DE60029301T2 - Method and apparatus for controlling the strategy of compounding pharmaceutical mixtures - Google Patents

Abstract

A method and apparatus for controlling the compounding of pharmaceutical parenteral admixtures id disclosed. The apparatus preferably comprises a computer that contains a memory for storing instructions for operating the apparatus and for controlling compounders that prepare a prescription admixture, with the memory including data relating to a plurality of the pharmaceutical components that may be transferred to prepare the prescription admixture, and data concerning the operating characteristics of the compounders that the apparatus is adapted to control. The apparatus determines the order of admixing by general rules of admixing and by categorized compatibility groups of components, so that the number of rinses that must be done are minimized.

Description

The The present invention relates generally to a method and a device for producing and balancing pharmaceutical Mixtures. It particularly relates to strategies for making recipes for parenteral Mixtures, for controlling the compounding devices, and for accurate balancing of the produced mixture with the strategies which are implemented in computer software.

BACKGROUND THE INVENTION

pharmaceutical Parenteral mixtures are a combination of aseptic drugs, which are mixed together under aspetic conditions and for intravenous Infusion are determined. These mixtures can be relatively simple or extreme be complex, with the complexity of including many active ingredients increases. Food blends are one Example of complex parenteral mixtures commonly found in a hospital pharmacy for treating patients in the hospital getting produced. In general, parenteral food mixtures ("PN") most types from nutrient solutions to intravenous Respectively. Total Parenteral Food Mixtures ("TPN") generally concern those PNs that do not have lipids as a component contain, and total nutrient mixtures ("TNA") refer to those PNs containing lipids.

The Pharmacy of a hospital, a compounding center or a treatment facility Make a recipe or compound a recipe that is typically by a doctor alone or in conjunction with a dietician, Pharmacists or other nutritionist was determined. It may be necessary that the pharmacy has a size Number of PN compounded on a daily basis. The actual PN compounding is mainly performed by an electromechanical mixing equipment, the Compounder is called, which are extremely sophisticated and adapted are, many different components in different proportions which are laid down in pharmaceutical legislation.

compounder include compounder with large or high volume, which are adapted to PN by transmission those components that are normally produced in relatively large volumes can be found in a PN, for example, amino acids, germ-free water, lipids and dextrose, at a relatively high speed. Such compounders include the AUTOMIX 3 + 3 compounder, the from the Clintec Nutrition Division of Baxter Healthcare Corporation will be produced.

compounder also include low volume compounders, such as Compounder from the same corporation that sells as a MICROMIX compounder become. The MICROMIX compounder is adapted to those components to transfer precisely which are usually found in relatively small volumes in a PN become.

It is common in pharmacies, a mandatory PN by using both a MICROMIX as well as an AUTOMIX compounder, typically by adding the Components with big ones Volume to the final container or the end bag with the AUTOMIX Compounder and then transferring the final bag to the MICROMIX compounder for transferring the components with to produce smaller volume. It should be clear that a single Compounder the ability can have both high volume components and components low or low volumes either sequentially or simultaneously transferred to. Alternatively, the single compounder can be both a high volume module and a small volume module that forms a fluid into a fluid common distributor, a common transfer tube that with a Final bag or container connected or transferred to separate terminals in a final bag can.

Around producing such PN at acceptable cost, it is important that the PN is as efficient as possible be compounded. Efficiency is generally achieved by an attempt is made to maximize the number of PNs over one given period of time or "throughput". The complexity However, the correct production of PN tends to be such Slow down throughput. Complexity areas can be Determine the correct PN for a given rule for a special patient in the precise production of the PN and balancing or calculating the PN can be found. The safety of the patient However, priority is given and efficient PN production must comply with little possibility of Errors performed become.

In making the right prescription for a particular patient, the pharmacist has to perform many tasks, including evaluating and determining the right components and theirs odd quantities. Patient-specific factors, including the type of patient, ie, neonatal, and weight of the patient are taken into account. Improving the pharmacist's ability to make such assessments and determinations will increase throughput and reduce the possibility of errors. For recording purposes, it is desirable and from time to time required that the pharmacist note in a permanent record why the recipe deviates from generally desired amounts of swelling solutions.

As it is well known in the pharmacy practice, much of the results Complexity, involved in the production of PN, compatibility issues, which concern the components inserted in the prescribed PN are. compatibility is considered the interaction between a drug and all other components defined with which the drug comes into contact, including the Solvent, the container and other drugs in the same PN, but not limited to it. Compatibility is in two Subdivided into categories that include the physical as well as the chemical compatibility are. Physical compatibility is considered an incompatibility defined that will change the physical appearance of the drug, which is typically a visual change, such as precipitation, Gas evolution or a color change, leads. Chemical incompatibilities are not visually observed, but must be tested analytically become. Chemical incompatibilities occur as a result of changes in the active drug, such as oxidation and photodegradation, on. Factors that can affect compatibility include the total volume of solvent, Concentration levels, the order of mixing and the pH, are but not limited to that.

It There are two steps in the evaluation of compatibility and parenteral Mixtures. First, the compatibility of the whole PN over the Period between preparation of the mixture and completion of administration be evaluated on the patient before compounding. Secondly the compounding manufacturing process needs to be planned in a way for compatibility to take into account during the Compounding process is progressing. For example, the compatibility should be between a source solution, the final mixing tank or any intermediate mixing container, and the solution, the in the container exists, be evaluated. In many cases, swelling solutions must be used at concentrations are packed with other solutions are incompatible, diluted before they come into contact with each other in such chambers.

As will be clear, will be the highest dilution occur when the largest amount on dilution fluids already in the container is present in which the solutions be added. For example, amino acid or dextrose source solutions become one larger share of a PN form and yet are typically the most additives compatible. This will therefore give the impression that these Solutions first to the final container or any intermediate mixing chambers to add added source solutions dilute.

A additional Complexity, the considered must be the prevention of contact between highly concentrated Solutions, which are incompatible with each other, along a common path in the compounder. In characteristic examples, it may, though source solutions along separate hoses for the large part a transmission path flow down can, a section along a transmission path which is common to the two incompatible source solutions. This joint walk can be found along any part of the route be such as in an intermediate mixing chamber or after the intermediate mixing chamber or after a switching valve.

One Method for reducing the possibility that a solution with a second solution is incompatible along a common path, is the common Way after transferring to rinse off every solution. One such flushing comes with a solution carried out, that with both the earlier solution as well as with the solution, the after washing away is compatible. As will be clear, dilute one frequent wash away the incompatible solutions, making them compatible, but also the Throughput is reduced.

There must also be a fluid source for such a flushing scheme. The source of such scavenging solutions can either be a compatible swelling solution which forms part of the formulation or solution present in a downstream chamber, such as a mixture in the final mixing vessel. However, in current pharmacy practices, the prescribed amounts of solutions used as lavage solutions are typically first transferred to the final container for convenience and dilution purposes, and are not available as lavage solutions. In this example, and by default, the solution in the final bag must be compatible with the solution that is to be rinsed off, and the flushing solution will be withdrawn from the final container. The removal of the Wegspülmittels from the end bag and returning the Wegspülmittels to the end bag reduce the throughput. On the other hand, retaining a quantity of the dilution source solutions for wash away can lead to examples in which two incompatible solutions come into contact with each other in the final mixing chamber without being properly diluted to a compatible concentration.

In An aspiration to increase efficiency typically becomes a pharmacist Solution container in dependence group the composer's operating pattern so that components, the (at source solution concentration) compatible with each other, added sequentially together between rinses which are fixed by the pharmacist. After executing a Determination in terms of compatibility of different solutions can the pharmacist a set of compatible solutions on stations 1-4, one second set of compatible solutions on stations 5-8 etc. with rinses grouped by station 4, station 8 and so on. However, a particular mixture may require 5 solutions that are compatible are. Because fixing rinses greater time and requires effort, the pharmacist may take the fifth ingredient to a station hang, the rinses before and after, instead of the station layout and rinsing scheme adjust. However, this is not optimal.

A other consideration for one Pharmacists in compounding many recipes that are a mixture of TNA and TPN is a lipid haze in which a lipid trace in a final solution is present, which should contain no lipids. A cloudiness can are produced by lipids that are present in amounts that are so low as one to 3 parts per million. Such turbidity will typically occur when a prescription that contains lipids occurs immediately is compounded before a prescription that should not contain lipids. It is not believed that lipid clouding generally poses a health hazard, but a lipid clouding in a PN, which should be infused, later than a PN with unacceptable precipitation missunderstood which are the result of an error in formulating a compatible PN solution arises, and the cloudy solution can be rejected incorrectly.

If a lipid clouding is an issue, the pharmacist can try such problems by rinsing Avoid the compounder after each recipe, the lipids contains is compounded. However, such flushing becomes the throughput reduce and not be effective overall. To increase throughput, can the pharmacist such rinsing reduce by grouping lipid recipes; such groupings however, have a negative effect on flexibility. If a lipid clouding No issue is, should the opportunity be a lipid turbidity Persons who compound the solution and who administer the PN to the patient to prevent the administering erroneously believes that the mixture has become unstable.

Other Methods to attempt to prevent lipid turbidity are Use of a complete separate way for the lipids to the final mixing container. However, if lipids are present in an end container, a wash away or rinsing using a solution from the final container Introduce lipids in the way and may be a lipid clouding in a subsequent PN cause.

In addition to the complexity compounding, the pharmacist must meet the accuracy limits of Consider compounders, so that recipes containing components in volume levels below the accuracy limit of the compounder, probably by hand using be added to a syringe. Such a manual addition reduces throughput. To have to also inefficiencies associated with the administration of PN to the Patient inherent are, such as residual volumes in administration sets, as well considered become. It has been shown that accounting for the complexities is time consuming and inefficient activities and practices.

For replacement and recording purposes, the mixture produced has to be balanced generally, by reports from either manually or electronically transmitted Information is performed in a company's accounting system. The steps that the pharmacist must perform to ensure that a mixture is properly balanced, should be minimized to to increase efficiency.

It is therefore a primary object of the present invention to provide an improved method and apparatus for making and balancing parenteral food solutions. It is a further object of the present invention to provide a method and apparatus for preparing a parenteral mixture to reduce instances of incompatibility, which preferably includes a software implementation of the method that will accommodate many known active ingredients and other components. which are defined in different recipe mixtures. It is In particular, a related object is to provide strategies for preparing parenteral mixture prescriptions, controlling the compounding device, and properly balancing the prepared mixture with the strategies implemented in the computer software.

It is another primary Object of the present invention, such an improved Method and such an improved device for manufacturing a parenteral mixture by increasing the throughput of a compounder, in principle, by minimizing the number of flushes that are performed have to.

A A related object of the present invention is to provide a selective determination of order or reordering a variety of mixture solutions or compatibility groups, who can be present in a recipe to the recipes, such as by maximizing the number of prescriptions over a set period of time can be produced to produce more efficiently.

A more detailed object of the present invention is such a improved method and apparatus for controlling a To provide compounders of the type comprising an intermediate mixing chamber, such as a funnel for mixing components a transfer the contents of the chamber to a final mixing chamber, such as a final bag, used.

A Another object of the present invention is to provide from patient-specific data to the pharmacist's ability to Improve formulation of mixtures of recipes efficiently and safely to compound.

A Still another object of the present invention is an improved To provide a method and a device to the pharmacist to allow the accuracy limits of the compounder and inefficiencies when administering the PN to the patient, such as the Fluid, in administration kits is lost, compensate.

A Still another object of the present invention is an improved To provide method and apparatus, the one or Formulation with higher Concentrate on a component that is required for a prescribed formulation should be replaced, but determines whether the dilution fluid by compatible other ingredients can be provided so that the volume of the resulting mixture is minimized.

A Another object of the present invention is to provide such an improved To provide a method and a device, the one or Compound controls to alert users when recommended Limits are not followed, and such alarms are not accidental to ignore. A related task is typing and typing Record the declarative explanation of the passing to provide a warning.

A Another object of the present invention is a method and to provide a device that reduces the examples or user of the possibility a lipid turbidity and of the possibility alarmed that such lipid turbidity accidentally as a unacceptable precipitate misunderstood.

These and other tasks will become apparent to those skilled in the art reading the following detailed description with reference to the attached Drawings, be clear in which:

1 Fig. 3 is a block diagram illustrating the apparatus of the present invention shown in the context of a hospital having a centralized billing and patient computer networked with the apparatus of the present invention, and wherein the apparatus is also operatively connected to compounders and printers;

2 Figure 11 is a perspective view of a representative compounder that may be controlled by the method and apparatus of the present invention, and particularly showing the compounder having a hopper or tundish into which source components are placed, either sequentially or collectively, before transferring to a final bag become; and

3 is a perspective view of a second representative compounder associated with the Ver drive and the device of the present representation can be controlled.

4a - 4h together comprise a flow chart for controlling the compounding of a prescribed mixture according to the present invention.

DETAILED DESCRIPTION

The The present invention provides an apparatus for use in the control of the operation of at least one pharmaceutical compounder according to claim 1 and a method for controlling the operation of at least one Pharmaceutical compounder according to claim 24 ready.

Generally speaking, the present invention relates to a method and apparatus in the control of compounding of pharmaceutical mixtures wherein the compounding is performed with one or more compounders remotely located relative to the control computer or processing means. which is connected to the compounder. With reference to 1 indicates the control computer or controller 10 sufficient memory for storing pharmaceutical data in the form of a database as well as operating software for use in the control of compounders and other peripherals. The computer 10 is preferably a multi-user multi-program operation computer and has a data transfer interface for connection to compounders 12 . 14 and 16 and other peripherals, such as printers 18 and 20 through data transmission connections 22 which may be wired or wireless, which may be part of a local area network, a long distance network, or the Internet, or a combination of the foregoing. The computer 10 can an ad 23 and keyboard 25 and other accessories and features common to commercially available computers during this period.

Other peripherals can be a dumb terminal 24 with a keyboard and display or other input devices, such as a laptop computer 26 or other hand-operated device adapted to input recipes and input commands for operating the control computer software. The compounders may be located in different areas of a healthcare service, such as a hospital, or in different corridors of a hospital, or even in different hospitals. The compounders 12 and 14 as well as the printer 18 and terminal 24 are in hospital B in 1 localized while the rest of the equipment shown is located in Hospital A. There is preferably a printer located near each compounder or combination of compounders as shown for printing labels attached to the prescribed mixtures being compounded. The control computer 10 is preferred with a general hospital computer 28 which can be used to create and record accounting results among other functions.

The present invention is adapted to compounders, such as compounders 12 . 14 and 16 to control. The presence of two machines in Hospital B is to indicate that two different types of compounders can be used in combination to make recipe mixtures, such as the aforementioned AUTOMIX and MICROMIX compounders. The compounders 12 may thus be a compounder adapted for transfer of high volume additives and the compounder 14 may be a compounder adapted for low volume additives. In addition, the compounder 16 be adapted to transfer both quantities of high volume and low volume components.

With reference to 2 Figure 3 is a perspective view of a low flow module compounder illustrated and adapted to contain small volumes of components such as micronutrients and other medicaments from individual source containers 30 transferred to. However, recipe mixtures can be made from a single compounder 16 which is adapted to transfer high volume, low volume additives or many compounders to a single final bag 46 are attached.

In one embodiment, when high accuracy is desired, such as when low volume additives are added to a PN, the fluids from the containers become 30 through a separate, individual fluid line 32 to a single intermediate container or funnel 34 transferred to a load cell arrangement 36 is suspended. The load cell arrangement 36 weighs the total weight of the funnel 34 to develop an output signal that measures the amount of fluid in the hopper 36 at any given time. The funnel 34 is sealed and comes with a pressure line 38 ver bound with a pressure medium and containment means, such as a valve 40 connected is. The pressure means is preferably a single peristaltic pump which selectively provides positive and negative pressures in the funnel 34 can generate the direction and flow of fluid in and out of the funnel 34 to control. The funnel 34 is also with an outlet pipe 42 connected, resulting in a second inclusion 44 that extends between the funnel 34 and the final bag or container 46 is positioned. By selectively operating the containment means 40 and 44 and the pressure medium, fluid can be drawn into the funnel and transferred out of it. The same sections of the machine can also control the flow direction, allowing fluid into the tail bag 46 can be transferred and from the final bag for the purpose of purging the funnel 34 can be removed.

One detailed operation of an example of a compounder adapted is to transfer low volume components, at least from about April 1990 is described in US Patent No. 5,228,485, which is the same Assignee assigned as the present invention. The currently commercial Commercial MICROMIX compounders may have certain improvements in their performance Comparison to the '485 patent but it is believed to be in the patent described similarly is.

The compounder 12 may also include an arrangement that transmits the additives using various operating techniques, such as one or more pumping mechanisms and switching mechanisms, alone or in combination with volumetric delivery techniques, which may include calibration, such as the compounding apparatuses available from BAXA Corporation of Englewood, Colorado can be delivered commercially.

With reference to 3 becomes another embodiment of a compounder 50 which is particularly suitable for transferring high volume additives. The compounder 50 includes a number of individual pumping stations 52 those with an attachable transfer set 24 cooperate to deliver fluids from individual source containers 56 to a final container 58 to pump. A detailed operation of an example of a compounder adapted to transmit low volume components, at least about 1999, is described in US Patent Nos. 4,712,590 and 5,927,349 assigned to the same assignee as the present invention. The currently commercially available AUTOMIX compounder may have certain improvements over the '485 and' 349 patents, but is believed to be similar to that described in the patent.

manufacturing of the recipe

In one example of a process for using the preferred embodiment of the present invention, a physician or other healthcare manufacturer or a group of manufacturers determine what the parenteral nutritional needs of a patient are and arrive at a prescription. A pharmacist will then need to convert the prescription into particular amounts or concentration of additives in the PN which is then administered to the patient. These amounts will vary depending on the particular patient. For example, a patient may not be able to parenterally accept a large amount of fluid, and nutritional needs will have to be achieved within a minimal amount of fluid. An example of a fluid-impaired patient is a neonatal patient. In order to administer the desired amount of additive in a smaller total volume, the level of concentration of the additive in the final bag 46 be higher in the PN than if a larger dilution volume could be used. This higher concentration may lead to a greater possibility of compatibility problems with other additives in the PN and may exceed acceptable limits for the patient.

With reference to 4A In the preferred embodiment, the pharmacist enters patient-identifying data, such as a patient ID code, into the controller using the keyboard 25 (Block 70 ) one. The control unit 10 then asks patient-specific data (block 72 ) from a data storage location, such as the computer system 28 of the service and displays such information on the display 23 at. A type of patient-specific data, preferably from the controller 10 used in the preferred embodiment is the type of patient, such as preterm, neonatal, child or adult etc. In another embodiment, the manufacturer inputs the patient-specific data directly into the controller 10 or a location in it.

The control unit 10 also maintains in a storage location preferred ranges for the acceptable concentration levels of the various mixtures in a final bag 46 firmly. In one embodiment, the controller 10 also maintain concentration ranges for the constituents for the different patient types in the data storage location and the preferred concentration range with a type-dependent one Assess area for the particular patient. In a further embodiment, areas of patient characteristics, such as various patient ages and weights, may also be held in the data storage location, and the storage device 10 may set the preferred concentration range with associated specific ranges.

In a further embodiment can the controller also an algorithm for setting the concentration range dependent on of predetermined patient-specific factors, such as the age of the patient, included.

Depending on the patient-specific data, the control unit 10 thus, evaluate whether the preferred ranges are appropriate for the patient-specific type, and then can adjust the range (Block 74 ).

The healthcare provider will then enter the recipe (block 76 ) by, for example, using the keyboard 25 , When entering the recipe, the manufacturer will set concentration levels of the ingredient solutions such that when compounding, the PN will conform to the recipe. The control unit 10 allows the recipe to be entered in various different formats. For example, the controller 10 Accept inputs of ingredients in percent of final solution, concentration per unit volume, or an amount equal to the patient's weight per unit.

When the manufacturer enters the recipe, the controller checks 10 the concentrations entered against certain areas (block 78 ). If a concentration is entered that is out of range, will appear on the display 23 an error message appears. In addition, if the manufacturer inputs a component in an inappropriate format, an error or alarm message is displayed on the display to alert the health care manufacturer. An example of an inappropriate format is where the concentration is entered in units of measure per the weight of the patient, but the weight of the patient has not been entered as part of the patient-specific data.

In another embodiment, after all the concentrations have been entered, the controller may 10 then check the various components and highlight with error messages those components that fall outside the range stated for the component.

In another embodiment, templates from different recipes corresponding to different types of patients may be retained in a storage location. The pharmacist or the control unit 10 can then call the template and either accept or set the template. In yet another embodiment, a previous prescription of the patient may be stored in a storage location. The pharmacist or the control unit 10 can then call up the earlier recipe and either discontinue or accept the earlier recipe to be used as the current recipe.

When an alarm is displayed. Even if the concentration is out of range, the concentration may still be desired in a manufacturer's medical evaluation. The control unit 10 may then, in certain predetermined cases, allow the manufacturer to override the alarm (block 82 ). The control unit 10 will allow for the occurrence of one or a combination of certain factors. One factor is whether the manufacturer who enters the recipe has permission to ignore the special alert. Each alarm may require a different level of approval before accepting an override. Some alarms can not be overridden.

The identity and clearance levels of the manufacturer may be set up as a single password provided by the controller 10 is queried and at an appropriate time, such as the beginning of the input of the recipe or the occurrence of an alarm is entered (block 84 ). Other methods of determining the identity of the manufacturer are also contemplated, such as keycards, retinal scans, or the like.

In addition to determining the manufacturer's approval, in order to verify that the manufacturer recognizes and accepts the error message and for recording purposes, the controller may 10 require that the decent reasoning be entered into a note on the ad 23 is shown. The control unit allows for certain alarm situations 10 no transitions even with a reasonable explanation (block 86 ).

compatibility groups

The preferred embodiment of the present invention assesses the compatibilities of the ingredients and solutions with which the ingredient comes in contact during the compounding process, and also the solution in the final solution bag 46 after the compounding is completed.

In current Practice is the evaluation of the finished PN a process, routinely of Pharmacists performed becomes. The pharmacists compare the components of the finished product Mixture with the literature providing information in relation to the compatibility having. In many cases the literature is not sufficiently specific for the exact type of components in the mixture that is prepared, which requires the pharmacist used a professional rating by determining if that resulting mixture will be compatible.

According to the present Invention focuses on the overall compatibility assessment for complex Mixtures mainly on compounding parenteral food, which in the farthest Meaning PN screening and calcium phosphate solubility screening.

The process preferably involves a first screening step of comparing all PN additives to sets from the controller 10 which may include the steps of establishing ranges of preferred concentration limits, as described above.

One second step involves comparing the final concentration of amino acids, Dextrose and lipid-based components with the database of tested Mixtures. amino acid comparisons are brand specific. Databases of mixtures were prepared by the Testing mixtures and also published by using Literature created. The mixture database preferably comprises concentrations for both stable as well as unstable mixtures with a comment of the study conditions, such as time and temperature. Preferably, the database includes Mixtures with identified source components, such as amino acids with brand names.

In the second step is the prescribed mixture with the database compared to the mixtures. The comparison is preferred first with Mixtures performed, have the identified source components. If the prescribed Mixture falls within a range of a stable mixture, the present invention with the next Step by step without generating a note to the pharmacists. The range can be set in a variable amount, for example by a fixed percentage of the amounts or concentration levels of corresponding basic components in a stable mixture.

mixtures with matches (or mixed stable and unstable hits) to the unstable formulation contained in the database (preferred plus or minus a fixed variation of the amounts of base components) and have yet to go through the first screening step, however be described as potentially unstable.

In an embodiment of the present invention, when the prescribed mixture with an unstable mixture, carried out another step such as screening, whether the examination conditions of the matching Mixture equivalent to the present conditions. The present invention provides a warning for Pharmacists prepared that the mixture would be equivalent to a potential one unstable mixture under the conditions of the mixture is.

In a further embodiment are mixtures that are not stable or unstable with any Mixtures match, which are included in the database, reassessed. If that carried out is, becomes the amino acid tag ignored, and the mixture is then used with the entire database compared. The results of this comparison will be the same Following steps as described above. The pharmacist is preferably warned about ignoring the amino acid tag of the database mixture. When the mixture after the revaluation of the entire database no hits in the Database has, the present invention is a warning notice Provide the pharmacist with no similar PN previously tested has been.

With regard to calcium phosphate solubility screening, the solubility of calcium salts and phosphate salts in the same solution is dependent on many variables, including, but not limited to, concentration, temperature, salt form, mixing order, pH, amino acid concentration, other additives and time. In the prior art, it was the practice for the pharmacist, the final concentration of both the calcium salt and the phosphate salt with a solubility curve specific for a given level of amino acids and final concentration.

In the present invention, the calcium phosphate solubility screening is done in a complex compounding process by the controller 10 which compares the final concentration of both the calcium salt and the phosphate salt with a matrix of known compatibility. The matrix may be entered into a storage location by the pharmacist or previously entered into the database. The present invention uses the matrix to read compatibility with the amino acid tag and final concentration. For example, a calcium phosphate solubility matrix for a specific amino acid tag may have compatible levels of calcium salts and phosphate salts for a 1%, 2%, and 4% final amino acid concentration. The present invention determines the solubility limits that have been exceeded and will generate a warning to the pharmacist if exceeded.

In a further embodiment, the control device 10 on the display 25 and generate and display a graph of a shape representing the calcium phosphate solubility for a particular amino acid, and may also represent a designation of the above-described solubility-form mixture to assist the pharmacist in making a recipe that is compatible.

In addition to determining whether the recipe that is present in the final bag is compatible, however, must have compatibility during the compounding process be rated. For example, the compatibilities a solution with a second solution be evaluated at the contact time. The second fluid can in a common line, an intermediate mixing chamber or a final bag being found. To overcome this potential problem the pharmacist can adjust rough rules for the compounding process. It is common, for example Practice that all dilution volumes fed to the final bag first so that all the additives that are present in the final bag, as far as possible at the time of adding an additional ingredient to the Diluted final bag become. However, such a practice reduces the ability to with such a diluent while of the compounding process.

According to an important aspect of the present invention, the control computer 10 use the known compatibilities of components to allow simultaneous compounding of such compatible components in the final bag or intermediate mixing chamber. In addition, rinsing may be performed with a source solution that is compatible with the solutions that flow through the rinsed section both before and after rinsing. Consequently, large volume additives can be transferred to the final container or bag or transferred to an intermediate mixing chamber at the same time as small volume additives or used as flushing fluids. Such compatibility screening or simultaneous compounding enables the present invention to maximize the speed at which mixtures are compounded, resulting in more efficient use of the compounder as well as the control computer.

According to one important aspect of the present invention is the testing of Components on compatibility characteristics used to build a database containing a variety of Includes groups that have a concentration-dependent compatibility at the Basis of testing components. In an example there There are seven groups of components that appear in the below Table 1 based on the current Knowledge is identified. It should be clear that much more Groups of components can be defined, the greater the knowledge about compatibility characteristics of various components acquired, even until to the extent that there is a group for each individual component or even separate groups for the same Component in different concentrations there.

TABLE 1 Group Compatibility

The compatibility groups can Become known on the basis of test results and are in the database of the control computer so that the compounding process with the information in the database can be executed. It is preferable that the database is more localized only in the control computer, as being distributed to different places, so that they are reliably controlled, can be managed and modified if additional knowledge and information through history, continued Testing and the addition of other drugs and components too the database is obtained.

In a preferred embodiment of the present invention, based on the database, the controller becomes the fluids in the source containers 30 ( 2 ) into the compatibility groups regardless of their physical placement on one of the compounders 12 . 14 . 16 logically group.

In a further embodiment the present invention, the control unit for a special recipe is the Number of existing groups and the reading of groups in sets of compatibility groups calculate between which a rinse necessary so that the total number of flushes is minimized.

In yet another embodiment of the present invention, the controller uses other inputs, such as physical limitations of the system, to determine the proper compounding sequence to efficiently use source solutions as rinses as opposed to rinses from the final bag. Examples of a physical constraint may be the volume of an intermediate chamber or funnel 34 and the purging volume for such a chamber.

In In one example, the intermediate chamber has a funnel with a Volume of 60 ml and a rinsing volume requirement of 30 ml. If the recipe is 5 ml of group 1, 20 ml of group 2; 20 ml of Group 3; 55 ml of Group 4 and 40 ml of Group 6 needed can the controller 10 a compounding order of Group 1, Group 2, Group 3, Adjust group 6 and group 4 instead of an ascending sequence.

By partially filling the funnel 34 with only group 1, group 2, group 3, and 10 ml of group 6, then emptying the partially filled funnel prior to the addition of the remainder of group 6, at least 30 ml of group 6 will remain after the funnel 34 is filled first, and this fluid from Grup pe 6 can serve as a purge, thereby eliminating the need to rinse the end bag omitted.

Other examples of reading relationships or algorithms may be defined and implemented by the controller to meet users' needs, such as allocating the volume of one group to other compatible groups to reduce the number of evacuations of the chamber, or the funnel 34 can be minimized.

In this regard, and with repetition, as described above, while seven separate groups are included in Table 1, it is expected that additional groups based on more sophisticated knowledge and testing will be defined. The precise number of groups may become radio It will be the development of compatibility knowledge over all the other components that are used, and it is intended that a significantly larger number of groups be defined.

This will lead to, that the control computer is capable of, more precisely, the compounding steps to control, resulting in even greater efficiency and speed compounding leads. additionally can the database as protected be considered as their development increases and control the database in a single location is a significant protection, that would not exist for example, if the database is in a processor in each compounder would be distributed.

Kompoundierstrategien

In a further embodiment of the present invention, a blending strategy or process which recognizes the possibility of fluid haze and which preferably uses minimum flushes from the end bag is disclosed in US Pat 4b to 4h which illustrate the preferred embodiment of a method for defining the operation of at least one compounder to provide a molded food mix. The start (block 100 ) of the process or process is in 4b and appears following recipes entered into the control computer.

In another embodiment of the present invention, the recipe is initially initiated by the controller 10 screened in one or more of the methods described above.

The next step is the compounding strategy (block 102 ), which depends in part on the type of compounding equipment that is present.

In this regard, and as mentioned above, a hospital, other health care facility, or pharmacy may only have one high flow module compounder 12 exhibit ( 1 ) adapted to transfer high volume fluids at a relatively high flow rate. In the event that the service is also a low-flow module compounder 12 it may then transfer solutions at a low flow rate, which generally allows very small volumes or amounts of a component to be added to a sack. Therefore, in cases where specially adapted large volume and low volume compounders are used, the controller decides the compounding strategy (Block 2 ), and determines which strategy is used. The program is adapted to either a high flow rate (block 104 ), which will control, for example, a high-flux module compounder, a low flow rate (block 106 ), which will control, for example, a low flow module compounder, or high and low flow rates (Block 108 ) to control what happens to both machines that are used or to a single compounder 16 For example, it is suitable for both high volume and low volume volume transfers.

Initially referring only to high flows, the controller will perform initial compounder computations for high-flow compounder setups (Block 104 ), which include several calculations that the program will execute for each large volume component that will be part of the final bag. This includes the specific gravity calculation to convert the volume measure to the weight measure when the transmission is performed by using the weight of a component being transmitted rather than the volume being transmitted. In this regard, a recipe may be written using measures, entered in grams or milliliters, or a percentage of the final solution, and it may be necessary for the software to convert the measures to weight if the compounders function as a function of the weight sampled transferred transmitted component. For example, the high-flux module 14 and the low-flux module compounders 12 using the weight or a weight change of an intermediate or final container.

After the calculations are done, line extends 110 to 4c where a determination is made as to whether, in a prescription containing lipids, the lipids are to be first transferred to the final bag (Block 112 ), which is a determination by a user. In this regard, users may desire that the lipids be first or last in the final bag, which is strictly a choice that may specify the use. Such a specification is preferably based on criteria that are initially set before the compounder runs in a service at all.

This involves reading out all the additives in compatibility groups, and this is done by grouping together common compatibility components as shown in Table 1 above. When lipids are first transferred to the final bag, a determination is made of the number of compatibility metal groups and the number of flushes N that will be required (block 114 ) and then the program first specifies with lipids a sequence of high volume carries. When the sequence is determined, then line extends 118 to 4d where the commands to operate the compounder are transferred to the compounder (block 120 ).

• 1. Phosphatsalze werden vor Calciumsalzen zugegeben.
• 2. Die Bestimmung von der Calciumphosphatlöslichkeit sollte auf Basis des Lösungsvolumens in dem TPN-Sack zu der Zeit gemacht werden, wenn Calcium zugegeben wird.
• 3. Außer wenn Lipide als das letzte Additiv benötigt werden, sollte Calcium immer das letzte Additiv zu dem TPN-Sack sein, wobei, wenn möglich, eine Spülung vorenthalten werden kann.
• 4. Kompatibilitätsgruppen werden sequenziell durchnummeriert, um mit der Mischreihenfolge zusammenzufallen, es sei denn, dass spezifische Ausnahmen identifiziert werden.

Alternatively, the controller 10 transmit the fluids using other user settings that include settings that reflect the general rules for mixing TPN's (blocks 116 . 124 ). With regard to the general rules for mixing total parenteral nutrition, they include the following:

• 1. Phosphate salts are added before calcium salts.
• 2. Determination of calcium phosphate solubility should be made based on the volume of solution in the TPN sack at the time calcium is added.
• 3. Except when lipids are needed as the last additive, calcium should always be the last additive to the TPN sack, with scavenging, if possible, being withheld.
• 4. Compatibility groups are sequentially numbered to coincide with the blend order, unless specific exceptions are identified.

If the compounder 14 has separate lines to the end bag for each of the source solutions sets the controller 10 the order of pumping to ensure that the fluid is added to the end bag, the primary determination of the order of pumping being the compatibility of the fluid entering the bag with the fluid present in the bag.

With reference to 4c If the lipids are not first in the final bag, the number of compatibility groups as well as the number of flushes required is also determined (Block 122 ), and the sequence of lipid transfers and rinses last is determined using one or more compounding methods that are performed and the final step by line 126 is shown, which is too 4d extends to the transfer instructions sent to the compounder (block 120 ).

Now, turn only to the low flow path, which begins with the initiation of compounding calculations only for the low flow (Block 106 ), this is used for compounding recipes performed, for example, with a low flux module compounder. Although it is likely that a high flow compounding device will exist in the same area, it is common to choose the low flux compounder if the volume to be added to the final bag is relatively low, which for example is neonatal Prescription or a very small infusion will occur.

An initial determination is made as to whether the final bag already contains lipids (Block 130 ). The reason that this determination is made is that there may be a recipe that is compounded in two stages, with high volume flow components already transferred to a sack, and the sack then transferred to a low flow module for transferring micronutrients is placed in it. If lipids are already in the bag, this will make a difference as flushes are made from the final bag into a hopper or intermediate mixing chamber, which may be present in a low flow module compounder.

The program determines from the recipe whether lipids are contained in the sac, and if so, the entire mixture recipe is checked to determine if lipids are or will be in the sac. If they are, then the request is made as to whether the user cares if there is lipid turbidity in a following mixture recipe (Block 132 ). This is due to the fact that if any rinse is made using fluid from the final bag, some of the lipids will remain behind the funnel. These lipids can be transferred to a number of the following bags and in sufficient quantity to produce visible cloudiness in the solution. If the current sack is made with lipids and the next sack does not contain lipids and there is no rinsing of the surfaces that come into contact with the contents of the two sacks, then there is a possibility that the lipids cloud the next sack especially if the previous sack uses a rinse from the end sack. In the event that the service does not desire lipid turbidity, the compound will then not be made at that time, but will remain in the series compounded at another time (Block 134 ). If the hospital accepts lipid turbidity, then a warning is printed by a printer (or by a visual indicator) indicating that there is a possibility that lipid turbidity exists in the funnel (Block 136 ).

If the final bag contains no lipids (block 130 ) or if they contain lipids but do not care for lipid turbidity (Block 136 ), then the solubility and compatibility tables are used and continue to compute the compound, keeping in mind that rinses will take place from the final bag (Block 138 ). This step is intended to perform calculations designed to minimize the number of flushes to maximize efficiency, and may use any of the methods described above. When this is done, line stretches 140 to 4d and the transmission commands to the compounder are then sent to the compounder (block 142 ).

Now on the high and low flow branch, the in 4b Referring to Figure 1, the initial step is to initiate the compounding setup (Block 108 ) that requires conversion calculations performed as described with respect to the pure high-flow routine (Block 104 ) and line 144 extends to 4c where the number of compatibility groups and flushes is determined (block 146 ). Basically, this is a determination of whether there will be a problem with the recipe when it is compounded in the way that is described. The determination is made as to whether lipids are contained in the final bag (Block 152 ). If lipids are required, the determination is made as to whether lipids must be first transferred, last or otherwise optimized (Block 154 ). Whether lipids are needed first, last, or optimized is a user preference programmed in the sense that the user first defines it, and then it is not recipe dependent. Optimized generally means that lipids are introduced first. The criteria for compounding initially created by the user will thus determine the path of the selected steps. When they are first or optimized, then line extends 156 to 4d and 4c to a step that will be described later. If lipids are not contained in the final bag, then line extends 158 to 4d and 4e to steps that will be described later. If lipids are needed last, then line extends 160 to 4d , and it is determined whether the prescription is stable without the lipid volume (Block 162 ).

If the prescription without lipid volume is not stable, the program alerts the user that the prescription can not be compounded if the lipids are the last and that a review by a pharmacist may be required (Block 164 ). The program then determines if lipids can be transferred to the final bag first (Block 166 ), which, if not, results in the compound not being made (block 168 ). If the lipids can be transferred first, then line extends 170 to 3d wherein the number of rinses including the volume of lipids and lipids are first transferred to the final bag (Block 172 ).

To block 162 returning, if the recipe is stable without entrapping the lipid volume, the program then calculates all solubilities, including the volume of lipids, and the lipids are then transferred last to the final bag (Block 174 ) ( 4d ). The calculation of solubilities, not including the volume of lipids, (Block 174 ) is performed to perform the calcium phosphate solubility based on possibly less volume than that contained in the original screening. Therefore, for example, if there were 50 milliliters of lipids in a total volume of PN of 200 milliliters, the phosphate calcium solubility rating is performed on 150 milliliters.

After the compatibility groupings and flushes are calculated (blocks 172 and 174 ), the program then determines if the total volume, excluding lipids, is more than the funnel volume (Block 176 ). If yes, line extends 178 to 4f where the program determines if lipids are the first (block 180 ), which, if yes, leads to the program determination as to whether the number of flushes, a source purge of a base for a purge can be retained in an acceptable sequence (Block 182 ). If it can, the program splits into compatibility groups and proceeds compounding with necessary flushes coming from the selected source container (block 184 ) and the commands are transmitted to the compounder (block 168 ). As described above, the steps are in blocks 182 and 184 while identified as separate steps in the flowchart, are actually linked in reality. This is because the number of flushes is a function of the compatibility groups, and the compatibility groups must be determined to identify where flushing should occur, as previously described.

If the total volume, excluding lipids, is no more than the funnel volume, then the completion of the compounding is performed using the low flow module and may be performed in the funnel of the low flow module compounder. The program determines whether a source purge volume of a component solution for a final purge can be retained (Block 188 ), which, if yes, results in retention when the source purge volume of a base component and all other constituents in the hopper is compounded and transferred to the end bag, and the hopper is then associated with the reserve base has to be flushed (block 190 ), where the rinse is transferred to the final bag and transmission commands are sent to the compounder block ( 192 ).

Around to determine if a source flush volume retain It is necessary to screen the fluid during the procedure Mixing in the funnel without the dilution effect of the detergent present is to see if it is allowed to keep something out, that is, if that is resulting mixture will be stable. The capacity of the funnel is also important in terms of the volume required to perform a complete flush can be kept out. If, for example, funnel capacity is 50 milliliters is, and retained only 30 milliliters can be then it will not be complete hopper flushing take place, and the decision as to whether this is adequate or not can be made by performed by the user become. It is also intended that the rinsing process the final rinse which originates from a component source, such as germ-free water, dextrose or amino acids, and that intermediate rinse using a solution from the final bag with the source detergent of a component volume carried out that can be for the final rinse retained so that the funnel is cleaned as much as possible.

If there is insufficient source purge volume, the program determines whether any amount of source purge volume can be retained for a final purge (Block 194 ), which, if yes, is done, and all other ingredients are compounded in the funnel, and it is flushed with the reserve base (Block 196 ). The transmission commands are then sent to the compounder (block 198 ).

If there is no source amount that can be retained for the final rinse, then all ingredients are compounded in the funnel without any rinse (Block 200 ) and commands are sent to the compounder (block 202 ).

It should be clear that from block 152 if the answer is that there are no lipids in the final bag, then the way through the flow chart, assuming that the total volume is in excess of the funnel volume, leads to the determination of whether lipids are the first in block 180 are what is actually inapplicable because lipids are not present. In this case, the steps 182 and 184 be carried out with the Quellenspülmittel, which is from the container source and / or the final bag. As described above, the controller will preferably use a rinse and compounding sequence that eliminates the need to rinse from the end bag.

Back to block 204 returning, if the answer is no, or if the mixture contains lipids, the lipids must first be transferred and a rinse from a final bag is required (block 182 ), the program determines if lipids can be transferred last (block 206 If not, the program will ask if lipid turbidity is acceptable (block 208 ), which, if not, results in compounding not continuing (Block 210 ). If it is acceptable, the program will generate a warning about lipid clouding (Block 212 ).

If the lipids can be transferred last, then the program determines whether the number of rinses of the rinse source rinse can be withheld and an acceptable sequence can be performed with a rinse originating from the tail (Block 214 ). If it can then the recipe is analyzed for compatibility groups and compounding is continued with the rinse agents occurring at the appropriate times, preferably the next to the last rinse with the final bag with all others from the component sources (Block 216 ). In this way, when rinsing with the contents of the final sack, the ingredients present in the final sack are diluted as much as possible while allowing final container swell. The commands are transmitted to the compounder (block 218 ).

If the answer from block 214 No, leads line 220 that are too 4g extends to the program which determines whether the number of flushes minus 2 (N-2) times the component source flush for a flush can be maintained at an acceptable level, with two flushes determined from the end bag (block 222 ). If yes, then the compatibility group step is executed again (block 224 ) and commands are issued to the compounder (block 226 ). If no, then another determination is made for the number of flushes minus 3 (N-3) (block 228 ), whereby a compatibility analysis is performed if Yes (Block 230 ), and transmission commands are sent to the compounder (block 232 ). If no, the determination is made with respect to N-4 (block 234 ). If the determination of block 234 Yes, then the compatibility analysis is performed again (Block 236 ), and the commands are transmitted to the compounder (block 238 ). If the provision is on line 240 If no, then the program determines if a source purge can be held for a final purge (block 242 ), which, if yes, causes the compatibility analysis to be redone (Block 244 ), and the compounding commands are displayed (Block 246 ).

If no, the program determines if any amount of source solution can be retained to produce the volume needed, excluding lipids, below the funnel volume (Block 248 ). If the answer is yes, then the appropriate volume is retained and the ingredients are compounded in the funnel and the retained base component is used to rinse the funnel (block 250 ), and the transmission commands are displayed to the compounder (block 252 ). If no, the program determines if lipids are in the recipe (block 254 ), which, if not, results in the program compounding all the flushes emanating from the final bag (Block 256 ), and the commands are displayed to the compounder (block 258 ), but if lipids are present, the program determines if lipid turbidity is being taken care of (Block 258 ). If not, a warning will be displayed (Block 260 ), and if yes, the compound will not be made (block 262 ). After displaying the warning, compounding proceeds with all flushes from the end bag (block 256 ), which causes the transmission commands to be sent to the compounder (block 258 ).

When sending the commands to the compounder (blocks 192 . 186 , etc.), the compounder and the controller may use various methods and adjustments to perform the compounding. For example, the controller 10 Send commands to a controller as part of the compounder 12 . 14 . 16 or the controller may directly operate the compounder or any combination or similar method.

In addition to the compounding strategies performed in the manner described in connection with the flowcharts of 4a to 4h There are other functionalities that are practiced by the present invention. In this regard, the control computer is 10 adapted to examine the composition of each recipe mixture present in a series of recipe mixtures for which commands are sent to the compounder who is to produce the mixture. By examining the components of each recipe mixture in the series to determine those mixtures containing, for example, lipids, those mixtures containing no lipids can be grouped together so that lipid turbidity is of no concern until the last of the lipid-containing ones Mixtures is produced.

As in US Pat. No. 4,653,010, recipe mixtures useful in U.S. Pat Rows remain, read out and grouped around common components become. In one embodiment Others can be used in the invention desired Groupings of mixtures, such as the patient type, in a similar way be determined. Such a reordering of the recipe mixtures in The series may have the effect of increasing throughput the needs and have requirements of a service.

Another important aspect of the present invention involves the ability of the computer 10 for a user, to set a defined overflow volume by increasing the volume of each of the components to be added to the recipe mixture in a predetermined amount to achieve a mixture with the same recipe but a slightly higher volume, thereby increasing the volume to prepare an administrator set or address accuracy if the recipe requires extremely small concentrations of a mixture so that the correct amount of the component at the desired concentrations is actually delivered to the patient.

Yet another important aspect of the present invention involves the ability of the computer 10 to receive a user-changeable option which, when activated, allows one to replace a dilute ingredient of higher concentration with a lower concentration ingredient as described above. In many cases where the patient is not fluid-limited, dilution of a higher concentration solution with a compatible rinse solution, such as sterile water, will produce the prescribed mixture with the minimum amount of potential instability. In another embodiment of the present invention, particularly when the patient is fluid-constrained, the stability of the mixture in excluding or minimizing the dilution solution is accounted for by consideration of other components than diluting fluids 10 which may employ one of the methods described above to determine stability during or after compounding.

In another embodiment of the method of the present invention, a compounding strategy may be used to overfill the final sack 46 be executed. As previously described, a Überfül be desired to compensate for the amount of mixture that can not be administered due to the delivery system. For example, part of the solution in a final bag may be retained even after administration.

In One aspect of the present invention may be the desired method for fixing the abundance be specially configured. For example, the overfill volume in absolute terms, by a percentage, or so fixed be that the final bag has a specific desired volume. At the To prepare such a recipe, the method calculates the new quantities of ingredients required to form a mixture to achieve that, essentially equivalent to the prescribed Mixture is, but at a slightly larger volume.

When determining the correct constituent quantities of the ingredients, the controller may 10 check the resulting mixture for various criteria to determine if the resulting mixture can be administered. For example, for a fluid-constrained patient, excess may create a mixture with an amount of fluid in excess of the allowable amount. An alarm can be generated, an error message can be displayed to the user.

In a further embodiment, the control device 10 adjust or adjust the volume of the mixture to prevent one or more of the ingredients from being in an amount less than a predetermined level than that corresponding to the minimum amount of precision required for a compounder 12 . 14 . 16 Is accepted. For example, the amount of a component may be 90% of the minimum assumed amount. The controller may then increase the total volume of the mixture such that the amount of the component reaches the minimum accepted amount and indicates to the user that only a portion of the resulting mixture is to be administered to the patient.

It It should be clear that the arrangement of steps in the various preferred embodiments changed the present invention can be. For example, the stability of the final mixture before and determined after determining the correct compounding strategy become.

report

The compounders 12 . 14 . 16 can with the control unit 10 communicate during and after the compounding process. For example, if a scanner as described in US Patent No. 5,927,349 detects a false source solution passing through one of the conduits 32 flows, an alarm can be communicated or communicated. Similarly, during and after compounding, the exact amounts of the ingredients that attach to the final bag 46 be transmitted to the control unit 10 be sent.

When receiving the quantities of ingredients that are transferred during compounding, the controller may 10 Present the pharmacist with cost data or such data to the hospital computer system 28 communicate. The control unit 10 can adjust the cost data to reflect the current cost of providing the mix. For example, some ingredients may come in containers that can only be accessed once before discarding. Consequently, when such ingredient is used in an amount less than that in a container, the controller becomes 10 indicate the cost of the entire container as opposed to the proportion of the component used in the mixture.

It should be clear from the foregoing that an improved procedure and an improved device for controlling the production of parenteral mixtures, resulting in a faster, more efficient production of the same without sacrificing safety leads in any way. In addition, some of the features provide additional collateral. The present invention requires excessive analysis of the mixture components and uses known characteristics of components a new way to control compounders so that such Recipe mixtures reliable and can be manufactured safely without violating known manufacturing rules, but also on a way that with certain user-defined preferences is consistent.

While different embodiments of the present invention have been and should be described be clear that other modifications, substitutions and alternatives the skilled person will be clear.

Claims (31)

Device for use in the control of Operation of at least one pharmaceutical compounder, adapted is, selectively prescribed amounts of pharmaceutical components from individual container sources through extended hollow transmission means in a final container transferred to, to prepare a recipe mixture, the apparatus comprising: calculation means with storage means for storing instructions for operating the Device and for controlling the at least one compounder, to produce a prescribed mixture, wherein the storage means Data concerning a majority of the pharmaceutical components, the transfer can be to prepare the prescribed mixture, and data representing the Concern operating characteristics of the at least one compounder, include wherein the calculating means at least one communication port include a communication link with the at least to build a compounder wherein the calculating means are adapted to receive a recipe mix, the pharmaceutical Components of it to identify the compatibility of the pharmaceutical Components relative to each other determine the order too determine in which the components transfer in the preparation of the recipe mixture and instructions for making the recipe mix to transmit to the at least one compounder that is used to make the recipe mix, being the compatibility of the pharmaceutical Components relative to each other concentration-dependent compatibility includes. Apparatus according to claim 1, wherein said calculating means are adapted to convert the amount of each component into a measure, in which the at least one compounder containing the recipe mixture to transfer can. Apparatus according to claim 2, wherein the calculating means Are adjusted amounts of components in a recipe mix are set as volumes by multiplying the relative ones Density of the component with that specified in the recipe mixture To convert volume into a weight measure. The device of claim 1, wherein the one plurality pharmaceutical data is a database comprising a plurality of compatibility groups, each one Group has at least one of the pharmaceutical components, and wherein the database also includes data indicating compatibility and / or incompatibility of each group other groups specified. Apparatus according to claim 4, wherein at least one first of the compatibility groups Includes components that include lipids, and a second of the compatibility groups includes a component that is germ-free water. Apparatus according to claim 4, wherein the calculating means determine the order in which the components transmit be, so the order with a set of general rules the order of mixing matches, the general rules include: Phosphate salts are added in front of calcium salts; calcium phosphate solubility is based on the volume of the solution in the recipe mixture prepared at the time of addition of calcium; and calcium is the last addition to the recipe mix. Apparatus according to claim 6, wherein the calculating means the number and location of douches determine that during the order of transmission of components are, being a conditioner a cleaning of at least part of the elongated hollow transfer means near the final container with a solution is that with the next downstream component to be transferred to the final container. Apparatus according to claim 6, wherein the cleaning solution comprises one of the individual container sources or the final container is removed. Apparatus according to claim 4, wherein the calculating means at least one port for receiving input data for selection include whether a pharmaceutical Component that includes lipids, the order of transmission so determine that the lipid-containing component is either transmitted first or last relative to all other pharmaceutical components becomes. The device of claim 1, wherein the communication link at least one of an internet connection, a local area network connection and a wireless connection. The device of claim 1, wherein the device is adjusted, used by users in at least two places to be, where each place at least one compounder and one Printer for printing labels, a terminal with a display and an input device for entering recipe mixtures and selectable Settings regarding the operation of the device and the compounder may have. Apparatus according to claim 11, wherein the calculating means are adapted to control two compounders at each location, taking a compounder is adapted to transfer components at a flow rate the much higher than with the other compounder. Apparatus according to claim 9, wherein the calculating means adapted to investigate and determine the recipe mixture Whether lipid components are a part of it, determine if the user the following recipe mixture that will be prepared and a likely cloudy one Appearance due to the presence of a lipid component in the present having produced recipe mixture complains, the production of the recipe mixture for to cancel the case that the user indicates a complaint, and a warning regarding to issue such a likely cloudiness in the event that the user indicates no complaint. Apparatus according to claim 9, wherein the calculating means adapted to receive a plurality of recipe mixtures and to arrange them in a row for production, the calculation means being adapted are to examine each recipe mixture in the series and to determine the commonality of predetermined components in and rearrange the recipe mixes in the row to make the recipe mixes to group together such a commonality of predetermined Have components. Apparatus according to claim 1, wherein said calculating means are adapted to receive data concerning a patient profile, for the a recipe mixture is to be prepared, the patient profile data include at least the name, age and weight of the patient, wherein the calculating means are adapted to receive data, which relate to a plurality of patient categories, each one Category predetermined limits for Contains mixture components, the for each category are specific, with the calculation means adapted are the amounts of components in a recipe mixture for one Compare patients in one of the categories and get a signal to provide, if a component outside the predetermined limits for the Component in the recipe mixture is. The device of claim 15, wherein the patient categories adult, pediatric, neo-natal and premature birth patients includes. The apparatus of claim 15, wherein the signal is adjusted is to prevent the recipe mixture from being made. The apparatus of claim 15, wherein the profile data the patient continues to have a history of patient weight and from recipe mixes over include a period of time, with the processing means adapted are to produce a patient-related report, including one estimate the patient's weight at a future time. Apparatus according to claim 1, wherein said calculating means are adapted to receive data concerning a patient profile, for the a recipe mixture is to be prepared, the patient profile data include at least the name, age and weight of the patient, wherein the calculating means are adapted to receive data, which relate to the limit quantities of mixture components that belong to be added to a special recipe mixture of a patient can, wherein the calculating means are adapted, the component quantities in a recipe mix for comparing a patient and an authoritative data entry to require the rational explanation for exceeding one or more explained such limits. The device of claim 19, wherein an authorized one Data entry is a data input by at least one doctor or Pharmacist is. The device of claim 19, wherein there is a lack of required Data, what the rational explanation for the passing explain one or more such limits, leads to the calculating means cancel the preparation of the recipe mixture. Apparatus according to claim 1, wherein the storage means Data include the amount of fluid which is necessary to the at least one compounder from a container source through the extended hollow transmission means to the final container to prepare, the processing means are adapted, the Quantity of a component to increase the amount that is required to prepare the at least one compounder. Apparatus according to claim 1, wherein the processing means are adapted to receive a changeable input which the Production of a recipe mixture concerns and which a first Component in a predetermined amount, a diluent amount for the first component and one or more additional components in relative terms requests small amounts, the entire recipe mixture a predetermined Total quantity, the calculation means being adapted, the volume of one or more additional components in relative terms small amounts as a replacement for the same volume of diluent to be used such that the predetermined total amount is not exceeded becomes. Method for controlling the operation at least a pharmaceutical compounder that is adapted selectively prescribed quantities of pharmaceutical components of individual source Files through extended hollow transmission means in a final container transferred to, to prepare a recipe mix, the method being calculating means with storage means for storing instructions for operating the Device and for controlling the at least one compounder used to prepare a recipe mixture, wherein the storage means Data concerning a plurality of the pharmaceutical components, the transfer can be to make the recipe mix, and include data which concern the operating characteristics of the at least one compounder, for the control of which the device is adapted, the calculation means include at least one communication port to a communication connection with the at least one compounder to build, the method the steps includes: receiving a recipe mixture in the calculation means; identifying and determining the Amounts of the pharmaceutical components of the recipe mixture; the Determine the compatibility the pharmaceutical components relative to each other; the determining the order in which the components transfer during the preparation of the recipe mixture be, and the transmitting the instructions for preparing the recipe mixture to the at least a compounder used in the preparation of the recipe mixture use, being the compatibility of the pharmaceutical components relative to each other concentration-dependent compatibility includes. The method of claim 24, wherein the step of Identifying and determining the quantities, the step of converting the amount of each component in a measure, in which the at least one compounder who is to produce the recipe mixture transferred can. The method of claim 24, wherein the data is a plurality of pharmaceutical components, a database of pharmaceutical components that comprise a majority are categorized by groups, with the components of each group have common compatibility properties, wherein the database comprises data indicating compatibility and / or incompatibility specify each group relative to other groups, the Compatibility determining step further comprises: Examining the recipe mixture to the individual component groups present therein and the compatibility properties identify each group relative to the other identified groups. The method of claim 26, wherein the order determination step further comprises: determining the order of mixing such that the components within groups are related to each other are compatible, in accordance with known general rules of mixing at the same time or one behind the other in the final container be added. The method of claim 27, wherein the known general rules of mixing include: adding phosphate salts to calcium salts; basing the phosphate solubility on the volume of the solution in the prescription mixture at the time of calcium addition; and adding calcium to a recipe mixture last. The method of claim 26, wherein the order determination step further comprises: determining the order of mixing, creating components within groups that are compatible with each other are, one after the other in the final container be added so that the number of flushes is minimized, wherein the rinses carried out Be the hollow transfer agent near the final container due to incompatibility a component of one group relative to a component in another Group, which the next in the order of transmission is to clean. The method of claim 24, wherein the step of Identify and determine the amounts of the pharmaceutical components further identifying lipids as a component of the recipe mixture and providing the user with the option of aborting the Preparation of the recipe mixture, if so selected by the user. The method of claim 30, wherein a warning in the case is issued that the lipid-containing recipe mixture is not is canceled, the warning is such that an as next to be prepared recipe mixture a cloudy appearance due to the Presence of lipids may have.