AMPOULE FILLED WITH A MEDICAL LIQUID AND METHOD FOR PRODUCING SAME AND SYSTEM USED THEREFOR

Abstract

Disclosed is a method and a system for producing an ampoule filled with a medical liquid. A preform is produced by plastic injection moulding that is then inhomogeneously heated and blown to form an ampoule body. Further disclosed is an ampoule produced by means of stretching and blowing, which comprises a connector with a break-off part in which the predetermined breaking point is aligned with the septum of the connector.

Claims

1. A method for producing an ampoule filled with a medical liquid, wherein a preform is produced by a plastic injection molding process, which is reshaped to form an ampoule by heating and blowing, which comprises a longitudinal side and a narrow side in the cross-section, wherein the preform is heated prior to reshaping by blowing in such manner that it is heated more strongly in a region of the side wall, which is reshaped to form a region of the side wall of the longitudinal side of the ampoule, than in an adjoining side wall region of the narrow side.

2. The method according to claim 1, wherein the preform is heated by introducing it into a nozzle of a hot air blower.

3. The method according to claim 2, wherein the nozzle comprises a perforated insert, in particular formed as a sleeve, wherein the perforation is formed to varying extents around the circumference of the insert.

4. The method according to claim 2, wherein an insert [with a side wall is used, wherein a first region of the side wall has a perforation with a larger open area than a second region of the side wall, in particular wherein in particular only the first region of the side wall has a perforation and the side wall is closed in the second region.

5. The method according to claim 4, wherein the first region extends into two perforated and opposing rows axially along the side wall of the insert.

6. The method according to claim 2, wherein an insert with a front collar is used, in particular with a collar which has a perforation.

7. The method according to claim 1, wherein the preform is provided by plastic injection molding in a hot state and the hot preform is heated by blowing.

8. The method according to claim 7, wherein the hot preform has a top surface temperature and/or a core temperature of over 80° C., preferably over 90° C., particularly preferably over 95° C. and/or of below 110° C.

9. The method according to claim 1, wherein the preform is produced as a hollow body with a base, in particular wherein the base of the preform has a smaller wall thickness than an adjoining side wall), in particular in that the wall thickness of the base is, at least in sections, 0.2 to 0.8 times, preferably 0.3 to 0.7 times, the wall thickness of the side wall.

10. The method according to claim 1, wherein the ampoule has an average wall thickness of between 0.2 and 0.8 mm, preferably between 0.3 and 0.6 mm and/or in that the preform is produced with an averaged side wall thickness which is 2 to 10 times, preferably 3 to 5 times, an averaged side wall thickness of the ampoule.

11. The method according to claim 1, wherein the preform is heated, at least in sections, to a temperature of the outer top surface of 120 to 150° C., preferably 120 to 140° C. and/or in that a hottest region of the side wall of the preform is heated to a temperature at least 3° C., preferably at least 5° C., hotter than a coldest region of the side wall of the preform and/or in that the hottest region of the side wall of the preform is heated to a temperature at least 20° C., preferably at least 15° C., hotter than the coldest region of the side wall of the preform.

12. The method according to claim 1, wherein the ampoule has a base with a central invagination and/or in that the ampoule is formed oval in a cross-section and/or in that the ampoule has a base with a standing surface.

13. The method according to claim 1, wherein the preform has a circular inner and/or outer cross-section and/or in that the preform produced by the plastic injection molding has a head which is formed for attaching a connector, in particular wherein a geometry of the head is not changed when the preform is reshaped.

14. The method according to claim 1, wherein the ampoule is filled with a medical liquid after reshaping and is sealed and/or in that the ampoule is sealed with a connector, which comprises a septum and preferably a break-off part, in particular wherein the ampoule sealed with the connector is sterilized, preferably thermally sterilized.

15. An ampoule with a medical liquid, in particular produced using a method according to claim 1, wherein a body of the ampoule is formed integrally and comprises a base with a standing surface and a head, wherein the body of the ampoule is produced from a preform expanded by means of blowing, wherein the head has an attached connector, with which the ampoule is sealed, wherein the connector comprises a septum and a break-off part, and wherein a predetermined breaking point for the break-off part aligns substantially with an upper side of the septum, in particular wherein the ampoule has an inwardly arched base.

16. A system for producing an ampoule filled with a medical liquid, in particular an ampoule filled with a medical liquid according to claim 1, comprising: a station for injection molding a preform, an apparatus for heating the preform, wherein the apparatus for heating the preform is formed in such manner that a side wall of the preform is heated to varying extents along its circumference, and a station for blowing the preform to form the ampoule.

17. The system according to claim 1, wherein the apparatus for heating the preform comprises a hot air blower with an insert for accommodating the preform, wherein the insert comprises regions perforated to varying extents around its circumference and/or in that the apparatus for heating the preform comprises a nozzle having an insert with a side wall, wherein a first region of the side wall has a perforation with a larger open area than a second region of the side wall, wherein in particular only the first region of the side wall has a perforation and the side wall is closed in the second region.

18. The system according to claim 17, wherein the first region extends into two perforated and opposing rows axially along the side wall of the insert and/in that the insert is formed as a sleeve with a front collar, in particular with a collar which has a perforation.

19. The system according to claim 17, wherein the system comprises a station for filling and sealing the ampoule and/or a transport apparatus for moving towards the station for injection molding the preform, for moving towards the apparatus for heating and for moving towards the station for blowing the preform to form the ampoule.

20. A use of a system according to claim 1 for producing an ampoule, in particular an ampoule filled with a medical liquid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0095] The subject matter of the invention will be explained in more detail below with reference to the drawings FIG. 1 to FIG. 10 on the basis of an exemplary embodiment.

[0096] FIG. 1 is an axial sectioned view and a perspective view of an exemplary embodiment of a preform.

[0097] FIG. 2 also shows in an axial sectioned view and a perspective view the ampoule or the ampoule body produced from the preform, i.e. the ampoule without attached connector.

[0098] FIG. 3 is a schematic representation of an exemplary embodiment of a system for producing an ampoule filled with a medical liquid.

[0099] FIG. 4a and FIG. 4b are side views of an insert according to one exemplary embodiment, as is used for the nozzle to heat the preform prior to blowing.

[0100] FIG. 5a and FIG. 5b are side views of an alternative exemplary embodiment of such an insert.

[0101] FIG. 6 shows how such an insert is attached in the nozzle.

[0102] FIG. 7 shows in one view the ampoule provided with the connector.

[0103] FIG. 8 is a sectioned view of the head of the ampoule and of the connector.

[0104] FIG. 9 shows the connector, with the break-off part now removed.

[0105] FIG. 10 is a flow diagram and shows the steps according to an exemplary embodiment of the method according to the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

[0106] FIG. 1 shows, in an axial sectioned view and in a juxtaposed perspective view, an exemplary embodiment of a preform 100 made of plastic.

[0107] The preform 100 is produced by plastic injection molding and is formed substantially as a pot-shaped hollow body.

[0108] The preform 100 comprises a side wall 101 and a base 102.

[0109] The side wall 101 is thicker than the base 102.

[0110] The base 102 is also spaced from the underside of the side wall 101 such that a circumferential ring-shaped bar 103 is provided. The ring-shaped bar 103 is reshaped to form the standing surface 203 of the ampoule body 200.

[0111] Furthermore, the preform 100 comprises a head 110 which serves to attach a connector 210.

[0112] The head 110 comprises a ring groove 111 which forms a receiving region for the septum 221.

[0113] The head 110 comprises the collar 112 which serves to clip on the connector 210.

[0114] At least one bar 113 extending axially along the head 110 serves as the torsion-proof connection for the connector 210, in other words for the connecting section 211 of the connector 210.

[0115] The collar 114 present further back on the head 110 can serve as a stop for the connecting section 211 of the connector.

[0116] The preform 100 in FIG. 1 is further processed in the hot state after plastic injection, by it being reshaped by blowing to form the ampoule body 200 represented in FIG. 2, i.e. to form the ampoule 200 that is still not sealed with connector 210.

[0117] Prior to blowing, the side wall 101 of the preform 100 is heated inhomogeneously in such manner that the regions, which are reshaped to form the longitudinal side 201b of the side wall 201 of the ampoule body 200, are heated more strongly than the regions which are reshaped to form the narrow side 201a of the ampoule body 200.

[0118] As represented in FIG. 2, the geometry of the head 110 does not change, the head 110 of the ampoule body 200 thus corresponds in its geometry to the head 110 of the preform 100.

[0119] Otherwise, an ampoule body 200 is shaped from the circular-cylindrical preform 100 which has a substantially oval cross-section with a longitudinal side 201b and a narrow side 201a of the side wall 201. It is understood that, in the case of an oval cross-section of the ampoule body 200, longitudinal side 201b and narrow side 201a follow one another seamlessly, without it being possible to define a clear border. In the sense of the invention, it is only essential that the preform 100, prior to reshaping by blowing, is hottest in the region of its side wall 101, which lies roughly in the middle of the longitudinal side 201b after reshaping. The base of the ampoule body 200 comprises a central invagination 202 which merges into a circumferential standing surface 203 via an edge 204.

[0120] The standing surface 203 merges into the side wall 201 of the ampoule body 200 via a rounded corner 205.

[0121] In this exemplary embodiment, the shoulders 206a of the narrow side and the shoulders 206b of the longitudinal side are formed in such manner that they slope down and each merge in a rounded manner into the side wall 201 of the ampoule body 200.

[0122] FIG. 3 is a schematic view of a system 300 according to the invention for producing an ampoule 200 filled with a medical liquid.

[0123] The system 300 comprises a transport apparatus 301 which is represented schematically and which moves towards the different stations of the system 300.

[0124] The first station of the system is a station 302 for injection molding the preform 100. Details of the station 302 for injection molding the preform 100 are not represented. It is understood that such a station 302 for injection molding has for example an apparatus for heating a plastic granulate and an apparatus for injecting the melted plastic into a mold. Such systems are known from the prior art.

[0125] The preform produced by means of injection molding is transported further by the transport apparatus 301 to the station 303 for blowing the ampoule body 200.

[0126] To this end, the still hot preform 100 is removed by the transport apparatus 301 from the station 302 for injection molding.

[0127] Before the still hot preform 100 is expanded to form the ampoule body 200, it is heated by means of an apparatus for heating 310 the preform 100.

[0128] The apparatus 310 for heating the preform 100 comprises a nozzle 311 from which hot air flows out.

[0129] The apparatus for heating 310 the preform can be located in the station 302 for injection molding the preform and in the station 303 for blowing the ampoule.

[0130] Likewise, according to a further embodiment, it is possible that the apparatus 310 for heating the preform 100 is located between the station 302 for injection molding and the station 303 for blowing the ampoule.

[0131] In the exemplary embodiment represented schematically here, the apparatus 310 for heating the preform 100 is arranged behind the station 302 for injection molding. The nozzle 311 can be moved relative to the preform 100 such that the preform 100 can be introduced into the nozzle 311.

[0132] The station 303 for blowing the ampoule 200 is followed by a station 304 for filling and sealing the ampoules 200 with a connector 210.

[0133] The system 300 represented here can be formed to be very compact. In particular, the system can be formed in such manner that it occupies a volume of less than 20 m.sup.3, preferably less than 5 m.sup.3.

[0134] FIG. 4a and FIG. 4b are side views of an insert 312 which are used for the nozzle 311 in order to inhomogeneously heat the side wall 101 of the preform 100.

[0135] As represented in FIG. 4a, the insert 312 comprises a first region 313 which is provided with a perforation 314. In order to targetedly heat the preform on two opposing sides of the side wall 101, two first regions 313 each with one perforation 314 are located opposite one another.

[0136] In this exemplary embodiment, the perforation 314 has multiple rows in the first region 313 in each case and extends axially along the side wall of the nozzle 311.

[0137] As represented in FIG. 4b, an angularly-offset second region 315 is, in contrast, not provided with a perforation.

[0138] The nozzle comprises a collar 316 which is also provided with a perforation 317 from which hot air can leave the nozzle 311.

[0139] A gap is thus formed between the collar 316 and the inner side wall of the nozzle 311 through which hot air flows.

[0140] Hot air can flow out of the gap towards the opposing side wall 101 of the preform 100 through the perforation 314 in the first region 313.

[0141] In this way, the regions of the side wall 101 of the preform 100 opposite the perforation 314 are heated more strongly than the regions of the side wall 101 arranged at an angular offset, which are opposite the non-perforated second region 315.

[0142] FIG. 5a and FIG. 5b show an alternative exemplary embodiment of such an insert 312.

[0143] In the case of this exemplary embodiment, a first region 313 is also provided with a perforation 314 and a second region 315 without a perforation.

[0144] The perforation 314 comprises only one row of openings in this exemplary embodiment which extend axially along the side wall of the insert 312.

[0145] The insert 312 comprises a collar 316 with perforation 317.

[0146] The insert 312 further comprises a perforation 318 extending in a ring-shaped manner around the insert on the side opposite the collar 316.

[0147] Hot air can also flow through the perforation 318 in the region of the base 102 of the preform 100 towards the preform 100. In this way, targeted heating of the base region can also be provided.

[0148] FIG. 6 shows how such an insert 312 is inserted into the nozzle 311.

[0149] In this exemplary embodiment, the nozzle 311 comprises a union nut 319 via which the insert 312 is secured in the nozzle 311. A gap is thus located between the outer side wall of the sleeve 312 and the inner side wall of the nozzle 311 through which hot air flows.

[0150] FIG. 7 shows in one view an ampoule 200 now provided with a connector 210.

[0151] The connector 210 comprises a connecting section 211 which is clipped onto the head 110 of the ampoule 200.

[0152] The connector 210 can comprise a thread 213 such that the connector 210 is for example formed as a Luer lock connection.

[0153] The connector 210 comprises a break-off part 212 by way of which the sterile septum 221, which is located under the break-off part 212, is released.

[0154] FIG. 8 shows in an axial sectioned view the head 110 of the ampoule 200 sealed with a connector 210.

[0155] The connector 210 comprises the connecting section 211 which is clipped onto the collar 112 of the head 110.

[0156] The connecting section 211 reaches up to the lower collar 114 of the head 110.

[0157] The connecting section 211, on the one hand, provides the thread 213 and, on the other hand, secures the substantially pot-shaped seal element 220 with the septum 221 in the intermediate space between connecting section 211 and head 110 provided by the connecting section 211.

[0158] The seal element 220 comprises a collar 223 which sits on the head 110 at the front.

[0159] A collar 224 spaced apart therefrom rests on the inner wall of the connecting section 211 tapering in this region.

[0160] The seal element 220 further comprises on the side adjoining the head 110 a front, ring-shaped, axially extending bar 225 which engages into the ring groove 111 of the head 110.

[0161] The connecting section 211 merges into the break-off part 212 via a predetermined breaking point 215, which is formed as a constricted portion.

[0162] The predetermined breaking point 215 formed as a constricted portion is roughly aligned with the upper side 222 of the septum 221.

[0163] The adjoining upper side 214 of the connecting piece 211 is located at roughly the height of the septum 221 in the case of the broken break-off part 212, as represented in FIG. 9.

[0164] The septum 221 is accessible to the user and can for example be wiped off for regulatory reasons.

[0165] FIG. 10 shows in a flow diagram the method steps for producing an ampoule 200 according to the invention in accordance with an exemplary embodiment of the invention.

[0166] A preform 100 is first produced by injection molding.

[0167] The preform 100 is removed from the injection casting mold preferably by means of a transport apparatus 301.

[0168] The preform 100, which is still hot from the injection molding, is heated by means of hot air from a nozzle 311 in such manner that the preform is heated to varying extents around its circumference.

[0169] The preform 100 is then blown to form an ampoule 202 with an oval cross-section. Regions of the side wall 101, which are reshaped to form the longitudinal side 201b of the ampoule 200, are heated more strongly here than the regions, which are reshaped to form the narrow side 201a.

[0170] An even wall thickness of the side wall 201 of the ampoule 200 is thus ensured.

[0171] The ampoule 200 is then filled and sealed with a connector 210.

[0172] A very efficient and quick method for producing an ampoule 200 can be provided by the invention.

[0173] An ampoule could also be provided with an integral ampoule body 200, which has a standing surface 203 and can be sealed with a connector 210, with the predetermined breaking point 215 of a break-off part 212 aligning with the upper side 222 of the septum 221.

LIST OF REFERENCE NUMERALS

[0174] 100 Preform [0175] 101 Side wall [0176] 102 Base [0177] 103 Bar [0178] 110 Head [0179] 111 Ring groove [0180] 112 Collar [0181] 113 Bar [0182] 114 Collar [0183] 200 Ampoule/ampoule body [0184] 201 Side wall [0185] 201b Longitudinal side of the side wall [0186] 201a Narrow side of the side wall [0187] 202 Invagination [0188] 203 Standing surface [0189] 204 Edge [0190] 205 Rounded corner [0191] 206a Shoulder narrow side [0192] 206b Shoulder longitudinal side [0193] 210 Connector [0194] 211 Connecting section [0195] 212 Break-off part [0196] 213 Thread [0197] 214 Upper side of the connecting piece [0198] 215 Predetermined breaking point [0199] 220 Seal element [0200] 221 Septum [0201] 222 Upper side of the septum [0202] 223 Collar [0203] 224 Collar [0204] 225 Bar [0205] 300 System for producing an ampoule filled with a medical liquid [0206] 301 Transport apparatus [0207] 302 Station for injection molding the preform [0208] 303 Station for blowing the ampoule [0209] 304 Station for filling and sealing the ampoule [0210] 310 Apparatus for heating the preform [0211] 311 Nozzle [0212] 312 Insert [0213] 313 First region [0214] 314 Perforation of the first region [0215] 315 Second region [0216] 316 Collar [0217] 317 Perforation of the collar [0218] 318 Perforation [0219] 319 Union nut