CH716516A1 - Method for preparing at least one solution for injection in a pocket, unit for preparing said solution for injection and pocket containing said solution for injection. - Google Patents

Abstract

The present invention relates to a method and a device (10) for manufacturing at least one injectable solution packaged in pouches, said injectable solution being composed of at least a predetermined quantity of at least one sample of at least one solid material soluble in water and a predetermined volume of water for injections, said device (10) comprising at least one mixing vessel, for individually mixing by dissolving said at least one sample of solid matter soluble in water, and individually a conformity check of the said injectable solution obtained. The invention also relates to a pocket for the solution for injection.

Description

Description

Technical area

The present invention relates to a process for the preparation of at least an injectable solution contained in a pocket, said solution being composed of at least one sample of at least one solid material soluble in water, process in which one prepares said solution by successively introducing into a mixing tank at least a predetermined quantity of said sample of said at least one water-soluble solid material and a predetermined volume of water for injections, process in which a dosage control of said at least one sample of solid matter soluble in water, and process in which a conformity control of the said injectable solution obtained is carried out individually.

[0002] It also relates to a device for preparing at least one injectable solution contained in bags, said injectable solution being composed of at least a predetermined quantity of at least one sample of at least one solid material soluble in water. water and a predetermined volume of water for injections, said device comprising at least one mixing tank, for individually mixing by dissolving said at least one sample of water-soluble solid material for injections, and individually a compliance check of said injectable solution obtained.

[0003] Finally, it relates to a bag conditioning an injectable solution manufactured according to the method and with the device defined above.

[0004] As examples of solutions for injection in bags which can be manufactured by the aforementioned unit, they include glucose for rehydration and calorie intake; glycocoll, a solution for irrigation; mannitol, a solution for irrigation; a glucose/sodium chloride mixture for rehydration; a lactate ringer for hydroelectric rebalance of hypovolemia or maintenance of acid-base balance; sodium chloride for rehydration or hydroelectric balance, water for injections, in particular in the form of a solution for irrigation; Ciprofloxacin as an antibiotic; fluxonazole as an antifungal, ketoprofen as an analgesic or anti-inflammatory; levobupivacane as an anesthetic; levofloxacin as an antibiotic; metronidazole as an antibiotic or antiparasitic; morphine hydrochloride as an analgesic; moxifloxacin as an antibiotic; ofloxacin as an antibiotic; paracetamol as an analgesic or antipyretic, ropivacaine hydrochloride as an anesthetic; tirofiban as a blood thinner; zoletronic acid for patients with osteoporosis.

[0005] This list of substances is given as an indication and is not exhaustive, since other injectable solutions, contained in bags, can be manufactured by the unit according to the invention, according to the needs of the market or of the evolution of technology and because each of the products that can be manufactured by the unit can be presented in different dosages and in different packaging sizes.

Prior technique

[0006] Installations for the manufacture of injectable solutions in pouches are generally assembled in industrial production plants arranged to manufacture large volumes of products which must then be stored, packaged and distributed to medical centers distributed in various places. These procedures are complicated and costly and involve manipulations with health and/or medical risks, in particular because of the transport of the products, and the real-time supply of the medical centers which are intended to use these products according to their patients and depending on the processing they are intended to perform.

[0007] It has been observed that the supply of medical centers is complicated, costly and risky and often results in shortages of drug supplies which handicap the optimal functioning of the care centers, by disrupting the precise and complete care of the patients who are subject to constraints that producers are often unable to respect, especially in areas where processing centers are very far from production centres. However, the supply of medical centers would be considerably simplified, and at the same time less costly and less risky, if the production of injectable solutions packaged in bags were relocated compared to massive production in distant production sites and if the manufacturing of these products was made, on the one hand, in an area close to at least one medical center and preferably within a sufficiently small radius in relation to a group of medical centers, so as to be able to guarantee a regular supply corresponding to demand of users, a distribution thanks to which the risks associated with transport would be reduced, and limited costs to ensure the guaranteed regular supply of treatment centres.

[0008] Currently, the injectable solutions packaged in existing bags are manufactured in large conventional units which are very large production plants manufacturing standardized injectable solutions and which then supply the major medical centers for the use of the solutions. . For these medical centers, the rule of operation is often more economic than medical and the most regularly supplied products depend more on markets than on patient needs. As a result, the availability of certain drugs is not always guaranteed or at least not always regularly guaranteed, because their mass production imposes ordering conditions that small health centers are not able to ensure regularly.

[0009] This invention is particularly advantageous in areas which are difficult to access and control and which are complicated to supply by easily controllable delivery systems. It makes it possible to create supply centers in areas that are difficult to access and above all to control and monitor the products needed in large quantities in sites with difficult access.

Disclosure of invention

[0010] The relocation of the production of injectable solutions packaged in pockets mentioned above involves the multiplication of production units, these units having relatively small dimensions and being located relatively close to medical centers. This is why the present invention, which proposes to make a production unit for injectable solutions packaged in pouches, is particularly suited to the needs of relatively small medical centers. Indeed, these production units all have a modular structure. Their mode of operation, ie the manufacturing process, is identical whatever the unit, so that the construction of the units is the same. The product manufacturing process, as well as all the preparation and component management procedures, as well as all the maintenance operations and all the safety procedures are identical, in order to guarantee the quality of the products manufactured, an optimized production cost. and assured security of supply to medical centres.

This object is achieved by said process according to the invention, characterized in that it comprises the following operating phases:

- a phase of taking a sample of each of said solid materials to be dissolved in said volume of water for injectable preparations,

- a phase of analysis of each of said samples of solid materials to be dissolved in said volume of water for injectable preparations, to control their quality,

- a phase of weighing each of said samples of solid materials to be dissolved in said volume of water for injectable preparations, to determine the quantity by weight of said solid materials to be introduced into said predetermined volume of water for injectable preparations,

- a solution preparation phase consisting in introducing and dissolving said quantity by weight of said samples of soluble solids in said predetermined volume of water for injections,

- a phase of filling an empty bag with the solution prepared by dissolving said quantity by weight of said samples of soluble solids in said predetermined volume of water for injections,

- a phase of overwrapping said pouch filled with said solution, injectable

- a sterilization phase of said overwrapped bag, filled with said injectable solution,

- a candling phase of said solution for injection in a pocket obtained,

- a packaging phase of said bag filled with said solution, injectable.

[0012] In particular, the analysis phase of each of said samples of said solid materials to control their quality, comprises a first intermediate step which consists in verifying the conformity of said samples with the theoretical quality defined by at least one certificate attesting to the nature and the composition of the materials concerned.

[0013] According to an advantageous embodiment, the analysis phase of each of said samples of solid materials to control their quality, comprises a second intermediate step, corresponding to the measurement of the purity of the solid materials, which consists in determining the mass of each of said samples of said solid materials which corresponds to the mass of the pure corresponding active principle contained in these solid materials according to their respective purity.

Said phase of preparing said solution for introducing and dissolving said quantity by weight of said solid materials in said predetermined volume of water for injectable preparations advantageously comprises an intermediate step during which is introduced into said mixing tank, the quantity by weight of said solid materials necessary to produce said solution for injection, said mixing tank initially containing a fraction of said predetermined volume of water for injections.

According to a particularly advantageous embodiment, said fraction of said predetermined volume of water for injectable preparations is at least approximately between 20 and 90%, advantageously between 50 and 80% of said predetermined volume, and preferably close to two thirds said predetermined volume.

According to a preferred solution, said solution preparation phase for introducing and dissolving said quantity by weight of said solid materials in said predetermined volume of water for injections, comprises another intermediate step during which is added in the mixing tank, to the solution obtained following another intermediate step, the balance of said predetermined volume of water for injections.

[0017] In a preferential way, the phases of the process and the intermediate steps are carried out in dedicated modules which are interconnected to carry out a central management of the flows of ambient air circulating through said modules, of the flows of liquids entering and leaving of the various modules, pressurized gas flows, electrical energy flows used by the equipment of said modules and the circulatory flows of the participants and components used during the process.

[0018] According to an advantageous form, in order to carry out central management of the ambient air flows circulating through said modules, an upper zone of each of said modules concerned is provided, in an isolated space containing circulation paths of an incoming atmosphere. and an outgoing atmosphere communicating respectively with a central air treatment module.

[0019] According to a preferred embodiment, in order to carry out central management of the flow of liquids, the water inlets and outlets for injectable preparations of all of the said modules concerned are connected to one another and/or respectively to an inlet and at an outlet of a central water treatment unit.

The device according to the invention is advantageously characterized in that it comprises a combination of the following modules:

- a sampling module (PREL) for taking at least one sample of at least one predetermined solid material soluble in water, said sample being arranged to be dissolved in said predetermined volume of water for injections,

- a laboratory module (LABO) arranged to analyze said at least one sample of determined solid matter soluble in water, said laboratory module (LABO) being arranged to control the conformity and the quality of said determined solid matter sample,

- a weighing module (PESE) arranged to determine the quantity of said at least one sample of solid matter determined and soluble in water,

- a preparation module (P.R.E.P) for mixing in said mixing tank said quantity of said determined solid matter sample, soluble in water with said predetermined volume of water for injections,

- a filling module (R.E.M.P) for filling empty pockets with said injectable solution prepared in said mixing tank,

- an overpacking module (S.U.R.E) for overpacking said bags filled with said injectable solution,

- a Sterilization module (S.T.E.R) to sterilize said bags filled with said injectable solution and overwrapped, and

- a candling and conditioning module (M.I.C.D) of said injectable solution contained in the pockets and sterilized.

[0021] In a particularly advantageous manner, said laboratory module (L.A.B.O) comprises First analysis means arranged to carry out during a first intermediate step of analysis of each of said samples of predetermined solid matter soluble in water, a quality control which consists in verifying the compliance of the samples with a theoretical quality defined by at least one certificate attesting to the nature and composition of the materials concerned, as well as compliance with the regulatory texts in force.

According to a particularly favorable embodiment, said laboratory module (L.A.B.O) comprises second analysis means arranged to carry out, during a second intermediate step of analysis of each of said samples of predetermined and soluble solid matter in water, a purity check which consists in determining the actual mass of each of said samples of predetermined solid materials, which corresponds to the mass of at least one pure active principle, contained in each of these predetermined solid materials, by according to their respective purity.

[0023] According to a preferred embodiment, said production unit comprises coupling means for interconnecting all of the dedicated modules to respectively perform central management of the flows of purified air circulating through said modules, of the flows of liquids entering and leaving the various modules, flows of pressurized gas, flows of electrical energy used by the equipment of said modules and circulatory flows of the participants and the components used during the process, during the course of said phases of the process and of the steps intermediaries.

[0024] Advantageously, the device comprises central equipment for purifying the atmosphere circulating through said modules and means for specific regulation of the pressure of the air contained in each of said respective modules, means for connecting the modules with said central purification equipment and means for interconnecting the modules with each other and/or with said central purification equipment.

[0025] According to an advantageous embodiment, said means for connecting the modules with said central purification equipment comprises a network of air ducts arranged in a sealed space arranged above a "false ceiling" reserved in the upper part of each of said modules, said network of ducts comprising, for each of said modules, at least one inlet orifice and at least one outlet orifice, each of said inlet and outlet orifices being equipped with a coupling valve for ensuring an interconnection of at least one of said ducts of said network of ducts.

[0026]Preferentially, the device advantageously comprises central water treatment equipment which supplies at least part of said modules, means for distributing the treated water in each of said respective modules, means for collecting waste water in each of said respective modules, means for connecting the modules with said central water treatment equipment and means for interconnecting the modules with each other and/or with said central water treatment equipment.

[0027] The invention further relates to a bag characterized in that it contains an individual injectable solution, suitable for a specific medical treatment with an appropriate composition and a predetermined concentration with a view to

of a treatment adapted to an identified patient, said injectable solution packaged in said pocket being produced by dissolving at least one solid material soluble in water and a predetermined volume of water for injectable preparations.

Brief description of the drawings

The present invention and its advantages will appear better in the description below of an embodiment given by way of non-limiting example, with reference to the appended drawings in which:

- Figure 1 is a schematic overview representing the production unit 10 of injectable solutions in pockets manufactured according to the method of the invention. Said at least one solid material used for the manufacture of Solutions for injection in bags and the predetermined volume of water for injections in which said at least one solid material is dissolved, are called raw materials PM. Said at least one solution for injection in a pocket made from said raw materials MP is called finished product PF.

- Figure 2 is a detail view of the weighing module, which illustrates the equipment making it possible to ensure a preliminary weighed phase for the manufacture of solutions for injection in bags according to the method of the invention,

- Figure 3 is a detail view of the preparation module, which illustrates the equipment for ensuring the actual preparation of injectable solutions in pockets, according to the method of the invention,

- Figure 4 is a detail view of the filling module, which illustrates the equipment for ensuring the filling of the pockets of injectable solutions, according to the method of the invention,

- Figure 5 is a detail view of the overpacking module, which illustrates the equipment for ensuring the overpacking of injectable solutions in pouches, according to the method of the invention,

- Figure 6 is a detail view of the sterilization module, which illustrates the equipment for ensuring the sterilization of injectable solutions in pockets, according to the method of the invention,

- Figure 7 is a detail view of the candling module and packaging of injectable solutions in pockets obtained according to the method of the invention,

- Figure 8 is a detailed view of the module for sampling solid materials used for the manufacture of injectable solutions in pockets, with a view to controlling them,

- Figure 9 is a detailed view of the chemical, physical and bacteriological laboratory module intended to control the quality and purity of the raw materials which enter into the composition of the solutions for injection in pockets obtained according to the process of the invention, as well as the quality and conformity of finished products or injectable solutions in bags,

- Figure 10 is a detail view of the water treatment module which is part of the composition of the Injectable Solutions in pockets obtained according to the process of the invention and which is used during the phases of this process,

- Figure 11 is a detail view of the utility module which is arranged to process, prepare and condition the fluxes and/or the energies used during the process of the invention,

- Figure 12 is a detail view of the washing area which is arranged to control the entries of operational personnel, equipment and products used during the process of the invention.

- Figure 13 is a detail view of the air treatment module which is arranged to ensure in particular the dehumidification and purification of the air which circulates in the various modules, and

- Figure 14 is a schematic overall view representing, by way of example, the air flows circulating in the preparation module, illustrated by Figure 3. The integrated ventilation means consist of channels 137a which run horizontally along the walls of the different modules, and 137b which run vertically along the walls of the different modules. Hs are also made up of wall valves 138 and spillways 139.

Best way to carry out the invention

[0029] With reference to the figures, in particular figure 1, the device 10 for the production of injectable solutions packaged in pockets, as shown, consists of a set of modules, shown in detail by figures 2 to 13, which are all coupled and interconnected in such a way that the functions of the respective modules and of the equipment they contain can be activated in accordance with the phases of the method according to the invention. Among said modules, there is a first group of modules called production modules 11 (P.R.O.D) which have the function of manufacturing the injectable solutions packaged in bags, from solid materials, soluble in water.

Among these modules, the group designated by (P.R.O.D), comprises a first module, called weighing module 12 (P.E.S.E), which has the function of preparing doses of solid materials, soluble in water, which are then used to manufacture injectable solutions, and which correspond to previously determined formulations. A second module called preparation module 13 (P.R.E.P) has the function of mixing the solid materials with appropriate water, called water for injections, forming said injectable solutions. A third module called filling module 14 (R.E.M.P) has the function of filling the empty pockets of said prepared injectable solutions. A fourth module, called overwrapping module 15 (S.U.R.E) has the function of overwrapping with a film, in particular a synthetic material, said pockets filled with injectable solution. A fifth module, called Sterilization module 16 (S.T.E.R) has the function of sterilizing said overwrapped pouches. Finally, a sixth module, called mirage module

and packaging 17 (M.I.C.D) has the function of visualizing the sterilized injectable solutions, and of packaging them in suitable packaging, in particular cardboard boxes or the like.

[0031] It will be noted that the first group of modules 11, called the production module (P.R.O.D) is designed to start initially with a sample of suitable raw materials and to lead to the finished products, ready for distribution, after having undergone all the checks , all the validations and all the safety and quality interventions required for a product for medical use as sensitive as the injectable solutions packaged in bags.

[0032] Among said modules that make up the device 10, there will be a second group 21 of modules, called control modules (C.O.N.T), which have the function of ensuring both the control of solid materials, and that of finished products. , in this case injectable solutions packaged in bags. A first module, called sampling module 22 (P.R.E.L) is part of this second group 21, and consists of taking samples of solid materials, soluble in water, in order to check whether they comply with the data declared by the suppliers, to the regulatory texts in force and with the specificity sheets. A second module, called laboratory module 23 (L.A.B.O) is part of this second group 21, and consists in carrying out chemical, physical and bacteriological analyzes of samples of solid matter previously isolated in the sampling module 22 (P.R.E.L), as well as of the finished product, that is to say the solution for injection packaged in bags.

Among said modules that make up the device 10, there will be a third group 31, of modules called flow modules (F.L.U.X), which ensure the preparation and management of the fluids and energies necessary for the implementation of the process according to the invention. They help to organize the circulation of the flow of water for injections, the flow of air in the various modules, the flow of compressed air, the flow of effluents, the flow of the circulation of workers and the power supply electrical of operational components.

The first module of said third group 31 (F.L.U.X) is a so-called water treatment module 32, called module (T.H.2.O), which has the function of preparing water for injections in which will be dissolved solid materials to manufacture solutions for injection packaged in bags. It may for example comprise a filtration machine by reverse osmosis or the like in order to eliminate all solid mineral residues and to neutralize organic and/or bacteriological residues.

The second module of this third group 31 (F.L.U.X), called the utility module 33 (U.T.I.L), which can in particular group together a compressed air generator which supplies all the positions of the device 10, requiring fair compression, a generator of hot water, arranged to supply hot water at the required temperature to the stations concerned of the device 10, a storage tank for the hot water produced and an electrical current distributor ensuring the electrical supply of all the workstations of the modules of the device 10.

A third module of this third group 31 of modules is called washing module 34 (L.A.V.A), which is structured to control and manage the flow of workers and equipment by means of controlled passage systems called "SAS" and washing equipment.

A fourth module, of this third group 31, which is called air treatment module 35 (T.A.I.R), is designed to ensure in particular the dehumidification and purification of the air which circulates in the various modules. To this end, the air treatment module 35 comprises air treatment equipment provided with a dehumidifier and heating and/or air conditioning means.

The production of injectable solutions packaged in bags, begins in the first group of modules called production modules 11 (RR.O.D) and more precisely the weighing module 12 (RE.S.E), illustrated in Figure 2. This module 12 is equipped with weighing means 122 arranged under a suction hood 123. A zone 124 makes it possible to manage the secure entry of personnel, a zone 125 making it possible to carry out the weighing of solid materials, soluble in water and an area 126 for conditioning the weighed products.

Following the weighing module 12 (RE.S.E) illustrated in Figure 2, is the preparation module 13 (RR.E.P), illustrated in Figure 3, which aims to dissolve solids previously weighed, in water for injections. For this purpose, said solid materials are introduced into a mixing tank 132 or 133 containing at least a fraction of the planned volume of water for injectable preparations to manufacture the planned volume of injectable solutions packaged in pockets, during a first step. , puls, after mixing this mixture, the volume of water for injections is completed to achieve the predetermined objectives. The solid materials are transported from module 12 to module 13 in containers 134.

[0039] Following the preparation module 13 (RR.E.P), illustrated in Figure 3, is the filling module

14 (R.E.M.P), represented by Figure 4, which aims to fill the empty pockets with the injectable solution. This module is equipped with filling means 142.

[0040] Following the filling module 14 (R.E.M.P), illustrated in Figure 4, is the overwrapping module

15 (S.U.R.E), represented by Figure 5, which aims to overpack the bags filled with injectable solution. This module is equipped with overwrapping means 152.

Following the overwrapping module 15 (S.U.R.E), illustrated in Figure 5, is provided a sterilization module

16 (S.T.E.R), represented by Figure 6, which aims to sterilize overwrapped bags. This module is equipped with appropriate sterilization means 162.

Finally, following the Sterilization module 16 (S.T.E.R), illustrated in Figure 6, there is a candling and conditioning module 17 (M.I.C.D), represented by Figure 7. This module has the function of candling the pockets sterilized, at the candling station 171, then to condition them at the conditioning station 172.

As illustrated by Figures 2, 3, 4, 5, 6 and 7, the weighing modules (P.E.S.E) 12, preparation (P.R.E.P) 13, filling (R.E.M.P) 14, overpack (S.U.R.E) 15, Sterilization (S.T.E.R) 16 and candling and conditioning (M.I.C.D) 17, comprise integrated ventilation means consisting of channels, respectively 127a, 137a, 147a, 157a, 167a and 177a, which run horizontally along the walls of the various modules, and 127b , 137b, 147b, 157b, 167b and 177b, which run vertically along the walls of the various modules.

These channels are in communication on the one hand with a general aeration and ventilation network which supplies all the modules and the interior of all the zones arranged in the modules, according to specific needs. Hs are equipped with wall valves, respectively 128, 138, 148, 158, 168 and 178, and with evacuators, respectively 129, 139, 149, 159, 169 and 179, which allow the circulation to fair in the modules and the power supply to the zones arranged inside the various modules.

The channels 127a, 137a, 147a, 157a, 167a and 177a are housed in the upper part of the modules, for example in a space separated from the inside of the modules by a false ceiling or the like.

Furthermore, the device 10 comprises a second group of modules called control modules 21 (C.O.N.T), in particular a first module, called the sampling module 22 (P.R.E.L), represented by FIG. 8, which is used to take samples of solid materials, in order to check whether they comply with the data declared by the suppliers and with the corresponding specification sheets.

The module 22 includes an entrance lock 182 to control the entry of personnel and a hood 183 to control the flow of air circulating in the module and in particular in the area 184 where the samples are taken. It is also equipped with two channels, 187a which runs horizontally along the walls of the module and 187b which runs vertically along the walls of the module and which are in communication with the entire Ventilation and Air Distribution Circuit include means of intercommunication with the other channels having the same functions of the other modules of the production unit 10. These channels are in communication on the one hand with a general aeration and ventilation network which supplies all the modules and on the other hand with inside all the zones of the module, according to the specific needs, through wall valves 188 and evacuators 189. The channel 187a is housed in the upper part of the sampling module (RR.E.L), for example in a space separated from the interior of the module by a false ceiling or similar.

A second module, represented by FIG. 9, called the laboratory module 23 (L.A.B.O), is part of this second group of control modules 21 (C.O.N.T) and is assigned to chemical, physical and bacteriological analyzes of the samples of solid materials, soluble in water, previously isolated in the module (P.R.E.L), and finished products. It comprises three separate zones, arranged inside the module 23, namely a bacteriological analysis zone 191, a physical analysis zone 192 and a chemical analysis zone 193, which are carried out on solid materials, soluble in water, or on various products used in the process, including water for injections and circulating air.

It is also equipped with two channels, 197a which runs horizontally along the walls of the module and 197b which runs vertically along the walls of the module and which are in communication with the entire ventilation and air distribution circuit comprising means of intercommunication with the other channels having the same functions of the other modules of the unit 10. These channels are in communication on the one hand with a general aeration and ventilation network which supplies all the modules and on the other hand with the interior of all the zones of the module, according to the specific needs, through wall valves 198 and evacuators 199. The channel 197a is housed in the upper part of the laboratory module (L.A.B.O) for example in a separate space from inside the module through a false ceiling or similar.

The first module of the third group 31 (F.L.U.X) is a module 32 called water treatment or module (TH.2.0), represented by Figure 10, which has the function of preparing water for injections in which the solid matter will be dissolved, in particular to manage the cooled water and the hot water in two separate loops. It may for example comprise a reverse osmosis filtration machine 202 or the like. It comprises a tank 203 for storing water for injectable preparations, to make it possible to have a permanent reserve of water, for its use in the production phase. In addition, the module 32 can contain a softener 204, a refrigeration exchanger 205 and a heating exchanger 206 in order to manage independent hot water and chilled water circuits.

[0051] Figure 11 illustrates the second module of the third group 31 (F.L.U.X) called utility module 33 (U.T.I.L), which is arranged to process, prepare and condition flows and/or energies used during the process according to the invention. The module 33 may include in particular an electrical management unit 212, a softened water tank 213, a steam production unit 214 and a compressed air generation unit 215.

[0052] Figure 12 illustrates the third module of the third group 31 (F.L.U.X) called washing module 34 (LA.V.A) and is provided with a laundry 122 to clean all the equipment which is useful for the production of packaged injectable solutions. in pockets. Entrance airlocks 123 are provided to secure and control all incoming material as well as operational personnel. A storage area 124 under a controlled atmosphere, advantageously under overpressure, and at a determined temperature, is provided in the washing module 34 (L.A.V.A). It is also equipped with two channels,

Claims (28)

1127a which runs horizontally along the walls of the module and 1127b which runs vertically along the walls of the module, and which are in communication with the entire Ventilation and Air Distribution Circuit comprising means of intercommunication with the other channels having the same functions as the other modules of the device 10. These two channels are in communication on the one hand with a general aeration and ventilation network, which supplies all the modules, and on the other hand with the interior of all the zones of the module, according to specific needs, through wall valves 1128 and evacuators 1129. The channel 1127a is housed in the upper part of the washing module 34 (L.A.V.A). [0053] Figure 13 illustrates the fourth module of the third group (F.L.U.X) called air treatment module 35 (T.A.I.R) and is provided with air treatment equipment 131 and heating and/or air conditioning means 132 . [0054] The modular construction of this device 10 has several advantages linked in particular to the constructive concept and to the distribution of all the operational components which are organized according to validated rules which are immutable from one device 10 to another. [0055] The common centralized management of all the flows and of all the energies constitutes a guarantee of security by allowing an overall vision and generalized maintenance. The costs of an Installation are predictable and independent of local parameters. The training of the operational personnel can be carried out in any similar device 10 and the personnel can be replaced from one device 10 to another, if necessary, without requiring specific training. The invention is not limited to the embodiments described and may appear in different aspects depending on certain foreseeable developments or on the basis of improvements in certain components. However, the scope of the invention falls within the scope defined by the claims. Claims 1. Process for the preparation of at least one injectable solution packaged in a pocket, called the finished product PF, at least a predetermined quantity of at least one sample of at least one solid material, soluble in water suitable for the preparation of injectable solutions, and a predetermined volume of water for injectable preparations, adapted to produce said at least one injectable solution, contained in said pocket, said method consisting in carrying out at least individually a mixture by dissolving said at least one sample of material solid, water-soluble material suitable for the preparation of Solutions for Injection, with said predetermined volume of water for injections, said water-soluble solids and said water for injections being referred to as PM raw materials. Said process being characterized in that it comprises the following phases: - a phase of taking a sample of each of said solid materials to be dissolved in said volume of water for injections, - a phase of analysis of each of said samples of solid materials to be dissolved in said volume of water for injectable preparations, to control their quality, - a phase of weighing each of said samples of solid materials to be dissolved in said volume of water for injectable preparations, to determine the quantity by weight of said solid materials to be introduced into said predetermined volume of water for injectable preparations, - a solution preparation phase consisting in introducing and dissolving said quantity by weight of said samples of soluble solids in said predetermined volume of water for injections, - a phase of filling an empty bag with the solution prepared by dissolving said quantity by weight of said samples of soluble solids in said predetermined volume of water for injections, - a phase of overwrapping said pouch filled with said solution, injectable - a sterilization phase of said overwrapped bag, filled with said injectable solution, - a candling phase of said solution for injection in a pocket obtained. - a packaging phase of said bag filled with said solution, injectable. 2. Method according to claim 1, characterized in that the phases of the method and the intermediate steps are carried out in dedicated modules which are interconnected to carry out a central management of the flows of ambient air circulating through said modules, of the flows liquids entering and leaving the various modules, flows of pressurized gas, flows of electrical energy used by the equipment of said modules and circulatory flows of the participants and components used during the process, during the course of said phases of the process and intermediate steps. 3. Process according to claim 2, characterized in that a plurality of samples is taken from said solid materials to be dissolved in at least a predetermined volume of water for injections, mixtures are prepared to be carried out by dissolving at least a determined mass of at least one sample of solid materials and at least a part of said predetermined volume of water for injectable preparations and various conformity checks of said solution are put in place injection obtained according to the products to be injected envisaged. 4. Method according to claim 2, characterized in that one carries out, in a determined space, with at least a first group (11) of production modules, the preparation steps of at least one injectable solution packaged in a pocket, by means of a weighing module (12), arranged to prepare at least one dose of a sample of solid matter, soluble in water, by means of a preparation module (13) arranged to mix the solid mallets with appropriate water, called water for injectable preparations, by means of a filling module (14) arranged to fill the empty pockets with the injectable solutions, by means of an overwrapping module ( 15) agency to overwrap said bags filled with injectable solution, by means of a Sterilization module (16) agency to sterilize said overwrapped bags, and by means of a candling and packaging module (17) agency to test and then condition in packaging, the bags filled with solution for injection. 5. Process for the preparation of at least one injectable solution contained in a pocket, according to claim 2, characterized in that one uses in a determined space, at least a second group (21) of modules called control modules, agencies to ensure both the control of solid materials and that of finished products, with, in particular, a sampling module (22) arranged to take samples of solid materials, with a view to verifying whether they comply with the data declared by the suppliers, and in particular with a laboratory module (23) arranged to carry out chemical, physical and bacteriological analyzes of samples of solid materials as well as of finished products. 6. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that it is carried out in a determined space, with at least a third group (31) of modules, called modules of flow, arranged to ensure the preparation and management of the fluids and energies necessary by helping to organize the circulation of the flow of water for injectable preparations, the flow of air from the atmosphere in the various modules, the flow of compressed air, the flow of effluents, the circulation flow of workers, equipment and the electrical power supply of operational components, in particular with a water treatment module (32), by performing reverse osmosis filtration or similar, in order to eliminate all solid mineral residues and to neutralize organic and/or bacteriological residues, and with a module managing the utilities (33), to group together a generation of compressed air which supplies all the equipment of the device (10) requiring compressed air, supplying hot water at the required temperature to the relevant workstations of the device (10), distributing the hot water produced and supplying electrical current to all the workstations of the device (10 ), a washing module (34) which is also structured to control and manage the entry flows of workers and equipment by means of controlled passage systems and washing equipment, this third group (31) of modules comprising also an air treatment module (35) comprising a dehumidifier and heating and/or air conditioning means. 7. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that coupling means are used to interconnect all the dedicated modules to respectively perform central flow management of purified air circulating through said modules, flows of liquids entering and leaving the various modules, flows of gas under pressure, flows of electrical energy used by the equipment of said modules and circulatory flows of the speakers and components used during the process, during the course of said phases of the process and intermediate steps. 8. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that a central equipment for purifying the atmosphere circulating through said modules and specific regulation means are used. the pressure of the air contained in each of said respective modules, means for connecting the modules with said central purification equipment and means for interconnecting the modules with each other and/or with said central purification equipment. 9. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that said means for connecting the modules with said central purification equipment are carried out by a network of air ducts formed in a sealed space arranged above a "false ceiling" reserved in the upper part of each of said modules, said network of ducts comprising, for each of said modules, at least one inlet orifice and at least one outlet, each of said inlet and outlet orifices being equipped with a coupling valve to ensure interconnection of at least one of said ducts of said network of ducts. 10. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that a central water treatment equipment is used which supplies at least a part of said modules, that the the treated water is distributed in each of said respective modules, that the waste water is collected in each of said respective modules and that modules are connected with said central water treatment equipment and that modules are interconnected with each other and/or with said central water treatment equipment. 11. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that the analysis phase of each of said samples of said solid materials to control its quality, comprises a first intermediate step which consists to verify the compliance of said samples with the theoretical quality defined by at least one certificate attesting to the nature and composition of the materials concerned. 12. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that the analysis phase of each of said samples of solid materials to control its quality, comprises a second intermediate step, corresponding to the measurement of the purity of the solid materials, which consists in determining the actual mass of each of the said samples of the said solid materials which corresponds to the mass of the pure corresponding active principle contained in these solid materials according to their respective purity. 13. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that said phase of preparing said solution for introducing and dissolving said quantity by weight of said solid materials in said predetermined volume of water for injections, comprises an intermediate stage during which the quantity by weight of said solid matter necessary to produce said solution for injection is introduced into said mixing tank, said mixing tank initially containing a fraction of said predetermined volume of water for injectable preparations. 14. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that said fraction of said predetermined volume of water for injectable preparations is at least approximately between 20 and 90%, advantageously between 50 and 80% of said predetermined volume, and preferably close to two thirds of said predetermined volume. 15. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that said solution preparation phase for introducing and dissolving said quantity by weight of said solid materials in said predetermined volume of water for injections, comprises an intermediate stage during which the required balance of said predetermined volume of water for injections is added to the mixing tank, to the solution obtained following another intermediate stage. 16. Process for the preparation of at least one injectable solution packaged in a pocket, according to claim 2, characterized in that the phases of the process and the intermediate steps are carried out in dedicated modules which are interconnected to perform central management. ambient air flows circulating through said modules, liquid flows entering and leaving the various modules, pressurized gas flows, electrical energy flows used by the equipment of said modules and circulatory flows of workers and components used during the process, during the course of said phases of the process and intermediate steps. 17. Device (10) for preparing at least one injectable solution packaged in a pocket, said injectable solution, comprising at least a predetermined quantity of at least one sample of at least one solid material, soluble in water suitable for the preparation of injectable solutions, and a predetermined volume of water for injectable preparations, adapted to produce said at least one injectable solution, contained in said pocket, said device (10) comprising at least one mixing tank, to perform individually a mixture by dissolution of said at least one sample of solid material, soluble in water, suitable for the preparation of injectable solutions, with said predetermined volume of water for injectable preparations, said device (10) being characterized in that it comprises means for taking at least one sample of each of said solid materials to be dissolved in said predetermined volume of water for injectable preparations, means for preparing mixtures to be made between said at least one sample of each of said solid materials and at least part of said predetermined volume of water for injections and means for checking the conformity of said solid materials used and of said injectable solution obtained. 18. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises, in a determined space, at least a first group (11) of production modules comprising a weighing module (12), arranged to prepare doses of solid materials, soluble in water, a preparation module (13) arranged to mix the solid materials with appropriate water, called water for injections, a filling module (14) arranged to fill empty pouches, an overwrapping module (15) arranged to overwrap said pouches filled with injectable solution, a Sterilization module (16) arranged to sterilize said overwrapped pouches, and a candling module and conditioning (17) arranged to mire puls to condition in packages the pockets filled with solution for injection and sterilized. 19. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises, in a determined space, at least a second group (21) of modules, called modules of control, agencies to ensure both the control of solid materials and that of finished products, in particular a sampling module (22) arranged to take samples of solid materials, with a view to verifying whether they comply with the data declared by the suppliers, and a laboratory module (23) arranged to carry out chemical, physical and bacteriological analyzes of samples of solid materials as well as of finished products. 20. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises, in a determined space, at least a third group (31) of modules, called modules flows, arranged to ensure the preparation and management of the necessary fluids and energies by helping to organize the circulation of the flow of water for injectable preparations, the flow of air from the atmosphere in the various modules, the flow of compressed air, the flow of effluents, the circulation flow of the workers, the equipment and the electrical energy supply of the operational components, with in particular a water treatment module (32), comprising a filtration machine by reverse osmosis or similar, in order to eliminate all solid mineral residues and to neutralize organic and/or bacteriological residues, and with in particular a utility module (33) arranged to group together a compressed air generator which supplies all the stations of the device (10) requiring compressed air, a hot water generator, arranged to supply hot water at the temperature required at the relevant workstations of the device (10), a storage tank for the hot water produced and an electrical current distributor ensuring the electrical supply to all the workstations of the device (10), and with in particular a module washing machine (34) which is structured to control and manage the input flows of workers and equipment by means of controlled passage systems called "SAS" and washing equipment, and with in particular a module for processing the air (35), to ensure the dehumidification and purification of the air circulating in the various modules. 21. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises coupling means for interconnecting all of the dedicated modules to respectively perform central management flows of purified air circulating through said modules, flows of liquids entering and leaving the various modules, flows of pressurized gas, flows of electrical energy used by the equipment of said modules and circulatory flows of workers and components used during the process, during the course of said phases of the process and intermediate steps. 22. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises central equipment for purifying the atmosphere circulating through said modules and means of specific regulation of the pressure of the air contained in each of said respective modules, means for connecting the modules with said central purification equipment and means for interconnecting the modules with each other and/or with said central purification equipment. 23. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that said means for connecting the modules with said central purification equipment comprises a network of air ducts in a sealed space arranged above a "false ceiling" reserved in the upper part of each of said modules, said network of ducts comprising, for each of said modules, at least one inlet orifice and at least one outlet orifice, each of said inlet and outlet orifices being equipped with a coupling valve to ensure interconnection of at least one of said ducts of said network of ducts. 24. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises central water treatment equipment which supplies at least part of said modules, means for distributing the treated water in each of said respective modules, means for collecting waste water in each of said respective modules and means for connecting the modules with said central water treatment equipment and means for interconnecting the modules with each other and/or with said central water treatment equipment. 25. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises equipment allowing the analysis of each of said samples of said solid materials, means for quality control, which consists in verifying the compliance of said samples with the theoretical quality defined by at least one certificate attesting to the nature and composition of the materials concerned. 26. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises equipment which allows the analysis of each of said samples, means for controlling the quality of the solid materials, comprising a second intermediate step, corresponding to the measurement of the purity of the solid materials, to determine the actual mass of each of the said samples of the said solid materials which corresponds to the mass of the pure corresponding active principle contained in these solid materials as a function of their respective purity. 27. Device (10) for preparing at least one injectable solution packaged in a pocket, according to claim 17, characterized in that it comprises dedicated modules in which the phases of the process and intermediate steps are carried out, said modules being interconnected to carry out a central management of the ambient air flows circulating through said modules, of the flows of liquids entering and leaving the various modules, of the flows of gas under pressure, of the flows of electrical energy used by the equipment of said modules and the circulatory flows of the participants and the components used during the process. 28. Pouch conditioning an injectable solution manufactured according to the process of claims 1 to 16 with the device according to claims 17 to 27, characterized in that said injectable solution is individual, adapted to a specific medical treatment with an appropriate composition and a predetermined concentration. for said medical treatment of an identified patient, said injectable solution being made by dissolving at least one water-soluble solid material and a predetermined volume of water for injections.