RU2668018C2 - Method for checking of result of training personnel in quality control - Google Patents

Abstract

FIELD: physics.SUBSTANCE: method includes the following steps: a) at least one providing step, wherein, in the providing step, at least one test set (112) of filled primary packaging means (118) is provided, test set (112) comprising a plurality of primary packaging means (118) filled with the amorphous product, wherein at least one primary packing means (118) of filled primary packing means (118) has at least one impurity (138), said impurity (138) comprising at least one fluorescent marker (142), b) at least one training step, wherein, in the training step, test set (112) is presented to at least one person to be trained, person to be trained carrying out visual quality control for detecting impurities (138), wherein the result of the training step is documented, c) at least one verification step, wherein, in the verification step, test set (112) is irradiated with excitation light (116), in which fluorescent impurities (138) are detected, and wherein the result of the verification step is documented, and d) at least one comparison step, wherein, in the comparison step, the result of the training step and the result of the verification step are compared.EFFECT: method for training quality control personnel in the packaging of amorphous goods (128) into primary packaging means (118) is disclosed.19 cl, 3 dwg

Description

Field of Invention

The invention relates to a method for training personnel in quality control when packaging amorphous goods in a primary packaging tool. In addition, the invention relates to a test kit for training personnel in quality control when packaging amorphous products in a primary packaging product, as well as a kit that includes a test kit and a UV light source. In addition, the invention relates to the use of the proposed test kit and a method for manufacturing the proposed test kit. The devices and methods according to the invention can be used primarily in the pharmaceutical industry to train personnel who are involved in quality control in the packaging of amorphous products. Amorphous products may be primarily pharmaceutical products, for example diagnostic products and / or therapeutic products. First of all, it can be amorphous products in the form of fluid substances, especially liquids. Along with its use in the pharmaceutical industry, it is also possible to use the present invention in medicine, in the natural sciences, in the engineering sciences or in other fields, for example, in food packaging.

State of the art

The prior art there are many methods and devices by which amorphous products, especially homogeneous amorphous products, such as liquids, can be packaged in the appropriate primary means, especially vessels. First of all, in the field of pharmaceutical products and their packaging in the appropriate primary means, for example, such as syringe cases, test tubes, ampoules, or similar vessels, quality control plays an essential role. So, before packaging, during packaging or after packaging of amorphous products into the primary packaging product, in many cases, automated or manual quality checks should be carried out during which the primary packaging product containing the goods contained therein should be examined for contamination and / or damage.

The following is a link, first of all, and without limitation of other possible areas of use, first of all, to the packaging of pharmaceutical products, that is, therapeutic and / or diagnostic products and, above all, medicines. First of all, it can be liquid medicines. First of all, medications can be parenteral medications or the so-called parenteral medications, that is, medications that are injected. In such parenteral medicinal products, as a rule, quality control is required, during which a 100% check of the filled primary packaging product is carried out, that is, in which the filled primary packaging product is not put into circulation without quality control.

In general, quality control can be carried out, first of all, automatically. Automated quality control may include, for example, automated optical quality control, for example, through appropriate camera systems and optional checks through appropriate image analysis systems. Such automated quality control can be used primarily in the field of large-scale production.

However, as an alternative or in addition to automated quality control, in many areas of filling the primary packaging with parenteral drugs, a quality check is also carried out by appropriately trained personnel. Such manual quality checks by trained personnel are hereinafter also referred to as “manual quality control” or “human quality control”. First of all, in small-scale production with a small turnover, such a human quality check can be carried out.

But before work on manual quality control, the personnel involved for this must undergo appropriate training. So during manual optical testing of parenteral drugs used, the personnel involved for this activity usually undergo training using prepared test kits. Through such training, personnel must learn to reliably recognize contamination and damage. Previously used test kits, for example, contain several primary packaging means, for example, such as ready-made syringes and / or ampoules (flasks) filled with an amorphous product or (which is not further distinguished from the test set) with a sample product, for example, a sample solution. Additionally, at least one drawback, which should be recognized by personnel, is accordingly provided in some or more of the primary packaging for the test kit. First of all, this deficiency may be contamination and / or another type of deficiency, for example damage and / or defective packaging, for example, defective closing of the primary packaging means. For example, various particles of various sizes are introduced into the test kits, for example, such as metal chips, plastic fragments, glass fragments, fiber strands or hair. These contaminants and / or damage must be confidently and reliably recognized by trained personnel. For example, a test kit may be configured such that 20-30% of the filled primary packaging means of this test kit may have corresponding disadvantages.

However, when evaluating the result of training in practice, they can constantly come to an erroneous assessment. First of all, a case may arise that the particles will not be recognized, because they cannot be recognized by trained personnel. For example, particles can hide in the wells of the surface of an amorphous medium or during the formation of foam. In addition, particles can be hidden in the niches of the primary packaging means, for example, between a cork and a glass wall and / or in a needle. Such cases of particle unrecognition should, in principle, be separated in assessing the success of training from unrecognition due to insufficient thoroughness of the trained personnel, which, however, is practically impossible with popular teaching methods. Due to this indistinguishability of unsatisfactory learning outcomes, which occurred due to insufficient thoroughness, and unsatisfactory learning outcomes, which are associated with the impossibility of recognizing contaminants, the assessment of the success of training is practically impossible in many cases, and the corresponding state of affairs can only be tracked with difficulty.

Object of the invention

Therefore, the object of the present invention is to provide a method and a test kit for training personnel in quality control when packaging amorphous products in a primary packaging means, which at least substantially prevent the disadvantages of known methods and test kits. First of all, it must be possible to verify the success of training in the sense that failure to recognize shortcomings based on insufficient thoroughness of the trained personnel can be distinguished from failure to recognize shortcomings based on the fundamental impossibility of recognizing shortcomings.

Disclosure of invention

This problem is solved on the basis of the method and test set and set with signs of independent claims. In addition, it is proposed the use of the proposed test kit and / or the proposed kit and a method of manufacturing the proposed test kit. Preferred improvements of the invention, which may be carried out separately or in any combination, are contained in the dependent claims.

In general, it is indicated that the verbs “have” and “include” and the grammatical variants of these verbs are used in such a way that they can have exceptional and non-exclusive meaning. So the expression “A includes B” or “A has B”, on the one hand, means that A consists exclusively of B, that is, it does not have, along with B, other components. Alternatively, the corresponding expression can also be used non-exclusively in the sense that A, along with B, has other components.

In one aspect of the present invention, there is provided a method of training personnel in quality control when packaging amorphous products in a primary packaging device. As explained above, these amorphous products can be, above all, homogeneous amorphous products. First of all, amorphous products can be presented in liquid form, for example, in the form of a liquid, especially a transparent liquid. Moreover, by primary packaging means, in General, understand the packaging means, which has at least one inner space for accommodating amorphous goods. First of all, it can be a closable primary packaging tool. First of all, the primary packaging means includes at least one vessel in which the amorphous product can be placed. By packaging, in general, is meant a process in which an amorphous product is introduced into the primary packaging means, especially in the interior of the primary packaging means. After this, optionally, the primary packaging means can be closed, for example, by sealing and / or cork. Examples of appropriate primary packaging means will be further explained below. Quality control can be performed, first of all, before and / or during and / or after the packaging of amorphous goods in the primary packaging tool.

The proposed method includes the following steps. The above steps can be performed, first of all, but not necessarily in the specified sequence. However, in principle, another sequence is also possible. In addition, the proposed method may further include steps not listed below. In addition, individual, some or all of the steps of the method can also be repeated. In addition, some or some of the following steps of the method can be performed sequentially, superimposed in time or simultaneously.

The method includes at least one providing step (step a) of the method): at the providing step, at least one test set of filled primary packaging means is provided. The test kit includes several primary packaging products filled with goods. At least one primary packaging means of the filled primary packaging means also has at least one contamination, the contamination having at least one fluorescent marker.

Under the provision, in General, in the framework of the present invention is understood the process in which a test kit is made or provided in such a way that it can be used in the next steps of the method, especially in the training step and / or verification step described below.

Under the test kit, in General, understand several primary packaging means. For example, a test kit may include several primary packaging materials of the same type, for example at least 5 primary packaging means, especially at least 10 primary packaging means, and particularly preferably at least 50 primary packaging means. Examples of implementation will be listed in more detail below.

In this case, by means of a filled primary packaging means is understood a primary packaging means filled with the corresponding goods, the goods being placed in at least one interior space of the primary packaging means. As explained above, with reference to the test kit, cases are not distinguished that the product is truly an amorphous product for the packaging of which personnel must be trained, or also cases covered by the invention, that the product is a “sample product” or “substitute product” . The latter case may, for example, include that instead of a truly amorphous product, a substitute is introduced into the primary packaging product, for example, a substitute in liquid form, which, when examined by the human eye, has the same properties as the amorphous product used later in packaging.

An amorphous product as a whole is understood within the framework of the present invention to mean a product or a substitute for that product used exclusively for educational purposes, which is presented in an amorphous form, i.e., for example, a liquid and / or gas and / or an amorphous solid, for example, such as a powder. First of all, an amorphous product can be a fluid amorphous product, for example a liquid, first of all, an amorphous product can be at least partially transparent in the visible spectral range by an amorphous product.

The test kit includes at least one primary packaging agent that has at least one contamination. Moreover, the test kit may, in general, have one or more primary packaging means in the form filled with an amorphous product, which have the same contamination or with the same type of contamination. Alternatively, the test kit may also include several primary packaging products that have various types of contaminants. In addition, the test kit may also include at least one primary packaging tool, which has several different contaminants.

By contamination, in general, within the framework of the present invention, at least one foreign object which is different from an amorphous product and which is undesirable in the interior of the primary packaging agent filled with the amorphous product is to be understood. First of all, this pollution, as will be explained below, may have particles, fiber filaments, hairs or other types of pollution. Under the filled primary packaging means, which has at least one pollution, it should be understood as the primary packaging means, in the interior of which, along with at least one amorphous product, contains at least one pollution.

By a fluorescent marker, in general, within the framework of the present invention, is meant a chemical element or chemical compound which, under the influence of excitation light, emits fluorescence light. A fluorescent marker may include, for example, at least one fluorescent dye and / or at least one fluorescent chemical compound and / or group. The dye may be an integral part of the contamination and / or may be mixed into the contamination, whereby the fluorescent marker and other components of the contamination form a mixture, and / or the fluorescent marker may be chemically and / or physically associated with the contamination, for example, by covalent bonding and / or a complex compound and / or adsorption and / or absorption and / or ionic compounds. As examples of fluorescent dyes that can be used in the framework of the present invention, fluorescent dyes from the group consisting of coumarins, fluoresceins, rhodamines and stilbenes can be selected. Combinations of these dyes and / or other dyes may also be used.

Particularly preferably, if the contamination, as will be explained below, includes contamination, especially non-fluorescent pollution, which is marked by a fluorescent marker. So, for example, contaminants that usually occur during the packaging of amorphous products in primary packaging can be used, which were additionally marked with at least one fluorescent marker. For example, such contaminants may include particles. These contaminants may be, for example, impregnation and / or wetting and / or other type of labeling with one or more fluorescent markers. As will be explained below, first of all, in order to supply contaminants with at least one fluorescent marker, at least one fluorescent varnish, especially UV varnish, can be used, as a result of which fluorescent contaminants occur.

In addition, the method includes at least one training step (step b) of the method). In the training step, the test kit described above is presented to at least one learner. This person should later be involved in quality control when packaging amorphous goods in primary packaging. At the same time, a learning step is understood as a learning process in which a learner is prepared for work on quality control through appropriate training activities. The training step can be carried out, first of all, in the conditions closest to reality.

At the training step, the student conducts visual quality control of the test kit provided for him to detect contaminants. Under visual quality control, in general, we can mean quality control in which the learner with the naked eye and / or eyes and one or more optical aids, for example, such as a magnifier and / or a microscope, tries to recognize contaminants in the filled primary packaging of the test kit . For example, a trainee may label the primary packaging agent in which contaminants have been recognized, and / or classify and / or mark in a list or database that the corresponding primary packaging agent has contamination. For example, the primary packaging agent may be labeled, for example, with identification numbers and / or other forms that provide identification of the primary packaging agent.

The result of the training step is documented. This may, first of all, mean that it is documented whether the learner correctly identified the conditions of the filled primary packaging tool of the test kit. In general, by the state of the filled primary packaging means of the test kit, it is possible to understand, for example, the absence of deficiencies or the presence of deficiencies, and if there are deficiencies, it can still be distinguished whether these deficiencies arose in introducing one or more contaminants, if necessary in combination with the corresponding type of contaminants, and / or whether there are other types of deficiencies, for example damage to the filled primary packaging agent, for example in the form of damage to the primary packaging agent, cracks , holes or other types of damage and / or due to poor closure of the primary packaging material, for example due to improperly installed plugs. When documenting the result of a training step, for example, for each filled primary packaging tool, it can be recorded whether the trainee correctly recognized the state of the filled primary packaging tool, including possible shortcomings, and whether, if necessary, the existing shortcomings were correctly and completely identified. In this case, for example, it can be documented whether, for one or more filled primary packaging products, existing flaws were not identified, especially pollution, and / or flaws that were not identified by mistake were identified.

Documentation of the result of the training step can be performed, for example, in the form of a protocol, for example, in paper form and / or in electronic form, for example, in the form of a list, especially an electronic list and / or database, in which the filled primary packaging tool and the corresponding result are recorded visual quality control for this filled primary packaging product.

In addition, the method includes at least one verification step (step c) of the method). Under the verification step, in general, within the framework of the present invention, we understand the step of the method in which the result obtained in one way or another is checked. At the verification step, the test set is irradiated with excitation light. Under the light of the excitation, in General, in the framework of the present invention means light in the ultraviolet and / or blue spectral range, for example ultraviolet light in the spectral range from 100 nanometers to 400 nanometers, especially in the spectral range from 200 nanometers to 400 nanometers, and particularly preferably in the spectral range from 280 nanometers to 380 nanometers, and / or blue light in the spectral range from 380 nanometers to 480 nanometers, which is suitable for excitation of fluorescence in a fluorescent pollution marker.

When the test set is irradiated at the verification step, the entire test set can be irradiated with excitation light, or individual or several elements of the test set can be sequentially irradiated with excitation light. For example, the excitation light can be created by at least one excitation light source, such as a UV lamp. For example, the primary packaging of the test kit can be sequentially introduced into the rays of the excitation light.

At the verification step, fluorinating contaminants of the test set are detected. Under fluorescent compounds should be understood equipped with a fluorescent marker contamination of the test kit. Detection of fluorescent contaminants can again be carried out optically, first of all, again with the naked eye and / or using one or more optical aids, for example, such as a magnifier and / or microscope and / or camera.

The result of the verification step is documented. This documentation may, for example, contain that fluorescent contaminants were detected in a particular primary packaging product at this verification step, and, if necessary, the location of these fluorescent contaminants and / or their nature. So the result of the verification step can, for example, be documented again in the form of a list and / or database, in which for each filled primary packaging tool of the test set it is noted whether fluorescent contaminants were detected at the verification step, and also, if necessary, the amount and / or type of fluorescent contamination and / or location of fluorescent contamination. The list may again be available, for example, in paper form or also in electronic form.

It is particularly preferred that appropriate documentation is also drawn up in at least one step of procurement. Thus, in the provisioning step for each filled primary packaging medium, it can be documented whether it has one or more deficiencies, and also, if necessary, the type of deficiency.

First of all, for each filled primary packaging product, it can be documented whether it has at least one contamination and / or at least one other deficiency, as well as, if necessary, the quantity and / or type and / or location of the deficiency. In this form of implementation, after carrying out step c) of the method, there are preferably three documentation, namely the documentation of the provisioning step (hereinafter also referred to as test suite documentation), in which the actual deficiencies were documented, the documentation of the training step (hereinafter also referred to as training documentation) and verification step documentation (hereinafter also referred to as verification documentation). However, in principle, an implementation form with only two documents is also possible, namely the documentation of the training step and the documentation of the verification step.

In addition, the method includes at least one comparison step (step d) of the method). In the comparison step, the result of the learning step is compared with the result of the verification step. So, for example, at the comparison step, the documentation of the training step and the verification step can be compared with each other. At the same time, a comparison should, first of all, be understood as a process in which similarities and / or differences in the documentation are revealed.

First of all, the comparison step can be designed in such a way that it is revealed whether the learner correctly recognized the shortcomings of the test set at the training step. For example, for this purpose, the documentation of step b) of the method can be compared with the documentation of step a) of the method. At the same time, it is possible to establish deviations that contain that the student did not recognize the fault, that is, pollution and / or another fault, or incorrectly recognized the fault, which was not. If this is so, then you can additionally draw on the result of the verification step, first of all, the documentation of the verification step in order to verify the learning result. So, for example, by comparing the result of the verification step with the result of the learning step, you can check whether the student was able to recognize the deficiency at all. First of all, it is possible to check whether the unrecognized contamination, as described above, for example, was located in the invisible to the learner person or only in the area of the primary packaging means, for example, in the well of the amorphous product and / or foam and / or the intermediate space between the blockage and the wall of the vessel of the primary packaging means. If this is the case, then, for example, in terms of this unrecognized deficiency, the learning result can be improved in that the unrecognition of this deficiency, primarily the unrecognition of the corresponding pollution, is not considered and / or associated with an insignificant value when evaluating the learning outcome, therefore, the learning outcome is corrected .

The method can be advantageously improved in various ways. As explained above, the product can be selected, first of all, from the group consisting of: a diagnostic agent, primarily a liquid diagnostic agent, a therapeutic agent, especially a liquid therapeutic agent, a medicament, especially a liquid medicament, and particularly preferably a parenteral medication. First of all, an amorphous product may thus include parenteral medications.

The primary packaging agent may include, in particular, vessels. In this case, a vessel is generally understood to mean a packaging means that has at least one inner space, which includes at least one wall of the vessel. First of all, the vessel can be made completely closed and / or can have at least one blockage, through which the vessel can be closed, for example, at least one cap and / or at least one stopper. First of all, the primary packaging tool may include vessels selected from the group consisting of: the body of the syringe, ampoules (flasks), tubes, karpuli.

Several of the amorphous merchandise primary packaging for a test kit may include, first of all, similar, preferably identical, primary packaging products. Particularly preferably also the amorphous product is identical for the entire filled primary packaging means of the test kit.

In the provision step (step a) of the method), first of all, as explained above, documentation on the presence of contaminants in the filled primary packaging agent (documentation of the test kit) can be compiled. Along with contamination, other flaws can also be documented.

That is, the generic concept of disadvantage in the sense of the present invention includes all improper or non-compliant properties and conditions of the filled primary packaging product. These fields are distinguished by pollution and "other fields", that is, fields that are caused by pollution. Other shortcomings may be, first of all, damage or improper blockage of the primary packaging product. As explained above, the documentation may include, first of all, a list of primary packaging for the test kit, as well as, if necessary, marks for the corresponding deficiencies.

As explained above, the disadvantages may include, in general, one or more contaminants and / or one or more other disadvantages, such as damage. So for each primary packaging product, on the one hand, it can be noted whether it has a drawback. If there is a flaw, then a flaw can be noted. For example, it may be noted whether the defect is contamination or another defect, such as damage. In addition, if necessary, it can be noted which type of contamination and / or damage is involved, for example, particle and / or other type of contamination. In addition, it is also possible to note the number of possible contaminants, for example, the number of particles. In addition, according to other possible shortcomings, it can be noted what type of deficiency we are talking about, that is, for example, a crack and / or an incorrectly installed blockage. In addition, the position of other disadvantages can also be noted. In addition, this documentation can also naturally be noted in the natural way if the primary packaging of the test kit has no drawbacks.

In another form of implementation of the proposed method, step a) of the method is carried out in such a way that several of the primary packaging means of the test set filled with goods are free from contamination. First of all, several primary packaging products of a test kit filled with goods may be completely free from defects, that is, free from contamination and free from other defects. In addition, the test kit may include a primary packaging tool that has only one or more contaminants as a disadvantage. In addition, the test kit may include a primary packaging tool that has only one or more other disadvantages. In addition, the test kit may include one or more primary packaging means, which has only one or more contaminants, and one or more other disadvantages. But, it is particularly preferable that several primary packaging products of the test set filled with goods are completely free from disadvantages.

The test kit may include, first of all, several contaminated primary packaging materials filled with amorphous goods and several contamination filled primary packaging materials filled with amorphous goods. In addition, the test kit may, in general, include several primary packaging means filled with amorphous goods without flaws and several primary packaging means filled with amorphous goods with deficient test kits. A few product-filled primary packaging for a test kit with deficiencies may include, for example, several product-filled primary packaging for a test kit with one or more contaminants and / or several product-filled primary packaging for a test kit with other deficiencies and / or several product-filled primary packaging of the test kit with one or more contaminants, or with one or more other flaws.

The amount of primary packaging of the test kit filled with the product with contaminants can, first of all, have a share of 5% to 50% of all primary packaging of the test kit filled with goods, especially a share of 10-40%, and a share of 20-30% is particularly preferred . Also, the number of flawed primary packaging for a test kit with defects, generally, may have a share of 5% to 50% of all primary packaging for a test kit filled with goods, especially a share of 10-40%, and a 20- thirty%.

As explained above, in addition, at least one primary packaging tool of the test kit may have at least one other drawback, especially one drawback selected from the group consisting of: incorrect closure of the primary packaging tool and damage to the primary packaging tool, especially cracks.

A test kit may include, in particular, at least 5 primary packaging materials. Particularly preferably, the test kit may include from 10 to 1000 filled with primary packaging products, especially from 50 to 200, and particularly preferably 100 filled with primary packaging products. However, in principle, other forms of test suite implementation are also possible.

As explained above, pollution can be performed in various ways. First of all, contamination may include at least one particle. In this case, a particle is generally understood to mean a particle in principle of any shape. First of all, the particle can be an interconnected solid. At least one particle may include one or more particles selected from the group consisting of: at least one fiber strand, at least one hair, at least one chip, especially at least one metal chip and / or at least wood chips and / or at least one plastic chip, at least one glass particle, at least one wood particle, at least one metal particle, at least one ceramic particle, at least e of one plastic particle.

The particle may have, first of all, a diameter or equivalent diameter of from 100 μm to 500 μm. Alternatively or additionally, the particle may have in at least one dimension a length that is at least 50 μm, preferably at least 100 μm, for example from 50 μm to 3 mm, especially from 100 μm to 1 mm.

As explained above, the fluorescent marker may include, first of all, at least one fluorescent dye, first of all, the fluorescent marker may include at least one varnish, and the varnish is made so that under the influence of excitation light of at least one length waves in the ultraviolet spectral range and / or in the blue spectral range emit fluorescent light, especially fluorescent light in the visible spectral range.

In another possible implementation form of the proposed method, at the comparison step, the result of the training step is evaluated. At the same time, as explained above, at the training step, unrecognized contaminants are checked as to whether it was established at the verification step that these contaminants were located in an invisible or only hardly visible place of the primary packaging means during visual quality control. As explained above, it may be, for example, a well of at least one liquid of amorphous product and / or at least foam and / or a place between the clogging of the primary packaging means and the wall of the primary packaging means, which is not visually inspected visible or visible only with difficulty. If such a situation is revealed, then, as explained above, it is possible to re-evaluate the learning outcomes in accordance with this verification, for example, due to the fact that unrecognized defects, primarily unrecognized contaminants, which are classified as invisible or distinguishable only with difficulty by visual quality control , when assessing the result of training, they are not taken into account as pollution or when they are taken into account, they are only given less importance than pollution that are located in a clearly visible visual quality control location of the primary packaging agent.

In yet another embodiment of the proposed method, one or more primary packaging means of the test kit, for which it was established at the verification step that the contaminants during visual quality control are located in an invisible or only difficult to distinguish location of the primary packaging means, can be removed from the test kit and optionally replaced by another primary packaging agent.

In yet another aspect of the present invention, there is provided a test kit for training personnel in quality control when packaging amorphous products in a primary packaging device. First of all, the test kit can be made for use in the method according to one or more of the above forms of implementation and / or according to one or more of the forms of implementation that are explained in more detail below.

Accordingly, for many forms of implementation of the test kit, you can specify the description of the method above. The test kit includes several primary packaging products filled with goods. At least one primary packaging means of the filled packaging means has at least one contamination, the contamination having at least one fluorescent marker.

With regard to optional forms of implementation, a description of the method may be indicated. First of all, in relation to possible forms of implementation of the amorphous product, the primary packaging means, in relation to possible forms of implementation of the test kit with additional, made from pollution-free primary packaging means, you can specify the above description. First of all, the test set may include the number of primary packaging means filled with amorphous goods with defects and the number of primary packaging means filled with amorphous goods of the test set without defects. The quantity of primary packaging materials with defects filled with goods may again be partially the amount with pollution, the quantity with other defects, as well as the quantity of both pollution and other defects. For these quantities, as well as for possible measurements of these quantities, the above description may be indicated. In addition, in relation to the volume of the indicated quantities and / or in relation to the volume of the test set, the above description can be indicated. In addition, also in relation to possible forms of implementation of the particles, you can specify the above description.

In addition, the test kit may include at least one documentation that documents the deficiencies of the primary packaging means. For example, we can talk about the optional documentation described above, which can be compiled at the step of providing (step a) of the method) and which is also called test suite documentation. This documentation may, for example, be part of a test suite, for example, in paper form or in electronic form, for example, on a data medium.

In yet another aspect of the present invention, there is provided a training kit for personnel in quality control when packaging amorphous products in a primary packaging device. First of all, this kit can be made for use in the method according to one or more of the above, or according to still further explained in more detail below forms of implementation. The kit includes a test kit as described above. In addition, the kit includes at least one excitation light source, in particular at least one UV light source, wherein the excitation light source is configured to emit excitation light with at least one wavelength in the ultraviolet spectral range and / or in the blue spectral range.

For example, this excitation light source may be a UV lamp, which can be made stationary or which can also be made, for example, as a hand lamp.

In yet another aspect of the present invention, there is provided the use of a test kit and / or kit according to one or more of the embodiments described above, or according to one or more further described embodiments, for training quality control personnel in packaging amorphous goods in a primary packaging device.

In yet another aspect of the present invention, there is provided a method for manufacturing a test kit for training personnel in quality control when packaging amorphous products in a primary packaging device. The test kit can be performed, primarily for use in the method according to one or more of the above and / or according to one or more of the forms of implementation that are explained in more detail below. In the manufacturing method, several primary packaging means filled with goods are provided, and at least one filled primary packaging means is provided with at least one contamination, the contamination having at least one fluorescent marker. For example, an amorphous product can be introduced into primary packaging means, and then at least one contamination that has a fluorescent marker can be added to one or more primary packaging means. This may be, for example, about one or more of the above contaminants. Alternatively, or in addition to the subsequent introduction of contaminants, the introduction of pollution can also be carried out in the amorphous product before it is introduced into the corresponding primary means. Various forms of implementation are possible.

Additionally, the manufacturing method can be performed in such a way that at least one of the primary packaging means is provided with at least one other disadvantage. So, as described above, at least one of the primary packaging means may be damaged, for example at least one crack. Alternatively or additionally, at least one blockage of at least one of the primary packaging means may be worn and / or inserted incorrectly. Thus, in the manufacturing method, a test kit and / or a kit can be made in which one or more primary packaging means filled with goods may have at least one drawback, the drawback being selected from the group consisting of at least one contamination and at least one more drawback.

The proposed methods and devices have many advantages in comparison with known methods and devices. First of all, according to the invention, learning outcomes can be checked and evaluated more reliably and accurately. First of all, it is possible to prevent or at least correct incorrect assessments of the learning outcome in that the trained personnel, using the means at their disposal, could not recognize the shortcomings, especially pollution.

First of all, contaminants can be marked by UV due to a fluorescent marker in the form of particles. Thus, in case of doubt, it is possible to provide confirmation by illuminating the primary packaging means with excitation light whether the particle is present or not in a certain way, or, if necessary, is located in the primary packaging means hidden in such a way that the trained personnel cannot recognize it using available means . Thus, it is possible to more accurately formulate the result of training, primarily visual training, first of all, it is possible to more accurately formulate training for viewing, that is, training in visual control using the transparency of the primary packaging tool and the amorphous environment. In addition, if necessary, unsuitable primary packaging for the test kit can be replaced.

Summarizing, in the framework of the present invention, the following forms of implementation are particularly preferred:

The implementation form 1: a method of training personnel in quality control when packaging amorphous goods in a primary packaging tool, and the method includes the following steps:

a) at least one provisioning step, the provisioning step providing at least one test kit of the filled primary packaging means, the test set having several primary packaging means filled with goods, and at least one primary packaging means of the filled packaging means at least one contamination, wherein the contamination has at least one fluorescent marker.

b) at least one training step, and at the training step, the test kit is presented to at least one learner, the learner performing visual quality control to detect contaminants, and the result of the learning step is documented,

c) at least one verification step, and at the verification step, the test set is irradiated with excitation light, and fluorescent contaminants are detected, the result of the verification step being documented, and

d) at least one comparison step, and at the comparison step, the result of the learning step and the result of the verification step are compared.

The form of implementation 2: the method according to the preceding form of implementation, wherein the amorphous product is selected from the group consisting of: a diagnostic agent, especially a liquid diagnostic agent, a therapeutic agent, especially a liquid therapeutic agent, a medicine, especially a liquid medicine, and particularly preferably a parenteral drug .

The form of implementation 3: the method according to one of the preceding forms of implementation, wherein the primary packaging means includes vessels, especially vessels selected from the group consisting of: syringe bodies, ampoules (flasks), tubes, carpules.

The form of implementation 4: the method according to one of the preceding forms of implementation, moreover, several filled with amorphous goods of the primary packaging means includes similar, especially identical, primary packaging means.

The form of implementation 5: the method according to one of the preceding forms of implementation, moreover, at the step of providing compilation of documentation on the presence of the filled primary packaging product pollution.

The form of implementation 6: the method according to one of the preceding forms of implementation, moreover, several filled with amorphous goods primary packaging means of the test set does not contain pollution.

The implementation form 7: the method according to one of the preceding forms of implementation, and the test kit includes the number filled with amorphous merchandise primary packaging means without pollution and the number filled with amorphous merchandise primary packaging means with pollution.

The form of implementation 8: the method according to one of the preceding forms of implementation, wherein the amount of primary packaging materials filled with amorphous goods with contaminants forms a proportion of 5% to 50% of all primary packaging means of the test kit filled with goods, especially a share of 10-40%, and especially preferably a proportion of 20-30%.

The form of implementation 9: the method according to one of the preceding forms of implementation, moreover, at least one primary packaging tool of the test kit has at least one other drawback, especially another drawback selected from the group consisting of: incorrect blockage of the primary packaging means and damage to the primary packaging material, especially cracks.

The form of implementation 10: the method according to one of the preceding forms of implementation, and the test kit includes 10-1000 filled with amorphous goods primary packaging means, especially 50-200, and particularly preferably 100.

The implementation form 11: the method according to one of the preceding forms of implementation, and at least one pollution includes at least one particle.

The form of implementation 12: the method according to one of the preceding forms of implementation, and the particle is selected from the group consisting of: at least one fiber strand, at least one hair, at least one chip, especially at least one metal chip and / or at least wood chips and / or at least one plastic chip, at least one glass particle, at least one wood particle, at least one metal particle, at least one ceramic particle, p at least one plastic particle.

The form of implementation 13: the method according to one of the preceding forms of implementation, wherein the particle has a diameter or equivalent diameter of from 100 μm to 500 μm.

The form of implementation 14: the method according to one of the preceding forms of implementation, and the fluorescent marker includes at least one varnish, and the varnish is made so that under the influence of excitation light with at least one wavelength in the ultraviolet spectral range and / or in the blue spectral range to emit fluorescent light.

The form of implementation 15: the method according to one of the preceding forms of implementation, moreover, in the comparison step, the result of the training step is evaluated, the contaminants not recognized in the training step are checked as to whether it was established in the verification step that these contaminants were located in the visual quality control the invisible or only with difficulty visible place of the primary packaging product.

The form of implementation 16: the method according to one of the preceding forms of implementation, wherein one or more primary packaging means of the test kit, for which, at the verification step, it was found that the contaminants during visual quality control are located in an invisible or only hardly visible place of the primary packaging means, are removed from a test kit and optionally replaced with another primary packaging agent.

The implementation form 17: a test kit for training personnel in quality control when packaging amorphous goods in a primary packaging tool, primarily for use in the method according to one of the preceding forms of implementation, and the test kit has several filled with goods primary packaging means, at least one primary the packaging means from the filled packaging means has at least one contamination, the contamination having at least one fluorescent marker.

The implementation form 18: a kit for training personnel in quality control when packaging amorphous goods in a primary packaging tool, primarily for use in the method according to one of the preceding forms of implementation related to the method, the kit has at least one test kit according to the preceding implementation form, moreover, the kit also has at least one source of excitation light, primarily a UV light source, and the excitation light source is designed to emit excitation light at least Leray one wavelength in the ultraviolet spectral range and / or in the blue spectral range.

The implementation form 19: the use of a test kit and / or a kit according to one of the two previous forms of implementation for training personnel in quality control when packaging amorphous goods in a primary packaging tool.

The implementation form 20: a manufacturing method for the production of a test kit for training personnel in quality control when packaging amorphous goods in a primary packaging tool, primarily for use in the method according to one of the preceding forms of implementation related to the method, and the manufacturing method provides several filled with amorphous goods primary packaging means, and at least one primary packaging means of the filled primary packaging means provide at least m Here is one contamination, and the contamination has at least one fluorescent marker.

Brief Description of the Drawings

Further details and features of the invention follow from the following description of preferred embodiments, especially in combination with the dependent claims. Moreover, the corresponding features can be implemented on their own or several at once in combination with each other. The invention is not limited to the embodiments. Examples of implementation are shown in the drawings schematically. The same reference signs in the individual figures in this case mean the same or identical functioning or corresponding to each other in relation to their functions elements.

The drawings show:

FIG. 1 is a first embodiment of a proposed test kit and a proposed kit.

FIG. 2 is a second example of the implementation of the proposed test kit and the proposed kit.

FIG. 3 - a schematic plan for the implementation of the proposed method of training personnel for quality control.

Examples of implementation

In FIG. 1 and 2 show various exemplary embodiments of the proposed kit 110 in a highly schematic representation. Kits 110 respectively include each one test kit 112 for training quality control personnel, as well as an excitation light source 114 for emitting excitation light 116.

Test set 112 includes several primary packaging means 118, which in the embodiment shown in FIG. 1 are presented as syringe bodies for illustration purposes, and in the embodiment shown in FIG. 2 of the embodiment, for illustrative purposes, as ampoules 122. In FIGS. 1 and 2, three primary packaging means 118 are symbolically and graphically presented, respectively. But in practice, a test set typically includes at least 10 primary packaging means 118, preferably according to at least 20 or even at least 50, for example 100-200 primary packaging means 118. If the case 120 of the syringe can be closed, for example, with stoppers 124, then the ampoules 122 can be additionally closed, for example, with stoppers 124 with flanged caps by swords 126.

Other embodiments of primary packaging means 118 are also possible.

The primary packaging means 118 in the embodiments is suitably filled with amorphous product 128. This amorphous product 128 may be primarily a liquid, for example, a test liquid or also a parenteral medication may be used. Preferably, the amorphous product 128 is made transparent.

The kit 110 includes, in the illustrated embodiments, a number of one or more primary packaging means 130 without deficiencies and a number of one or more primary packaging means 132 with disadvantages, respectively. Packaging means 132 with drawbacks can again be divided into a quantity with one or more contaminants 134 and a quantity with one or more other drawbacks. Moreover, as shown in the example of the right primary packaging means 118 in FIG. 1, quantities 134, 136 may also have an intersection of quantities, i.e., the number of primary packaging means 118, which has one or more contaminants, and one or more other disadvantages.

Contaminants are indicated in FIG. 1 and 2 by symbolic reference 138. First of all, these contaminants 138 may have one or more particles 140. These contaminants 138, as explained above, are provided with at least one fluorescent marker 142. For example, this fluorescent marker 142 may be UV varnish . In this case, the same type of particles 140 can be provided, for example, with the same fluorescent marker 142, as well as different types of contaminants 140 can be equipped with the same fluorescent marker 142. As an alternative or additionally, in this or also in other In embodiments, the possibility may also be made that various types of contaminants 138 may be provided with different types of fluorescent markers 142, for example, fluorescent markers that emit fluorescent light with different flowers.

With regard to contaminants 138, contaminants that can be well recognized by the naked eye and those that are located on the sections of the primary packaging means 118, which can only be seen with the naked eye, should be distinguished. These contaminants, which are also referred to as latent contaminants 144 hereinafter, can be, for example, as shown in the right primary packaging means 118 in FIG. 1 or on the middle primary packaging means 118 in FIG. 2, contaminants that are located in the clogging area of the primary packaging means 118, and / or which are located in the well region of the amorphous product 128 and / or foam.

Primary packaging means 134 with other drawbacks may have one or more drawbacks 146, i.e., drawbacks that are not caused by contaminants 138, respectively. By way of example, the other drawbacks 146 in FIG. 1 shows improper blockage 148 in the right primary packaging means 118, and in FIG. 2 - crack 150 or other damage in the left primary packaging means 118.

Kits 110 may also include, respectively, documentation 152, which in FIG. 1 and 2, respectively, are marked symbolically, and listing the corresponding deficiencies in the respective primary packaging means 118 of the test kit 112. The documentation 152 may be presented, for example, in electronic form and / or in paper form.

In FIG. 3 schematically shows an example of the implementation of the proposed method of training personnel in quality control when packaging amorphous goods in a primary packaging tool as an implementation plan. The method includes a provision step 310 in which a test kit 112 is provided, for example, according to the exemplary embodiments in FIG. 1 and 2. When providing this test suite 112, the documentation 152 of the test suite may also be primarily compiled or provided.

Also shown in FIG. 3, the method includes at least one training step 312, in which test suite 112 is presented to at least one learner. In this case, the trainee performs visual quality control to detect contaminants 138 and, preferably, also other defects 146. In this case, the result of training step 312 is documented with training documentation 154.

Also shown in FIG. 3, the method includes at least one verification step 312. In this verification step, the test kit 1112 is irradiated with excitation light 116. This irradiation can be performed, for example, individually, in groups or as a whole. For this purpose, the primary packaging means 118, for example, can be displaced relative to the excitation light source 114 individually, in groups or as a whole, as a result of which irradiation can be carried out. For example, primary packaging means 118 may be placed in a beam of excitation light 116 individually, in groups, or as a whole. In this case, contaminants 138, which are equipped with a fluorescent marker 142, are detected based on their fluorescence. Detection can be done with the naked eye. Alternatively or additionally, one or more optical aids, for example, at least one magnifying glass and / or at least one microscope and / or at least one camera, can also be used for detection.

The result of the verification step is documented in the verification documentation 156. It is indicated that the types 152, 154 and 156 of the documentation can be performed as separate documentation. Alternatively or additionally, these types of documentation 152, 154 and 156 can also be compiled into general documentation in pairs or as a whole.

Also shown in FIG. 3, the method includes at least one comparison step 316. In the comparison step 316, at least the results of the training step 312 and the verification step 314 are compared, for example, due to the fact that at least the types of documentation 154 and 156 are compared with each other, and preferably also the documentation 152.

First of all, in step 134 of the verification, hidden contaminants 144 can be detected and appropriately labeled in the verification documentation 156. For example, if in the comparison step 316 deviations of the learning result according to the training documentation 154 from the test suite documentation 152 are detected, then it can be checked based on the verification documentation 156 and optionally corrected. Thus, for example, learning outcomes in the form of non-recognition of hidden contaminants 144 may remain unaccounted for when assessing learning outcomes, or at least they will be given less importance than other learning outcomes. In addition, the primary packaging tool 118, which has latent contamination 144, can be removed from the test kit 112 and replaced with another primary packaging tool 118.

An example implementation of the manufacturing method

The following describes an example implementation of a manufacturing method for manufacturing a test kit 112. With this method, several primary packaging means 118 in an unfilled state are first provided. In addition, an amorphous product is provided, for example, in the form of a liquid, and preferably in the form of a clear liquid. In addition, several contaminants of the same type 138 are provided, especially in the form of particles 140. These contaminants 138 are marked with a fluorescent marker 142. In addition, the amorphous product 128 is placed in the primary packaging means 118. Then it is targeted in one or more primary packaging means 118 of the test the kit is placed marked with a fluorescent marker 142 contamination 138, and the primary packaging means 118 is closed. Thus, primary packaging means 132 with disadvantages are provided. Along with this, primary packaging means 130 can be provided without flaws, as a result of which the test kit 112 can include several primary packaging means 140 without flaws and several primary packaging means 132 with flaws.

As a specific embodiment, the use of syringe bodies 120 may be given. The syringe bodies 120 are closed with caps 158, as is clearly shown in FIG. 1. Then, a predetermined amount of liquid, such as water, as an amorphous product 128 is placed in the syringe body 120, for example, by means of a pipette.

For the manufacture of contaminants 138, for example, various kinds of particles 140 can be used. Particles 140 were marked with a fluorescent marker 142 due to the fact that they were dipped in varnish. The resulting particles, marked with a fluorescent marker 142, were placed in single or multiple primary packaging means 118. The primary packaging means 118 was then closed with a stopper 128.

LIST OF REFERENCE NUMBERS

110 set

112 test kit

114 excitation light source

116 light excitation

118 primary packaging agent

120 syringe bodies

122 ampoules

124 traffic jams

126 flanged cap

128 amorphous goods

130 primary packaging product without flaws

132 primary packaging tool with flaws

134 primary packaging agent with contamination

136 primary packaging agent with other disadvantages

138 pollution

140 particle

142 fluorescent marker

144 hidden pollution

146 other disadvantages

148 improper blockage

150 crack

152 test suite documentation

154 training documentation

156 verification documentation

158 cap

310 step provision

312 training steps

314 verification step

316 step comparison

Claims (23)

1. A method of verifying the result of training personnel in quality control when packaging amorphous goods (128) in a primary packaging tool (118), the method including the following steps: a) at least one provision step, in which at least one test kit (112) of filled primary packaging means (118) is provided, comprising several primary packaging means filled with amorphous goods (118), and at least one primary packaging means ( 118) of the filled primary packaging (118) has at least one contamination (138) containing at least one fluorescent marker (142), and the test kit (112) includes some (130) filled with amorphous goods aroma (128) of primary packaging means (118) without pollution and some (134) filled with amorphous goods (128) primary packaging means (118) with pollution, and at least one primary packaging means (118) of the test kit (112) has at least one other flaw (136), b) at least one training step, in which a test kit (112) is presented to at least one learner who performs visual quality control to detect contaminants (138), and the result of the training step is documented, c) at least one verification step, in which the test kit (112) is irradiated with excitation light (116) and fluorescent impurities are detected (138), the result of the verification step being documented, and d) at least one comparison step in which the result of the learning step and the result of the verification step are compared. 2. The method according to claim 1, wherein the amorphous product (128) is selected from the group consisting of a diagnostic agent, therapeutic agent, medicament. 3. The method according to one of paragraphs. 1 or 2, and at the provision step, they draw up the documentation (152) of the test kit about the presence of contaminants (138) in the filled primary packaging tool (118). 4. The method according to one of paragraphs. 1 or 2, and the test kit (112) includes from 10 to 1000 primary packaging materials filled with amorphous goods (128) (118). 5. The method according to one of paragraphs. 1 or 2, and at least one pollution (138) includes at least one particle (140). 6. The method according to claim 5, wherein the particle (140) is selected from the group consisting of at least one fiber strand, at least one hair, at least one chip, at least one metal particle, at least one ceramic particles of at least one plastic particle. 7. The method according to one of paragraphs. 1 or 2, and the fluorescent marker (142) includes at least one varnish, and the varnish is made to emit fluorescent light under the influence of light (116) excitation with at least one wavelength in the ultraviolet and / or blue spectral range. 8. The method according to one of paragraphs. 1 or 2, moreover, at the comparison step, the result of the training step is evaluated, and the contaminants unrecognized at the training step (138) are checked as to whether it was established at the verification step that these contaminants (138) were located in invisible or under visual quality control only with difficulty in the area of the primary packaging agent (118). 9. The method according to one of paragraphs. 1 or 2, moreover, one or more primary packaging means (118) of the test kit (112), for which it was established at the verification step that the contaminants (138) are located in an invisible or only hardly visible place of the primary packaging means during visual quality control ( 118) are removed from the test kit (112). 10. The method according to claim 2, wherein the diagnostic tool is a liquid diagnostic tool. 11. The method according to claim 2, wherein the therapeutic agent is a liquid therapeutic agent. 12. The method according to claim 2, wherein the medicament is a liquid medicament. 13. The method according to p. 12, wherein the liquid medication is a parenteral medication. 14. The method according to claim 1, wherein at least one other flaw (136) is another flaw (136) selected from the group consisting of incorrect blockage (148) of the primary packaging means (118) and damage to the primary packaging means (118) . 15. The method according to claim 14, wherein the damage to the primary packaging means (118) is a crack (150). 16. The method according to claim 4, wherein the test kit (112) includes from 50 to 200 primary packaging materials filled with amorphous goods (128) (118). 17. The method according to claim 16, wherein the test kit (112) includes 100 primary packaging materials filled with amorphous goods (128) (118). 18. The method of claim 6, wherein the at least one chip is one or more of at least one metal chip, at least a wood chip, and at least one plastic chip. 19. The method according to claim 9, wherein one or more primary packaging means (118) of the test kit (112), for which, at the verification step, it was found that the contaminants (138) are located in an invisible or only difficult to see place during visual quality control primary packaging means (118), replace with other primary packaging means (118).

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