrical permittivity and / or electrical capacity and / or other electrical characteristic in relation to the second vial F2 positioned in the second detection means 400.M2; 1.10)_carry out, during the freeze-drying process, comparisons between said first electrical values and said second electrical values.

[0112] With reference to said first operational configuration, the three vial bodies, C.Fb C.F1 C.F2, are three vial bodies that are equal and / or identical to each other, in which at least the first vial body C.F1 and foe second vial body C.F2 have at least one same first electrical characteristic, in which said first electrical characteristic changes in foe same manner when foe same temperature values vary and / or when the same environmental conditions vary and, therefore, by carrying out during foe freeze-drying process, at certain programmed moments in time, a comparison between said first electrical values and said second electrical values, it will be possible, for example:

[0113] >_detect the differences between the two electrical values at specific moments in time;

[0114] >_detect the variation of the differences between the two values over time during freeze-drying,

[0115] >_detect when these two electrical values are equal to each other.

[0116] -Therefore, by way of example, by observing the results of the aforementioned comparison, it is possible to estimate the status of the basic substance Sb during the freeze-drying procedure since, by analogy and / or similarity, at the same time, or at two different time points temporally close to each other, the freeze-drying status pertaining to the basic substance Sb will be identical to the status pertaining to the first substance S1, since, substantially, these two substances, Sb and S1, were identical at the beginning of the freeze-drying process and then underwent an identical freeze-drying treatment while they are contained in two respective vial bodies C.F1 and C.Fb which are equal / identical to each other.

[0117] -Therefore, again as an example, if said second vial F2 contains a second substance S2, where said second substance S2 corresponds to a freeze-dried form of the basic substance Sb contained in each basic vial Fb, where said second substance S2 has a degree of humidity equal to the degree of humidity that is desired to be obtained at the end of freeze-drying in relation to the basic substance Sb to be freeze-dried, when said first and second electrical values are equal to each other, as, for example, when the value of the electrical permittivity and / or the electrical capacity and / or another electrical characteristic relating to the first vial F1 , detected in the system described above, is equal to the value of the electrical permittivity and / or the electrical capacity and / or another electrical characteristic relating to the second vial F2, detected by means of the system described above, it can also be estimated / determined that the substance Sb contained in the plurality of vials Fb has reached the desired degree of humidity at the end of freeze-drying, since, for the reasons specified above, analogy and / or similarity, at the same time, or at two different time points temporally close to each other, the freeze-drying status of the basic substance Sb will be identical to the freeze-drying status of the first substance S1.

[0118] -Therefore, by means of this system, the freeze-drying process can be interrupted as soon as a desired degree of humidity has been reached in relation to the basic substance Sb, as well as, if desirable, closing of the basic vials Fb by lowering the relative cap T.Fb as soon as a desired degree of humidity has been reached, thus avoiding, in both cases, mainly:

[0119] >_an erroneous interruption of the freeze-drying process with the basic substance Sb still too moist;

[0120] > -incorrect dosing of the Fb base vials with the Sb base substance still too moist;

[0121] >_an incorrect excessive drying of the basic substance Sb;

[0122] >_an erroneous, useless and expensive continuation of the freeze-drying process.

[0123] _The same considerations indicated above in relation to the embodiment illustrated in fig. 4 also apply equally in relation to the embodiment illustrated in fig. 5.

[0124] Technical Troubleshooting

[0125] _The system and / or method which is the object of the present invention solves the problems reported above and more particularly:

[0126] >_probes must not be inserted into contact with the substance to be freeze-dried;

[0127] >_it is not necessary to theoretically estimate, “on the table", freeze-drying procedures to presume that a freeze-dried product with a certain degree of humidity will be obtained;

[0128] >_it is possible to estimate the developments of the freeze-drying process in relation to the substance to be freeze-dried;

[0129] >Jt is possible to estimate, in real time, during the freeze-drying process, when the substance to be freeze-dried has reached a certain degree of humidity, such as for example the degree of humidity it must have at the end of freeze- drying;

[0130] >_during the freeze-drying process, it is avoided to carry out non-optimal procedures that could damage the substance to be freeze-dried; >_It is possible to perform correct freeze-drying in relation to a substance to be freeze-dried without knowing the characteristics of the vial body and / or the characteristics of the substance to be freeze-dried;

[0131] >_It is possible to optimize the freeze-drying process in relation to a substance to be freeze-dried without having to know the characteristics of the vial body and / or the characteristics of the substance to be freeze-dried;

[0132] >_It is possible to estimate the developments of the freeze-drying process of the basic substance to be freeze-dried contained in the basic vials;

[0133] >_avoid performing non-optimal procedures during the freeze-drying process that could damage the basic substance to be freeze-dried.

Claims

CLAIMS01)_SYSTEM relating to the freeze-drying of basic substances (Sb) contained within basic vials (Fb) characterized by the fact that to comprise:>_a freeze-drying chamber (400 / 500);>_FIRST detection means (400.M1 / 500.M1), positioned within said freeze-drying chamber (400 / 500), suitable for detecting a first electrical characteristic in relation to at least a FIRST vial (F1);>_SECOND detection means (400.M2. / 500. M2), positioned within said freeze- drying chamber (400 / 500), suitable for detecting said first electrical characteristic in relation to at least a SECOND vial (F2);>_power supply means (420 / 520), suitable for powering said first detection means (400.M1 / 500.M1) and said second detection means (400.M2 / 500. M2);>_switching means (430 / 530), suitable for switching the activation between said FIRST detection means (400.M1 / 500.M1) and said SECOND detection means (400.M2 / 500.M2);>_receh / ing means (440 / 540), suitable for receiving FIRST signals from said first detection means (400.M1 / 500.M1) and suitable for receiving SECOND signals from said second detection means (400.M2 / 500.M2);>_control means (450 / 550), suitable for controlling said power supply means (420 / 520) and / or said switching means (430 / 530) and / or suitable for receiving and processing the signals received from said receiving means (440 / 540).02)_SYSTEM according to claim 1, characterized by the fact that said switching means (430 / 530) are positioned within said freeze-drying chamber (400 / 500).03)_SYSTEM according to claim 1 or 2, characterized by the fact that said FIRST detection means (400.M1 / 500.M1) and said SECOND detection means (400.M2 / 500.M2) are identical to each other.04)_SYSTEM according to one of the previous claims, characterized by the fact that said receiving means (440 / 540) are suitable for conditioning the signals received from said first detector means (400.M1 / 500.M1) and received from said second receiving means (400.M2 / 500.M2).05)_SYSTEM according to one of the previous claims, characterized by the fact that said receiving means (440 / 540) are suitable for processing the signals received from said first detector means (400.M1 / 500.M1) and from said second receiving means (400.M2 / 500.M2).06)_SYSTEM according to one of claims from 1 to 5, characterized by the fact that said FIRST detection means (400.M1) comprise at least a FIRST electrode (400.M1.a) and at least a SECOND electrode (400.M1 ,b); In which said FIRST electrode (400.M1.a) and said SECOND electrode (4OO.M1.b) are spaced apart (400.D.M1) from each other by a certain measurement; in which said FIRST electrode (4OO.M1a) and said SECOND electrode (400. M1.b) form a capacitive coupling between them; in which at least a first portion of the field lines of the capacitive coupling obtained by means of said FIRST electrode (4OO.M1a) and said SECOND electrode (4OO.M1.b) affects at least a first vial (F1) positioned in the first detection means (400.M1).07)_SYSTEM according to one of claims from 1 to 6, characterized by the fact that said SECOND detection means (400.M2) comprise at least a THIRD electrode (4OO.M2.a) and at least a FOURTH electrode (4OO.M2.b); in which said THIRD electrode (4OO.M2.a) and said FOURTH electrode (4OO.M2.b) are spaced apart (400.D.M2) from each other by a certain measurement; in which said THIRD electrode (4OO.M2a) and said FOURTH electrode (4OO.M2.b) form a capacitive coupling between them; in which at least a first portion of the field lines of the capacitive coupling obtained by means of said THIRD electrode (4OO.M2a) and said FOURTH electrode (400.M2.b) affects at least a second vial (F2) positioned in the second detection means (400.M2).08)_SYSTEM according to claim 6 or 7, characterized by the fact that the value of the electrical permittivity and / or of the electrical capacitance and / or other electrical characteristic pertaining to said at least FIRST vial (F1) is detected and considered as FIRST electrical values and / or by the fact that the value of the electrical permittivity and / or of the electrical capacitance and / or of other electrical characteristic pertaining to said at least SECOND vial (F2) is detected and considered as SECOND electrical values.09)_SYSTEM according to one of claims 1 to 5, characterized by the fact that said FIRST detection means (500.M1) comprise a FIRST plurality of electrodes(500.M1.a1_500.M1.a2_500.M1.a3) and a SECOND plurality of electrodes (500.M1.b1_500.M1.b2_500.M1.b3); In which said FIRST plurality of electrodes (500.M1.a1_500.M1.a2_500.M1.a3) and said SECOND plurality of electrodes (500.M1.b1_500.M1.b2_500.M1.b3) are spaced apart (500. D.M1) from each other of a certain size; in which said FIRST plurality of electrodes (500.M1.a1_500.M1.a2_500.M1.a3) and said SECOND plurality of electrodes (500.M1 b1_500.M1 b2_500.M1 ,b3) form a capacitive coupling between them; in which said FIRST plurality of electrodes (500.M1.a1_500.M1.a2_500.M1.a3) and said SECOND plurality of electrodes (500.M1.b1_500.M1.b2_500.M1.b3) are positioned in proximity ov a plurality of FIRST vials (F1, F1, F1) positioned in the respective detection means (500.M1); in which at least a first portion of the field lines of the capacitive coupling obtained by means of said FIRST plurality of electrodes (500.M1.a1_500.M1.a2_500.M1.a3) and said SECOND plurality of electrodes (500.M1.b1_500 .M1 .b2_500.M1.b3) affects at least said plurality of FIRST vials (F1, F1 , F1) positioned in the FIRST detection means (500.M1).10)_SYSTEM according to one of claims 1 to 5 or according to claim 9, characterized by the fact that said SECOND detection means (500.M2) comprise a THIRD plurality of electrodes (500.M2.a1_500.M2.a2_500.M2.a3) and a FOURTH plurality of electrodes (500.M2.b1_500.M2. b2_500.M2.b3); In which said THIRD plurality of electrodes (500.M2.a1_500.M2.a2_500.M2.a3) and said FOURTH plurality of electrodes (500.M2.b1_500.M2.b2_500.M2.b3) are spaced apart (500. D.M2) from each other of a certain size; in which said THIRD plurality of electrodes (500.M2.a1_500.M2.a2_500.M2.a3) and said FOURTH plurality of electrodes (500.M2.b1_500.M2.b2_500.M2.b3) form a capacitive coupling between them; in which said THIRD plurality of electrodes (500.M2.a1_500.M2.a2_500.M2.a3) and said FOURTH plurality of electrodes (500.M2.b1_500.M2.b2_500.M2.b3) are positioned in proximity of a plurality of SECOND vials (F2, F2, F2) lying in the respective detection means (500.M2); in which at least a first portion of the field lines of the capacitive coupling obtained by means of said THIRD plurality of electrodes (500.M2.a1_500.M2.a2_500.M2.a3) and said FOURTH plurality of electrodes (500.M2.b1_500.M2 .b2_500.M2.b3) affects at least said plurality of SECONDvials (F2, F2, F2) positioned in the SECOND detection means (500.M2).11)_SYSTEM according to claim 9 or 10, characterized by the fact that the value of the electrical permittivity and / or the electrical capacitance and / or other relevant electrical characteristic pertaining said FIRST plurality of vials (F1, F1, F1) is detected and considered as FIRST electrical values and / or by the fact that the value of the electrical permittivity and / or the electrical capacitance and / or other relevant electrical characteristic pertaining said SECOND plurality of vials (F2, F2, F2) is detected and considered as SECOND electrical values.12)_SYSTEM according to one of the previous claims, characterized by the fact that said FIRST vial (F1) comprises a first vial body (C.F1), by the fact that said SECOND vial (F2) comprises a second vial body (C.F2) and by ttie fact that said first vial body (C.F1) has at least a first electrical characteristic equal to that of the second vial body (C.F2).13)_SYSTREM according to claim 12, characterized by the fact that said first electrical characteristic changes in the same way with respect to the first vial body (C.F1) and with respect to the second body vial (C.F2) when the temperature values vary and / or when the environmental conditions vary.14)_SYSTEM according to one of the previous claims, characterized by the fact that said FIRST vial (F1) comprises a first vial body (C.F1), by the fact that said SECOND vial (F2) comprises a second vial body (C.F2) and by the fact that said two vial bodies (C.F1 , C.F2) are identical to each other.15)_SYSTEM according to one of the previous claims, characterized by the fact that said FIRST vial (F1) comprises a first vial body (C.F1); by the fact that said SECOND vial (F2) includes a second vial body (C.F2); by the fact that said base vial (Fb) includes a base vial body (C.Fb) and by the fact that said three vial bodies (C.F1, C.F2, C.Fb) are identical to each other.16)_METHOD relating to the freeze-drying of basic substances (Sb) contained within basic vials (Fb) using a system according to one of the previous claims, characterized by the fact to comprises the following operations: 1.1 )_set up one or more open basic vials (Fb), in which each basic vial (Fb) has a basic vial body (C.Fb), in which each basic vial (Fb) contains a basic substance (Sb), in which said basic substance (Sb) is a substance to be freeze-dry; 1.2)_set up at least a first open vial (F1 ), in which said first vial (F1 ) Includes a respectivefirst vial body (C.F1) equal to said basic vial body (C.Fb), in which said first vial (F1) contains a first substance (S1), wherein said first substance (S1) is the same as said base substance (Sb); 1 ,3)_set up at least a second closed vial (F2), in which said second vial (F2) includes a respective second vial body (C.F2) equal to said basic vial body (C.Fb) and equal to said first vial body (C.F1), wherein said second vial (F2) contains a second substance (S2), wherein said second substance (S2) corresponds to a freeze-dried form of the basic substance (Sb) contained in each basic vial (Fb), in said second substance / S2) has a known degree of humidity; 1.4)_position within said freeze-drying chamber (400 / 500) a plurality of said base vials (Fb) as set up in point 1.1) above; 1.5)_position in the first detection means (400.M1 / 500.M1) at least one first vial (F1) as set up in point 1.2) above; 1.6)_position in the second detection means (400.M2 / 500. M2) at least a second vial (F2) as set up in point 1.3) above; 1.7)_start the freeze-drying process in said freeze-drying chamber (400 / 500); 1.8)_detect during said freeze-drying process the values relating to a first electrical characteristic in relation to said first vial (F1), in order to obtain first electrical values; 1.9)_detect during the freeze-drying process the values relating to said first electrical characteristic in relation to said second vial (F2), in order to obtain second electrical values; 1.10)_carry out, during said freeze-drying process, comparisons between said first electrical values and said second electrical values.

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