Method for producing a parenteral or enteral nutritional composition, system designed for same, and computer product

Abstract

The invention relates to a method for producing a parenteral or enteral nutritional composition, having the steps of: - providing a formulation which contains a plurality of components of the nutritional composition; - assigning an unambiguous identification to the components using a first data processing system, wherein the unambiguous identification is stored in a first database of the first data processing system; - clearing the formulation by means of the first data processing system if the unambiguous identification of the component is present; - transmitting the cleared formulation, by means of the first data processing system, to a second data processing system; - checking the transmitted formulation by means of the second data processing system, wherein the composition of the plurality of components of the nutritional composition is checked for stability and compatibility, and the stability and compatibility criteria are stored in a second database of the second data processing system; - clearing the formulation checked by the second data processing system for stability and compatibility if the stability and compatibility criteria are satisfied; - transmitting the clearance of the second data processing system to the first data processing system; and - filling a target container with the nutritional composition according to the formulation by means of an automated filling system.

Description

[0001] Method for producing a parenteral or enteral nutritional composition and system and computer product designed therefor

[0002] Field of the invention

[0003] The invention relates to a method for producing a parenteral or enteral nutritional composition using an automated filling system.

[0004] The invention further relates to a system designed to carry out the method and to a computer program product.

[0005] Background of the invention

[0006] It is known that nutritional compositions for parenteral or enteral nutrition can be prepared based on a recipe tailored to the individual patient. From this recipe, a formulation is created in which the components of the nutritional composition and their respective amounts are clearly defined.

[0007] Automated filling systems, so-called compounders, are used to fill the components into a target container. Such a compounder can comprise a pump and a transfer set with a plurality of valves. The transfer set can be connected to a plurality of source containers. By controlling the valves, the compounder can fill the target container with the various components of the nutritional composition according to a formulation. Such a compounder is known, for example, from the published patent application WO 2017 / 158032 A1.

[0008] Typically, the basic components of such a nutritional composition are a glucose-containing liquid, a lipid-containing liquid, and an amino acid-containing liquid. Liquids that additionally contain vitamins and / or trace elements, for example, can be added using the compounder, adapted to the respective formulation.

[0009] In addition to ensuring the most precise dosing of the individual components possible, it is important when mixing such a nutritional composition that, for example, individual components of the nutritional composition do not come into contact with each other in such high concentrations when filling the target container that undesirable, particularly chemical or physical, reactions occur, such as the precipitation of solids. This can occur, for example, when mixing calcium- and phosphate-containing solutions.

[0010] To avoid this, a mixing sequence must be observed, among other things.

[0011] Furthermore, one of the source containers usually contains a universal liquid, e.g., water, which is transferred to the destination container. The universal liquid is used to rinse the transfer set between switching the withdrawal from one source container to another.

[0012] Published patent application WO 01 / 39874 A1 describes a method for reducing the number of such rinse cycles. The pharmacist is usually responsible for adhering to the recipe, i.e., based on a recipe, a formulation is created that contains the clearly identifiable components of the respective nutritional composition. The formulation usually also includes the mixing sequence of the components.

[0013] In addition to the general compatibility of the individual components, the overall composition influences the chemical stability of the mixture, its physical stability (e.g., in the case of emulsions), and its shelf life. Regarding the compatibility and stability of the individual components of a nutritional composition with each other, there are often studies that the pharmacist can refer to.

[0014] Object of the invention

[0015] The invention, in contrast, is based on the object of reducing the aforementioned disadvantages of the prior art. In particular, the invention aims to provide a process for producing an enteral or parenteral nutritional composition that is as simple as possible and offers a high level of safety.

[0016] Summary of the invention

[0017] The object of the invention is already achieved by a method for producing a parenteral or enteral nutritional composition, by a system for producing an enteral or parenteral nutritional composition, and by a computer program product according to one of the independent claims. Preferred embodiments and developments of the invention can be found in the subject matter of the dependent claims, the description, and the drawings.

[0018] The invention relates to a process for the preparation of a parenteral or enteral nutritional composition, which comprises the following steps:

[0019] - providing a formulation which includes a plurality of components of the nutritional composition;

[0020] - Assigning a unique identification to the components by a first data processing system, wherein the unique identification is stored in a first database of the first data processing system;

[0021] Release of the formulation by the first data processing system when the unique identification of the components is given;

[0022] - transmission of the approved formulation by the first data processing system to a second data processing system;

[0023] - checking the transmitted formulation by the second data processing system, wherein a composition of the plurality of components of the nutritional composition is checked for stability and / or compatibility, wherein stability and / or compatibility criteria are stored in a second database of the second data processing system;

[0024] Releasing the formulation tested for stability and / or compatibility by the second data processing system if the stability and / or compatibility criteria are met;

[0025] - transmitting the release of the second data processing system to the first data processing system;

[0026] - Filling a target container with the nutritional composition according to the formulation using an automated filling system.

[0027] A formulation is understood to be a compilation of components according to quantity and clearly identifiable type of component, such as the exact drug name.

[0028] The formulation can be prepared by the pharmacist based on the recipe.

[0029] For example, the formulation may contain, in whole or in part, only information on specific substances in the desired quantity. Depending on the formulation, the pharmacist selects suitable drug compositions, particularly components of parenteral or enteral nutrition solutions, from which the formulation is created.

[0030] However, it is also possible that the recipe already contains a clear identification of the components, so that a formulation is already created by creating the recipe.

[0031] For example, the formula may specify the amount of a trace element, such as potassium. However, potassium is a solid that cannot be added in its pure form to the nutritional composition. Based on this, the pharmacist selects a suitable potassium solution, such as a potassium chloride or potassium phosphate solution from a specific manufacturer, to incorporate the desired amount of potassium. Alternatively, the formula may already specify a uniquely identifiable potassium solution from a specific manufacturer.

[0032] According to the method, a first data processing system is used, to which the pharmacist in particular has access.

[0033] The first data processing system comprises a database in which unique identifications of components of a nutritional composition are stored.

[0034] For example, the first data processing system can access the first database to check whether a unique identification exists and assign it to the component based on a trade name, a drug number, such as a PZN number, securPharm or a National Drug Code.

[0035] The unique identification may, for example, be a sequence of numbers and / or letters assigned to a component of the food composition.

[0036] Components that are, for example, named differently in different countries or have a different drug number can be assigned to a single identification.

[0037] In addition to manually entering the formulation into a computer, one embodiment of the invention provides for the formulation to be already stored as a data record in a database or to be read in using an external unit, such as a barcode scanner that reads, for example, an ID or 2D barcode. If a unique identification of the components of the formulation is provided, the formulation is released by the first data processing system.

[0038] If this is not the case, the first data processing system can generate a corresponding notice for the user so that he or she has the option, for example, to use another component with the same relevant substances.

[0039] The first data processing system transmits the approved formulation to a second data processing system.

[0040] The test is therefore carried out in two stages, with the first data processing system at least checking whether the components are uniquely identified.

[0041] Release within the meaning of the invention by the first and / or second data processing system is understood to mean checking the criteria stored in the first or second data processing system and evaluating them. Consent for the compounder to mix the nutritional composition, i.e., release for production, is given by the user, typically the pharmacist.

[0042] This can accelerate the corresponding check. Furthermore, the second data processing system is preferably a data processing system on which the user of the first data processing system cannot change at least the data stored in a second database of the second data processing system. The user of the first data processing system therefore only has write access to the first database of the first data processing system, but not to the second database of the second data processing system.

[0043] The second data processing system can thus be easily administered and maintained without the involvement of the user of the first data processing system.

[0044] The second data processing system comprises a second database in which stability and / or compatibility criteria of the components are stored.

[0045] The stability criteria of components and of mixtures with other components include in particular the shelf life of the corresponding nutritional composition.

[0046] The stored compatibility criteria determine whether and in what quantity the respective components can be mixed with each other without causing undesirable reactions, such as chemical reactions.

[0047] The relevant information is stored in the second database.

[0048] The second data processing system can rely on the unique identification of the respective components.

[0049] If the stability and / or compatibility criteria are met, the formulation tested for stability and / or compatibility by the second data processing system can be released. To this end, the second data processing system transmits the release to the first data processing system.

[0050] The user of the first data processing system thus receives at least the release from the second data processing system and can then initiate the filling of the target container if the corresponding release is available.

[0051] The security of the system is further increased by the fact that the user preferably does not have write access to the second database of the second data processing system. Compared to manual review of studies, security is increased by the automated testing of stability and / or compatibility by the second data processing system.

[0052] The control of the automated filling system to initiate the filling process can be carried out in particular via the first data processing system.

[0053] In particular, after approval by the second data processing system, the first data processing system transmits the formulation to the automated filling system. Transmission is preferably initiated by the user, e.g., by an input on the client.

[0054] The automated filling system is designed, in particular, as a compounder with a metering pump. A transfer set, via which liquid is withdrawn from the source container and pumped into the target container, can be connected to the compounder. Regarding the design of the compounder, reference is made to the disclosure of published patent application WO 2017 / 158032 A1. According to one embodiment, the compounder can therefore comprise all the feature combinations disclosed in this document.

[0055] In a further development of the invention, the second data processing system transmits to the first data processing system a data set which, in addition to the release, also contains the wording. This can be a write-protected, encrypted data set in which the wording is stored together with the release by the second data processing system.

[0056] In a further development of the invention, the first data processing system at least partially suggests the formulation on the basis of a recipe entered into the first data processing system.

[0057] As explained above, the recipe may only include the quantities of certain substances in the nutritional composition.

[0058] The recipe can be entered into the first data processing system, whereby the first data processing system then suggests components based on the desired substances, for which a unique identification is stored.

[0059] The user of the first data processing system now selects a component for which a unique identification exists. From this, the formulation is formed.

[0060] Preferably, the first data processing system checks a limit value based on data stored in the first database regarding the dosage of a component of the formulation and / or regarding a volume of the formulation. This means that the first data processing system can already check in advance whether the desired volume is compatible with the selected target container. Furthermore, the first data processing system can, for example, check whether the formulation contains at least one substance for which a minimum or maximum quantity is exceeded or not reached. Furthermore, the first data processing system can, for example, check based on the patient's weight whether a maximum quantity of the volume to be transferred has been exceeded.

[0061] If one of these criteria is not met, the first data processing system can generate a warning for the user and the formulation will not be released.

[0062] The limit value is checked, in particular, based on patient-specific data entered into the first data processing system. This may include, in particular, the patient's weight, gender, and / or age.

[0063] The first data processing system can, in particular, access the first database to check whether the target container is sufficiently dimensioned for the desired nutritional composition, whether the mixing sequence is maintained in such a way that no undesirable chemical and / or physical reactions occur and / or whether the total volume of the target container is not too high for the respective patient.

[0064] In a further development of the invention, the step of assigning a unique identification to the components by the first data processing system comprises converting a drug number or a drug name of the component into the unique identification.

[0065] The first data processing system may contain a conversion database in which national authorisation numbers, such as PZN number or National Drug Code and / or national trade names, are assigned to a unique identification which is used by the second data processing system during the check.

[0066] This has the advantage that the first data processing system can be adapted to the specific drug available, particularly at the specific location.

[0067] The second data processing system, however, can dispense with the use of such a conversion database, i.e. for the assignment of the individual components, only the unique identifications of the respective components are stored in the second database of the second data processing system.

[0068] This simplifies the administration and maintenance of the second data processing system.

[0069] Preferably, the checking of the mixing sequence of the components is carried out by the first data processing system, particularly preferably only by the first data processing system.

[0070] In a preferred embodiment of the invention, the check by the first and / or second data processing system includes a check of the type of target container. For example, the first data processing system checks whether the volume of the selected target container is compatible with the volume of the formulation.

[0071] The second data processing system checks, for example, the extent to which the target container is compatible with the components of the formulation in terms of material and other design so that they are stable for a sufficient period of time.

[0072] The second data processing system can generate a shelf life indication and / or a storage condition.

[0073] This is preferably generated taking into account the type of target container.

[0074] The second data processing system can, for example, display together with the release how long and at what temperature the target container can be stored and, in particular, whether it needs to be protected from light, etc.

[0075] In a further development of the invention, if the second data processing system fails to check the formulation, the second data processing system generates a proposed change to the formulation and forwards this to the first data processing system.

[0076] For example, as part of the stability and / or compatibility testing, study data stored in the second database can be used to determine the minimum or maximum amount and / or concentration of a specific component that may be present in the food composition. If a minimum amount is not met or a maximum amount is exceeded, the second data processing system can create a corresponding correction proposal and transmit it to the first data processing system.

[0077] The user can then decide whether to accept the proposed change.

[0078] The first data processing system communicates with the second data processing system via a network, preferably the Internet.

[0079] Preferably, communication is encrypted.

[0080] The target containers and components are assigned based on unique identification.

[0081] According to one embodiment of the invention, the first data processing system is provided in such a way that it comprises a backend server that communicates, on the one hand, with at least one client for inputting the recipe and / or formulation, and, on the other hand, with the second data processing system. The client and backend server can be located on the same computer system. In particular, the client can be configured as a terminal of the backend server.

[0082] The first data processing system thus serves as an interface for the user using the client. In particular, the second data processing system can transmit the approval to the client via the backend server.

[0083] After approval by the second data processing system, the transmission of the formulation to the automated filling system can also be initiated via the client. This is preferably done via the backend server.

[0084] The first database, which the backend server uses to check the formulation, is preferably integrated in such a way that the second data processing system has no access to the first database.

[0085] Communication within the network can be via TCP / IP, for example. Transmission can occur via a bidirectional interface from the first data processing system to the automated filling system and / or the second data processing system.

[0086] The data format used can be ASCII, XML or JSON, for example.

[0087] Preferably, only the backend server has access to the first database. The first data processing system thus preferably does not allow external or Active Domain User access to the database. The first data processing system can thus be designed to be closed.

[0088] According to an alternative embodiment, access to the first data processing system can be provided by other Active Domain users, thus enabling central administration.

[0089] The first database is preferably protected against tampering by encryption. Encryption is activated by the database administrator, and a key for access is generated and managed in the system.

[0090] According to one embodiment, the second database contains

[0091] Study data on the stability and / or compatibility of components, which are forwarded from the second data processing system to the first data processing system.

[0092] In addition to the release, the user of the first data processing system thus receives easy access to study data that are relevant for the selected formulation.

[0093] For example, a single-chamber container or a multi-chamber container can be provided as the target container. The target container can, in particular, be designed as a bag. During a check, in particular during a compatibility and / or stability check by the second data processing system, the first and / or second data processing system takes into account whether the components are mixed in a single-chamber container or whether they are distributed among the various chambers of a multi-chamber container.

[0094] The invention further relates to a system which is designed to carry out the method described above.

[0095] The system comprises in particular the first and the second data processing system as well as software that controls the system so that it operates according to the method described above.

[0096] The invention further relates to a system for producing an enteral or parenteral nutritional composition comprising a plurality of components, comprising a first data processing system which is designed to assign a unique identification to the components of the nutritional composition, wherein the unique identification is stored in a first database of the first data processing system, wherein the first data processing system is designed to release the formulation when the unique identification of the components is given and to transmit the released formulation to a second data processing system, wherein the second data processing system comprises a second database in which stability and / or compatibility criteria are stored, and is designedtesting the formulation transmitted by the first data processing system with the composition of the plurality of components of the nutritional composition for stability and / or compatibility, and wherein the second data processing system is configured to release the formulation tested for stability and / or compatibility if the stability and / or compatibility criteria are met and to transmit the release to the first data processing system, and an automated filling system for filling a target container with the nutritional composition according to the formulation tested and released by the second data processing system.

[0097] The invention further relates to a system which is designed as a first data processing system.

[0098] The first data processing system is designed in particular for use in the system described above for producing an enteral or parenteral nutritional composition.

[0099] The system is designed to assign a unique identification to the components of a formulation of an enteral or parenteral nutritional composition, wherein the unique identification is stored in a first database of the system, and wherein the system is designed, when a unique identification is assigned to the components, to release the formulation and to transmit it to a second data processing system, which is designed to check the formulation for stability and / or compatibility of the components and to release the formulation if the stability and / or compatibility criteria are met, and wherein the system is designed to receive the release of the second data processing system and to display the release of the second data processing system to a user.

[0100] Preferably, the first data processing system is designed to transmit the formulation checked and released by the second data processing system to an automated filling system, in particular after the user's consent.

[0101] Furthermore, the invention relates to a computer product which comprises instructions which, when a program is executed, carry out the above-mentioned method steps.

[0102] The invention further relates to a computer program product comprising instructions that cause a first data processing system to assign a unique identification to the components of a formulation of an enteral or parenteral nutritional composition and, if a unique identification is assigned to the components, to release the formulation and to transmit it to a second data processing system that is designed to check the formulation for stability and / or compatibility of the components and to release the formulation if the stability and / or compatibility criteria are met, and to receive the release of the second data processing system and to display the release of the second data processing system to a user.

[0103] Preferably, the computer program product also comprises instructions to cause the first data processing system to transmit the formulation checked and approved by the second data processing system to an automated filling system, in particular after the user's consent.

[0104] Short descriptions of the drawings

[0105] The subject matter of the invention will be explained in more detail below with reference to the drawings Fig. 1 to Fig. 5c.

[0106] Fig. 1 is a flowchart of an embodiment of a method according to the invention.

[0107] Fig. 2 is a flow diagram of an embodiment of a method according to the invention.

[0108] Fig. 3 shows an embodiment of a system for carrying out a method according to the invention.

[0109] Referring to Fig. 4a to 4c, screenshots are used to explain in more detail the entry of a recipe until it is released by the second data processing system.

[0110] Fig. 5a to Fig. 5c show a corresponding alternative embodiment in which no release occurs.

[0111] Detailed description of the drawings Fig. 1 to 3 serve to illustrate an embodiment of a system according to the invention (Fig. 3) on which a method according to the invention (Fig. 1 and Fig. 2) runs.

[0112] Fig. 1 is a flowchart of an embodiment of a method according to the invention.

[0113] First, the user, who has access to the first data processing system 10 via a client lla-llc, enters a recipe, the mixing sequence and the type of desired target container 33 for an enteral or parenteral nutritional composition 101.

[0114] As a recipe, the user can enter desired substances which should be added to the nutritional composition.

[0115] The first computer system 10 then suggests a component containing this substance. The first data processing system 10 can, among other things, make the display dependent on whether the respective component is available. The user then specifies the type of desired target container 33. For example, the material of the target container 33 is defined, whether it is a foil bag, and / or whether it is a multi-chamber container.

[0116] Furthermore, the user can also enter patient-specific data, in particular the patient's weight, age and / or gender.

[0117] With the aid of the first database 13 of the first data processing system 10, more precisely the backend server 12 (see Fig. 3) which is part of the first data processing system, the first data processing system 10 supports the user in creating at least one electronic formulation of components for the nutritional composition, in which each component, including the target container 33, is uniquely defined 102.

[0118] For this purpose, for example, a unique identification is assigned to the trade name of a medicinal product or a regional pharmaceutical number.

[0119] The first computer system 10, more precisely the backend server 12, checks the formulation including the type of the desired target container 33 at least to determine whether each component, including the target container 33, is assigned a unique identification 103.

[0120] Furthermore, the first data processing system 10 preferably also checks the formulation for criteria such as mixing order, maximum / minimum volume and / or limit values ​​for certain substances present in the nutritional composition.

[0121] If the check criteria are not met, the formulation will not be released, but the user will be notified of the failed release on the lla-llc client.

[0122] In case of release, the formulation is forwarded to a second data processing system 20 104.

[0123] The second data processing system 20 now checks the formulation components for chemical and / or physical stability and compatibility. In the event of a failed release, this is also displayed on the client lla-llc. The transmission occurs from the second data processing system 20 via the backend server 12.

[0124] The second data processing system 20 accesses a second database 21 to which the first data processing system 10 has at least no write access 105.

[0125] In the event of a successful release by the second data processing system 20, at least the release is forwarded to the first data processing system 10, more precisely to the backend server 12, and displayed 106 on the client lla-llc.

[0126] The released formulation can now be transferred to the compounder 30 and the target container 33 can be filled.

[0127] The transmission of the formulation is preferably initiated via the client lla-llc of the first data processing system 10.

[0128] Fig. 2 is a flow diagram of the method according to the invention, which in this representation is divided into the levels marked 1 - 4.

[0129] "1" indicates the location where the prescription is created, for example, the hospital where the prescription is created. "2" indicates the procedures that take place at the pharmacist's office. "3" indicates the automated filling system (production), and "4" the second data processing system 20. First, a prescription for an enteral or parenteral nutritional composition is created. This is usually done by the attending physician.

[0130] Based on the recipe, the pharmacist creates an electronic proposal for a formulation with the help of the first data processing system 10.

[0131] The first data processing system 10 checks the formulation and releases it.

[0132] In the event of a failed test, for example, because the limit values ​​for a particular substance are exceeded or undershot, the treating physician is notified that the formulation cannot be released. A new, adjusted recipe or formulation can then be created.

[0133] Once all testing criteria have been met, the formulation is released. Each component, including the target container 33, contains a unique identification.

[0134] This data set, which contains the components, their quantity and the type of target container 33 along with a unique identification for each, is forwarded from the first data processing system 10 to the second data processing system 20.

[0135] The second data processing system 20 checks the chemical and physical stability of the components of the formulation relative to one another using a second database 21 in which compatibility and stability criteria are stored.

[0136] If the test fails, feedback is sent to the first data processing system 10. If the test is successful, the formulation is released for filling, which the second data processing system 20 forwards to the first data processing system 10.

[0137] The first data processing system 10 then authorizes the filling of the target container 33, preferably manually by the user. The first data processing system then transmits the formulation to the compounder 30.

[0138] If the target container 33 is successfully filled, the target container 33 is released and delivered.

[0139] During filling by the Compounder 30, monitoring also takes place, for example to ensure that all quantities of the individual components are adhered to.

[0140] If an error occurs, the compounder 30 does not release the target container 33. In this case, the system reverts, so the formulation must be released again, checked for chemical stability, and filled into the target container.

[0141] Fig. 3 is a schematic representation of a system for carrying out the method according to the invention.

[0142] The system comprises a first data processing system 10.

[0143] In this embodiment, the first data processing system 10 comprises a backend server 12 which has read and write access to a first database 13.

[0144] The backend server 12 is connected to the clients 11a - 11c, via which the pharmacist can enter recipes and create a formulation with the help of the first database 13.

[0145] The backend server 12 can also be designed as a virtual machine, for example.

[0146] A second data processing system 20 communicates, for example, via the Internet, with the backend server 12 of the first data processing system 10.

[0147] The first data processing system 10 has no write permissions on the second data processing system 20.

[0148] Therefore, in principle, no user-specific criteria are stored on the second data processing system 20.

[0149] Rather, the second data processing system 20 comprises, as a second database 21, a stability database in which information on the stability and compatibility of components of the nutritional composition is stored.

[0150] If the release is successful by the second data processing system 20, a compounder 30 can be controlled to fill a target container 33.

[0151] Such a compounder 30 comprises a pump and a valve unit 31, via which the withdrawal from the source containers 32a - 32n is controlled.

[0152] The valve unit 31 can be part of a so-called transfer set, which includes the hoses to the source containers 32a-32n and at least one hose to the target container 33. The target container 33 can be either a single-chamber or a multi-chamber container.

[0153] In this exemplary embodiment, a third data processing system 40 is also present, to which the first data processing system 10 has read access. The first data processing system 10 can thus receive data from the third data processing system 40. For example, specific formulations can be retrieved and used from the third data processing system.

[0154] Referring to Fig. 4a - Fig. 4c, the user input into the system will be explained in more detail using screenshots.

[0155] As shown in Fig. 4a, the user can enter a recipe into the first data processing system 10.

[0156] The input is made on the client lla-llc.

[0157] In this example, the trade names of the respective components and their quantities are entered in the respective national language (here Belgian).

[0158] As shown in Fig. 4b, the first data processing system 10 can access the first database 13 and create a recipe therefrom, which includes a unique identification of the respective component. An individual identification code is used for each component, which, in this exemplary embodiment, is generated by uniquely assigning the trade name entered in the respective national language to a component. The user can also enter the type of target container 33, the target volume of the components, and the patient's body weight.

[0159] As shown in Fig. 4b, a unique assignment exists for each component, so that the formulation can be forwarded to the second data processing system 20. This is graphically indicated by a check mark in this embodiment.

[0160] Fig. 4c shows the release of the formulation by the second data processing system 20, which is forwarded to the client lla-llc of the first data processing system 10.

[0161] In this case, approval has been granted.

[0162] In addition to the actual release, the system also provides a link to a study.

[0163] The system also provides temperature-specific shelf life information.

[0164] The filling of the target container 33 can now be released.

[0165] Referring to Fig. 5a - Fig. 5c, alternative embodiments will be used to explain what happens if the second data processing system 20 does not issue a release.

[0166] As shown in Fig. 5a and Fig. 5b, the input into the first data processing system 10 is identical, ie the user, in particular the pharmacist, first enters the recipe in the national language, then the first data processing system 10 supports the creation of a formulation in which each component has a unique identification, as shown in Fig. 5b.

[0167] In this embodiment, the maximum concentration of a component for a pediatric nutritional composition is exceeded.

[0168] Furthermore, the calcium concentration in the composition is exceeded.

[0169] The second data processing system 20 not only informs the user of the failed release, but also recommends reducing the amount of a component and reducing the substance calcium.

[0170] Thus, after receiving feedback from the second data processing system 20, the user can change both the recipe and the formulation created from the recipe on the first data processing system 10 in order to then achieve release in a repeat step.

[0171] In an alternative embodiment, after receiving feedback from the second data processing system 20, the user can modify both the recipe and / or the formulation created from the recipe on the second data processing system 20 in order to then achieve approval in a repeat step. The modified recipe or formulation is transferred back from the second data processing system 20 to the first data processing system 10 and adopted, particularly after user approval.

[0172] The invention has made it possible to provide a method by which an enteral or parenteral nutritional composition can be produced simply and with high safety. List of reference symbols:

[0173] 10 first data processing system l la-l lc Client

[0174] 12 backend servers

[0175] 13 first database

[0176] 20 second data processing system

[0177] 21 second database

[0178] 30 compounders

[0179] 31 Valve unit

[0180] 32a-32n source tank

[0181] 33 target containers

[0182] 40 third data processing system

[0183] 101 Enter recipe, mixing sequence and type of desired target container on the client

[0184] 102 Creating a formulation with a unique identification of the components

[0185] 103 Checking the formulation by backend server

[0186] 104 Forwarding the formulation to second s

[0187] Data processing system

[0188] 105 Checking the formulation for chemical and / or physical stability and / or compatibility using the stability and / or compatibility database

[0189] 106 Forwarding a release to the backend server

[0190] 107 Transfer of formulation to compounder

[0191] 108 Filling the target container

Claims

Claims:

1. A process for the preparation of a parenteral or enteral nutritional composition comprising the steps of: - providing a formulation comprising a plurality of components of the nutritional composition (101); - Assigning a unique identification to the components by a first data processing system (10), wherein the unique identification is stored (102) in a first database (13) of the first data processing system (10); - releasing the formulation by the first data processing system (10) when the unique identification of the components is given (103); - transmitting (104) the released formulation by the first data processing system to a second data processing system (20); - checking the transmitted formulation by the second data processing system (105), wherein a composition of the plurality of components of the nutritional composition is checked for stability and / or compatibility, wherein stability and / or compatibility criteria are stored in a second database (21) of the second data processing system (20); - releasing (106) the formulation tested for stability and / or compatibility by the second data processing system (20) if the stability and / or compatibility criteria are met; - transmitting the release of the tested formulation by the second data processing system (20) to the first data processing system (10); - Filling a target container (33) with the nutritional composition according to the tested and approved formulation by an automated filling system (30).

2. Method according to the preceding claim, characterized in that the formulation is provided by the first data processing system (10) at least partially suggesting the formulation on the basis of a recipe entered into the first data processing system (10).

3. Method according to one of the preceding claims, characterized in that the first data processing system (10) checks a limit value on the basis of data stored in the first database (13) relating to the dosage of at least one component of the formulation and / or relating to a volume of the formulation, in particular wherein the limit value is checked on the basis of patient-specific data entered into the first data processing system (10), in particular on the basis of weight, gender and / or age.

4. Method according to one of the preceding claims, characterized in that the step of assigning a unique identification to the components (102) by the first data processing system (10) comprises assigning a drug number or a drug name of the components to the unique identification.

5. Method according to one of the preceding claims, characterized in that the check by the first data processing system (10) includes a check of the mixing sequence of the Components and / or that the check by the first (10) and / or second data processing system (20) comprises a check of the type of target container (33), in particular wherein the type of target container (30) comprises its volume, its number of chambers and / or its material.

6. Method according to one of the preceding claims, characterized in that the stability and / or compatibility of the components with respect to the target container (33) is checked by the second data processing system (20) and / or that a shelf life indication and / or a storage condition is generated by the second data processing system (20), in particular wherein the shelf life indication and / or the storage condition is generated taking into account the type of target container (33).

7. Method according to one of the preceding claims, characterized in that the formulation comprises a unique identification of the components and / or the target container (33) or that a unique identification of the target container is proposed by the first data processing system (10).

8. Method according to one of the preceding claims, characterized in that a result of the check for stability and / or compatibility by the second data processing system (20) is forwarded from the second data processing system (20) to the first data processing system (10).

9. Method according to one of the preceding claims, characterized in that in the case of a failed Checking the formulation by the second data processing system (20), the second data processing system (20) generates a proposed change for the formulation, wherein the proposed change is forwarded from the second data processing system (20) to the first data processing system (10).

10. Method according to one of the preceding claims, characterized in that the first data processing system (10) communicates with the second data processing system (20) via a network, in particular the Internet, in particular via an encrypted connection and / or that the first data processing system (10) is provided in such a way that it has a backend server (12) which communicates on the one hand with at least one client (lla-llc) for entering the recipe and / or the formulation and on the other hand with the second data processing system (20).

11. Method according to one of the preceding claims, characterized in that the release by the second data processing system (20) is displayed on the client, in particular via the first data processing system (10) and / or that, after the release (106) by the second data processing system (20), the transmission of the formulation to the automated filling system (30) is initiated via the client (11a-11c).

12. Method according to one of the preceding claims, characterized in that, after the release (106) by the second data processing system (20), the first Data processing system (10) transmits the formulation to the automated filling system (30).

13. Method according to one of the preceding claims, characterized in that the backend server (12) accesses the first database (13), which is in particular encrypted, to check the formulation, wherein the second data processing system (20) has no access to the first database (13).

14. Method according to one of the preceding claims, characterized in that the second database (21) contains study data on the stability and / or compatibility of components, which are forwarded from the second data processing system (20) to the first data processing system (10).

15. System for producing an enteral or parenteral nutritional composition comprising a plurality of components, in particular designed to carry out a method according to one of the preceding claims, comprising a first data processing system (10) which is designed to assign a unique identification to the components of the nutritional composition, wherein the unique identification is stored in a first database (13) of the first data processing system (10), wherein the first data processing system (10) is designed to release the formulation (10) when the unique identification of the components is given and to transmit the released formulation to a second data processing system (20), wherein the second data processing system comprises a second database (21) in which stability and / or Compatibility criteria are stored, and is designed to check the formulation transmitted by the first data processing system (10) with the composition of the plurality of components of the nutritional composition for stability and / or compatibility, and wherein the second data processing system (20) is designed to release the formulation tested for stability and / or compatibility when the stability and / or compatibility criteria are met and to transmit the release to the first data processing system (10), and an automated filling system (30) for filling a target container (33) with the nutritional composition according to the formulation checked and released by the second data processing system (20).

16. System, designed as a first data processing system (10), in particular designed for use in a system according to the preceding claim and / or for implementation in a method according to one of the preceding claims, wherein the system (10) is designed to assign a unique identification to the components of a formulation of an enteral or parenteral nutritional composition, wherein the unique identification is stored in a first database (13) of the system (10), and wherein the system (10) is designed, when a unique identification is assigned to the components, to release the formulation and to transmit it to a second data processing system (20), which is designed to check the formulation for stability and / or to check the compatibility of the components and to release the formulation if the stability and / or compatibility criteria are met, and wherein the system (10) is designed to receive the release of the second data processing system (20) and to indicate the release of the second data processing system (20) to a user.

17. A computer program product comprising instructions that cause a first data processing system (10) to assign a unique identification to the components of a formulation of an enteral or parenteral nutritional composition and, if a unique identification is assigned to the components, to release the formulation and to transmit it to a second data processing system (20) that is designed to check the formulation for stability and / or compatibility of the components and to release the formulation if the stability and / or compatibility criteria are met, and to receive the release of the second data processing system (20) and to display the release of the second data processing system (20) to a user.

18. Computer program product according to the preceding claim, characterized in that the first data processing system (10) transmits the formulation checked and approved by the second data processing system (20) to an automated filling system, in particular after the user's consent.

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