An ampoule filled with a liquid medicine, a manufacturing method thereof, and equipment used in the manufacturing method

Abstract

The present invention discloses a method for manufacturing an ampoule filled with a liquid medicine and an apparatus for manufacturing an ampoule filled with a liquid medicine. A preform is manufactured by injection molding, and then the preform is heated non-uniformly and blown into an ampoule body. The present invention also discloses an ampoule manufactured by stretching and blowing, the ampoule including a connecting member with a break-off portion, wherein a preset breaking position is aligned with a diaphragm of the connecting member.

Description

Field of the Invention

[0001] The present invention relates to a method for manufacturing ampoules filled with a liquid medicament. The present invention also relates to such ampoules and an apparatus for manufacturing ampoules filled with a liquid medicament. Background Art

[0002] The published document WO 2015 / 007703 A1 (Fresenius Kabi Deutschland GmbH) describes an ampoule filled with a liquid medicament and a method for manufacturing the same.

[0003] According to the teachings of this document, an ampoule, which is particularly composed of multiple components, is manufactured by an injection molding process. By means of injection molding, complex and precise geometries can also be formed, especially in the regions of the head and the bottom of the ampoule.

[0004] Thus, in particular, an ampoule can be manufactured that has a head for attaching a connecting member and / or a bottom that forms a standing surface.

[0005] However, manufacturing the ampoule body by means of an injection molding process is costly, requires relatively large tools, and in the case of an ampoule composed of multiple components, the individual components also need to be assembled.

[0006] Methods for manufacturing ampoules from plastic that are known from practice are generally blow-fill-seal processes, in which a plastic profile is first extruded by an extruder. The extruded plastic profile is blown into a bottle shape in a blow mold and shaped by means of a tool to form a bottom. Then, the ampoule in the production process is filled and also shaped by means of a tool in order to seal the ampoule.

[0007] However, it is difficult to achieve complex and precise geometries with this method. Thus, in particular, it is almost impossible to provide an ampoule body with a head that is designed as an interface for the connecting member.

[0008] The method includes a septum that can be penetrated by a needle or a puncture to remove the contents of the ampoule. Such a connecting member is usually provided with a break-off part, below which a sterilized septum is arranged.

[0009] The seal used for this purpose is latched onto the head of the ampoule body. Therefore, dimensional stability (Maβhaltigkeit) of the head of the ampoule body is required.

[0010] This is especially the case when the surface of the septum and the surface of the adjacent seal are at the same height. Thus, in the prior art described above, the preset break position of the break-off part is spaced apart from the septum in terms of its height. Thereby, shape tolerances, such as those that may occur when assembling the individual components of the ampoule body, can be compensated for.

[0011] However, due to regulatory requirements, the diaphragm of the ampoule needs to be constructed to be wipeable. This construction also places higher requirements on the dimensional stability of the head of the ampoule body. Technical Field

[0013] Compared with the prior art, the present invention aims to provide a method for manufacturing an ampoule and a device used in this method. Using this method and this device, plastic ampoules can be produced simply and effectively with high dimensional stability. In particular, it should provide a simple manufacture of an ampoule with a standing surface in the bottom area and a head for receiving a connecting member. The present invention also aims to provide an ampoule that is easy to hold and can be used flexibly. Summary of the Invention

[0014] The object of the present invention has been achieved by a method for manufacturing a medicated ampoule according to any one of the dependent claims, a medicated ampoule, and a device for manufacturing a medicated ampoule.

[0015] Preferred embodiments and further improvements of the present invention come from the subject matter of the dependent claims, the description, and the description drawings.

[0016] The present invention relates to a method for manufacturing a medicated ampoule, wherein a preform is manufactured by injection molding, and the preform is formed into an ampoule by heating and blow molding. The ampoule has a wide side and a narrow side in cross-section. Before blow molding, the preform is heated in such a way that the preform is heated more strongly in the region of the side wall that is formed into the wide side of the ampoule than in the side wall region of the adjacent narrow side.

[0017] Therefore, the preform preferably extends in its main extension direction and transversely to its main extension direction in order to be formed into an ampoule.

[0018] Preferably, in order to form the ampoule, the preform is blow molded in such a way that the extended wall of the preform contacts the mold wall, and in this way, at least part of the shape of the ampoule body is defined.

[0019] The present invention is based on the recognition that precise geometric shapes can be formed by injection molding of the preform, especially in the head region of the ampoule.

[0020] Then, the preform is formed into an ampoule by heating, extending, and blow molding. In particular, except for the head, the ampoule body is expanded into its final shape.

[0021] In the scope of the present invention, an ampoule is understood to be a container that contains a single dose of a medicament solution and / or an active ingredient, such as eye drops. In particular, the filling capacity of such an ampoule is less than 50 ml. According to one embodiment, the ampoule is filled with a liquid volume of 5 ml to 20 ml.

[0022] An ampoule is manufactured according to the present invention. The ampoule or the ampoule body, when viewed in cross-section, includes a wide side and a narrow side. The ampoule particularly has an oval cross-section, through which a narrow side wall and a wide side wall are defined, and the side walls transition into each other to form an edge.

[0023] In particular, a preform having at least partially an annular cross-section is formed into an ampoule body.

[0024] Preferably, the forming is achieved only by blowing the heated preform. Thus, with the aid of a gas, especially air, the preform body is expanded into an ampoule body.

[0025] Before blow molding, the preform according to the present invention is heated such that the side wall region of the preform to be formed into the wide side of the ampoule is heated more strongly than the side wall region adjacent to the narrow side.

[0026] Therefore, according to the present invention, the region of the preform formed into the wide side and thus first in contact with the outer shape of the tool has a higher temperature before further processing. The preform is thus non-uniformly heated around its outer circumference. In particular, two sections that are hotter relative to the middle side wall are arranged opposite each other, and these two sections are formed into the wide side by blow molding.

[0027] This achieves a more uniform wall thickness of the ampoule body compared to a uniform preform temperature. In the wide side region that first contacts the tool wall, the temperature of the plastic material is higher. The wall in this region extends more violently at the beginning of the blow molding process, so that the wall in this region ideally has approximately the same wall thickness as the center of the side wall of the narrow side after expansion, which has the widest distance when viewed from the center line of the ampoule body after molding.

[0028] According to a preferred embodiment of the present invention, the preform is heated by hot air, especially by a hot air blower.

[0029] According to another embodiment, the preform is heated by infrared rays. Heating by infrared rays can also be combined with heating by hot air.

[0030] The hot air can flow through the side wall regions of the preform in a targeted manner, so that these regions are heated more strongly than the adjacent regions of the side wall that should be formed into the narrow side.

[0031] The preform is especially heated by being inserted into the nozzle of a hot air blower.

[0032] According to a preferred embodiment of the present invention, a nozzle with a perforated insert, especially formed as a sleeve, is used, and perforations are formed around the outer circumference of the insert with different densities.

[0033] The insert especially includes a side wall, wherein a first region of the side wall has perforations with a larger opening area compared to a second region of the side wall. In particular, an insert can be used, wherein only the first region of the side wall has perforations, and wherein the side wall is closed within the second region.

[0034] Therefore, on the insert, the first region formed as the wide side is heated more strongly than the second region by openings with different numbers and / or different distributions and / or different sizes.

[0035] In particular, two relatively arranged first regions are provided.

[0036] In particular, the first region extends axially along the side wall of the insert in two perforated and relatively arranged columns.

[0037] Hot air flows through the region of the side wall of the parison formed as the narrow side via the relatively arranged columns of openings.

[0038] The use of such an insert enables a simple implementation of the method, especially with respect to the good reproducibility of the required temperature.

[0039] In particular, the insert can have end-side flanges, especially perforated flanges.

[0040] When inserting the nozzle, hot air flows along the outer wall of the insert and exits the nozzle through the perforations of the flange.

[0041] A part of the air flowing on the side flows through the perforations of the side wall to the inside, and thus heats the side wall region of the parison to be formed as the wide side more strongly.

[0042] According to a further improvement of the invention, the parison is provided by injection molding in a warm state, and the warm parison is heated by blowing.

[0043] Therefore, according to this embodiment of the invention, the thermal energy brought by injection molding is used to non-uniformly heat the parison afterwards and further process the parison.

[0044] This enables the rapid manufacture of the ampoule body, because by heating the parison, especially by means of a hot air blower, only a part of the required thermal energy has to be introduced. In addition, during heating with a hot air blower, it is not necessary to wait until the core of the parison wall has a high enough temperature by heat conduction in order to form the parison by the subsequent blowing.

[0045] This is understood to mean that the parison is made of a thermoplastic, especially made of polypropylene or polyethylene, or also made of a mixture of polypropylene and additives.

[0046] In particular, a matrix-phase-polymer system can be provided by additives.

[0047] There are at least two different polymers in the matrix-phase-polymer system, wherein one polymer undergoes phase separation, in particular phase separation into discrete solidified droplets present in the matrix of the other polymer.

[0048] The matrix is especially composed of polypropylene, and the phase polymer is a styrene-ethylene / butene-styrene block copolymer (SEBS).

[0049] The phase polymer can provide a material that is softer than polypropylene especially at temperatures below 10°C.

[0050] Preferably, the still-warm parison after injection molding has a surface temperature and / or core temperature of more than 80°C, preferably more than 90°C and especially preferably more than 95°C before it is heated by a hot air blower. However, the surface temperature and / or core temperature is preferably below 110°C.

[0051] According to an embodiment of the present invention, the parison is manufactured into a hollow body with a bottom.

[0052] In particular, the parison is designed to be substantially can-shaped.

[0053] Preferably, the bottom of the parison has a smaller wall thickness than the adjacent side wall. In particular, the wall thickness of the bottom is at least partially 0.2 to 0.8 times, preferably 0.3 to 0.7 times the wall thickness of the side wall adjacent to the bottom.

[0054] Compared with the adjacent side wall, the thinner bottom is less stretched during blowing. By designing the thinner bottom of the parison, the wall thickness of the blown ampoule body in the bottom region is approximately the same as the wall thickness of the side wall.

[0055] Preferably, the ampoule is manufactured in such a way that the ampoule body has an average wall thickness between 0.2 and 0.8 mm, preferably between 0.3 and 0.6 mm for the bottom and the side wall.

[0056] Within the scope of the present invention, the average wall thickness can be determined, for example, by measuring the wall thickness at 10 randomly selected positions of the ampoule body and forming the mean value.

[0057] Preferably, the side wall is designed such that the fluctuation of the side wall thickness around the mean wall thickness is less than 20%, preferably less than 10%.

[0058] According to an embodiment of the present invention, a parison with the following average side wall thickness is manufactured, and this average wall thickness is 2 to 10 times, preferably 3 to 5 times the average side wall thickness of the ampoule.

[0059] Preferably, the preform is at least partially heated to an outer surface temperature of 120 to 150 °C, preferably 120 to 140 °C, before blowing.

[0060] Preferably, the temperature of the hottest region of the preform sidewall is at least 3 °C, preferably at least 5 °C, higher than the temperature of the coldest region of the sidewall.

[0061] However, according to an embodiment of the present invention, the hottest region of the preform sidewall is heated to a temperature less than 20 °C, preferably less than 15 °C, higher than the coldest region of the preform sidewall.

[0062] Therefore, preferably, a small temperature difference of less than 15 °C between the hottest and coldest regions of the sidewall is sufficient to obtain the effects according to the present invention.

[0063] An ampoule is manufactured according to a preferred embodiment of the present invention, wherein the ampoule body has a bottom with a central indentation.

[0064] The indentation forms a standing surface.

[0065] In particular, the indentation can transition to the standing surface through an edge.

[0066] Preferably, a preform with a circular inner cross-section or outer cross-section is used.

[0067] According to a preferred embodiment of the present invention, a preform made by injection molding has a head designed for attaching a connector.

[0068] In particular, the head includes a flange and / or a form-fitting connector for latching the connector, especially an axially extending connecting plate or an engaging portion that serves as a twist-fastening member for the connector.

[0069] Preferably, the geometry of the head does not change due to blowing during the process of forming the preform into the ampoule body. Thus, the precise geometry achieved by injection molding is maintained as much as possible.

[0070] After forming, the ampoule is filled with a medicinal solution and sealed.

[0071] In particular, the ampoule can be sealed with a connector having a septum and preferably a discard portion.

[0072] In addition, the ampoule sealed with a connector can be sterilized, especially heat-sterilized, or manufactured in a sterile environment. The ampoule manufactured according to the present invention is especially designed such that it can be autoclaved.

[0073] The injection molding of the preform, the blowing of the ampoule body, and the filling, sealing, and preferably also the sterilization can be carried out on one device according to a preferred embodiment of the present invention.

[0074] Since only relatively small-sized tools are required for injection molding, the device can be designed compactly.

[0075] Furthermore, the present invention relates to an ampoule filled with a liquid medicine, in particular an ampoule manufactured by the aforementioned method.

[0076] The present invention is defined by an ampoule filled with a liquid medicine, wherein the ampoule body is designed as an integral unit and includes a bottom with a standing surface and a head, wherein the ampoule body is manufactured from a preform blown and expanded, wherein the head has an attached connecting piece through which the ampoule is sealed, wherein the connecting piece includes a septum and a break-off part, and wherein a preset breaking position for the break-off part is substantially flush with the upper side of the septum.

[0077] The ampoule is successfully manufactured by injection molding of the preform, wherein the ampoule body has a head with such dimensional stability that the connecting piece can also be provided with a septum, and wherein the septum is flush with the preset breaking position of the break-off part.

[0078] If the breaking piece is removed, the upper side of the connecting part of the remaining connecting piece and the septum form substantially mutually transitional surfaces. The septum is accessible and can be wiped, for example.

[0079] Furthermore, the present invention relates to a device for manufacturing an ampoule filled with a liquid medicine.

[0080] In particular, the device is designed for manufacturing the aforementioned ampoule.

[0081] Preferably, the device is designed for implementing the aforementioned method.

[0082] The device includes a workbench for injection molding a preform; a device for heating the preform, wherein the device for heating the preform is designed such that the side wall of the preform is heated with different intensities on its outer periphery; and a workbench for blowing the preform into an ampoule.

[0083] Therefore, the device according to the present invention includes at least two workbenches, namely a workbench for injection molding a preform and a workbench for blowing the preform into an ampoule or an ampoule body.

[0084] The device further includes a device for heating the preform, which is designed such that the side wall of the preform is heated with different intensities on its outer periphery.

[0085] Due to the implementation of injection molding and blowing of the parison into ampoules in one device, the still warm parison can be directly further processed, and the thermal energy of the injection molding process can be used to provide the basic temperature for further processing. In particular, the device is a device including a conveying device to first convey the parison to a heating device and then convey the parison to a workbench for blowing the parison into an ampoule.

[0086] In particular, since the core of the used parison is still warm after injection molding, parisons with a larger sidewall thickness can be further processed without having to subject the core to a long and continuous heating process before blowing. The core temperature is the central temperature of the parison wall, especially the central temperature of the sidewall.

[0087] Preferably, the device further includes a workbench for filling and sealing the ampoules.

[0088] The device for heating the parison is preferably designed as a hot air blower with an insert for receiving the parison, wherein the insert has different perforated areas around its outer circumference.

[0089] In particular, the nozzle includes an insert with a sidewall, wherein the first region of the sidewall has perforations with a larger opening area compared to the second region of the sidewall.

[0090] In particular, the insert is only perforated in the region where the sidewall of the parison is heated more strongly in order to subsequently form the wide side of the ampoule or the ampoule body by blowing.

[0091] In particular, the first region can axially extend along the sidewall of the insert in two relatively arranged perforated columns.

[0092] Furthermore, the insert can be designed as a sleeve with end-side flanges, especially flanges with perforations.

[0093] A throttle orifice is formed by the flange, and a more uniform pressure is generated in the gap between the nozzle and the insert by this throttle orifice.

[0094] This ensures a substantially uniform flow along the length of the insert flowing out of the openings formed by the perforations in the direction of the parison wall.

[0095] Preferably, the aforementioned ampoules are manufactured using the device according to the invention. Description of the Drawings

[0096] The following describes the subject matter of the present invention in detail with reference to the embodiments Figures 1 to 10 and the drawings.

[0097] Figure 1 is an axial sectional view and a perspective view of an embodiment of the parison.

[0098] Figure 2 Also shown are an axial sectional view and a perspective view of an ampoule or an ampoule body (i.e., an ampoule without an attached connecting member) made from a preform.

[0099] Figure 3 Is a schematic view of an embodiment of an apparatus for manufacturing an ampoule filled with a liquid medicine according to the present invention.

[0100] Figure 4a and Figure 4b Is a side view of an insert according to an embodiment and how it is used in a nozzle to heat a preform before blowing.

[0101] Figure 5a and Figure 5b Is a side view of an alternative embodiment of such an insert.

[0102] Figure 6 Shows how such an insert is attached in a nozzle.

[0103] Figure 7 A view of an ampoule provided with a connecting member is shown.

[0104] Figure 8 Is a sectional view of the head of the ampoule and the connecting member.

[0105] Figure 9 The connecting member with the discard portion removed is shown.

[0106] Figure 10 Is a flow chart and shows the steps of an embodiment of a method according to the present invention. Detailed Description

[0107] Figure 1 An embodiment of a preform made of plastic is shown in an axial sectional view and in a contrasting perspective view.

[0108] The preform 100 is made by injection molding and is basically designed as a hollow body in the shape of a can.

[0109] The preform 100 includes a side wall 101 and a bottom 102.

[0110] The side wall 101 is designed to be thicker than the bottom 102.

[0111] Furthermore, the bottom 102 is spaced apart from the bottom side of the side wall 101, thereby creating a circumferential annular rib 103. The annular rib 103 is formed into the standing surface 203 of the ampoule body 200.

[0112] Furthermore, the preform 100 includes a head 110 for attaching a connecting member 210.

[0113] The head 110 includes an annular groove 111 which forms a receiving area for the diaphragm 221.

[0114] The head 110 includes a flange 112 for the snap - lock connection 210.

[0115] At least two ribs extending axially along the head 110 serve as anti - torsion fixings for the connection 210, more precisely for the connecting part 211 of the connection 210.

[0116] A flange 114 located further below the head 10 can serve as a stop for the connecting part 211 of the connection.

[0117] After injection molding, Figure 1 the preform 100 is further processed in a warm state, which is done in such a way that the preform is blow - molded into Figure 2 the ampoule body 200 shown, i.e., molded into an ampoule not yet sealed with the connection 210.

[0118] Before blow - molding, the side wall 101 of the preform 100 is heated non - uniformly such that the area of the wide side 201b of the side wall 201 which is to be molded into the ampoule body 200 is heated more strongly than the area of the narrow side 201a which is to be molded into the ampoule body 200.

[0119] As Figure 2 shown, the geometry of the head 110 does not change, so that the head 110 of the ampoule body 200 corresponds in its geometry to the head of the preform 100.

[0120] Furthermore, the ampoule body 200 is formed from a cylindrical preform 100 and has a substantially elliptical cross - section with a wide side 201b and a narrow side 201a of the side wall 201. It is understood that on the elliptical cross - section of the ampoule body 200, the wide side 201b and the narrow side 201a merge seamlessly without a defined clear boundary. Thus, in the sense of the present invention, it is only important that the preform 100 is hottest in the area of its side wall 101 before blow - molding, and this area is approximately in the middle of the wide side 201b after molding.

[0121] The bottom of the ampoule body 200 includes a central indentation 202 which transitions via an edge 204 to a surrounding standing surface 203.

[0122] The standing surface 203 transitions via a rounded corner 205 to the side wall 201 of the ampoule body 200.

[0123] In this embodiment, the narrow - side shoulder 206a and the wide - side shoulder 206b are designed such that the shoulders slope downwards and each transition with a rounded corner into the side wall 201 of the ampoule body 200.

[0124] Figure 3 is a schematic view of an apparatus for manufacturing ampoules filled with a liquid medicament according to the present invention.

[0125] The apparatus 300 includes a conveying device 301, which is schematically shown and by means of which the various different work stations of the apparatus 300 are moved.

[0126] The first work station of the apparatus is the work station 302 for injection molding the preform 100. Details of the work station for injection molding the preform 100 are not shown. It will be understood that such a work station 302 for injection molding has, for example, means for heating plastic granules and means for injecting the molten plastic into a mold. Such means are known from the prior art.

[0127] The preform manufactured by injection molding is further conveyed by the conveying device 301 to the work station 303 for blowing the ampoule body 200.

[0128] For this purpose, the still warm preform 100 is taken from the work station for injection molding by the conveying device 301.

[0129] Before the still warm preform 100 expands into the ampoule body 200, the preform is heated by means of a device for heating the preform 100.

[0130] The device 310 for heating the preform 100 includes a nozzle 311 from which hot air flows out.

[0131] The device 310 for heating the preform may be located within the work station 302 for injection molding the preform or within the work station 303 for blowing the ampoule.

[0132] Also according to another embodiment, the device 310 for heating the preform 100 may be located between the work station 302 for injection molding and the work station 303 for blowing the ampoule.

[0133] In the embodiment schematically shown here, the device 310 for heating the preform 100 is arranged behind the work station 302 for injection molding. The nozzle 311 can be moved relative to the preform 100, whereby the preform 100 can be introduced into the nozzle 311.

[0134] Following the work station for blowing the ampoule body 200 is a work station for filling and sealing the ampoule body 200 with a connecting piece 210.

[0135] Here, the apparatus 300 shown can be designed to be very compact. In particular, the apparatus can be designed such that it has a volume of less than 20 m 3 and preferably less than 5 m 3 in volume.

[0136] Figure 4a and Figure 4b is a side view of insert 312 for nozzle 311 for non-uniformly heating sidewall 101 of preform 100.

[0137] As shown in FIG. 4, insert 312 includes a first region 313 provided with perforations 314. To specifically heat the preform on two opposite sides of sidewall 101, two first regions 313 each having perforations 314 face each other.

[0138] In this embodiment, perforations 314 are correspondingly multi-columned within the first region and axially extend along the sidewall of nozzle 311.

[0139] As Figure 4b shown, in contrast, a second region 315 that is angularly displaced is not provided with perforations.

[0140] The nozzle includes a flange 316 which is also provided with perforations 317 through which hot air can exit nozzle 311.

[0141] Thus, a gap is formed between flange 316 and the inner wall of nozzle 311 through which hot air flows.

[0142] Hot air can flow from the gap through perforations 314 within the first region 313 to the sidewall of the opposite preform 100.

[0143] Thereby, the region of sidewall 101 of preform 100 opposite perforations 314 is heated more strongly than the region of sidewall 101 that is angularly displaced and opposite the unperforated second region 315.

[0144] Figure 5a and Figure 5b shows an alternative embodiment of such insert 312.

[0145] In this embodiment, a first region 313 with perforations 314 and a second region 315 without perforations are also provided.

[0146] In this embodiment, perforations 314 only include a row of openings axially extending along the sidewall of insert 312.

[0147] Insert 312 includes a flange 316 with perforations 317.

[0148] Furthermore, on the side opposite flange 316, insert 312 includes perforations 318 that annularly surround the insert.

[0149] Through this perforation 318, hot air can also flow towards the parison 110 in the region of the bottom 102 of the parison 100. Thereby, targeted heating of the bottom region can also be provided.

[0150] Figure 6 Shows how such an insert 312 is inserted into the nozzle 311.

[0151] In this embodiment, the nozzle 311 includes a locknut 319 by which the insert 312 is fixed within the nozzle 311. There is a gap between the outer wall of the sleeve 312 and the inner wall of the nozzle 311 through which hot air flows.

[0152] Figure 7 Figure showing an ampoule currently provided with the connecting piece 210.

[0153] The connecting piece 210 includes a connecting portion 211 that has been latched onto the head 110 of the ampoule body 200.

[0154] The connecting piece 210 may include a thread 213 such that the connecting piece 210 is designed as, for example, a luer lock connection device.

[0155] The connecting piece 210 includes a breakaway portion 212 through which the sterilization diaphragm 221 located below the breakaway portion 212 is opened.

[0156] Figure 8 Axial sectional view showing the head 110 of the ampoule body 200 sealed with the connecting piece 210.

[0157] The connecting piece 210 includes a connecting portion 211 that has been latched onto the flange 112 of the head 110.

[0158] The connecting portion 211 extends to the lower flange 114 of the head 110.

[0159] The connecting portion 211 is provided with a thread 213 on the one hand and fixes the sealing element 220, which is basically of a can-like construction, and the diaphragm 221 in the intermediate space provided by the connecting portion 211 between the connecting portion 211 and the head 110.

[0160] The sealing element 220 includes a flange 223 seated on the head 110 on the end side.

[0161] The spaced-apart flange 224 abuts against the tapering inner wall of this region of the connecting portion 211.

[0162] Furthermore, the sealing element 220 includes, on the side adjacent to the head 110, an end-side, annular, axially extending rib 225 that engages in the annular groove 111 of the head 110.

[0163] The connecting part 211 transitions to the discard part 212 through a preset breaking position 215 designed to be necked down.

[0164] The preset breaking position 215 designed to be necked down is located approximately flush with the upper side of the diaphragm 221.

[0165] As Figure 9 shown, in the case where the discard part 212 is broken, the adjacent upper side 214 of the connecting member 211 is located approximately at the height of the diaphragm 221.

[0166] Therefore, for the user, the diaphragm 221 is accessible and can be wiped, for example, for regulatory reasons.

[0167] Figure 10 Method steps for manufacturing an ampoule according to an embodiment of the present invention are shown in the flow chart.

[0168] First, a preform 100 is manufactured by injection molding.

[0169] The preform 100 is preferably removed from the injection mold by means of a conveying device 301.

[0170] The injection-molded still warm preform 100 is heated by hot air from a nozzle 311 such that the preform is heated with different intensities around its outer circumference.

[0171] Then, the preform 100 is blown into an ampoule 202 having an oval cross-section. Here, the region of the side wall 101 that forms the wide side of the ampoule body 200 is heated more strongly than the region formed as the narrow side 201a.

[0172] Thus, a uniform wall thickness of the side wall 201 of the ampoule body 200 is ensured.

[0173] Next, the ampoule body 200 is filled and sealed with a connecting member 210.

[0174] A very efficient and rapid method for manufacturing an ampoule can be provided by the present invention.

[0175] In addition, an ampoule with an integrated ampoule body 200 can be provided, the ampoule body having a standing surface 201, and the ampoule is sealed with a connecting member 210, wherein the preset breaking position 215 of the discard part is flush with the upper side 222 of the diaphragm 221.

[0176] List of reference numerals

[0177] 100 Preform

[0178] 101 Side wall

[0179] 102 Bottom

[0180] 103 Convex rib

[0181] 110 Head

[0182] 111 Annular groove

[0183] 112 Flange

[0184] 113 Convex rib

[0185] 114 Flange

[0186] 200 Ampoule body

[0187] 201 Side wall

[0188] 201b Wide side of the side wall

[0189] 201a Narrow side of the side wall

[0190] 202 Depression

[0191] 203 Upright surface

[0192] 204 Edge

[0193] 205 Fillet

[0194] 206a Narrow side of the shoulder

[0195] 206b Wide side of the shoulder

[0196] 210 Connecting piece

[0197] 211 Connecting part

[0198] 212 Discardable part

[0199] 213 Thread

[0200] 214 Upper side of the connecting piece

[0201] 215 Preset breaking position

[0202] 220 Sealing element

[0203] 221 Diaphragm

[0204] 222 Upper side of the diaphragm

[0205] 223 Flange

[0206] 224 Flange

[0207] 225 Convex rib

[0208] 300 Equipment for manufacturing ampoules filled with liquid medicine

[0209] 301 Conveyor device

[0210] Workbench for injection molding preforms

[0211] Workbench for blowing ampoules

[0212] Workbench for filling and sealing ampoules

[0213] Device for heating preforms

[0214] Nozzle

[0215] Insert

[0216] First region

[0217] Perforation of the first region

[0218] Second region

[0219] Flange

[0220] Perforation of the flange

[0221] Perforation

[0222] Locknut

Claims

1. A method for manufacturing an ampoule filled with a liquid medicine, Among them, wherein a preform (100) is manufactured by injection molding, the preform is formed into an ampoule body (200) by heating and blow molding, the ampoule body is filled with the liquid medicine after molding and sealed with a connecting piece (210), wherein the ampoule body (200) has a wide side (201b) and a narrow side (201a) in cross-section, and wherein the preform (100) is heated before blow molding such that the region of the side wall (101) of the preform in the side wall region of the wide side (201b) to be formed into the ampoule body (200) is heated more strongly than in the adjacent side wall region of the narrow side (201a), wherein the preform (100) manufactured by injection molding has a head (110), the head being designed for attaching the connecting piece (210), and wherein the geometry of the head (110) does not change when the preform (100) is heated and blow molded, wherein the connecting piece includes a sealing element (220) with a diaphragm (221) and a break-off part (212), wherein a preset breaking position (215) for the break-off part (212) is substantially flush with the upper side of the diaphragm (221), and wherein the head (110) has an annular groove (111), and the sealing element (220) has an end-side, annular, axially extending rib (225) on the side adjacent to the head (110), and the rib is snapped into the annular groove.

2. The method according to claim 1, characterized in that, the preform (100) is heated by being inserted into the nozzle (311) of a hot air blower.

3. The method according to claim 2, characterized in that, the nozzle (311) includes a perforated insert (312), and wherein perforations are formed around the outer periphery of the insert (312) with different densities.

4. The method according to claim 3, characterized in that, the insert (312) is formed as a sleeve.

5. The method according to claim 2 or 3, characterized in that, an insert (312) with side walls is used, and wherein the first region (313) of the side walls has perforations with a larger opening area compared to the second region (315) of the side walls.

6. The method according to claim 5, characterized in that, only the first region (313) of the side walls has perforations, and the side walls are closed in the second region (315).

7. The method according to claim 5, characterized in that, the first region (313) extends axially along the side walls of the insert (312) in two rows that are perforated and opposed to each other.

8. The method according to claim 2 or 3, characterized in that, an insert (312) with an end-side flange (316) is used.

9. The method according to claim 8, characterized in that, the flange (316) has perforations.

10. The method according to claim 1, characterized in that, The preform (100) is manufactured by injection molding in a warm state, and the warm preform (100) is heated by blowing.

11. The method according to claim 10, characterized in that the warm preform (100) has a surface temperature and / or a core temperature that exceeds 80 °C and / or is lower than 110 °C.

12. The method according to claim 11, characterized in that the warm preform (100) has a surface temperature and / or a core temperature that exceeds 90 °C.

13. The method according to claim 12, characterized in that the warm preform (100) has a surface temperature and / or a core temperature that exceeds 95 °C.

14. The method according to claim 1, characterized in that the preform (100) is manufactured as a hollow body with a bottom (102).

15. The method according to claim 14, characterized in that the bottom (102) of the preform (100) has a smaller wall thickness than the adjacent side wall (101).

16. The method according to claim 15, characterized in that the wall thickness of the bottom (102) of the preform (100) is at least partially 0.2 to 0.8 times the wall thickness of the side wall (101).

17. The method according to claim 16, characterized in that the wall thickness of the bottom (102) of the preform (100) is at least partially 0.3 to 0.7 times the wall thickness of the side wall (101).

18. The method according to claim 1, characterized in that the ampoule body (200) has an average wall thickness between 0.2 mm and 0.8 mm, and / or the preform (100) is manufactured to have an average wall thickness that is 2 to 10 times the average wall thickness of the ampoule body (200).

19. The method according to claim 18, characterized in that the ampoule body (200) has an average wall thickness between 0.3 and 0.6 mm.

20. The method according to claim 18, characterized in that the preform (100) is manufactured to have an average wall thickness that is 3 to 5 times the average wall thickness of the ampoule body (200).

21. The method according to claim 1, characterized in that the preform (100) is at least partially heated to an outer surface temperature of 120 to 150 °C, and / or the temperature of the hottest region of the side wall (101) of the preform (100) is heated to be at least 3 °C higher than the temperature of the coldest region of the side wall (101) of the preform (100), and / or the hottest region of the side wall (101) of the preform (100) is heated to a temperature that is less than 20 °C higher than the coldest region of the side wall (101) of the preform (100).

22. The method according to claim 21, characterized in that the preform (100) is at least partially heated to an outer surface temperature of 120 to 140 °C.

23. The method according to claim 21, characterized in that The temperature of the hottest region of the side wall (101) of the preform (100) is heated to be at least 5 °C higher than the temperature of the coldest region of the side wall (101) of the preform (100).

24. The method according to claim 21, wherein the hottest region of the side wall (101) of the preform (100) is heated to a temperature less than 15 °C higher than the coldest region of the side wall (101) of the preform (100).

25. The method according to claim 1, wherein the ampoule body (200) has a bottom with a central indentation (202), and / or the ampoule body (200) is designed to be oval in cross-section, and / or the ampoule body (200) has a bottom with an upright surface (203).

26. The method according to claim 1, wherein the preform (100) has a circular inner cross-section and / or outer cross-section.

27. The method according to claim 1, wherein the ampoule sealed with the connecting piece (210) is sterilized.

28. The method according to claim 27, wherein the ampoule sealed with the connecting piece (210) is heat-sterilized.

29. An ampoule filled with a liquid medicine, the ampoule being manufactured by the method according to any one of claims 1 to 28.

30. The ampoule according to claim 29, characterized in that, The ampoule has an inwardly curved bottom.

31. An apparatus (300) for manufacturing an ampoule filled with a liquid medicine, the ampoule being the ampoule according to claim 29 or 30, comprising - a workbench for injection molding the preform (100), - a device (310) for heating the preform (100), wherein the device (310) for heating the preform (100) is designed such that the side wall (101) of the preform (100) is heated with different intensities on its outer periphery, and a workbench for blowing the preform (100) into an ampoule body (200).

32. The apparatus (300) according to claim 31, wherein the device (310) for heating the preform (100) includes a hot air blower with an insert (312) for receiving the preform, wherein the insert (312) includes different perforated regions (313, 315) around its outer periphery, and / or the device (310) for heating the preform (100) includes a nozzle (311) with an insert (312) having a side wall, wherein the first region (313) of the side wall has perforations with a larger opening area compared to the second region (315) of the side wall.

33. The apparatus (300) according to claim 32, wherein only the first region (313) of the side wall has perforations, and the side wall is closed in the second region (315).

34. The apparatus (300) according to claim 32, wherein The first region (313) extends axially along the side wall of the insert (312) in two perforated and oppositely arranged columns, and / or the insert (312) is designed as a sleeve with end-side flanges (316).

35. The device (300) according to claim 34, characterized in that the flange (316) has perforations.

36. The device (300) according to claim 31, characterized in that the device (300) includes a workbench and / or a conveying device (301) for filling and sealing the ampoule body, the conveying device being for moving the workbench for injection molding the preform (100), for moving the device for heating, and for moving the workbench for blowing the preform (100) into the ampoule body (200).

37. Use of a device according to any one of claims 31 to 36 in the manufacture of an ampoule, the ampoule being an ampoule filled with a liquid medicament according to any one of claims 29 or 30.

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