EP2831814A1 - Verfahren zur schulung von personal in der qualitätskontrolle - Google Patents
Verfahren zur schulung von personal in der qualitätskontrolleInfo
- Publication number
- EP2831814A1 EP2831814A1 EP13712288.3A EP13712288A EP2831814A1 EP 2831814 A1 EP2831814 A1 EP 2831814A1 EP 13712288 A EP13712288 A EP 13712288A EP 2831814 A1 EP2831814 A1 EP 2831814A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- primary packaging
- training
- primary
- filled
- amorphous
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
- 238000000034 method Methods 0.000 title claims abstract description 96
- 238000012549 training Methods 0.000 title claims abstract description 91
- 238000003908 quality control method Methods 0.000 title claims abstract description 60
- 238000009516 primary packaging Methods 0.000 claims abstract description 113
- 238000012360 testing method Methods 0.000 claims abstract description 110
- 239000012535 impurity Substances 0.000 claims abstract description 63
- 238000012795 verification Methods 0.000 claims abstract description 47
- 230000005284 excitation Effects 0.000 claims abstract description 31
- 239000003550 marker Substances 0.000 claims abstract description 29
- 230000000007 visual effect Effects 0.000 claims abstract description 18
- 239000000356 contaminant Substances 0.000 claims description 49
- 239000000047 product Substances 0.000 claims description 48
- 239000002245 particle Substances 0.000 claims description 44
- 239000007788 liquid Substances 0.000 claims description 22
- 239000003814 drug Substances 0.000 claims description 21
- 238000011109 contamination Methods 0.000 claims description 20
- 230000003595 spectral effect Effects 0.000 claims description 19
- 238000004519 manufacturing process Methods 0.000 claims description 13
- 239000007850 fluorescent dye Substances 0.000 claims description 10
- 239000011521 glass Substances 0.000 claims description 10
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- 229940079593 drug Drugs 0.000 claims description 9
- 238000001514 detection method Methods 0.000 claims description 7
- 238000011156 evaluation Methods 0.000 claims description 7
- 239000004744 fabric Substances 0.000 claims description 7
- 239000004922 lacquer Substances 0.000 claims description 7
- 239000004033 plastic Substances 0.000 claims description 7
- 239000000032 diagnostic agent Substances 0.000 claims description 6
- 229940039227 diagnostic agent Drugs 0.000 claims description 6
- 239000002023 wood Substances 0.000 claims description 6
- 239000000835 fiber Substances 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 239000012530 fluid Substances 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 4
- 229940124597 therapeutic agent Drugs 0.000 claims description 4
- 239000000919 ceramic Substances 0.000 claims description 3
- 239000002923 metal particle Substances 0.000 claims description 3
- 239000000463 material Substances 0.000 claims description 2
- 238000012856 packing Methods 0.000 abstract description 3
- 239000012602 primary packaging material Substances 0.000 description 27
- 230000007547 defect Effects 0.000 description 15
- 238000004806 packaging method and process Methods 0.000 description 8
- 230000002950 deficient Effects 0.000 description 4
- 230000005499 meniscus Effects 0.000 description 4
- 230000003287 optical effect Effects 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- 238000003149 assay kit Methods 0.000 description 3
- 239000000975 dye Substances 0.000 description 3
- 239000006260 foam Substances 0.000 description 3
- 239000000825 pharmaceutical preparation Substances 0.000 description 3
- 229940127557 pharmaceutical product Drugs 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000002966 varnish Substances 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 2
- 239000012502 diagnostic product Substances 0.000 description 2
- 230000037452 priming Effects 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 238000011179 visual inspection Methods 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 1
- 206010000496 acne Diseases 0.000 description 1
- 238000010923 batch production Methods 0.000 description 1
- ZYGHJZDHTFUPRJ-UHFFFAOYSA-N benzo-alpha-pyrone Natural products C1=CC=C2OC(=O)C=CC2=C1 ZYGHJZDHTFUPRJ-UHFFFAOYSA-N 0.000 description 1
- 229910052729 chemical element Inorganic materials 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 235000001671 coumarin Nutrition 0.000 description 1
- 150000004775 coumarins Chemical class 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000000834 fixative Substances 0.000 description 1
- GNBHRKFJIUUOQI-UHFFFAOYSA-N fluorescein Chemical compound O1C(=O)C2=CC=CC=C2C21C1=CC=C(O)C=C1OC1=CC(O)=CC=C21 GNBHRKFJIUUOQI-UHFFFAOYSA-N 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 238000005470 impregnation Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000003359 percent control normalization Methods 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 150000001629 stilbenes Chemical class 0.000 description 1
- 235000021286 stilbenes Nutrition 0.000 description 1
- 230000007306 turnover Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B19/00—Teaching not covered by other main groups of this subclass
-
- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
- G09B23/24—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for chemistry
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/88—Investigating the presence of flaws or contamination
- G01N21/90—Investigating the presence of flaws or contamination in a container or its contents
- G01N21/9018—Dirt detection in containers
- G01N21/9027—Dirt detection in containers in containers after filling
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/88—Investigating the presence of flaws or contamination
- G01N21/93—Detection standards; Calibrating baseline adjustment, drift correction
-
- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09F—DISPLAYING; ADVERTISING; SIGNS; LABELS OR NAME-PLATES; SEALS
- G09F3/00—Labels, tag tickets, or similar identification or indication means; Seals; Postage or like stamps
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/64—Fluorescence; Phosphorescence
- G01N21/645—Specially adapted constructive features of fluorimeters
- G01N21/6456—Spatial resolved fluorescence measurements; Imaging
- G01N2021/646—Detecting fluorescent inhomogeneities at a position, e.g. for detecting defects
Definitions
- 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.
- 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.
- amorphous goods in particular homogeneous amorphous goods, such as liquids
- primary packing means in particular containers.
- quality control plays a significant role.
- 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.
- 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.
- these may be liquid drugs.
- the medicaments can be parenteral medicines or so-called parenteralia, ie medicaments which are administered by means of an injection.
- 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.
- 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.
- 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.
- a model product for example a Model solution
- 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.
- 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.
- 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.
- a test set may be configured such that 20 to 30% of the primary primary packs of this test set have corresponding errors.
- 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.
- 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.
- 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.
- the respective expression can also be used non-exclusively, in that A comprises at least one further component in addition to B.
- the amorphous goods may in particular be homogeneous amorphous goods.
- the amorphous goods may be in fluid form, for example as a liquid, in particular as a transparent liquid.
- a Primärpackrnittel is generally understood a packaging, which has at least one interior for receiving the amorphous goods.
- it may be a closable Primärpackrnittel.
- 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.
- the proposed method may additionally comprise method steps not mentioned below.
- individual, several or all process steps can also be carried out repeatedly.
- 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.
- the Test kit includes a plurality of filled with the goods Pirmärpackschn. 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.
- 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 Primä ⁇ ackmittehl.
- 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.
- 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.
- the amorphous article may be a fluid amorphous article, for example a liquid.
- 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.
- 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.
- the kit may also include multiple primary packages having different types of cleansing.
- the test kit can also comprise at least one primary packaging agent which is associated with a plurality of different impurities.
- 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.
- 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.
- the impurity comprises an impurity, in particular a non-fluorescent impurity, labeled with the fluorescence marker.
- impurities typically occurring in the filling of amorphous goods in PrimaYpackrnittel can be used, which are subsequently labeled with at least one fluorescent marker.
- 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.
- 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.
- the method comprises at least one training step (method step b)).
- 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 Prmiärpacksch.
- 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.
- 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.
- 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 ackstoff is afflicted with an impurity.
- the primary packaging means may be identified, for example with identification numbers and / or other types which allow identification of the primary packaging means.
- 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.
- 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.
- 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.
- the method comprises at least one verification step (process step b)).
- a verification step is generally understood as a method step in which a result obtained in another way is checked.
- the test set is irradiated with excitation light.
- 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.
- 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.
- the excitation light can be generated by at least one excitation light source, for example a UV lamp.
- the primary pouches of the test set can be introduced successively into the radiation of the excitation light.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- the primary means may comprise vessels selected from the group consisting of: syringe bodies; Vials, glasses, carpules.
- the test set may in particular comprise identical, preferably identical, primary packaging.
- the amorphous product is identical in all filled primary packaging of the test set.
- a documentation about the adherence of the filled primary inking means with the contaminants can be prepared (test kit documentation).
- other errors can also be documented.
- 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.
- 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.
- the faults may generally include one or more contaminants and or one or more other faults, such as damage.
- 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.
- 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.
- 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.
- 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.
- the test set may comprise primary packaging means which only have one or more impurities as defects.
- the test set may comprise primary packaging means which have only one or more further errors.
- 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 Primä ⁇ ackstoffschn the test set completely free of errors.
- 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.
- 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%.
- 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%.
- 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.
- the test kit may comprise at least 5 primary packages.
- 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.
- other embodiments of the test set are in principle possible.
- the contaminant can be configured in various ways.
- the contaminant may comprise at least one particle.
- Under a particle is generally a particle in basically any form to understand.
- 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 ⁇ m to 500 ⁇ m.
- the particle may have an extension in at least one dimension, which is at least 50 ⁇ m, preferably at least 100 ⁇ m, for example 50 ⁇ m 3 mm, in particular 100 ⁇ m 1 mm.
- the fluorescent marker may in particular comprise at least one fluorescent dye.
- 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.
- an evaluation of the result of the training step is carried out in the comparison 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.
- 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 ⁇ 3 ⁇ 1 ⁇ 6 ⁇ 3, which in visual quality control or not difficult to see.
- 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.
- 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.
- a kit for training quality control personnel in filling amorphous goods into primary packaging is proposed.
- 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.
- 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 verumein Trent and further embodiments.
- 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.
- the test set may include at least one documentation documenting a fault liability of the primary packaging.
- 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.
- a kit is proposed for training quality control personnel in the filling of amorphous goods in primary equipment.
- 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.
- 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.
- this excitation light source may be a UV lamp, which may be stationary or which may also be designed, for example, as a flashlight.
- 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.
- a plurality of Prmiarpackschn filled with the product is provided, wherein at least one Prim ⁇ ac means of the filled primary packaging means is provided with at least one impurity, wherein the impurity has at least one fluorescence marker.
- 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.
- the impurity may be one or more of the above-mentioned 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.
- the manufacturing method can be configured such that at least one of is provided with at least one other error.
- at least one of the primary packaging means may be provided with damage, for example with at least one tear.
- at least one closure of at least one of the primary packaging means may be incorrectly set up and / or inserted.
- 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.
- impurities in the form of particles can be UV-marked by means of the fluorescence marker.
- 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.
- 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.
- inappropriate primary packaging of the kit may be replaced if necessary.
- Embodiment 1 Method for training quality control personnel in the packaging of amorphous goods in stamping materials, the method comprising the following steps:
- 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;
- 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;
- 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.
- 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.
- 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 ⁇ m to 500 ⁇ m.
- 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.
- 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 rimä ⁇ ackstoffsch the filled Primä ⁇ ackstoffsch is provided with at least one Vemngraphy, the impurity having at least one fluorescent marker.
- 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.
- FIG. 3 shows a schematic flow chart of a method according to the invention for training personnel for quality control.
- 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.
- FIGS. 1 and 2 are symbolically and by way of example in each case three primary packaging means 118 shown.
- 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.
- 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 Primä ⁇ ackstoff 118 are each filled with an amorphous product 128 in the exemplary embodiments.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 ⁇ 3 ⁇ 1 ⁇ 6 ⁇ 118 of the test set 112.
- the documentation 152 may be in electronic form and / or in paper form, for example.
- FIG 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 ackstoff 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.
- a test set documentation 152 can also be created or provided.
- 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.
- the method illustrated in FIG. 3 comprises at least one verification step 314.
- the test set 112 is irradiated with the excitation light 116.
- This irradiation can for example be done individually, in groups or in total.
- 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.
- the primary packaging means 118 can be introduced individually, in groups or as a whole into a light beam of the excitation light 116.
- 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.
- 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.
- 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.
- the method illustrated in FIG. 3 comprises at least one comparison step 316.
- 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.
- 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.
- a manufacturing method for producing a test set 112 will be described below.
- a plurality of PrimE acla panels 118 are initially provided in the unfilled state.
- an amorphous article 128 is provided, for example in the form of a liquid and preferably in the form of a transparent liquid.
- a plurality of identical different impurities 138 are provided. These contaminants 138 are labeled with a fluorescent marker 142.
- the amorphous fabric 128 is introduced into the primary packaging means 118.
- 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.
- the faulty primary packaging 132 is provided.
- 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.
- syringe bodies 120 may be used.
- the syringe bodies 120 are closed with caps 18, as shown by way of example in FIG.
- 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.
- 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 Primä ⁇ ackstoff 118 were closed by the plug 128th LIST OF REFERENCE NUMBERS
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- General Physics & Mathematics (AREA)
- Engineering & Computer Science (AREA)
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- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Theoretical Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Educational Administration (AREA)
- Educational Technology (AREA)
- Pathology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Computational Mathematics (AREA)
- Medicinal Chemistry (AREA)
- Entrepreneurship & Innovation (AREA)
- Algebra (AREA)
- Mathematical Optimization (AREA)
- Mathematical Analysis (AREA)
- Pure & Applied Mathematics (AREA)
- Mathematical Physics (AREA)
- Investigating Materials By The Use Of Optical Means Adapted For Particular Applications (AREA)
- Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
- Packages (AREA)
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Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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EP13712288.3A EP2831814A1 (de) | 2012-03-29 | 2013-03-27 | Verfahren zur schulung von personal in der qualitätskontrolle |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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EP12162162 | 2012-03-29 | ||
EP13712288.3A EP2831814A1 (de) | 2012-03-29 | 2013-03-27 | Verfahren zur schulung von personal in der qualitätskontrolle |
PCT/EP2013/056543 WO2013144215A1 (de) | 2012-03-29 | 2013-03-27 | Verfahren zur schulung von personal in der qualitätskontrolle |
Publications (1)
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EP2831814A1 true EP2831814A1 (de) | 2015-02-04 |
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ID=47997549
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EP13712288.3A Withdrawn EP2831814A1 (de) | 2012-03-29 | 2013-03-27 | Verfahren zur schulung von personal in der qualitätskontrolle |
Country Status (9)
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EP (1) | EP2831814A1 (de) |
JP (1) | JP2015519591A (de) |
KR (1) | KR20150001740A (de) |
CN (1) | CN104205131A (de) |
CA (1) | CA2868916A1 (de) |
HK (1) | HK1200562A1 (de) |
MX (1) | MX351731B (de) |
RU (1) | RU2668018C2 (de) |
WO (1) | WO2013144215A1 (de) |
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EP4016056A1 (de) | 2020-12-16 | 2022-06-22 | Tomas Pink | Verfahren zur erkennung von adsorptionsunterschieden, anlagerungs- und/oder rückhaltebereichen in teilweise lichtdurchlässigen behältnissen |
WO2022128756A1 (de) | 2020-12-16 | 2022-06-23 | Tomas Pink | Verfahren zur erkennung von adsorptionsunterschieden, anlagerungs- und/oder rückhaltbereichen in teilweise lichtdurchlässigen behältnissen |
WO2023183542A2 (en) * | 2022-03-25 | 2023-09-28 | Amgen Inc. | Artificial lyophilized product samples for automated visual inspection systems |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
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DE19818176A1 (de) * | 1998-04-23 | 1999-10-28 | Basf Ag | Verfahren zur Markierung von Flüssigkeiten mit mindestens zwei Markierstoffen und Verfahren zu deren Detektion |
US5453359A (en) * | 1988-06-13 | 1995-09-26 | American Biogenetic Sciences, Inc. | Immunoassay and kit for in vitro detection of soluble DesAABB fibrin polymers |
JP3123249B2 (ja) * | 1991-09-10 | 2001-01-09 | 株式会社日立製作所 | Dna分子の長さ計測方法および計測装置 |
GB9218131D0 (en) * | 1992-08-26 | 1992-10-14 | Slater James H | A method of marking a liquid |
US5781284A (en) * | 1996-04-24 | 1998-07-14 | Infante; David A. | System for detecting impurities contained in a fluid medium |
JP2001509257A (ja) * | 1996-12-02 | 2001-07-10 | トルー・テクノロジー・インコーポレーテツド | 漏れを検出するための方法及び機器 |
US5974150A (en) * | 1997-09-30 | 1999-10-26 | Tracer Detection Technology Corp. | System and method for authentication of goods |
US6093302A (en) * | 1998-01-05 | 2000-07-25 | Combimatrix Corporation | Electrochemical solid phase synthesis |
US7378675B2 (en) * | 2003-06-26 | 2008-05-27 | Ncr Corporation | Security markers for indicating condition of an item |
EP1494000A1 (de) * | 2003-07-02 | 2005-01-05 | Sicpa Holding S.A. | Methode zum Markieren eines Materials mit Ionen, die schon in besagtem Material enthalten sind, und Methode zur Bestätigung der Authentizizät dieses Materials |
JP5685591B2 (ja) * | 2009-07-23 | 2015-03-18 | エンバイロンメンタル・リソース・アソシエイツ | 目視残渣限界の基準を設定する装置および方法 |
JPWO2011052322A1 (ja) * | 2009-10-29 | 2013-03-21 | 学校法人近畿大学 | 注射剤の調製実習用教材およびそれを用いた調製実習方法 |
-
2013
- 2013-03-27 WO PCT/EP2013/056543 patent/WO2013144215A1/de active Application Filing
- 2013-03-27 RU RU2014143411A patent/RU2668018C2/ru not_active IP Right Cessation
- 2013-03-27 CN CN201380017727.4A patent/CN104205131A/zh active Pending
- 2013-03-27 CA CA2868916A patent/CA2868916A1/en not_active Abandoned
- 2013-03-27 KR KR1020147027091A patent/KR20150001740A/ko not_active Application Discontinuation
- 2013-03-27 JP JP2015502325A patent/JP2015519591A/ja not_active Ceased
- 2013-03-27 EP EP13712288.3A patent/EP2831814A1/de not_active Withdrawn
- 2013-03-27 MX MX2014010881A patent/MX351731B/es active IP Right Grant
-
2015
- 2015-02-02 HK HK15101087.5A patent/HK1200562A1/xx unknown
Non-Patent Citations (1)
Title |
---|
"Parenteral Quality Control", 1 January 2003, ISBN: 978-0-8247-0885-6, article MICHAEL J. AKERS ET AL: "Parenteral Quality Control", pages: 210 - 221, XP055349800 * |
Also Published As
Publication number | Publication date |
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CA2868916A1 (en) | 2013-10-03 |
MX2014010881A (es) | 2014-10-15 |
HK1200562A1 (en) | 2015-08-07 |
RU2014143411A (ru) | 2016-05-20 |
CN104205131A (zh) | 2014-12-10 |
KR20150001740A (ko) | 2015-01-06 |
MX351731B (es) | 2017-10-26 |
RU2668018C2 (ru) | 2018-09-25 |
WO2013144215A1 (de) | 2013-10-03 |
JP2015519591A (ja) | 2015-07-09 |
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