Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1654—Dialysates therefor
  • A61M1/1656—Apparatus for preparing dialysates
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/08—Solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1654—Dialysates therefor
  • A61M1/1656—Apparatus for preparing dialysates
  • A61M1/1666—Apparatus for preparing dialysates by dissolving solids
• • E—FIXED CONSTRUCTIONS
  • E04—BUILDING
  • E04H—BUILDINGS OR LIKE STRUCTURES FOR PARTICULAR PURPOSES; SWIMMING OR SPLASH BATHS OR POOLS; MASTS; FENCING; TENTS OR CANOPIES, IN GENERAL
  • E04H1/00—Buildings or groups of buildings for dwelling or office purposes; General layout, e.g. modular co-ordination or staggered storeys
  • E04H1/005—Modulation co-ordination
• • E—FIXED CONSTRUCTIONS
  • E04—BUILDING
  • E04H—BUILDINGS OR LIKE STRUCTURES FOR PARTICULAR PURPOSES; SWIMMING OR SPLASH BATHS OR POOLS; MASTS; FENCING; TENTS OR CANOPIES, IN GENERAL
  • E04H3/00—Buildings or groups of buildings for public or similar purposes; Institutions, e.g. infirmaries or prisons
  • E04H3/08—Hospitals, infirmaries, or the like; Schools; Prisons
• • E—FIXED CONSTRUCTIONS
  • E04—BUILDING
  • E04H—BUILDINGS OR LIKE STRUCTURES FOR PARTICULAR PURPOSES; SWIMMING OR SPLASH BATHS OR POOLS; MASTS; FENCING; TENTS OR CANOPIES, IN GENERAL
  • E04H5/00—Buildings or groups of buildings for industrial or agricultural purposes
  • E04H5/02—Buildings or groups of buildings for industrial purposes, e.g. for power-plants or factories
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3331—Pressure; Flow
  • A61M2205/3334—Measuring or controlling the flow rate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
  • A61M2205/3393—Masses, volumes, levels of fluids in reservoirs, flow rates by weighing the reservoir
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
  • A61M2207/10—Device therefor

Definitions

• 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.
• NaCl sodium chloride
• KCl potassium chloride
• CaCl 2 calcium chloride
• MgCfc magnesium chloride
• NaCl sodium chloride
• KCl potassium chloride
• CaCb calcium chloride
• MgC magnesium chloride
• 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.
• 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.
• the unit for preparing at least one hemodialysis concentrate solution 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
• a weighing module for determining the quantity by weight of said raw materials to be introduced into said predetermined volume of purified water
• a conditioning module of said solution obtained concentrates for hemodialysis 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. 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
• 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
• Figure 11 is a detailed view of a neutralization module (NEUT) effluents obtained in the part of the process of the invention.
• NEUT neutralization module
• 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.
• 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.
• PROD production modules
• PESE weighing module
• a second module called preparation module has the function of mixing the solid raw materials in purified water to produce said concentrates.
• a third module called storage module 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 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.
• production modules 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.
• modules called control modules 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).
• the said modules that make up unit 10 there will be a third group
• FLUX utility modules
• the first module of said third group 3 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.
• UTIL utilities module
• 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.
• LAVA washing module
• 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.
• TAIR air handling module
• 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).
• NEUT neutralization module
• the production of concentrates for hemodialysis 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.
• 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.
• the preparation module 41 (PREP), illustrated in FIG. 3, which aims to dissolve the raw materials (MA) previously dosed into the water. 'purified water.
• 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.
• 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.
• 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.
• the storage module 51 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.
• the conditioning module 61 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.
• 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
• 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
• the 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.
• a second module 81 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
• the first module of said third group 3, 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.
• 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.
• FIG. 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.
• 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.

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• 2016
  • 2016-03-18 CH CH00377/16A patent/CH712274B1/fr not_active IP Right Cessation
• 2017
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  • 2017-03-17 KR KR1020187030203A patent/KR20180135903A/ko not_active Application Discontinuation
  • 2017-03-17 EP EP17717615.3A patent/EP3429658A1/de active Pending
  • 2017-03-17 US US16/085,718 patent/US20190083691A1/en not_active Abandoned
  • 2017-03-17 WO PCT/CH2017/000029 patent/WO2017156643A1/fr active Application Filing
  • 2017-03-17 CN CN201780018190.1A patent/CN109069720B/zh active Active
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• 2018
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