WO2013144215A1

WO2013144215A1 - Method for training personnel in quality control

Info

Publication number: WO2013144215A1
Application number: PCT/EP2013/056543
Authority: WO
Inventors: Alexandra EHRHARDT
Original assignee: Roche Diagnostics Gmbh; F. Hoffmann-La Roche Ag
Priority date: 2012-03-29
Filing date: 2013-03-27
Publication date: 2013-10-03
Also published as: JP2015519591A; KR20150001740A; CA2868916A1; RU2014143411A; RU2668018C2; EP2831814A1; MX2014010881A; CN104205131A; HK1200562A1; MX351731B

Abstract

The invention relates to a method for training of personnel in quality control for the filling of amorphous products (128) into primary packaging means (118). The method comprises 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, the test set (112) comprising a plurality of primary packaging means (118) filled with the amorphous product (128), wherein at least one primary packing means (118) of the filled primary packing means (118) is affected with at least one impurity (138), the impurity (138) comprising at least one fluorescent marker (142); b) at least one training step, wherein, in the training step, the test set (112) is presented to at least one person to be trained, the person to be trained carrying out a 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, the 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.

Description

Procedure for training quality control personnel

Field of the invention

The invention relates to a method for training personnel for quality control in the filling of amorphous goods in Prirrjärpackrnittel. Furthermore, the invention relates to a kit for training quality control personnel in the filling of amorphous goods in primary packaging and a kit comprising the kit and a UV light source. Furthermore, the invention relates to a use of a test kit according to the invention and to a method for producing a test set according to the invention. Devices and methods according to the present invention can be used in particular in the pharmaceutical industry to train personnel who are used in the quality control in the filling of amorphous goods. The amorphous goods may in particular be pharmaceutical products, for example diagnostic products and / or therapeutic products. In particular, it may be amorphous goods in the form of fluid media, in particular liquids. In addition to use in the pharmaceutical industry, use of the present invention is also possible in medicine, in the natural sciences, in engineering or in other fields, for example in the packaging of foods.

PRIOR ART A large number of methods and devices are known from the prior art, by means of which amorphous goods, in particular homogeneous amorphous goods, such as liquids, can be packed into corresponding primary packing means, in particular containers. Particularly in the field of pharmaceutical products and their filling into corresponding primary pouches, such as, for example, syringes, jars, vials, or similar vessels, quality control plays a significant role. Thus, before, during or after filling of the amorphous goods into the primary packaging means, in many cases automated or manual quality controls must be carried out in which the primary packaging with the goods received therein are examined for conformity and / or damage. Particular reference will be made below to the packaging of pharmaceutical products, ie therapeutic and / or diagnostic products and in particular medicaments, in particular and without limitation of possible further fields of use. In particular, these may be liquid drugs. In particular, the medicaments can be parenteral medicines or so-called parenteralia, ie medicaments which are administered by means of an injection. Such parenterals generally require quality control in which a 100% control of the primary remedies is made, that is, in which no based primary packaging without a quality control is circulated.

In general, quality control can be automated in particular. The automated quality control may include, for example, an automated optical quality control, for example by means of appropriate camera systems and optional means of appropriate image evaluation systems. Such automated quality controls can be used in particular in the field of mass production.

Alternatively or in addition to an automated quality control, however, in many areas of the filling of ΡΓύτώ 3θ1αηίίΐε1η with parenteralia also a quality control by appropriately trained personnel instead. Such non-automated quality control by trained personnel will hereinafter also be referred to as "manual quality control" or "human quality control". Especially in small batch production with low turnover, such a human quality control can take place. However, before being used in a manual quality control, the staff assigned to it must be appropriately trained. Thus, in the manual visual inspection of Parenteralia, the staff employed for this activity is usually trained with the aid of prepared test kits. The staff must be enabled by this training to reliably detect contamination and damage. The test kits used for this purpose include, for example, a plurality of primary substances, such as pre-filled syringes and / or vials, which are associated with the amorphous product or (which is not differentiated below in relation to the test kit) of a model product, for example a Model solution, are filled. In addition, at least one error is provided in some or more of the primary packages of the test set, which must be recognized by the staff. In particular, this error may be an impurity and / or other type of defect, such as damage and / or defective packaging, such as a faulty closure of the primary packaging. In the test sets, for example, different particles various sizes introduced, such as metal chips, plastic splinters, glass splinters, fibers or hair. These contaminants and / or damage must be reliably and reliably recognized by the trained personnel. For example, a test set may be configured such that 20 to 30% of the primary primary packs of this test set have corresponding errors.

When evaluating a training result, however, it can often lead to a misjudgment in practice. In particular, the case may occur that particles are not recognized, because they are not recognizable by the staff to be trained. For example, particles in the meniscus may be concealing a surface of the amorphous medium or foaming. Furthermore, particles in niches of the

for example, between a plug and a glass wall and / or in a needle, hide. Such cases of non-recognition of the particles are basically to be separated in the evaluation of the training success from a non-recognition due to a lack of care of the staff to be trained, which in common training methods, however, is not possible in practice. This indisputability of inadequate training outcomes, due to a lack of care due to inadequate training results due to a principal impossibility of detecting contamination, often makes evaluation of training success scarcely possible, and the facts are difficult to understand.

Object of the invention

It is therefore an object of the present invention to provide a method and a test kit for training quality control personnel in the filling of amorphous goods in primary packaging, which at least largely avoid the disadvantages of known methods and test kits. In particular, a review of the training success should be possible to the extent that a non-recognition of errors due to lack of care of the staff to be trained by a non-recognition of errors due to a fundamental impossibility of detecting the error can be distinguished.

Disclosure of the invention

This object is achieved by a method and a test kit and a kit having the features of the independent patent claims. Furthermore, a use of a test kit according to the invention and / or of a kit according to the invention and a method for producing a test kit according to the invention are proposed. Predictive developments of the invention, which individually or in any combination are feasible, are shown in the dependent claims.

It is generally noted that the verbs "comprise" and "include" as well as grammatical modifications of these verbs are used in the following in such a way that they can have an exclusive or non-exclusive meaning. For example, the expression "A includes B" or the expression "A denotes B on the one hand means that A consists exclusively of B, ie does not include any further components besides B. Alternatively, the respective expression can also be used non-exclusively, in that A comprises at least one further component in addition to B.

In a first aspect of the present invention, a method is proposed for training quality control personnel in the packaging of amorphous goods in primary packaging. As stated above, the amorphous goods may in particular be homogeneous amorphous goods. In particular, the amorphous goods may be in fluid form, for example as a liquid, in particular as a transparent liquid. Under a Primärpackrnittel is generally understood a packaging, which has at least one interior for receiving the amorphous goods. In particular, it may be a closable Primärpackrnittel. In particular, the Primärpackrnittel comprise at least one vessel, in which the amorphous goods can be received. A filling is generally understood to mean a process in which the amorphous product is introduced into the primary packaging, in particular into an interior of the primary packaging material. Subsequently, optionally the Primärpackrnittel be closed, for example by a weld and or a plug, examples of corresponding Primärpackrnittel be explained in more detail below. The quality control can be carried out in particular before and / or during and / or after the filling of the amorphous goods in the Primärpackrnittel.

The proposed method has the following steps. The said steps may be carried out in particular, but not necessarily, in the order mentioned. However, a different order is possible in principle. In addition, the proposed method may additionally comprise method steps not mentioned below. Furthermore, individual, several or all process steps can also be carried out repeatedly. Furthermore, one or more of the method steps described below can be carried out successively, overlapping in time or simultaneously.

The method comprises at least one provisioning step (method step a)). At least one test set of filled primary packages is provided in the provisioning step. Of the Test kit includes a plurality of filled with the goods Pirmärpackmitteln. At least one primary packaging agent of the filled primary packaging material is furthermore subject to at least one contaminant, the contamination having at least one fluorescence marker. In the context of the present invention, provision is generally understood to mean an operation in which the test set is manufactured or made available in such a way that it can be used in the following method steps, in particular in the training step and / or verification step described below. Under a test set is generally understood a plurality of Primäφackmittehl. For example, the test kit may comprise a plurality of similar primary packaging means, for example a plurality of at least 5 priming agents, more particularly at least 10 primary packaging agents, and more preferably at least 50 primary packaging agents. Exemplary embodiments are mentioned in more detail below.

A primary packaging means is understood here to mean a primary packaging material filled with the respective product, the product being introduced into at least one interior of the primary packaging means. As stated above, the reference to the test set does not distinguish between the cases where the goods are the actual amorphous goods for which the staff is to be trained, or the case also covered by the invention in that the commodity is a "dummy commodity" or "substitute commodity". The latter case may involve, for example, replacing the actual amorphous commodity with a substitute in the primary packaging, for example a liquid substitute having similar properties when visually observed by the human eye to the amorphous commodity actually to be used later in the filling.

Under an amorphous product is generally understood in the context of the present invention, a product or used exclusively for training purposes substitute for this product, which is present in amorphous form, so for example a liquid and / or a gas and / or an amorphous solid such as a powder , In particular, the amorphous article may be a fluid amorphous article, for example a liquid. In particular, the amorphous article may be an amorphous article transparent at least partially in the visible spectral range. The kit includes at least one primary packaging which is contaminated with the at least one contaminant. In this case, the test kit may generally comprise one or more primary packaging materials in a form which is felt with the amorphous product and which has the same contamination or with the same contamination. same type of contamination. Alternatively, the kit may also include multiple primary packages having different types of cleansing. Furthermore, the test kit can also comprise at least one primary packaging agent which is associated with a plurality of different impurities.

Under a Vemnreinigung is generally understood in the context of the present invention, at least one foreign substance, which is different from the amorphous goods and which is undesirable in the interior of the filled with the amorphous goods Piimärpackmittels. In particular, as will be explained below, this contaminant may include particles, fibers, hair or other types of contaminants. Under a filled primary packaging, which is afflicted with at least one contaminant, is thus to be understood as a primary packaging, in the interior next to the at least one amorphous product, the at least one contaminant is added. In the context of the present invention, a fluorescent marker is generally to be understood as meaning a chemical element or a chemical compound which emits fluorescent light when exposed to excitation light. The fluorescent marker may comprise, for example, at least one fluorescent dye and / or at least one fluorescent chemical compound and / or group. The dye may be a constituent of the contaminant and / or may be mixed into the contaminant such that the fluorescent label and other contaminant components form a mixture, and / or the fluorescent label may be chemically and / or physically attached to the contaminant, for example, by covalent bonding and / or complex binding and / or adsorption and / or absorption and / or ionic bonds. Examples of fluorescent dyes which can also be used in the context of the present invention are fluorescent dyes selected from the group consisting of coumarins, fluorescein, rhodamines and stilbenes. It is also possible to use combinations of the stated dyes and / or other dyes.

It is particularly preferred if the impurity, as will be explained in more detail below, comprises an impurity, in particular a non-fluorescent impurity, labeled with the fluorescence marker. Thus, for example, impurities typically occurring in the filling of amorphous goods in PrimaYpackrnittel can be used, which are subsequently labeled with at least one fluorescent marker. For example, such contaminants may comprise particles. These impurities may be labeled, for example, by impregnation and / or wetting and / or by other means of labeling with one or more fluorescent labels. As will be explained in more detail below, in particular at least one fluorescent varnish, in particular a UV varnish, may be used to provide impurities with at least one fluorescent label, so that fluorescent impurities arise.

Furthermore, the method comprises at least one training step (method step b)). In the training step, the test set described above is presented to at least one person to be trained. This person should later be used for quality control in the filling of amorphous goods in Prmiärpackmittel. A training step is generally understood to mean a training process in which the person to be trained is prepared for use in quality control by appropriate training measures. The training step can take place, in particular, under conditions that are as realistic as possible.

In the training step, the person to be trained carries out a visual quality control for the detection of impurities on the test set presented to them. A visual quality control can generally be understood to mean a quality control in which the person to be trained attempts to contaminate the filled primary with the naked eye and / or the eye and one or more optical aids such as a magnifying glass and / or a microscope recognize the test set. For example, the person to be filled may be filled

in which contaminants were detected, mark and / or sort out and / or note in a list or database that the respective Primä ackmittel is afflicted with an impurity. For example, the primary packaging means may be identified, for example with identification numbers and / or other types which allow identification of the primary packaging means.

The result of the training will be documented. This may in particular mean that it is documented whether the person to be trained has correctly identified the states of the filled primary drugs of the test kit. In general, a state of a filled primary packaging material of the test set can be understood to mean, for example, freedom from error or adherence to defects, and it may still be necessary to differentiate between an error and a fault if one or more defects are present. in combination with the particular type of contamination, and / or other types of defects, such as damage to the filled one

for example, in the form of damage to the primary packaging by cracks, holes or other types of damage and / or by a poor closure of the primary packaging, for example by an incorrectly inserted plug. When documenting the result of the training step, for example, for each of the filled

whether the person to be trained has correctly identified the condition of the filled primary packaging, including possible errors, and if any errors have been correctly and completely identified. Here- For example, it may be documented whether or not any errors present, in particular impurities, have not been identified for one or more of the filled primary packaging materials and / or whether incorrectly identified errors have not been identified. The documentation of the result of the training step may be in the form of a log, for example in paper and / or electronic form, for example in the form of a list, in particular an electronic list and / or database, in which the filled primary packaging and the respective result of the visual Quality control for these filled primary packaging is listed.

Furthermore, the method comprises at least one verification step (process step b)). In the context of the present invention, a verification step is generally understood as a method step in which a result obtained in another way is checked. In the verification step, the test set is irradiated with excitation light. In the context of the present invention, an excitation light is generally understood as meaning 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 to stimulate fluorescence in the fluorescent marker impurity.

When the test set is irradiated in the verification step, the entire test set can be irradiated simultaneously with excitation light, or one or more elements of the test set can be irradiated with the excitation light one after the other. For example, the excitation light can be generated by at least one excitation light source, for example a UV lamp. For example, the primary pouches of the test set can be introduced successively into the radiation of the excitation light.

In the verification step, fluoridizing impurities of the test set are detected. Fluorescent impurities are to be understood as the impurities of the test set provided with the fluorescence marker. The detection of the fluorescent impurities can again be effected optically, in particular again with the naked eye and / or with one or more optical aids such as a magnifying glass and or a microscope and / or a camera.

The result of the verification step is documented. This documentation may include, for example, fluorescence in certain primary fixatives in the verification step. For example, the result of the verification step can again be documented in the form of a list and / or database in which for each filled primary packaging of the test set it is noted whether in the verification step, fluorescent impurities were detected, as well as, if necessary, the number and / or the type of fluorescent impurity and / or the position of the fluorescent impurity. The list may, for example, be in paper form or in electronic form.

It is particularly preferred if appropriate documentation also takes place in the at least one provisioning step. Thus, it can be documented in the provisioning step for each of the primary packaging means based, whether this is subject to one or more errors, and possibly the nature of the error. In particular, everyone can be filled

be documented whether it has at least one contamination and / or at least one other error, and if necessary, the number and / or type and / or position of the error. In this embodiment, after carrying out method step c), there are preferably three documentations, namely a documentation of the provisioning step (hereinafter also referred to as test set documentation) in which the errors actually present have been documented, a documentation of the training step (also referred to below as training documentation) and a documentation of the verification step (also called verification documentation below). An embodiment with only two documentations, namely the documentation of the training step and the documentation of the verification step is, however, possible in principle.

Furthermore, the method comprises at least one comparison step (method step d)). The comparison step compares the result of the training step and the result of the verification step. For example, in the comparison step, the documentation of the training step and the verification step can be compared with each other. A comparison is to be understood in particular as a process in which similarities and / or deviations of the documentation are ascertained.

In particular, the comparison step can be configured in such a way that it is determined whether the person to be trained has correctly recognized errors of the test set in the training step. For example, for this purpose a documentation of the method step b) can be compared with a documentation of the method step a). Dahei deviations can be detected, which include that the person to be trained has not recognized an error, so an impurity and / or other error, or has incorrectly detected an error that was not present. If this is the case, the result of the verification step, in particular ^In particular, the documentation of the verification step should be used to check the training results. For example, by comparing the result of the verification step with the result of the training step, it is possible to check whether the person to be trained was able to recognize any errors. In particular, it is possible to check whether an unrecognized contamination, as explained above, for example, is located in a region of the primary packaging material that is difficult or impossible to see by the personnel to be trained, for example in a meniscus of the amorphous product and / or a foam and / or a gap between a closure and a vessel wall of the primary packaging means. If this is the case, for example, with regard to this unrecognized error, the training result can be corrected such that the non-recognition of this error, in particular the non-recognition of the respective contamination, is not taken into account in the evaluation of the training result and / or with a lower one Weighting is linked so that the training result is corrected. The method can be advantageously developed in various ways. As stated above, the goods may be selected in particular from the group consisting of: a diagnostic agent, in particular a liquid diagnostic agent; a therapeutic agent, in particular a liquid therapeutic agent; a drug, especially a liquid drug, and more preferably a parenteral drug. In particular, the amorphous product can thus comprise a parenteral.

The primary packaging means may in particular comprise vessels. Under a vessel is understood to mean a packaging, which has at least one interior, which is enclosed by at least one vessel wall. In particular, the vessel can be configured completely closed and / or can have at least one closure by means of which the vessel can be closed, for example at least one cap and / or at least one stopper. In particular, the primary means may comprise vessels selected from the group consisting of: syringe bodies; Vials, glasses, carpules. The majority of filled with the amorphous goods

The test set may in particular comprise identical, preferably identical, primary packaging. Particularly preferably, the amorphous product is identical in all filled primary packaging of the test set.

In the provisioning step (method step a)), in particular, as stated above, a documentation about the adherence of the filled primary inking means with the contaminants can be prepared (test kit documentation). In addition to the impurities, other errors can also be documented. For the purposes of the present invention, the generic term of an error thus encompasses all the improper or improper properties and states of a filled primary packaging. These errors are differentiated into impurities and "other errors", ie errors that are not caused by impurities. The other errors may in particular be damage or improper closure of the primary packaging. As stated above, the documentation may in particular include a list of the primary packaging means of the test set, as well as possibly a description of the respective errors. As noted above, the faults may generally include one or more contaminants and or one or more other faults, such as damage. On the one hand, it is possible to record for each primary packaging material whether it has an error. If an error exists, the type of error can be recorded. For example, it can be recorded whether the fault is an impurity or another fault, for example damage. Furthermore, it can be recorded, if necessary, what type of contamination and / or damage it is, for example, a particle and / or another type of contamination. Furthermore, the number of possible impurities can be recorded, such as a number of particles. Furthermore, any other errors that may be present can be recorded as to which type of defect is involved, that is, for example, a tear and / or a faulty closure. Furthermore, the location of the other errors can also be recorded. Furthermore, this documentation can of course also be recorded if a primary packaging material of the test set is error-free.

In a further embodiment of the proposed method, method step a) is carried out in such a way that a majority of the primary packaging means of the test set filled with the product are free of the contamination. In particular, a plurality of the primary packaging means of the test set filled with the product can be completely free of defects, that is, free from contamination and free from other defects. Furthermore, the test set may comprise primary packaging means which only have one or more impurities as defects. Furthermore, the test set may comprise primary packaging means which have only one or more further errors. Furthermore, the test kit may include one or more primary packs which have one or more contaminants as well as one or more other defects. Particularly preferred, however, remains a plurality of filled with the goods Primäφackmitteln the test set completely free of errors.

In particular, the test kit may contain a contaminant-free quantity of primary packaging material filled with the product and a quantity of primary packaging filled with the product that is subject to contamination. include. Furthermore, the test kit may generally comprise an error-free amount of the primary packaging material filled with the product and a defective quantity of the primary article-based product. The faulty amount of primary packaging material filled with the product may include, for example, an amount of primary packaging filled with the product and / or a quantity of primary packaging filled with the product and / or one containing one or more impurities as well as having one or more other errors associated amount of primary packaging. The contaminated amount of the primary packaging material filled with the product may in particular form a proportion of 5% to 50% of the total primary packaging material of the test set filled with the product, in particular a proportion of 10% to 40% and particularly preferably a proportion of 20% to 30%. , Also, the generally flawed amount of the primary packaging material filled with the product can form a proportion of 5% to 50% of the total primary packaging of the test set filled with the product, in particular a proportion of 10% to 40% and particularly preferably a proportion of 20%. up to 30%.

As stated above, furthermore, at least one primary packaging agent of the test kit can be subject to at least one further error, in particular an error selected from the group consisting of an incorrect closure of the primary ingredient and a damage of the primary packaging material, in particular a tear.

In particular, the test kit may comprise at least 5 primary packages. Particularly preferably, the test set may comprise 10 to 1000 primary packs filled with the product, in particular 50 to 200 and particularly preferably 100 primary fillers filled with the product. However, other embodiments of the test set are in principle possible.

As stated above, the contaminant can be configured in various ways. In particular, the contaminant may comprise at least one particle. Under a particle is generally a particle in basically any form to understand. In particular, the particle may be a contiguous solid. The at least one particle may in particular comprise one or more particles selected from the group consisting of: at least one fiber; at least one hair, at least one chip, in particular at least one metal span and / or at least one wood chip and / or at least one plastic span; at least one glass particle; at least one wood particle; at least one metal particle; at least one ceramic particle; at least one plastic particle. The particle may in particular have a diameter or equivalent diameter of 100 μm to 500 μm. Alternatively or additionally, the particle may have an extension in at least one dimension, which is at least 50 μm, preferably at least 100 μm, for example 50 μm 3 mm, in particular 100 μm 1 mm.

As stated above, the fluorescent marker may in particular comprise at least one fluorescent dye. In particular, the fluorescent marker can comprise at least one lacquer, wherein the lacquer is set up to emit fluorescent light upon exposure to excitation light having at least one wavelength in the ultraviolet spectral range and / or in the blue spectral range, in particular fluorescent light in the visible spectral range.

In a further possible embodiment of the proposed method, an evaluation of the result of the training step is carried out in the comparison step. As noted above, in the training step unrecognized impurities are checked to see if the verification step has established that these impurities have been placed at a primary or non-visual point of view during visual quality control. As stated above, this may be, for example, a meniscus of at least one liquid of the amorphous product and / or at least one foam and / or a location between a closure of the primary packaging material and a wall of the ΡπΓηΕ 3ϋ1αΓΐϊΐί6ΐ3, which in visual quality control or not difficult to see. If such a situation is identified, the training results may be re-evaluated in accordance with this verification, for example by identifying unrecognized errors, in particular unrecognized impurities that are difficult or impossible to visualize during visual quality control Training results are not taken into account or are considered only with a lower weighting as impurities, which are arranged at a well visible in the visual quality control point of Primak ackm ttel.

In a further embodiment of the proposed method, one or more of the primary packaging means of the test set, in which it was determined in the verification step that the impurities are arranged at a location of the primary packaging means which is difficult or impossible to view during visual quality control, can be removed from the test set and optionally exchanged for other primary packaging. In another aspect of the present invention, a kit for training quality control personnel in filling amorphous goods into primary packaging is proposed. In particular, the kit may be used in a method according to one or more of be described above embodiments and / or according to one or more of the embodiments described in more detail below. Accordingly, for several embodiments of the test set, reference may be made to the above description of the method. The test kit comprises a plurality of primary filters filled with the product. At least one primary packaging agent of the filled primary packaging material is afflicted with at least one contaminant, wherein the contaminant has at least one fluorescence marker.

With respect to optional embodiments, reference may be made to the description of the method. In particular, with regard to possible embodiments of the amorphous product, the primary packaging means, reference may be made to the above description with regard to possible embodiments of the test set with additional primary agents designed to be free from verumeinigung and further embodiments. In particular, the test set may comprise a faulty quantity of primary packs filled with the goods and a faultless quantity of the primary packs filled with the goods. The defective quantity of the primary packaging material filled with the product may in turn be divided into a quantity subject to contamination, an amount subject to other errors and an amount contaminated with both impurities and other defects. In this respect, as well as with regard to possible dimensions of these quantities, reference may be made to the above description. Furthermore, reference may be made to the above description with regard to the scope of the stated amounts and / or with regard to the scope of the test set. Furthermore, reference may also be made to the above description with regard to possible configurations of the particles.

Furthermore, the test set may include at least one documentation documenting a fault liability of the primary packaging. For example, this can be the optional documentation described above, which can be created in the provisioning step (method step a)) and which is also referred to as test kit documentation. This documentation can be part of the test set, for example in paper form or in electronic form, for example on a data carrier. In a further aspect of the present invention, a kit is proposed for training quality control personnel in the filling of amorphous goods in primary equipment. In particular, this kit may in turn be adapted for use in a method according to one or more of the embodiments described above or the embodiments described in more detail below. The kit comprises a kit according to the preceding description. Furthermore, the kit comprises at least one excitation light source, in particular at least one UV light source, wherein the excitation light source is arranged to emit excitation light of 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 may be stationary or which may also be designed, for example, as a flashlight. In a further aspect of the present invention, there is proposed use of a kit and / or kit according to one or more of the above-described embodiments or one or more of the embodiments described below for training quality control personnel to fill amorphous goods in primary packages ,

In a further aspect of the present invention, a method of making a kit for training quality control personnel in filling amorphous goods in primary packages is proposed. The test set can be set up in particular for use in a method according to one or more of the embodiments described above or described in more detail below. In the manufacturing process a plurality of Prmiarpackmitteln filled with the product is provided, wherein at least one Prim φac means of the filled primary packaging means is provided with at least one impurity, wherein the impurity has at least one fluorescence marker. For example, the amorphous product can be introduced into the rim oil container and subsequently at least one contaminant, which has the fluorescence marker, can additionally be introduced into one or more of the primary packaging means. For example, it may be one or more of the above-mentioned impurities. Alternatively or in addition to a subsequent introduction of the impurities, the introduction of the impurity can also take place in the amorphous product before it is introduced into the respective primary packaging. Various configurations are possible.

In addition, the manufacturing method can be configured such that at least one of

is provided with at least one other error. Thus, as described above, at least one of the primary packaging means may be provided with damage, for example with at least one tear. Alternatively or additionally, at least one closure of at least one of the primary packaging means may be incorrectly set up and / or inserted. In this way, in the manufacturing process, a test kit and / or a kit can be produced in which one or more of the primary packaging material filled with the product have at least one defect, the error can be selected from the group consisting of at least one contaminant and at least one another mistake. The proposed methods and devices have a number of advantages over known methods and devices. In particular, according to the original training results can be more reliably and accurately checked and evaluated. In particular, it is possible to avoid or at least correct misjudgments in the training result to the extent that the personnel to be trained were unable to identify errors, in particular contaminants, with the means at their disposal.

In particular, impurities in the form of particles can be UV-marked by means of the fluorescence marker. In this way, in case of doubt, a proof can be provided by illuminating the pimple packs by excitation light, whether the particle is definitely present or not, or possibly hidden in the primary packaging, such that it is available to the staff to be trained Means is not recognizable. Thus, a result of the training, in particular a visual training, can be made more precise, in particular, a transparency training, so a training for a visual inspection using transparency of the primary packaging material and the amorphous medium can be made more precise. Furthermore, inappropriate primary packaging of the kit may be replaced if necessary.

In summary, the following embodiments are particularly preferred in the context of the present invention:

Embodiment 1: Method for training quality control personnel in the packaging of amorphous goods in stamping materials, the method comprising the following steps:

a) at least one providing step, wherein in the providing step at least one test set of filled primary packs is provided, the test set comprising a plurality of primary packs filled with the amorphous commodity, wherein at least one primary packer of the filled primary pouch means is afflicted with at least one contaminant; Contamination has at least one fluorescent label;

(b) at least one training step, where in the training step the test set is presented to at least one person to be trained, with the person to be trained performing a visual quality control for the detection of contamination, documenting the outcome of the training step;

c) at least one verification step, wherein in the verification step the test set is irradiated with excitation light, whereby fluorescent contaminants are detected, the result of the verification step being 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. Embodiment 2: Method according to the preceding embodiment, wherein the amorphous product is selected from the group consisting of: a diagnostic agent, in particular a liquid diagnostic agent; a therapeutic, especially a liquid therapeutic eutikum; a medicament, in particular a liquid medicament and particularly preferably a parenteral medicament.

Embodiment 3: Method according to one of the preceding embodiments, wherein the primary packaging means comprise vessels, in particular vessels selected from the group consisting of: syringe bodies; vials; glasses; Carpoulen.

Embodiment 4: Method according to one of the preceding embodiments, wherein the plurality of prima filling means filled with the amorphous product comprise identical, in particular identical, primary packaging means. Embodiment 5: Method according to one of the preceding embodiments, wherein in the provisioning step a documentation about the adhesion of the filled primary packaging means with the impurities is created.

Embodiment 6: A method according to any one of the preceding embodiments, wherein a plurality of the primary packs of the test set filled with the amorphous article are free of the contaminant.

Embodiment 7: Method according to one of the preceding embodiments, the test kit comprises a contamination-free amount of primary packaging material filled with the amorphous product and a contaminated amount of primary packaging material filled with the amorphous product.

Embodiment 8: Method according to the preceding embodiment, wherein the contaminated amount of the primary packaging material filled with the amorphous product forms a proportion of 5% to 50% of the total primary packaging material filled with the amorphous product, in particular a proportion of 10% to 40% and most preferably a proportion of 20% to 30%.

Embodiment 9: Method according to one of the preceding embodiments, wherein furthermore at least one primary pouch of the test set is afflicted with at least one further error, in particular a further error selected from the group consisting of an incorrect closure of the primary pouch and a damage of the primary packaging, in particular a crack. Embodiment 10: Method according to one of the preceding embodiments, wherein the test set comprises 10-1000 primary packaging materials filled with the amorphous product, in particular 50-200 and particularly preferably 100.

Embodiment 11: Method according to one of the preceding embodiments, wherein the at least one impurity comprises at least one particle.

Embodiment 12: The method of the preceding embodiment, wherein the particle is selected from the group consisting of: at least one fiber; at least one hair; at least one chip, in particular at least one metal chip and / or at least one wood chip 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 one plastic particle.

Embodiment 13 Method according to one of the two preceding embodiments, wherein the particle has a diameter or equivalent diameter of 100 μm to 500 μm.

Embodiment 14: Method according to one of the preceding embodiments, wherein the fluorescent marker comprises at least one lacquer, wherein the lacquer is set up to emit fluorescent light upon exposure to excitation light having at least one wavelength in the ultraviolet spectral range and / or in the blue spectral range.

Embodiment 15: Method according to one of the preceding embodiments, wherein in the comparing step an evaluation of the result of the training step is carried out, wherein in the training step unrecognized impurities are checked as to whether in the verification step it was determined that these impurities were present at a visual quality control not or only with difficulty viewable place of the primary means were arranged.

Embodiment 16: Method according to one of the preceding embodiments, wherein one or more of the primary substances of the test kit in which it was determined in the verification step that the impurities are arranged at a location of the primary packaging means which is difficult or impossible to access during visual quality control Test set removed and optionally replaced with other primary packaging. Embodiment 17: Test set for training personnel for quality control in the filling of amorphous goods in primary pouches, in particular for use in a method according to one of the preceding embodiments, wherein the test set comprises a plurality of priming means filled with the amorphous product, at least one primary packaging means the filled primary packaging material is contaminated with at least one veining, the contamination having at least one fluorescent marker.

Embodiment 18: Kit for training quality control personnel in the packaging of amorphous goods in primary packaging, in particular for use in a method according to any one of the preceding methods relating to a method, wherein the kit comprises at least one kit according to the preceding embodiment, wherein the kit furthermore, at least one excitation light source, in particular a UV light source, wherein the excitation light source is arranged to emit excitation light having at least one wavelength in the ultraviolet spectral range and / or in the blue spectral range.

Embodiment 19: Use of a test kit and / or a kit according to one of the two preceding embodiments for training quality control personnel in the filling of amorphous goods in primary packaging. Embodiment 20: A production method for producing a test set for training quality control personnel in the filling of amorphous goods in primary pouches, in particular for use in a method according to one of the preceding method embodiments, wherein in the manufacturing method a plurality of the amorphous goods filled primary ink · n is provided, wherein at least one rimäφackmittel the filled Primäφackmittel is provided with at least one Vemnreinigung, the impurity having at least one fluorescent marker.

BRIEF DESCRIPTION OF THE FIGURES Further details and features of the invention will become apparent from the following description of preferred embodiments, in particular in conjunction with the subclaims. In this case, the respective features can be implemented on their own or in combination with one another. The invention is not limited to the embodiments. The exemplary embodiments are shown schematically in the figures. The same reference numerals in the individual figures designate the same or functionally identical or with respect to their functions corresponding elements. In detail show:

FIG. 1 shows a first exemplary embodiment of a test kit according to the invention and of a kit according to the invention;

Figure 2 shows a second embodiment of a test kit according to the invention and a kit according to the invention; and

3 shows a schematic flow chart of a method according to the invention for training personnel for quality control.

Exemplary embodiments

FIGS. 1 and 2 show various exemplary embodiments of kits 110 according to the invention in a highly schematic representation. The kits 110 each include a test set 112 for training quality control personnel, and an excitation light source 114 for emitting excitation light 116.

The test set 112 includes a plurality of primary tapers 118, which are exemplarily designed as syringe bodies 120 in the exemplary embodiment shown in FIG. 1 and exemplarily in the embodiment example shown in FIG. 2 as vials 122. In FIGS. 1 and 2 are symbolically and by way of example in each case three primary packaging means 118 shown. In practice, however, the test set will typically each comprise at least 10 primary packaging means 118, preferably at least 20 or even at least 50, for example 100-200 primary packaging means 118.

For example, while the syringe bodies 120 may be closed with plugs 124, the vials 122 may be closed with crimp caps 126 in addition to plugs 124. Other embodiments of the primary packaging means 118 are conceivable.

The Primäφackmittel 118 are each filled with an amorphous product 128 in the exemplary embodiments. In particular, this amorphous article 128 may be a liquid, wherein, for example, a test liquid or else a parenteral medicament may be used. The amorphous fabric 128 is preferably made transparent.

The kit 110 in the exemplary embodiments illustrated comprises in each case a set of one or more defect-free primary packaging means 130 as well as a set of one or more error-prone primary packaging means 132. The faulty primary packaging means 132 can in turn, be distinguished into an amount of one or more contaminants 134 and an amount of one or more other defects. In this case, as shown by the right-hand primary packaging means 118 in FIG. 1, the quantities 134, 136 can also have an intersection, that is to say an amount

118 form, which have both one or more impurities and one or more other errors.

The impurities are indicated symbolically in FIGS. 1 and 2 by the reference numeral 138. In particular, these contaminants 138 may include one or more particles 140. These impurities 138 are, as stated above, provided with at least one fluorescent marker 142. For example, this fluorescent marker 142 may be a UV varnish. One and the same type of particles 140 may be provided, for example, with one and the same fluorescent marker 142, as well as different types of contaminants 140 may be provided with the same fluorescent marker 142. Alternatively or additionally, in this or in other exemplary embodiments, a possibility can also be realized in which different types of impurities 18 are provided with different types of fluorescence markers 142, for example with fluorescence markers which emit fluorescent light with different colors.

With respect to the contaminants 138, it is necessary to distinguish between impurities which are readily visible to the naked eye and impurities which are arranged in regions of the primary packaging means 118 which are very difficult to see with the naked eye. These contaminants, which are also referred to below as hidden contaminants 144, may, for example, as shown on the right primary packaging means 118 in FIG. 1 or the middle primary packaging means 118 in FIG. 2, be impurities which are in the region of a closure of the

118 are arranged, and / or which are arranged in the region of a meniscus of the amorphous fabric 128 and / or a foam.

The primary packaging means 134, which are afflicted with further errors, can each have one or more further errors 146, ie errors which are not caused by impurities 138. As an example of further errors 146, FIG. 1 shows a faulty closure 148 in the right-hand primary packaging means 118, and in FIG. 2 a tear 150 or other damage in the left-hand of the primary packaging means 118.

The kits 110 can furthermore each comprise a documentation 152, which is symbolically indicated in each case in FIGS. 1 and 2, and in which the respective errors are listed for the respective ΡπΓτώ 3θ1ίηιιΐί6ΐη 118 of the test set 112. The documentation 152 may be in electronic form and / or in paper form, for example. In Figure 3, an exemplary embodiment of a method according to the invention for training personnel for quality control in the filling of amorphous goods in Primäi ackmittel is shown schematically as a flowchart. The method comprises a provisioning step 310 in which a test set 112 is provided, for example according to the exemplary embodiments in FIGS. 1 and 2. In providing this test set 112, in particular a test set documentation 152 can also be created or provided.

Furthermore, the method illustrated in FIG. 3 comprises at least one training step 312, in which the test set 112 is presented to at least one person to be trained. The person to be trained carries out a visual quality control for the detection of contaminants 138 and preferably also of other errors 146. The result of the training step 312 is documented in a training documentation 154.

Furthermore, the method illustrated in FIG. 3 comprises at least one verification step 314. In this verification step, the test set 112 is irradiated with the excitation light 116. This irradiation can for example be done individually, in groups or in total. For this purpose, for example, the primary packaging means 118 can be moved individually, in groups or as a whole relative to the excitation light source 114, so that the irradiation can take place. By way of example, the primary packaging means 118 can be introduced individually, in groups or as a whole into a light beam of the excitation light 116. In this case, the impurities 138, which are provided with the fluorescent marker 142, are detected on the basis of their fluorescence. The detection can be done with the naked eye. Alternatively or additionally, one or more optical aids may also be used for detection, for example at least one magnifying glass and / or at least one microscope and / or at least one camera.

The result of the verification step is documented in a verification documentation 156. It should be noted that the documentations 152, 154 and 156 can be configured as separate documentations. Alternatively or additionally, these documentations 152, 154 and 156 can also be combined in pairs or in total to form a common documentation.

Furthermore, the method illustrated in FIG. 3 comprises 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 with one another, for example by comparing at least the documentation 154 and 156 and preferably also the documentation 152. In particular, contaminants 144 hidden in the verification step 314 may be detected and marked accordingly in the verification documentation 156. If, for example, deviations of the training result according to the training documentation 154 from the test set documentation 152 are determined in the comparison step 316, then they can be checked using the verification documentation 156 and optionally corrected. In this way, for example, training results in the form of not recognizing hidden contaminants 144 may be disregarded in the assessment of the training outcome or at least given a lower weighting than other training results. Furthermore you can

118, which have hidden contaminants 144, are removed from the kit 112 and replaced by other primary packages 118.

Exemplary embodiment of a production method:

An embodiment of a manufacturing method for producing a test set 112 will be described below. In this method, a plurality of PrimE acla panels 118 are initially provided in the unfilled state. Furthermore, an amorphous article 128 is provided, for example in the form of a liquid and preferably in the form of a transparent liquid. Furthermore, a plurality of identical different impurities 138, in particular in the form of particles 140, are provided. These contaminants 138 are labeled with a fluorescent marker 142. Furthermore, the amorphous fabric 128 is introduced into the primary packaging means 118. Subsequently, the impurities 138 labeled with the fluorescence marker 142 are introduced into one or more of the primary inking means 118 of the test set 112 in a targeted manner, and the

118 are closed. In this way, the faulty primary packaging 132 is provided. In addition, defect free primary packaging means 130 may be provided so that the kit 112 may include a quantity of defect free primary pack 130 and an amount of defective primary pack means 132.

As a concrete embodiment, the use of syringe bodies 120 may be used. The syringe bodies 120 are closed with caps 18, as shown by way of example in FIG. Subsequently, a predetermined amount of a liquid, for example water as an amorphous product 128 is introduced into the syringe body 120, for example by means of a pipette.

For example, various types of particles 140 may be used to produce the contaminants 138. The particles 140 were labeled with the fluorescent label 142 by immersing them in a lacquer. The resulting particles 142 marked with the fluorescent marker 142 were introduced into one or more of the primary packaging means 118. Subsequently, the Primäφackmittel 118 were closed by the plug 128th LIST OF REFERENCE NUMBERS

1 10 kit

1 12 test set

1 14 excitation light source

116 excitation light

118 ΡππΐΕ 3θ1ίηΊΪίίε1

120 syringe body

122 vials

124 plugs

126 crimp cap

128 amorphous goods

130 error-free primary packaging

132 faulty primary packaging

1 34 contaminated Primäφackmittel

136 prone residuals containing other defects

138 pollution

140 particles

142 fluorescent marker

144 hidden contaminants

146 more mistakes

148 faulty closure

150 crack

1 2 Test kit documentation

154 training documentation

156 verification documentation

158 cap

310 deployment step

312 training step

314 verification step

316 comparison step

Claims

claims

Method of training quality control personnel in the process of filling amorphous goods (128) in Ρπττώ 3ΰ1αΉΪίΐ6ΐ (118), the method comprising the following steps:

a) at least one providing step, wherein in the providing step, at least one test set (112) is provided on filled primary packaging means (118), the testing set (112) comprising a plurality of primary packaging means (118) filled with the amorphous fabric (128), wherein at least a primary packaging means (118) of the filled primary packaging means (118) is afflicted with at least one contaminant (138), the contaminant (138) having at least one fluorescent label (142);

(b) at least one training step, during which the test set (112) is submitted to at least one person to be trained, with the person to be trained performing a visual quality control for the detection of impurities (138), documenting the outcome of the training step;

c) at least one verification step, wherein in the verification step, the test set (112) is irradiated with excitation light (116), wherein fluorescent contaminants (138) are detected, documenting the result of the verification step; and

d) at least one comparing step, wherein in the comparing step the result of the training step and the result of the verification step are compared.

A method according to the preceding claim, wherein the amorphous article (128) is selected from the group consisting of: a diagnostic agent, in particular a fluid diagnostic agent; a therapeutic agent, in particular a liquid therapeutic agent; a drug, especially a liquid drug, and more preferably a parenteral drug.

The method of any one of the preceding claims, wherein in the providing step, a set of test records (152) about the adherence of the filled primary packaging means (118) to the contaminants (138) is established.

Method according to one of the preceding claims, the test set (112) comprises a contamination-free amount (130) of primary ink means (118) filled with the amorphous product (128). and a contaminated amount (134) of primary packaging means (118) filled with the amorphous fabric (128).

5. The method according to claim 1, further comprising at least one primary agent (118) of the test kit (112) having at least one further error (136), in particular a further error (136) selected from the group consisting of an incorrect one Closure (148) of the primary means (118) and a damage of the Primärpackrnittels (118), in particular a crack (150).

6. The method according to any one of the preceding claims, wherein the test set (112) 10-1000 with the amorphous fabric (128) filled primary packaging means (118), in particular 50-200 and particularly preferably 100.

The method of any one of the preceding claims, wherein the at least one contaminant (138) comprises at least one particle (140).

8. The method of the preceding claim, wherein the particle (140) is selected from the group consisting of: at least one fiber; at least one hair; at least one chip, in particular at least one metal chip and / or at least one wood chip 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 one plastic particle.

9. The method according to any one of the preceding claims, wherein the fluorescent marker (142) comprises at least one lacquer, wherein the lacquer is adapted to emit fluorescent light upon exposure of excitation light (116) having at least one wavelength in the ultraviolet spectral range and / or in the blue spectral range ,

10. The method of claim 1, wherein in the comparing step, an evaluation of the result of the training step is performed, wherein in the training step, unrecognized impurities are checked as to whether the contamination step (138) has been determined in the verification step a location of the primary packaging (118) which was difficult or impossible to see during visual quality control.

A method according to any one of the preceding claims, wherein one or more of the primary packaging means (118) of the kit (112) which has been identified in the verification step as contaminants (138) are difficult or impossible to access at visual quality control the primary packaging means (118) are located, removed from the test set (112) and optionally exchanged for other primary packaging means (118).

A kit (112) for training quality control personnel in filling amorphous goods (128) in primary packaging (118), particularly for use in a method as claimed in any one of the preceding claims, wherein said kit (112) comprises a plurality of said materials amorphous ware (128) was based on primary packaging means (118), wherein at least one primary means (118) of the filled primary packaging means (118) is afflicted with at least one contaminant (138), wherein the contaminant (138) comprises at least one fluorescent marker (142).

A kit (110) for training quality control personnel in filling amorphous goods (128) in primary packaging (118), in particular for use in a method according to any one of the preceding method claims, wherein the kit (110) comprises at least a kit (110) according to the preceding claim, wherein the kit (110) further comprises at least one excitation light source (114), in particular a UV light source, wherein the excitation light source (114) is arranged to excite light (116) with at least one Wavelength in the ultraviolet spectral range and / or in the blue spectral range to emit.

14. Use of a test kit (112) and / or a kit (110) according to one of the two preceding claims for training of quality control personnel in the filling of amorphous goods (128) in primary packaging (118).

A method of making a test kit (112) for training quality control personnel in the process of filling amorphous goods (128) in primary packaging (118), in particular for use in a method according to any one of the preceding claims relating to a method, wherein Manufacturing process, a plurality of primary packaging means (118) filled with the amorphous fabric (128) is provided, wherein at least one primary packaging means (118) of the filled primary packaging means (118) is provided with at least one contaminant (8), the contaminant (138) at least one Fluorescent marker (142).