OA18871A - Unit for preparing at least one solution of concentrates for haemodialysis and method for preparing said solution - Google Patents
Unit for preparing at least one solution of concentrates for haemodialysis and method for preparing said solution Download PDFInfo
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- OA18871A OA18871A OA1201800340 OA18871A OA 18871 A OA18871 A OA 18871A OA 1201800340 OA1201800340 OA 1201800340 OA 18871 A OA18871 A OA 18871A
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- Prior art keywords
- modules
- solution
- purified water
- module
- concentrâtes
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- 238000001631 haemodialysis Methods 0.000 title claims abstract description 51
- 239000012141 concentrate Substances 0.000 title abstract description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 67
- 230000000322 hemodialysis Effects 0.000 claims abstract description 50
- 239000008213 purified water Substances 0.000 claims abstract description 43
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 18
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 16
- 238000005070 sampling Methods 0.000 claims abstract description 11
- 238000005303 weighing Methods 0.000 claims abstract description 10
- UXVMQQNJUSDDNG-UHFFFAOYSA-L cacl2 Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims abstract description 9
- 239000001110 calcium chloride Substances 0.000 claims abstract description 9
- 229910001628 calcium chloride Inorganic materials 0.000 claims abstract description 9
- 239000011780 sodium chloride Substances 0.000 claims abstract description 9
- 239000001103 potassium chloride Substances 0.000 claims abstract description 8
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 8
- 239000011343 solid material Substances 0.000 claims abstract 5
- 239000002994 raw material Substances 0.000 claims description 54
- 239000003570 air Substances 0.000 claims description 24
- 238000004806 packaging method and process Methods 0.000 claims description 18
- 238000004458 analytical method Methods 0.000 claims description 15
- 238000003860 storage Methods 0.000 claims description 13
- 238000002156 mixing Methods 0.000 claims description 12
- 239000007787 solid Substances 0.000 claims description 10
- 238000000746 purification Methods 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 8
- 239000000126 substance Substances 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-M chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 4
- 230000001808 coupling Effects 0.000 claims description 4
- 238000010168 coupling process Methods 0.000 claims description 4
- 238000005859 coupling reaction Methods 0.000 claims description 4
- 239000012080 ambient air Substances 0.000 claims description 3
- 238000000502 dialysis Methods 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 2
- 238000005259 measurement Methods 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 239000002351 wastewater Substances 0.000 claims description 2
- 239000002195 soluble material Substances 0.000 claims 2
- 230000003750 conditioning Effects 0.000 abstract description 4
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L MgCl2 Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 abstract 4
- 239000007858 starting material Substances 0.000 abstract 4
- 229910001629 magnesium chloride Inorganic materials 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 description 23
- 238000009826 distribution Methods 0.000 description 8
- 238000009423 ventilation Methods 0.000 description 8
- 238000005406 washing Methods 0.000 description 6
- 238000004450 types of analysis Methods 0.000 description 5
- 230000000721 bacterilogical Effects 0.000 description 4
- 241000209149 Zea Species 0.000 description 3
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 3
- 230000005591 charge neutralization Effects 0.000 description 3
- 235000005822 corn Nutrition 0.000 description 3
- 235000005824 corn Nutrition 0.000 description 3
- 230000001264 neutralization Effects 0.000 description 3
- 238000006386 neutralization reaction Methods 0.000 description 3
- 238000001914 filtration Methods 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 238000007792 addition Methods 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000010926 purge Methods 0.000 description 1
- 238000001223 reverse osmosis Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000010200 validation analysis Methods 0.000 description 1
Abstract
The invention relates to a unit (10) for preparing at least one solution of concentrates for hemodialysis (CH), said solution being composed of water-soluble solid materials comprising at least sodium chloride (NaCl), potassium chloride (KC1), calcium chloride (CaC12) and magnesium chloride (MgC12). 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 in 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 hemodialysis.
Description
UNIT FOR PREPARING AT LEAST ONE SOLUTION OF CONCENTRATES FOR HEMODIALYSIS AND METHOD FOR PREPARING SAID SOLUTION
Technical scope
This invention relates to a unit for preparing at least one hemodialysis concentrâtes 5 solution, said solution being composed of solid water-soluble materîals comprising at least sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCl2) and magnésium chloride (MgCl2), including means for preparing said solution by introducing successively predetermined quantifies of said solid materîals in a predetermined volume of purified water in a mîxing container, means for carrying out indîvidualiy a dosage control iO of said solid materîals introduced in said predetermined volume of purified water and means tor carrying out indîvidualiy a compliance check of the concentrâtes solution obtained at the end of the process.
It also relates to a method for preparing at least one hemodialysis concentrâtes solution. 15 said solution being composed of solid water-soluble materîals comprising at least sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCl2) and magnésium chloride (MgCb), wherein one préparés said solution by introducing successively in a mixing container predetermined quantifies of said solid materîals in a predetermined volume of purified water contained in said mixing container, wherein one carries out 20 indîvidualiy a dosage control of said solid materîals introduced in said predetermined volume of purified water and wherein one carries out indîvidualiy a compliance check of said concentrâtes solution for hemodialysis obtained by the method.
Prior art
The production units for hemodialysis concentrâtes are generally assembled in industrial production facilities designed to produce important volumes of products that must then be stored, packaged and distributed to the treatment centers. These operations are compiicated and expensive, and they imply handling with health and/or medical risks, especialiy because of a complex packaging management linked with the spécifie needs of the various treatment centers. the transport and the real-time supply of said care centers.
It appears that the supply of the hemodialysis treatment centers would be significantly simplified. less expensive and less risky if the hemodialysis concentrâtes production was delocalized and if these products were manufactured on the one hand in an area close to at least one treatment center and preferably at a distance sufficiently small with respect to a group of treatment centers, to be able to guarantee a regular supply on demand. a distribution thanks to which the risks linked with the transport would be reduced, and limited costs to ensure the supply of the treatment centers with the regularity required for this type of treatment.
Article Unipharm JSC ; Products : Concentrâtes for hemodialysis describes the préparation protocol of hemodialysis concentrâtes as it is recommended by the European Pharmacopoeia. According to this protocol, the hemodialysis concentrâtes are produced in large classical units în the form of very important centralized production facilities. and the hemodialysis concentrâtes are produced according to methods known per se and which are standardized and implemented in most of the centers manufacturing these compounds. The concentrâtes are then distributed in the large treatment centers for the préparation of injectable solutions.
Description of the invention
The delocalization of the production of hemodialysis concentrâtes mentioned above implies the multiplication of production units, these units being of a relatively small sîze and being located relatively close to the hemodialysis treatment centers.
This is why this invention offers to realize a hemodialysis concentrâtes production unit with a modular structure, whose operating mode, i. e. the manufacturing method of the Products, is identical whatever the unit, so that the design of the units is the saine, the manufacturing method of the products, as well as ail préparation and component management operations, ail maintenance work and ail safety actions are identical, in order to guarantee the quality of the manufactured products, optimized production costs and the safety of the supply of the hemodialysis treatment centers.
This goal is achieved by the préparation unit of at least one solution of hemodialysis concentrâtes according to the invention, characterized in that it comprises the following modules:
- a sampling module to take a sample of each of said raw materials to be dissolved in said volume of purified water, an analysis phase of each of said raw material samples to check their quality, a weighing module to détermine the quantity in weight of said raw materials to be introduced in said predetermined volume of purified water,
- a solution préparation module to introduce and dissolve said quantity in weight of said raw materials in said predetermined volume of purified water, and
- a module for packaging said hemodialysis concentrâtes solution obtained.
According to a preferred embodiment, it comprises first analysis means to carry out, during a first intermediate step of said analysis phase of each of said raw material samples, a quality check that consists in checking the compliance of the samples with the theoretical quality defined by at least one certificate specifying the nature and composition of the concemed materials, as well as the compliance with the régulations in force.
According to said preferred embodiment, it also comprises second analysis means to carry out, during a second intermediate step of said analysis phase of each of said raw material samples, a purity check that consists in determining the actual weight of each of said raw materials which corresponds to the weight of the pure active substance contained in these raw materials according to their respective purity.
It moreover advantageously comprises coupling means to interconnect ali of the dedicated modules to perform respectively a centralized management of the ambient or purified air flows that circulate through said modules, of the liquid flows entering end exiting the various modules, of the pressurized gas flows, of the electrical energy flows 5 used by the equipment of said modules and of the circulation flows of the workers and of the components used durîng the method, in the course of said phases of the method and of the intermediate steps.
It preferably comprises a central purification equipment of the atmosphère that I0 circulâtes through said modules and spécifie régulation means of the pressure of the air contained in each of said respective modules, means for connecting the modules to said central purification equipment and means for interconnecting the modules to each other and/or to said central purification equipment.
Advantageously, said means for connecting the modules to said central purification equipment comprises an air duct network arranged in a tight space located above a false ceiling rcserved in the top section of each of said modules, said duct network comprising for each of said modules at least one inlet opening and at least one outlet opening. each of said inlel and outlet openings being equipped with a coupling valve to ensure an 20 interconnection of at least one of said ducts of said duct network.
It preferably comprises a central water treatment equipment that supplies at least a part of said modules, means for distributirig the Ireated water in each of said respective modules, means for collecting the waste water in each of said respective modules and 25 means for connecting the modules to said central water treatment equipment and means for interconnecting the modules to each other and/or to said central water treatment equipment.
In this context, the method aucording to the invention is characterized in that it comprises 30 the foilowing phases:
a sampling phase to take a sample of each of said raw materials to be dissolved in said volume of purified water,
- an analysis phase of each of said raw material samples to check their quality,
- a weighing phase to détermine the quantity in weight of said raw materials to be introduced in said predetermined volume of purified water,
- a solution préparation phase consisting in introducing and dissolving said quantity in weight of said raw materials in said predetermined volume of purified water, and
- a phase for packaging said hemodialysis concentrâtes solution obtained.
According to a preferred embodiment, the analysis phase of each of said raw material samples to check their quality comprises a first intermediate step that consists in checking the compliance of the samples with the theoretical quality defined by at least one certificate 10 specifying the nature and composition of the concemed materials.
The analysis phase of each of said raw material samples to check their quality preferably comprises a second intermediate step including the measurement of the purity of the raw materials, which consists in determining the actual weight of each of said raw materials 15 that corresponds to the weight of the pure active substance contained in these raw materials according to their respective purity.
Said solution préparation phase to introduce and dissolve said quantity in weight of said raw materials in said predetermined volume of purified water advantageously comprises a ÏO first intermediate step during which one introduces in said mixing container the quantity in weight of said raw materials requîred to realize said hemodialysis concentrâtes solution, said mixing container containing initîally a fraction of said predetermined volume of purified water.
!5 Said fraction of said predetermined volume of purified water is advantageously at least approximately comprised between 50 and 80% of said predetermined volume, and preferably close to two thirds of said predetermined volume.
Moreover, said solution préparation phase to introduce and dissolve said quantity in weight o of said raw materials in said predetermined volume of purified water can comprise a second intermediate step during which one adds in the mixing container, to the solution obtained after said first step, the remainder of said predetermined volume of purified water.
According to a particularly advantageous embodiment, said packaging phase of said obtained hemodialysis concentrâtes solution consists in transferring during a first intermediate step said obtained hemodialysis concentrâtes solution in at least one storage tank.
According to this particularly advantageous embodiment, said packaging phase of said obtained hemodialysis concentrâtes solution consists in packaging during a second intermediate step said obtained hemodialysis concentrâtes solution in containers arranged to supply a dialysis generator.
One preferably carries out the phases of the method and of the intermediate steps in dedicated modules, which are interconnected to perform a central management of the ambient air flows that circulate through said modules, of the liquid flows entering and exiting the various modules, of the pressurized gas flows, of the electrical energy flows used by the equipment of said modules and of the circulation flows of the workers and of the components used during the method, in the course of said phases of the method and of the intermediate steps.
In order to perform a central management of the ambient or purified air flows that circulate through said modules, one advantageous ly arranges an upper zone of each of said concemed modules, in an insulated space that contains circulation paths for an entering atmosphère and an exiting atmosphère, which are respectively in communication with a central air treatment module.
In order to perform a central management of the liquid flows, one advantageously connecta the purified water inlets and outlets of the whole of said concemed modules to each other and/or to an înlet and to an outlet of a central water treatment unit.
Brief description of the drawings
The présent invention and its advantages will be better revealed in the following description of an embodiment given as a non limiting example, in référencé to the drawings in appendix, in which:
figure l is a schematic general view that represents the unit for preparing the hemodialysis concentrâtes produced according to the method of the invention, figure 2 is a detailed view of the weighîng module that illustrâtes the equipment allowing to carry out a preiiminary phase for the production of hemodialysis concentrâtes according to the method of the invention, figure 3 is a detailed view of the préparation module that illustrâtes the equipment allowing to carry out the actual production of hemodialysis concentrâtes according to the method of the invention, figure 4 is a detailed view of the storage module that illustrâtes the equipment allowing to store the hemodialysis concentrâtes obtained according to the method of the invention, figure 5 is a detailed view of the packaging module of the hemodialysis concentrâtes obtained according to the method of the invention, figure 6 is a detailed view of the raw material sampling module în order to check their validation, figure 7 is a detailed view of the Chemical, physical and bacteriological laboratory module intended to check the quality and purity of the raw materials used in the composition of the hemodialysis concentrâtes obtained according to the method of the invention, as well as the quality and compliance of the finished or concentrated hemodialysis products,
S figure 8 is a detailed view of a treatment module for the water used in the composition of the hemodialysis concentrâtes obtained according to the method of the invention and that is used in the course of the phases of this method, figure 9 is a detailed view of a utilities module that is arranged for treating, preparing and conditioning tlows and/or energies used in the course of the method of the invention.
figure 10 is a detailed view of a washing module that is arranged for checking the entrance of the operational staff and of the equipment and products used in the course of the method of the invention, and figure 11 is a detailed view of a neutralization module (N.E.U.T) of the effluents produced in the course of the method of the invention.
Best way of realizing the invention
Referring to the figures, in particular to figure l, the represented unit 10 for the production of hemodialysis concentrâtes (CH) is made of a set of modules, detailed in figures 2 to 9, which are ail coupled and înterconnected in such a way that the fiinctions of the respective modules and of the equipment they contain can be activated in compliance with the phases of the method according to the invention. Among such modules, one counts a first group l of modules called production modules (P.R.O.D) whose function is to produce the (CH) from water-soluble raw materials (MA). Among these modules (P.R.O.D) there is a first module, called weighing module (P.E.S.E) whose function is to préparé the raw material doses that will then be used to produce the (CH) according to the prevîously elaborated formulations. A second module called préparation module (P.R.E.P) has the function of mixîng the solid raw materials in purified water to produce said concentrâtes. A third module called storage module (S.T.O.C) has the function of collecting in at least one storage tank the concentrâtes produced by the (P.R.E.P) module in order to contain them temporarily at the end of their manufacture. A fourth module called packaging module (C.O.N.D) has the function of packaging the concentrâtes in smaller volume containers, which hâve in particular a sufficient volume to allow, after a suitable final dilution, to carry out a hemodîalysis treatment session for a patient. This module could be limited to a packaging machine, without constituting on its own or filling a complex multi-functional module.
It must be noted that the production modules (P.R.O.D) or the spécifie modules and machines arranged as an addition with respect to the modules are designed to start initially with the sampling of the appropriate raw materîals (MA) and to end up with the finished products (CH), ready for distribution, after having imdergone ail checks, ail validations and ail safety and quality actions required for a product for medical use as sensitive as hemodîalysis concentrâtes.
Among said modules making up unit 10, one will count a second group 2 of modules called control (C.O.N.T) whose function is to ensure both the check of the raw materîals (MA) and that of the finished products, in this case the produced concentrâtes (CH). A fîrst module called sampling module (P.R.E.L) belongs to this second group, and it consists in taking raw material (MA) samples to check whether they comply with the data declared by the suppliers and with the régulations in force, and with the specificity sheets. A second module called laboratory module (L.A.B.O) belongs to this second group, and it consists in performing Chemical, physical and bacteriological analyses of the raw material (MA) samples previously isolated in module (P.R.E.L).
Among said modules making up unit 10, one will count a third group 3 of modules called utilities modules (F.L.U.X), which ensure the préparation and management of the fluids and energies required for the implémentation of the method. They contribute to tlie organization of the circulation of the water flow, of the air flow of the atmosphère in the varions modules, of the compressed air flow, of the effluents flow, of the circulation flow of the workers and of the electrical energy supply of the operational components.
The fîrst module of said third group 3, (F.L.U.X) is a so-called water treatment module or (T.H.2.O) module whose function is to préparé the purified water in which the raw materîals (MA) will be dissolved to produce the concentrâtes (CH). It can for example
ΙΟ comprise a reverse osmosïs filtration machine or the like in order to remove ail solid minerai residues and to neutralize the organic and/or bactériologie residues.
The second module of this third group 3 is called utilities module (U.T.I.L), and it can in particular group a compressed air generator that supplies the whole of the stations of unit 10 requiring compressed air, a hot water generator, arranged to provide ail concemed stations of unit 10 with hot water at the required température, a storage tank for the produced hot water and an electric current distributor that ensures the electrical supply of ail work stations in the various modules of unit 10.
A third module of this third group 3 of modules is called washing module (LAVA) and is organized to control and manage the workers entrance flow by means of controlled passage Systems called locks and of washing equipment.
A fourth module of this third group 3 is called air treatment module (T.A.l.R) and is designed to ensure in particular the dehumidî fi cation and purification of the air that circulâtes in the various modales. To this purpose it comprises an air treatment equipment including a dehumidifier and heating and/or conditioning means known per se, which could be mounted separately outside the other modules.
A fourth group 4 called (E.F.F.L), comprises one or several modules called effluents neutralization module (N.E.U.T), whose fonction is to treat and îf necessary neutralize the effluents generated by the production and the additional treatments, in order to be able to discharge them safety and lawfully at the end of the production of hemodialysis concentrâtes (CH).
The production of hemodialysis concentrâtes (CH) begins in fïrst group 1 of modules called production modules (P.R..O.D), and more precisely in weighing module (P.E.S.E) illustrated in figure 2. This module 31 is equipped with weighing means 32 arranged undemeath an extraction hood 33. An area 34 allows controlling the secured entrance of the staff, an area 35 allows weighing the raw materials (MA) and an area 36 allows packaging the weighed products. The weighing module comprises integrated ventilation
- H means, which are arranged laterally and are made of two channels 37a and 37b running along the side walls of the module. These channels communicate on the one hand with a general aération and ventilation network that supplies ail modules and, on the other hand, with the inside of ail areas of the module, according to the spécifie needs, through wallmounted flaps 38 and exhausts 39. Channels 37a and 37b are housed in the upper section of module 31, for example in a space separated from the inside of the module by a false ceiling or the like.
After weighîng module (P.E.S.E) illustrated in figure 2 cornes préparation module 41 (P.R.E.P), illustrated in figure 3, whose function is to dissolve the previously dosed raw materials (MA) in purified water. To this purpose, one introduces in a préparation container 42 or mixing container that contains a fraction of the volume intended for producing the planned volume of hemodialysis concentrâtes (CH) in the course of a fist step, then, after stirring this mixture, one complétés the volume of purified water to obtain the required resuit. The raw materials (MA) are brought from an area 43 to an area 44 in which the purified water is introduced in préparation container 41. As for the weighîng module illustrated in figure 2, préparation module 41 (P.R.E.P) comprises integrated ventilation means, which are arranged laterally and are made of two channels 47a and 47b running along the side walls of the module. These channels communicate with the whole of the ventilation and air distribution circuit and comprise means for intercommunication with the other channels having the same functions of the other modules of unit 10.
After weighîng module (P.E.S.E) illustrated in figure 2 and préparation module 41 (P.R.E.P) illustrated in figure 3, cornes storage module 51 (M.S.T.O), illustrated in figure 4, whose function is to store the hemodialysis concentrâtes (CH) produced, for example in three storage tanks 52, 53 and 54. The storage of the products in these tanks is temporary. and it will be used to supply containers or packagings intended for direct use with patients at the time of a hemodialysis treatment. As for the previous modules of the same production group (P.R.O.D), storage module 51 (M.S.T.O) is equipped with two channels 57a and 57b, which run along the side walls of the module and communicate with the whole of the ventilation and air distribution circuit and comprise means for intercommunication with the other channels having the saine functions of the other modules of unit 10.
After storage module 51 (M.S.T.O) cornes packaging module 61, illustrated in figure 5, whose function is to distribute the hemodialysis concentrâtes (CH) in containers 62 suitable for patients treatment. The produced concentrâtes (CH) are initially diluted. for example of the order of ten times, to allow their direct consomption by the dialysis machines. Packaging module 61 (C.O.N.D) is equipped with two channels 67a and 67b, which run along the side walls of the module and communicate with the whole of the ventilation and air distribution circuit and comprise means for intercommunication with the other channels having the same functions of the other modules of unit 10.
On the other hand, unit 10 comprises a. second modules group 2 called control modules (C.O.N.T), in particular a first module 71 called sampling module (P.R.E.L) illustrated in figure 6, whose function is to take raw materials (MA) samples in order to check whether they comply with the data declared by the suppliers and with the specificity sheets. Module 71 includes sampling means 72 for checkîng purposes. It is moreover equipped with two channels 77a and 77b, which run along the side walls of the module and communicate with the whole of the ventilation and air distribution circuit and comprise means for intercommunication with the other channels having the same functions of the other modules of unit 10. This module also comprises an entrance lock 73 to control staff entrance and a hood 74 to control the air flow that circulâtes in the module, and in particular in area 75, where sampling is performed.
A second module 81, illustrated in figure 7, called laboratory module (L.A.B.O), belongs to this second group of control modules (C.O.N.T), and it is intended for Chemical, physical and bacteriological analyses of the raw material (MA) samples previously isolated in module (P.R.E.L) and of the finished products. It includes three separated areas arranged inside of module 81, a bacteriological analyses area 82, a physical analyses area and a Chemical analyses area 84, which are performed on the raw materials (MA) or on various products used within the framework of the method such as the purified water, the circulating air of the effluents. It is moreover equipped with two channels 87a and 87b.
which run along the side walls of the module and communicate with the whole of the ventilation and air distribution circuit and comprise means for intercommunication with the other channels having the same functions of the other modules of unit 10.
The first module of said third group 3, (F.L.U.X) is a so-called water treatment module 91 or (T.H.2.O) module illustrated in figure 8, whose function is to préparé the purified water in which the raw materials (MA) will be dissolved to produce the concentrâtes (CH) and to manage the refrigerated water and the hot water in two separate loops. It can for example include a reverse osmosis filtration machine 92 or the like. It includes a purified water 10 storage tank 93 to allow having permanently a water reserve for use in the production phase. Moreover, module 91 can include a softener 94, a relrigerating exchanger 95 and a heating exchanger 96 in order to control independent hot water and refrigerated water circuits.
Figure 9 illustrâtes the utilities module that is arranged for treating, preparing and conditioning flows and/or energies used in the course of the method. Module 101 can in particular comprise an electricity control unit 102, a softened water tank 103. a hot water production unit 104 and a compressed air génération unit 105.
Figure 10 illustrâtes washing module (LAVA) 111, which is provided with a washing room 112 to clean everything that enters in the treatment circuit of unit 10. Entrance locks 113 are provided to secure and control the whole of the entering material, as well as the operational staff. A storage area 114 under controiled atmosphère, advantageously under positive pressure and at a determined température, is provided in washing module (LAVA) 25 111.
Figure 11 illustrâtes the effluents neutralization module called N.E.U.T, which belongs to group 4 (E.F.F.L), and whose function is to purge and neutralize the effluents before discharging them.
The modular design of this unit offers several advantages linked in particular to the constructive concept and to the distribution of ali operational components, which are organized according to validated rules, immutable from one unit to another. The common centralized management of ail flows and ail energies constitûtes a safety guarantee by allowing an overall view and generalized maintenance. The costs of an installation are foreseeable and do not dépend on local parameters. The operational staff can be trained in 5 any unit and the staff can be interchanged from one unit to another without requiring spécifie traîning.
The invention is not restricted to the examples of embodiment described and can présent different aspects according to certain foreseeable évolutions or according to improvements I0 of spécifie components. However, the scope of the invention is part of the framework defined by the daims.
Claims (18)
- Claims1. Unit (10) for preparing at least one hemodialysis concentrâtes solution (CH), said solution being composed of solid water-soluble materials comprising at least sodium chloride (NaCI), potassium chloride (K.C1), calcium chloride (CaCh) and magnésium chloride (MgCh), including means for preparing said solution by introducing successively predetermined quantities of said solid materials in a predetermined volume of purified water in a mixing container, means for carrying out individually a dosage control of said solid materials introduced in said predetermined volume of purified water and means for carrying out individually a compliance check of the concentrâtes solution obtained at the end of the process, said unit being characterized in that it comprises the following modules:a sampling module (MPRE) to take at least a 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 raw material samples to control its compliance and quality, a weighing module (MPES) to détermine the quantity in weight of said raw materials to be introduced in said predetermined volume of purified water,- a solution préparation module (MPRE) to introduce and dissolve said quantity in weight of said raw materials in said predetermined volume of purified water, and- at least one module (MCON) for packaging said hemodialysis concentrâtes solution obtained.
- 2. Unit according to claim 1, characterized in that it comprises first analysis means to carry out, during a first intermediate step of said analysis phase of each of said raw material samples, a quality check that consists in checking the compliance of the samples with the theoretical quality defined by at least one certificate specifÿing the nature and composition of the concemed materials, as well as the compliance with the régulations în force.I6
- 3. Unit according to claim l, characterized in that it comprises second analysis means to carry ont, during a second intermediate step of said analysis phase of each of said raw material samples, a purity check that consists in determining the actual weight of each of said raw materials which corresponds to the weight of the pure active substance contained in these raw materials according to their respective purity.
- 4. Unit according to claim l, characterized in that it comprises coupling means to interconnect ail of the dedicated modules to perform respective!}' a centralized management of the purified air flows that circulate through said modules, of the liquid flows entering end exiting the various modules, of the pressurized gas flows, of the electrical energy flows used by the equipment of said modules and of the circulation flows of the workers and of the components used during the method, in the course of said phases of the method and of the intermediate steps.
- 5. Unit according to claim 1, characterized in that it comprises a central purification equipment of the atmosphère that circulâtes through said modules and spécifie régulation means of the pressure of the air contained in each of said respective modules, means for connecting the modules to said central purification equipment and means for interconnecting the modules to each other and/or to said central purification equipment.
- 6. Unit according to claim 5, characterized in that said means for connecting the modules to said central purification equipment comprises an air duct network arranged in a tight space located above a false ceiling reserved in the top section of each of said modules, said duct network comprising for each of said modules at least one iniet opening and at least one outlet opening, each of said iniet and outlet openings being equipped with a coupling valve to ensure an interconriection of at least one of said ducts of said duct network.
- 7. Unit according to claim 1, characterized in that it comprises a central water treatment equipment that supplies at least a part of said modules, means for distributing the treated water in each of said respective modules, means for collecting the waste water in each of said respective modules and means for connecting the modules to said central water treatment equipment and means for interconnecting the modules to each other and/or to said central water treatment equipment.
- 8. Method for preparing at least one hemodialysis concentrâtes solution, said solution being composed of solid water-soluble materials comprising at least sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCb) and magnésium chloride (MgCli), wherein one préparés said solution by introducing successively in a mixing container predetermined quantities of said solid materials in a predetermined volume of purified water contained in said mixing container, wherein one carries out individually a dosage control of said solid materials introduced in said predetermined volume of purified water and wherein one carries out individually a compliance check of said concentrâtes solution for hemodialysis obtained by the method, said method being characterized in that it comprises the following phases:- a sampling phase to take a sample of each of said raw materials to be dissolved in said volume of purified water, an analysis phase of each of said raw material sampies to check their quality,- a weighing phase to détermine the quantity in weight of said raw materials to be introduced in said predetermined volume of purified water,- a solution préparation phase consisting in introducing and dissolving said quantity in weight of said raw materials in said predetermined volume of purified water, and- a phase for packaging said hemodialysis concentrâtes solution obtained.
- 9. Method according to claim 8, characterized in that the analysis phase of each of said raw material sampies to check their quality comprises a first intermediate step that consists in checking the compliance of the sampies with the theoretical quality defined by at least one certificate specifying the nature and composition of the concemed materials.
- 10. Method according to claim 8, characterized in that the analysis phase of each of said raw material sampies to check their quality comprises a second intermediate step including the measurement of the purity of the raw materials, which consists in determining the actual weight of each of said raw materials that corresponds to the weightÎ8 of the pure active substance contained in these raw materials according to their respective purîty.
- 11. Method according to claim 8, characterized in that said solution préparation phase to introduce and dissolve said quantity in weight of said raw materials in said predetermined volume of purified water comprises a first intermediate step durîng which one introduces in said mixing container the quantity in weight of said raw materials required to realize said hemodialysis concentrâtes solution, said mixing container containing initialiy a fraction of said predetermined volume of purified water.
- 12. Method according to claim 11, characterized in that said fraction of said predetermined volume of purified water is at least approximately comprised between 50 and 80% of said predetermined volume, and preferably close to two thirds of said predetermined volume.
- 13. Method according to claims 8 and 11, characterized in that said solution préparation phase to introduce and dissolve said quantity in weight of said raw materials in said predetermined volume of purified water comprises a second intermediate step during which one adds in the mixing container, to the solution obtained after said first step. the remainder of said predetermined volume of purified water.
- 14. Method according to claim 8, characterized in that said packaging phase of said obtained hemodialysis concentrâtes solution consists in transferring during a first intermediate step said obtained hemodialysis concentrâtes solution in at least one storage tank.
- 15. Method according to claim 8, characterized in that said packaging phase of said obtained hemodialysis concentrâtes solution consists in packaging during a second intermediate step said obtained hemodialysis concentrâtes solution in containers arranged to supply a dialysis generator.
- 16. Method according to claim 8, characterized in that one carries out the phases of the method and of the intermediate steps in dedicated modules, which are înterconnected to perform a central management of the ambient air flows that circulate through said modules, of the liquid flows entering and exiting the varions modules, of the pressurized gas flows, of the electrical energy flows used by the equîpment of said modules and of the circulation flows of the workers and of the components used during the method, in the course of said phases of the method and of the intermediate steps.
- 17. Method according to claim 16, characterized in that, in order to perform a central management of the ambient air flows that circulate through said modules, one arranges an upper zone of each of said concemed modules, in an insulated space that contains circulation paths for an entering atmosphère and an exiting atmosphère, which are10 respectively in communication with a central air treatment module.
- 18. Method according to claim 16, characterized in that, in order to peribrm a central management of the liquid flows, one connects the purified water inlets and outlets of the whole of said concemed modules to each other and/or to an inlet and to an outlet of a15 central water treatment unit.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CH00377/16 | 2016-03-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| OA18871A true OA18871A (en) | 2019-09-13 |
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