JP2004511846A - Apparatus and method for dispersing and producing a desired product from various starting materials and an automated process system - Google Patents

Abstract

The production of the desired products (1) is at least one distributed arrangement in which the prepared starting materials (2) are processed into each product (1) in relation to the formulation data (25) provided to the process system. In an automated process system (3). The processing system (3) is connected to a remote central computing device (28) via a communication medium (27). An input device (22), also connected to the communication medium (27), is used for inputting the product request (37), wherein the central computing device (28) relates to the received product request (37). To obtain or mediate the formulation data (25) necessary for the manufacture of the desired product (1) from a collection of formulation data for the automated process system (3). In a central computing device (28), each production step of the product (1) is recorded with process data (13 ') which is important for quantity and quality.

Description

[0001]
The present invention relates to an apparatus and method for dispersing and manufacturing a desired product from various starting materials, and an automated process system.
[0002]
In the fields of chemistry, pharmacy, medicine, biology or cosmetics, products may often be required only in relatively small amounts, and these products may be different for different applications, or for different people, from different starting materials. Manufactured according to the prescription formula. One example is the prescription of a patient's drug, by a formulation or a combination thereof tailored to the patient or each medical condition. In view of the small quantities and individual formulations of such products, their central production and sale to each end user is very expensive. On the other hand, often only one or a small number of possible manufacturers have knowledge, here especially the formulation knowledge, and the qualifications for producing the individual products, such as, for example, the rights of protection or license holder. Absent. Further reliability and / or quality requirements must be adhered to in the manufacture of many more products. This applies in particular to the manufacture of medicaments which are only accessible to persons, for example pharmacists, physicians or patients, each of which has a predetermined quality and composition.
[0003]
It is an object of the present invention to enable an economical production of products of various formulations in view of the above-mentioned problems.
[0004]
This object is achieved according to the invention by an apparatus as claimed in claim 1 or alternatively, by an automated process system as claimed in claim 10 or by a method as claimed in claim 11. You.
[0005]
Advantageous configurations of the solution according to the invention are given in the dependent claims.
[0006]
The solution according to the invention significantly reduces the conventional process chain from the manufacturer to the distributor to the end user.
[0007]
This is done in a distributed, i.e., local, automated process system where the production of the various desired products is in a position to process each prepared starting material as a desired product according to the given formulation data. Is made possible by Examples of such automated process systems can be found in German Patent Applications 199 54 855.2 and 100 15 423.9. The processing system described therein has configurable possibilities and consists of process modules, each of which automates and processes predetermined sub-processes, which are superordinated via a data connection. Connected to the control unit. The process modules may be various types of reactor modules including, for example, microreactors, pump modules, filter modules, energy supply modules, fluid supply and waste modules, analysis modules, and the like. Configurability means the parameterization of the individual process modules and their mutual arrangement and connection. The connection of the process modules here also involves the exchange of the material to be processed between the individual process modules.
[0008]
In addition, the formulating data required to produce the desired product is obtained or mediated from the computing device after transmission of the product request to a remote central computing device and transmitted to an automated processing system. Central here means that the remote computing device is free to at least one distributed processing system, as well as other such processing systems elsewhere, to obtain the required formulation data. means. The product request can be entered via user interaction at the input device in the form of a product name, chemical formula, general basic formulation, or by direct reading of the prescription from, for example, a patient chart. It is also possible to determine the desired product by interacting with a remote central computing device. Formulation data sought in connection with the product wishes and then communicated to the process system contains in the most general case all the important information for producing the desired product, especially the starting materials needed, It includes information such as required manufacturing steps, material quantities, process parameters such as flow rates or temperatures, and the like. In connection with this information, the processing system is trained to produce the desired product. Thus, in the case of the above-mentioned modular process system, the required process modules are respectively selected and configured. The configuration takes place at least partially automatically, for example by setting the process parameters of the individual process modules automatically on the basis of the transmitted formulation data. In addition, the processing system automatically selects the required starting material from a number of different prepared starting materials in relation to the information on the required starting material contained in the formulation data and supplies it to the process. be able to. As long as the configuration, such as the selection of the required process modules and their wiring, is performed manually, the actual configuration performed in each case is based on the target configuration predetermined by the formulation data. Can be checked for correctness.
[0009]
As a preferred communication medium for exchanging data between a distributed processing system and a remote central computing device, the Internet, a global network organized so that the computing devices can communicate with each other, is used. The basis here is the client-server principle, whereby a specific computing device (server) provides a service that can be called from another computing device (client). Access to the Internet server is made with the use of known Internet browsers and communications within the Internet using predefined Internet protocols. Internet services may be switched (einloggen) to other computing devices (hosts) after a check of access entitlement, copy data from it (download), and transfer specific data thereto (upload). ), Or the possibility of performing the operation on a remote computing device. Other communication media may be considered instead of the internet or intranet.
[0010]
The central computing device accesses a formulating data set containing formulating data for a number of different products in connection with the product wishes received according to the first alternative and provides at least one suitable formula for the desired product. One formulation data collection is selected, and the formulation data is transmitted to the process system. The compounding data set can then be divided into a plurality of compounding data banks that can be operated, for example, by various chemical or pharmaceutical companies, together with the other computing devices associated with them. A central computing device contacted by the distributed processing system may then access those formulating data banks to obtain formulating data via communication media and other computing devices.
[0011]
In a second alternative, the central computing device does not obtain the required formulation data per se, but rather one or more distributed formulation data comprising a formulation data set suitable for the desired product. Subsequent steps for mediating the product-desired sender in the bank and transmitting the appropriate formulating data in the processing system then take place between the process system and the respectively mediated formulating data bank.
[0012]
To ensure replenishment of spent starting material, the automated processing system preferably includes a device for managing stock of starting material connected to a data interface. As the stock nears end, the processing system will automatically provide the post-order of the required starting material via the data interface, a manufacturer that provides such services via a computing device connected to the communication medium. In a position to do it.
[0013]
In the case of pharmaceuticals, for example, the sender of the central computing device communicates the product wishes in order to fulfill the defined safety requirements and to enable the settlement of the reimbursement provided in connection with obtaining the formulation data. Preferably includes a device for checking the qualification and identity of the company, and possibly a device for clearing the reimbursement provided in connection with obtaining the formulation data, including the license required thereby. As long as the central computing device provides only partial repayment, for example by intermediating the processing system to a distributed formulation data bank, the distributed formulation data bank can also be provided with devices for qualification and / or identity checking. A device for clearing the payment made may be provided. The sender of the product request is, first of all, each processing system to a remote central computing device. A check of the identity or qualification of the person inputting the product request can then be performed by the input device itself.
[0014]
For quality assurance and / or licensing calculations, the process system automatically determines process data important to the quality and / or quantity of manufactured products and centralizes them via data interfaces and communication media. Is preferably configured to be transmitted to a computing device or a formula data bank which supplies the formula data. These process data are then evaluated and stored accordingly.
[0015]
In other words, the processing system of the device according to the invention is a local device capable of producing the desired product from a predetermined number of starting materials according to a particular formulation, comprising a user interface (input device) and A provider interface (data interface) is provided, in which the customer identifies himself in the user interface, inputs the product wishes, based on which the provider interface is the licensor for the desired product, the required departure A device that establishes contact with the material manufacturer and clearing department. In addition, devices for quality control and documentation of business activities are provided.
[0016]
Hereinafter, the present invention will be described with reference to embodiments shown in the drawings.
[0017]
For the manufacture of the currently required product 1 here dispersed from the starting material 2 in fluid, at least liquid and / or gaseous form, it is dispersed, for example in a modular, which is located in a lab, pharmacy or hospital An automated process system 3 is provided. Other similar processing systems 3 ', 3 "may be present in many other places. The processing system 3 comprises a variety of side-by-side process modules 4 to 9, each of which has a desired one. The partial processes for producing the product 1 are automatically performed, the process modules 4 to 9 being various types, including for example, microreactors, pump modules, filter modules, energy supply modules, fluid supply and waste modules, analysis modules and the like. The process modules 4, 6, 7 and 9, which carry out the active, ie partial, processes, each have a control unit 10 and a fluid unit 11, wherein the primary partial process is a fluid Control unit 1 in unit 11 The process signals 13 received in the fluid unit 11, for example temperature values, pressure values or analytical values, are transmitted to the control unit 10. The various process modules 4 to The control unit 10 in 9 is connected to one another via a data bus 14 and an energy supply bus 15. The fluid unit 11 is connected to a plurality of channels 17 through which the starting material 2 to be treated and possibly intermediate products are led. The channels 17 extend in parallel inside the active process modules 4, 6, 7 and 9 with two adjacent active modules being connected to each other. Of the channel 17 of the typical process module, here 4 and 6 or 7 and 9, from the parallel configuration A further connection is made possible by an intermediate connection of the passive process module 5 or 8 having a correspondingly fixed channel configuration, instead the connection of the channel 17 is controllable, for example the fluid unit is controllable. It can also be performed by an interconnected active process module configured as a channel matrix with various valves.
[0018]
The process module 4 is used to set up the basic functions for the process system 3, for which the control unit 10 connects to an external current supply 18 and via a data connection 19, for example an external bus, a visualization device 21 and an input device. 22 is connected to a higher-level control unit 20 having a control unit 22. Data connection 19 may also be configured as a direct extension of data bus 14.
[0019]
As outlined here, the data bus 14, the energy supply bus 15 and the fluid bus 16 each comprise an internal bus section inside the process modules 4 to 9 arranged on a common support 23. At this time, the buses 14 to 16 are formed by mounting the required process modules 4 to 9 on the holder 23.
[0020]
The process modules 4 to 9 can be configured both inside and outside. In this case, the inner configuration contains, in particular, the parameterization of the process modules 4 to 9, the parameter values being transferred from the upper control unit 20 via the data connection 19 and the data bus 14 to the individual process modules 4 to 9. Can be transmitted to the control unit 10. Furthermore, the settings in the process modules 4 to 9 can also be performed manually via the operating element 24. Here, the outer configuration refers to the incorporation of the individual process modules 4 to 9 into the process system 3. It also includes the connection of the channel 17 between adjacent process modules, as well as the selection and order of the process modules 4 to 9. If the channel 17 between two adjacent process modules, for example 4 and 5, must not be extended in parallel, this leads to a corresponding passive configuration with a corresponding channel configuration, as already explained above. This is performed by intermediate insertion of the process module 5. All information via the configuration inside and outside the individual process modules 4 to 9 is stored in a configuration device (not shown here) inside the individual control unit 10, These information can be called up by the upper control unit 20 via the data bus 14 and the data connection 19.
[0021]
The previously described examples of the automated processing system 3 are already the subject of the aforementioned German patent applications 199 54 855.2 and 100 15 423.9.
[0022]
The production of the respectively desired product 1 in the process system 3 comprises, on the one hand, the preparation of the required starting material 2, the specific inner and outer configuration of the process modules 4 to 9 and finally the process modules 4 to 9 requires a specific process sequence in the processing of the starting material 2 in the fluid unit 11, the general process sequence being carried out by the higher-level control unit 20 and the partial processes in the fluid unit 11. Are controlled by the associated control unit 10. All the information required for this is the formulation data 25 for the product 1 to be manufactured. To reach these formula data 25, the processing system 3 has a data interface 26 connected to a data connection 19 for exchanging data with a central computing device 28 via a communication medium 27, here the Internet. The central computing device 28 has access to formula data for a formula data collection containing a number of different products. This formula data collection is, on the one hand, in its own formula data bank 30 and, on the other hand, other formulating data banks 31 of other computing devices 34, 35, 36 in various information providers, here, for example, chemical or pharmaceutical companies. , 32, 33. An input device 22 of the distributed and automated process system 3 receives a product request 37 for the currently required product 1 via user interaction. At this time, the person who inputs the product request 37 identifies himself / herself by inserting the chip card 41 into the card reader 42 of the input device 22. Card reader 42 also allows for selective reading of product requests 37 from patient card 43. The product request 37 is further transmitted via the data interface 26 to a central computing device 28, which selects at least one formulating data set suitable for the desired product 1 from the formulating data set and converts it into a formulating data set. The contained formulation data 25 is transmitted to the process system 3 via the communication medium 27. The central computing device 28 therefore accesses their formulation data banks 31 to 33 via other computing devices 34 to 36 and obtains the formulation data 25 therefrom. Alternatively, the central computing device 28 may use the product request 37 as a clue to determine a suitable external compounding data bank, eg, 32, from the compounding data bank 32 between the computing device, eg, 35, and the process system 3. It mediates a connection for transmitting the formulation data 25 directly to the processing system 3 via the computing device 35. The formulation data 25 is provided on the visualization device 21 in such a way as to give the operator of the process system 3 information on the required starting materials 2 regarding the required process modules 4 to 9, their arrangement and their parameterization. Displayed with. As long as automatic configuration of the individual process modules 4 to 9 is possible, the formulation data 25 can be transmitted automatically to the associated control unit 10. The formulation data 25 containing the original process progress for producing the product 1 is automatically transmitted to the host control 20. The higher-level control unit 20 again supplies data necessary for the partial process to the control units 10 of the individual process modules 4 to 9.
[0023]
The selection and arrangement of the required process modules 4 to 9 and their configuration, performed according to the instructions of the formulation data 25, are made via the above-mentioned configuration notification device of the control unit 10 of the process modules 4 to 9, Since the control unit 20 is notified, the inspection of the actual configuration performed there is performed in consideration of the target configuration predetermined by the formulation data 25 of the process system 3, and an incorrect configuration or individual configuration of the process system 3 is performed. An incorrect parameterization of the process modules 4 to 9 can be recognized and displayed on the visualization device 21. If the ascertained error in the configuration or parameterization is not corrected, the entire progress in the processing system 3 is interrupted and this is signaled to the central computing device 28.
[0024]
The central computing device 28 has a device 38 for checking the eligibility and / or identity of the sender, here the processing system 3, which communicates the product request 37. In addition, the computing device 28 has a device 39 for reconciling the reimbursement provided in connection with obtaining the formula data 25. This is basically known from so-called "e-commerce" or "e-business" solutions. Similarly, the other computing devices 34 to 36 also include a corresponding device 39 for adjusting the power provided by them.
[0025]
As described above, the process signals 13 received during the process of manufacturing the product 1 in the fluid unit 11 are transmitted to the control units 10 of the individual process modules 4 to 9 and from there to the higher-level control unit 20. Is transmitted. Process data 13 ′ which is important for the quality and / or quantity of the product 1 to be manufactured is transmitted via a data interface 26 to a central computing device 28. The central computing device 28 stores these data 13 ′ in the memory device 40 for documentation of the quality and / or quantity of the manufactured product 1. In accordance with the documented quantity of manufactured product 1, central computing device 28 calculates license usage fees in connection with the settlement. Furthermore, data relating to the manufactured product 1, in particular the reception data for the end user of the product 1, can be printed using the printer 44 in the distributed processing system 3.
[0026]
The upper control unit 20 of the process system 3 includes a device 45 for managing the stock of the starting material 2. Either the predetermined minimum stock of the starting material 2 is below, or a specific starting material 2 is newly required for the product 1 to be produced, respectively, based on the received formulation data 25, or If a shortage of stock is determined during the production of the device 1 on the basis of the process data 13 determined at that time, the device 45 automatically sends a subsequent order of the corresponding starting material via the communication medium 27 to the corresponding internet. Command the computing device 46 of the manufacturer providing the service, also connected to the communication medium 27.
[Brief description of the drawings]
FIG.
The drawing is a configuration diagram of an embodiment of the present invention.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Product 2 Starting material 3, 3 ', 3 "Process system 4-9 Process module 10 Control unit 11 Fluid unit 12 Control signal 13 Process signal 14 Data bus 15 Energy supply bus 17 Channel 18 Current supply 19 Data connection 20 Controller Reference Signs List 21 visualization device 22 input device 23 support 24 operating element 25 formulation data 26 data interface 27 communication medium 28 computing device 31-33 formulation data bank 34-36 computing device 37 product request

Claims (11)

Various starting materials in at least one distributed processing system (3) for processing the prepared starting materials (2) into respective desired products (1) in relation to the formulation data given to the processing system Process for exchanging data (25, 37) with a remote central computing device (28) via a communication medium (27) in an apparatus for distributing and manufacturing a desired product (1) from (2) A data interface (26) associated with the system (3) and an input device (22) connected to the data interface (26) for inputting a product request (37); The computing device (28) has access to the formulation data (25) for a number of formulation data sets containing various products in relation to the product wishes (37) received. Selecting at least one compounding data set each corresponding to the desired product (1) and transmitting the compounding data (25) contained therein to the process system (3) via the communication medium (27). Equipment for dispersing and producing the desired product from various starting materials. The formulation data set is distributed to various formulation data banks (30 to 33), of which at least one formulation data bank (31 to 33) is associated with another computing device (34 to 36). 2. The device according to claim 1, wherein the central computing device (28) accesses their formulating data banks (31-33) via other computing devices (34-36). At least one decentralized automated processing system (3) for processing the prepared starting materials (2) into respective desired products (1) in relation to the formulation data (25) given to the processing system (3) ), The data (25, 37) is distributed via a communication medium (27) to a remote central computing device (28) in a device for the distributed production of the desired product (1) from the various starting materials (2). And a data interface (26) associated with the process system (3) for exchange with the input device (22) connected to the data interface (26) for inputting a product request (37). Other remote computing devices (34-36) connected to the medium (27) and associated with them, respectively, for many different products. A formula data bank (31-33) containing formula data (25) to be prepared, each of which has a desired product (1) in relation to a product request (37) received by a remote central computing device (28). Select at least one formula data bank (e.g. 32) containing the formula data set matching the formula data, and formulate the formula data (25) contained in the formula data set to the communication medium (27) and the data interface (26). Distributing the desired product from various starting materials, which mediates the connection between the attached computing device (eg 35) and the automated process system (3) for transmission to the process system (3) via Equipment for manufacturing. 4. The method as claimed in claim 1, wherein the communication medium comprises a network. The processing system (3) automatically selects and processes these from a number of different prepared starting materials in relation to the information on the respective required starting materials (2) contained in the formulation data (25). The method according to claim 1, wherein the method comprises supplying to the device. 6. The process system as claimed in claim 1, wherein the processing system has a device connected to the data interface for managing the stock of the starting material. the method of. 7. A device according to claim 1, wherein the central remote computing device has a device for checking the qualification and / or identity of the sender communicating the product request. The method described in one. The central computing device (28) and possibly other computing devices (34-36) are each characterized by having a device for clearing the reimbursement provided in connection with obtaining the formulation data (25). The device according to claim 7. The process system (3) automatically determines process data (13 ') that is important for the quality and / or quantity of the product (1) to be manufactured, and passes them on to the data interface (26) and the communication medium (27). 9. Method according to claim 1, wherein the formula data (25) is transmitted to the receiving computing device (28, 34 to 36) via (1). In the automated process system (3) that processes the prepared starting material (2) into the desired product (1) in relation to the formulation data (25) given to the process system, input the product request (37) Input device (22) to communicate the product request (37) to the remote central computing device (28) and to the remote central computing device (28) or other remote computing device mediated thereby. An automated processing system having a data interface (26) for receiving formulation data (25) from (eg, 35). Various processes in at least one distributed processing system (3) for processing the prepared starting materials (2) into respective desired products (1) in relation to the formulation data (25) given to the processing system In the method for dispersing and manufacturing the desired product (1) from the starting material (2) of the present invention, the product request (37) input to the input device (22) from the process system (3) is converted to the data interface (26). Formulation data (25) communicated to the remote central computing device (28) and supplied from the computing device (28) or other remote computing devices (e.g. 26) A method for dispersing and producing the desired product from the various starting materials received via