EP3429658A1

EP3429658A1 - Unit for preparing at least one solution of concentrates for haemodialysis and method for preparing said solution

Info

Publication number: EP3429658A1
Application number: EP17717615.3A
Authority: EP
Inventors: Henri Gauthier; Nicolas TILATTI; Philippe Courtiade
Original assignee: Hemo Plus Sarl
Current assignee: Hemo Plus Sarl
Priority date: 2016-03-18
Filing date: 2017-03-17
Publication date: 2019-01-23
Also published as: CN109069720A; JP2019510560A; WO2017156643A1; JP6964887B2; MX2018011321A; MA43323A1; US20190083691A1; CH712274A1; KR20180135903A; CN109069720B; CH712274B1; TN2018000305A1; ZA201806859B

Abstract

The invention relates to a unit (10) for preparing at least one solution of concentrates for haemodialysis (CH), said solution being composed of water-soluble solid materials comprising at least sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCl2) and magnesium chloride (MgCl2). This unit is produced in a modular manner and comprises the following modules: - a sampling module (MPRE) for taking at least one sample of each of said starting materials to be dissolved in said volume of purified water, - a laboratory module (MLAB) arranged for analysing each of said samples of starting materials in order to verify the conformity and quality thereof, - a weighing module (MPES) for determining the amount by weight of said starting materials to be introduced into said predetermined volume of purified water, - a module for preparing (MPRE) the solution for introducing and dissolving said amount by weight of said starting materials in said predetermined volume of purified water, and - at least one module for conditioning (MCON) said obtained solution of concentrates for haemodialysis.

Description

UNIT FOR THE PREPARATION OF AT LEAST ONE CONCENTRATE SOLUTION FOR HEMODIALYSIS AND PROCESS FOR THE PREPARATION THEREOF

Technical area

The present invention relates to a unit for the preparation of at least one solution of concentrates for hemodialysis, said solution being composed of water-soluble solids comprising at least sodium chloride (NaCl), potassium chloride (KCl) , calcium chloride (CaCl 2), and magnesium chloride (MgCfc), comprising means for preparing said solution by successively introducing predetermined amounts of said solids into a predetermined volume of purified water, into a mixing tank, means for individually performing a dosage control of said solids introduced into said predetermined volume of purified water and means for individually performing a conformity check of the concentrate solution obtained at the end of the process.

It also relates to a process for preparing at least one solution of concentrates for hemodialysis, said solution being composed of water-soluble solids comprising at least sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCb), and magnesium chloride (MgC), wherein said solution is prepared by successively introducing into a mixing tank, predetermined amounts of said solids in a predetermined volume of purified water contained in said tank of mixing, in which a dosage control of said solids introduced into said predetermined volume of purified water is individually carried out and in which a conformity check of said solution of hemodialysis concentrates obtained by the process is carried out individually. Prior art

Concentrate manufacturing facilities for hemodialysis are usually assembled in industrial production plants arranged to produce large volumes of products which will then have to be stored, packaged and distributed to the treatment centers. These approaches are complicated and costly and involve manipulation with health and / or medical risks, particularly because of a complex management of the packaging, related to the specific needs of the various treatment centers, transport and real-time supply of said care centers.

It turns out that the supply of treatment centers by hemodialysis would be considerably simplified, cheaper and less risky, if the production of concentrates for hemodialysis was relocated and if the manufacture of these products was made, on the one hand in a zone close to at least one treatment center and preferably in a sufficiently small radius compared to a group of treatment centers, to be able to guarantee a regular supply on demand, a distribution by which the risks related to transport would be reduced, and limited fees to ensure, with the regularity that is required for this type of treatment, the supply of treatment centers.

The article "Unipharm JSC; Products: Concentrates for hemodialysis "describes the protocol for preparing concentrates for hemodialysis, as recommended by the European Pharmacopoeia. Concentrates for hemodialysis, according to this protocol are produced in large conventional units, in the form of very large centralized manufacturing plants and concentrates for hemodialysis are produced according to methods known per se and which are standardized and implemented in most manufacturing centers for these compounds. The concentrates are then distributed to major treatment centers for the preparation of injectable solutions. Presentation of the invention

The relocation of the production of concentrates for hemodialysis, mentioned above, involves the multiplication of production units, these units having relatively small dimensions and being located relatively close to hemodialysis treatment centers.

This is why the present invention proposes to provide a unit for producing concentrates for hemodialysis, whose structure is modular, the mode of operation, namely the product manufacturing process is identical regardless of the unit, so that that the construction of the units is the same, the manufacturing process of the products, as well as all the procedures of preparation, management of the components, all the operations of maintenance and all the security steps are identical, in order to guarantee the quality of the products manufactured, an optimized production cost and a security of supply of treatment centers by hemodialysis.

This object is achieved by the unit for preparing at least one hemodialysis concentrate solution, according to the invention, characterized in that it comprises the following modules:

a sampling module for taking a sample of each of said raw materials to be dissolved in said volume of purified water,

an analysis phase of each of said samples of raw materials to control their quality,

a weighing module for determining the quantity by weight of said raw materials to be introduced into said predetermined volume of purified water,

a module for preparing the solution for introducing and dissolving said quantity by weight of said raw materials into said predetermined volume of purified water, and

- A conditioning module of said solution obtained concentrates for hemodialysis. According to a preferred embodiment, it comprises first analysis means for performing, during a first intermediate step of said analysis phase of each of said samples of raw materials, a quality control which consists in checking the conformity samples with the theoretical quality defined by at least one certificate attesting the nature and composition of the materials concerned, as well as compliance with the regulatory texts in force. According to said preferred embodiment, it also comprises second analysis means for performing, during a second intermediate step of said analysis phase of each of said raw material samples, a purity check which consists of determining the mass. actual of each of said raw materials which corresponds to the mass of the pure active ingredient contained in these raw materials according to their respective purity.

Furthermore, it advantageously comprises coupling means for interconnecting all the dedicated modules to respectively perform central management of ambient or purified air flows circulating through said modules, flows of the liquids entering and leaving the various modules, flow of pressurized gas, electrical energy flows used by the equipment of said modules and circulatory flows of the speakers and components used during the process, during the course of said process phases and intermediate steps.

Preferably, it comprises a central equipment for purifying the atmosphere flowing through said modules and means for regulating the specific pressure of the air contained in each of said respective modules, means for connecting the modules with said central purification equipment and interconnection means modules between them and / or with said central purification equipment. Advantageously, said means for connecting the modules with said central purification equipment comprises an air duct network arranged in a sealed space disposed above a "false ceiling" reserved in its upper part of each of said modules, said a duct network comprising, for each of said modules, at least one inlet orifice and at least one outlet orifice, each of said inlet and outlet ports being equipped with a coupling valve to ensure interconnection of at least one said conduits dudrt duct network. Preferably, it comprises a central water treatment equipment which supplies at least a portion of said modules, means for distributing the treated water in each of said respective modules, means for collecting the wastewater 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.

In this context, the method according to the invention is characterized in that it comprises the following phases:

a sampling phase for taking a sample of each of said raw materials to be dissolved in said volume of purified water,

a weighing phase for determining the quantity by weight of said raw materials to be introduced into said predetermined volume of purified water,

a solution preparation phase of introducing and dissolving said quantity by weight of said raw materials into said predetermined volume of purified water, and

a conditioning phase of said solution obtained from concentrates for hemodialysis. According to a preferred embodiment, the analysis phase of each of said samples of raw materials to control their quality comprises a first intermediate step which consists in verifying the conformity of the samples with the theoretical quality defined by at least one certificate attesting the nature of the samples. and the composition of the subject matter.

The analysis phase of each of said samples of raw materials to control their quality preferably comprises a second intermediate step comprising measuring the purity of the raw materials, which consists in determining the actual mass of each of said raw materials which corresponds to the mass. pure active ingredient contained in these raw materials according to their respective purity.

Said phase of preparation of the solution for introducing and dissolving said quantity by weight of said raw materials in said predetermined volume of purified water, advantageously comprises a first intermediate step during which the quantity by weight of said mixture tank is introduced into said mixing tank; raw materials needed to make said solution of concentrates for hemodialysis, said mixing vessel initially containing a fraction of said predetermined volume of purified water.

Said fraction of said predetermined volume of purified water is advantageously at least approximately between 50 and 80% of said predetermined volume, and preferably close to two-thirds of said predetermined volume.

In addition, said phase of preparing the solution for introducing and dissolving said quantity by weight of said raw materials into said predetermined volume of purified water may comprise a second intermediate step during which the mixing tank is added to the solution obtained following said first step, the balance of said predetermined volume of purified water.

According to a particularly advantageous embodiment, said phase of conditioning said solution obtained from concentrates for hemodialysis, consists in transferring, during a first intermediate step, in at least one storage tank said solution obtained concentrates for hemodialysis.

According to this particularly advantageous embodiment, said phase of conditioning said solution obtained concentrates for hemodialysis consists in conditioning, during a second intermediate step, said solution obtained concentrates for hemodialysis, in containers arranged to provide food a dialysis generator. Preferably, the process steps and the intermediate steps are carried out in dedicated modules which are interconnected for central management of the ambient air flows circulating through said modules, flows of the liquids entering and leaving the different modules, pressurized gas flows, electrical energy flows used by the equipment of said modules and circulatory flows of the speakers and components used during the process, during the course of said process phases and intermediate steps.

In order to carry out a central management of the ambient or purified air flows circulating through said modules, an upper zone of each of said modules concerned is advantageously housed in an isolated space containing circulation paths of an incoming atmosphere and an outgoing atmosphere communicating respectively with a central module for air treatment.

In order to perform a central management of the flow of liquids, it is advantageous to connect the purified water inlets and outlets of all of the said modules concerned to each other and / or to an inlet and an outlet of a central unit of water treatment. Brief description of the drawings

The present invention and its advantages will appear better in the following description of an embodiment given by way of non-limiting example, with reference to the appended drawings in which: FIG. 1 is a schematic overall view showing the production unit for concentrates for hemodialysis manufactured according to the method of the invention, - Figure 2 is a detailed view of the weighing module which illustrates the equipment to ensure a preliminary phase in the manufacture of concentrates for hemodialysis according to the FIG. 3 is a detailed view of the preparation module illustrating the equipment used to ensure the actual manufacture of concentrates for hemodialysis according to the method of the invention.

FIG. 4 is a detailed view of the storage module which illustrates the equipment making it possible to store the concentrates for hemodialysis obtained according to the method of the invention, FIG. 5 is a detailed view of the conditioning module of concentrates for hemodialysis obtained. according to the method of the invention, FIG. 6 is a detailed view of the sampling module of raw materials with a view to checking their validation, FIG. 7 is a detailed view of the chemical, physical and bacteriological laboratory module intended to control the quality and purity of the raw materials used in the composition of the hemodialysis concentrates obtained according to the method of the invention, as well as the quality and conformity of the finished or concentrated products for hemodialysis, FIG. 8 is a detailed view of a water treatment module which forms part of the composition of hemodialysis concentrates obtained according to the method of the invention and which is used during the phases of this process, FIG. 9 is a detailed view of a utilities module which is arranged to process, prepare and package flows and / or energies used in the process of the invention, FIG. 10 is a detailed view of a module of washing which is arranged to control the inputs of operating personnel and equipment and products used during the process of the invention, and Figure 11 is a detailed view of a neutralization module (NEUT) effluents obtained in the part of the process of the invention.

Best way to achieve the invention

With reference to the figures, in particular FIG. 1, the unit 10 for the production of concentrates for hemodialysis (CH) represented, consists of a set of modules, detailed in FIGS. 2 to 9, which are all coupled and interconnected. such that the functions of the respective modules and the equipment they contain can be activated according to the phases of the method according to the invention. Among said modules, there is a first group 1, modules called production modules (PROD) whose function is to manufacture the (CH) from raw materials (MA) soluble in water. Among these modules (PROD), is a first module, called weighing module (PESE) whose function is to prepare the doses of raw materials which are then used to produce the (CH) according to previously developed formulations. A second module called preparation module (PREP) has the function of mixing the solid raw materials in purified water to produce said concentrates. A third module called storage module (STOC) has the function of collecting in at least one storage tank, the concentrates produced by the module (PREP) and to contain them momentarily at the end of their manufacture. A fourth module called conditioning module (COND) has the function of conditioning the concentrates in containers of smaller volume, in particular having a sufficient volume to allow, after an appropriate final dilution, to perform a treatment session by hemodialysis. 'a patient. This module could be limited to a packaging machine, without constituting alone or fill a complex module with multiple functions.

It should be noted that the production modules (PROD) or the specific modules and machines arranged in addition to the modules, are designed to start initially with the collection of the appropriate raw materials (MA) and lead to the finished products (CH). , ready for distribution after having undergone all the verifications, all the validations and all the safety and qualitative interventions required for a product for medical use as sensitive as the concentrates for hemodialysis.

Among said modules that make up unit 10, there will be a second group

2, modules called control modules (C.O.N.T) whose function is to ensure both the control of raw materials (MA), and that of finished products, in this case concentrates (CH) manufactured. A first module, called the sampling module (PREL) is part of this second group, and it consists in taking samples of raw materials (MA) in order to verify that they comply with the data declared by the suppliers and with the regulatory texts. force, and with the specificity sheets. A second module, called laboratory module (L.A.B.O) belongs to this second group, and consists of performing chemical, physical and bacteriological analyzes of raw material samples (MA) isolated beforehand in the module (P.R.E.L). Among the said modules that make up unit 10, there will be a third group

3, of modules called utility modules (FLUX) which ensure the preparation and management of fluids and energies necessary for the implementation of the process. They help to organize the circulation of the flow of water, the air flow of the atmosphere in the different modules, the flow of compressed air, the flow of effluents, the flow of traffic of the speakers and the power supply of the operational components.

The first module of said third group 3 (FLUX) is a so-called water treatment module or module (TH2.0) whose function is to prepare the purified water in which the raw materials (MA) will be dissolved in order to produce the concentrates (CH). It may for example comprise a reverse osmosis filtration machine or the like in order to eliminate any solid mineral residues and to neutralize the organic and / or bacteriological residues.

The second module of this third group 3 is called utilities module (UTIL) which can include a group of compressed air that supplies all the units of the unit 10 requiring compressed air, a water generator hot, arranged to supply hot water at the required temperature to all the relevant stations of the unit 10, a hot water storage tank produced and an electric power distributor that ensures the power supply of all Workstations in the different modules of unit 10.

A third module of this third group of modules 3, is called washing module (LAVA) which is organized to control and manage the input flows of stakeholders through controlled passage systems called locks and washing equipment.

A fourth module, of this third group 3, which is said air handling module (TAIR) is designed to ensure in particular the dehumidification and purification of the air flowing in the various modules. For this purpose, it comprises an air treatment equipment comprising a dehumidifier and heating and / or air conditioning means known per se, which could be mounted separately outside the other modules. A fourth group 4, called (EFFL), comprises one or more modules called neutralization module (NEUT) effluents whose purpose is to treat and if necessary to neutralize the effluents from production and ancillary treatments, in order to be able to reject them safely and legally after the production of concentrates for hemodialysis (CH).

The production of concentrates for hemodialysis (CH) begins in the first group 1, modules called production modules (PROD) and more specifically by the weighing module (PESE) illustrated in Figure 2. This module 31 is equipped with weighing means 32, arranged under a fume hood 33. A zone 34 makes it possible to manage the secure entry of the personnel, a zone 35 makes it possible to weigh the raw materials (MA) and a zone 36 makes it possible to condition the weighed products. The weighing module comprises integrated ventilation means which are arranged laterally and consist of two channels 37a and 37b which run along the side walls of the module. These channels are in communication on the one hand with a general ventilation and ventilation network which feeds all the modules and on the other hand with the interior of all the zones of the module, according to the specific needs, through valves The channels 37a and 37b are housed in the upper part of the module 31, for example in a space separated from the interior of the module by a false ceiling or the like.

Following the weighing module (PESE) illustrated in FIG. 2, there is the preparation module 41 (PREP), illustrated in FIG. 3, which aims to dissolve the raw materials (MA) previously dosed into the water. 'purified water. For this purpose is introduced into a preparation tank 42, or mixing tank containing a fraction of the volume intended to manufacture the expected volume of concentrates for hemodialysis (CH), in a first step, and then after mixing this mixture , to complete the volume of purified water to achieve the objectives set. The raw materials (MA) are brought from a zone 43 into a zone 44 in which the purified water is fed into the preparation tank 41. Like the weighing module illustrated in FIG. 2, the preparation module 41 (PR) EP) comprises integrated ventilation means which are arranged laterally and consist of two channels 47a and 47b which run along the side walls of the module. These channels are in communication with the entire air distribution and ventilation circuit comprise means of intercommunication with the other channels having the same functions of the other modules of the unit 10.

Following the weighing module (PESE) illustrated in FIG. 2, and the preparation module 41 (PREP), illustrated in FIG. 3, is the storage module 51 (MSTO), represented by FIG. is intended to store the concentrates for hemodialysis (CH) produced, for example in three storage tanks 52, 53 and 54. The storage of the products in these tanks is temporary and it is used to feed containers or packaging intended directly to the customer. use in patients at the time of treatment with hemodialysis. Like the previous modules of the same production group (PROD), the storage module 51 (MSTO) is equipped with two channels 57a and 57b which run along the side walls of the module and which are in communication with the whole of the ventilation circuit and of air distribution comprise means of intercommunication with the other channels having the same functions of the other modules of the unit 10.

Following the storage module 51 (MSTO), there is the conditioning module 61, shown in FIG. 5, which aims to distribute the concentrates for hemodialysis (CH) in containers 62 suitable for the treatment of patients. The concentrates (CH) produced are initially diluted, for example of the order of ten times to be consumed directly by the dialysis machines. The conditioning module 61 (COND) is equipped with two channels 67a and 67b which run along the side walls of the module and which are in communication with the whole of the ventilation and air distribution circuit comprising means of intercommunication with the other channels having the same functions of other modules of unit 10. Furthermore, the unit 10 comprises a second group 2 of so-called control modules (CONT), in particular a first module 71, called the sampling module (PREL), represented by FIG. 6, which serves to take samples of materials (MA), in order to check whether they are

5 in accordance with the data declared by the suppliers and with the specificity sheets. The module 71 comprises sampling means 72 for verifications. It is also equipped with two channels 77a and 77b which run along the side walls of the module and which are in communication with the entire air distribution and ventilation circuit comprise means

10 of this module also comprises an entry lock 73 for controlling the penetration of the personnel and a hood 74 for controlling the flow of air flowing in. the module and in particular in the zone 75 where the samples are taken.

I 5

A second module 81, represented by FIG. 7, referred to as the laboratory module (LABO), is part of this second group of control modules (CONT) and is assigned to chemical, physical and bacteriological analyzes of the raw material samples (MA). previously isolated in module 0 (PREL) and finished products. It comprises three separate zones disposed within the module 81, a bacteriological analysis zone 82, a physical analysis zone and a chemical analysis zone 84 which are carried out on the raw materials (MA) or on various products used in the process, such as purified water, circulating air or effluents. He is also

25 equipped with two channels 87a and 87b along the side walls of the module and which are in communication with the entire air distribution and distribution circuit comprising means of intercommunication with the other channels having the same functions of others modules of the unit 10.

The first module of said third group 3, (FLUX) is a module 91 called water treatment or module (TH2.0), represented by FIG. 8, whose function is to prepare the purified water in which will be dissolved materials first (MA) to make concentrates (CH) and to manage cooled water and hot water in two separate loops. It may for example comprise a reverse osmosis filtration machine 92 or the like. It comprises a tank 93 of purified water storage, to allow to have a water reserve permanently for use in the production phase. In addition, the module 91 may contain a softener 94, a refrigeration exchanger 95 and a heat exchanger 96 for managing independent circuits of hot water and chilled water. Figure 9 illustrates the utilities module which is arranged to process, prepare and package flows and / or energies used in the process. The module 101 may comprise in particular an electrical management unit 102, a softened water tank 103, a hot water production unit 104 and a compressed air generation unit 105.

FIG. 10 illustrates the washing unit (LAVA) 111 which is provided with a laundry 112 for cleaning everything that enters the processing circuit of the unit 10. Inlet locks 113 are provided to secure and control all incoming equipment as well as operational staff. A storage area 114 under controlled atmosphere, advantageously at overpressure, and at a predetermined temperature, is provided in the washing module (LAVA) 111.

FIG. 11 illustrates the tributary neutralization module called N.E.U.T which is part of group 4 (E.F.F.L), and whose purpose is to purge and neutralize the effluents before evacuating them.

The modular construction of this unit has several advantages related in particular to the constructive concept and distribution of all operational components that are organized according to immutable validated rules from one unit to another. Centralized central management of all flows and energies is a guarantee of security by providing an overview and widespread maintenance. The costs of an installation are predictable and independent of local parameters. The training of the operational staff can be carried out in any unit and the personnel can be interchanged from one unit to another, if necessary without requiring specific training.

The invention is not limited to the described embodiments and can be presented in different aspects according to certain foreseeable evolutions or according to improvements of certain components. However, the scope of the invention falls within the scope defined by the claims.

Claims

claims

A unit (10) for preparing at least one solution of hemodialysis (CH) concentrates, said solution being composed of water-soluble solids comprising at least sodium chloride (NaCl), potassium chloride ( KCI), calcium chloride (CaCb), and magnesium chloride (MgC), comprising means for preparing said solution by successively introducing predetermined amounts of said solids into a predetermined volume of purified water, in a mixing tank , means for individually performing a dosage control of said solids introduced into said predetermined volume of purified water and means for individually performing a conformity check of the concentrate solution obtained at the end of the process, said unit being characterized in that it includes the following modules:

a sampling module (MPRE) for taking at least one sample of each of said raw materials to be dissolved in said volume of purified water,

a laboratory module (MLAB) arranged to analyze each of said samples of raw materials to check its conformity and quality,

a weighing module (MPES) for determining the quantity by weight of said raw materials to be introduced into said predetermined volume of purified water,

a preparation module (MPRE) of the solution for introducing and dissolving said quantity by weight of said raw materials into said predetermined volume of purified water, and

at least one conditioning module (MCON) of said solution obtained from concentrates for hemodialysis.

2. Unit according to claim 1, characterized in that it comprises first analysis means for performing, during a first step intermediate of said analysis phase of each of said samples of raw materials, a quality control which consists in verifying the conformity of the samples with the theoretical quality defined by at least one certificate attesting the nature and composition of the materials concerned, as well as the compliance with the regulations in force.

3. Unit according to claim 1, characterized in that it comprises second analysis means for performing, during a second intermediate step of said analysis phase of each of said samples of raw materials, a purity check. which consists in determining the actual mass of each of said raw materials which corresponds to the mass of the pure active principle contained in these raw materials as a function of their respective purity.

4. Unit according to claim 1, characterized in that it comprises coupling means for interconnecting all the dedicated modules to perform respectively a central management purified air flow flowing through said modules, fluid flu entering and leaving the various modules, pressurized gas flows, electrical energy flows used by the equipment of said modules and circulatory flows of the speakers and components used during the process, during the unfolding of said phases of the process and the steps intermediate.

5. Unit according to claim 1, characterized in that it comprises a central equipment for purifying the atmosphere flowing through said modules and means for specific regulation of the air pressure 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.

6. Unit according to claim 5, characterized in that said means for connecting the modules with said central purification unit comprises a network of air ducts formed in a sealed space disposed above a "false ceiling" reserved in the upper part of each of said modules, said duct network comprising, for each of said modules at least one inlet orifice and at least one outlet orifice, each of said inlet and outlet ports being equipped with a valve coupling arrangement for interconnecting at least one of said conduits of said conduit network.

7. Unit according to claim 1, characterized in that it comprises a central water treatment equipment which feeds at least a portion of said modules, means for distributing the treated water in each of said respective modules, means for collecting the wastewater 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.

Process for the preparation of at least one solution of concentrates for hemodialysis, said solution being composed of water-soluble solids comprising at least sodium chloride (NaCl), potassium chloride (KG), calcium (CaCfe), and magnesium chloride (MgC), wherein said solution is prepared by successively introducing into a mixing tank, predetermined amounts of said solids in a predetermined volume of purified water contained in said mixing tank, in which a dosage control of said solids introduced into said predetermined volume of purified water is individually carried out and in which a conformity check of said hemodialysis concentrate solution obtained by the process is carried out individually, said method being characterized in that 'it comprises the following phases:

a sampling phase for taking a sample of each of said raw materials to be dissolved in said volume of purified water, an analysis phase of each of said samples of raw materials to control their quality, a weighing phase for determining the quantity by weight of said raw materials to be introduced into said predetermined volume of purified water,

a solution preparation step of introducing and dissolving said amount by weight of said raw materials into said predetermined volume of purified water, and

a conditioning phase of said solution obtained from concentrates for hemodialysis.

H) 9. A method according to claim 8, characterized in that the analysis phase of each of said samples of raw materials to control their quality, comprises a first intermediate step which consists in checking the conformity of the samples with the theoretical quality defined by at least one certificate attesting the nature and composition of the subjects concerned.

15

10. The method of claim 8, characterized in that the analysis phase of each of said samples of raw materials to control their quality comprises a second intermediate step comprising measuring the purity of raw materials, which consists in determining the actual mass each of said raw materials which corresponds to the mass of the pure active ingredient contained in these raw materials according to their respective purity.

A process according to claim 8, characterized in that said step of preparing the solution for introducing and dissolving said quantity by weight of said raw materials into said predetermined volume of purified water comprises a first intermediate step in which one introduced into said mixing tank, the amount by weight of said raw materials necessary to make said solution of concentrates for hemodialysis, said mixing tank initially containing a fraction of said predetermined volume of purified water.

12. The method of claim 1 1, characterized in that said fraction of said predetermined volume of purified water is at least approximately between 50 and 80% of said predetermined volume, and preferably close to two-thirds of said predetermined volume.

13. Process according to claims 8 and 11, characterized in that said phase of preparation of the solution for introducing and dissolving said quantity by weight of said raw materials in said predetermined volume of purified water comprises a second intermediate step during which the balance of said predetermined volume of purified water is added to the mixing tank to the solution obtained following said first stage.

14. Method according to claim 8, characterized in that said conditioning phase of said solution obtained concentrates for hemodialysis, consists in transferring, during a first intermediate step, in at least one storage tank said solution obtained concentrates. for hemodialysis.

15. Method according to claim 8, characterized in that said phase of conditioning said solution obtained concentrates for hemodialysis consists in conditioning, during a second intermediate step, said solution obtained concentrates for hemodialysis, in containers arranged for provide power to a dialysis generator.

16. Method according to claim 8, characterized in that the process steps and the intermediate steps are carried out in dedicated modules which are interconnected to perform a central management of the ambient air flows flowing through said modules, flows liquids entering and leaving the various modules, pressurized gas flows, electrical energy flows used by the equipment of said modules and circulatory flows of the speakers and components used during the process, during the unfolding of said phases of the process and intermediate steps.

17. The method of claim 16, characterized in that for central management of ambient air flows flowing through said modules, an upper zone of each of said modules concerned is housed in an iso-space containing circulation paths of an incoming atmosphere and an outgoing atmosphere communicating respectively with a central air treatment module.

18. A method according to claim 16, characterized in that to perform a central management of the flow of liquids, the arrivals and departures of purified water are connected to all of said modules concerned with each other and / or to an inlet and outlet. an output of a central water treatment unit.