Device for producing container products from plastics material
11351715 · 2022-06-07
Assignee
Inventors
Cpc classification
B29C49/70
PERFORMING OPERATIONS; TRANSPORTING
B29C49/0021
PERFORMING OPERATIONS; TRANSPORTING
B29C49/48185
PERFORMING OPERATIONS; TRANSPORTING
B29C49/64
PERFORMING OPERATIONS; TRANSPORTING
B29L2031/712
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A device produces at least one container product made of plastics material, which is molded by a molding device (1). The container product is filled with a predefinable container content by a filling device and closed by a closing device. The finished container product is fed to a post-treatment zone in which the container product and/or the respective container content is subjected to a temperature-influencing effect.
Claims
1. An apparatus for producing a container product from plastic material, the apparatus comprising: an extruder forming a plastic tube; a blow molding device being located vertically below and downstream of said extruder and having relatively movable individual mold parts being rotatable about a horizontal axis, forming a container that is empty and open from the plastic tube, having a content filler filling the container with a predeterminable container content and having a sealing device sealing the container after filling to produce, fill and seal the container product while still in the molding device, the respective mold parts being movable toward and away from one another in pairs to open and close the mold parts and discharging the container product after being produced, filled and sealed downwardly along a vertical axis; and a temperature influencer in a post-treatment zone downstream of said sealing device extending along the vertical axis and exerting a temperature-influencing effect on the container product, said temperature influencer being a cooler through which the container product passes into and completely through said cooler along the vertical axis after exiting said blow molding device, said cooler including a cooling tunnel having a passage completely through which the container product is conveyed along the vertical axis and having tunnel walls at least partially defining said passage, said tunnel walls being cooled by a cooling medium flowing through said tunnel walls.
2. The apparatus according to claim 1 wherein said temperature influencer subjects the container product to a cooling duration of at least 20 seconds and maintaining the container product in a same orientation as during filling of the container.
3. The apparatus according to claim 1 wherein the apparatus has a dwell time of less than 7 seconds in a sealed production stage of the container product in the mold parts.
4. The apparatus according to claim 1 wherein said temperature influencer exerts a cooling effect on the container product and maintains the container product in a same orientation substantially over a duration of the container product in said post-treatment zone.
5. The apparatus according to claim 1 wherein said tunnel walls extend parallel to one another and to the vertical axis and define openings at top and bottom ends thereof through which the container product enters and exits, respectively, along the vertical axis.
6. The apparatus according to claim 5 wherein said tunnel walls have a length corresponding to a length of plural container products along the vertical axis.
7. The apparatus according to claim 5 wherein the length of said tunnel walls provides a cooling time of each container product of 40 to 60 seconds.
8. The apparatus according to claim 5 wherein said tunnel walls extend over an entire width of a multi-row container product chain.
9. The apparatus according to claim 5 wherein only two of said tunnel walls are provided.
10. An apparatus for producing a container product from plastic material, the apparatus comprising: an extruder forming a plastic tube; a blow molding device being located vertically below and downstream of said extruder and having relatively movable individual mold parts being rotatable about a horizontal axis, forming a container that is empty and open from the plastic tube, having a content filler filling the container with a predeterminable container content and having a sealing device sealing the container after filling to produce, fill and seal the container product while still in the molding device, the respective mold parts being movable toward and away from one another in pairs to open and close the mold parts and discharging the container product after being produced, filled and sealed downwardly along a vertical axis; and a temperature influencer in a post-treatment zone downstream of said sealing device extending along the vertical axis and exerting a temperature-influencing effect on the container product, said temperature influencer being a cooler through which the container product passes into and completely through said cooler along the vertical axis after exiting said blow molding device, said cooler being a conveyor advancing the container product vertically along the vertical axis and having conveyor elements cooled by a coolant flowing through said conveyor elements.
11. The method according to claim 10 wherein the container product is cooled for at least 20 seconds.
12. The method according to claim 11 wherein the container product is maintained in a same orientation as in the filling.
13. The apparatus according to claim 10 wherein said conveyor comprises a base plate movable between upper and lower positions along the vertical axis.
14. The apparatus according to claim 13 wherein said cooler comprises first and second cooling plates being mounted on said base plate and movable along a horizontal axis between open and closed positions thereof by actuators, said cooling plates being cooled by a cooling medium flowing through said cooling plates.
15. The apparatus according to claim 14 wherein said first and second cooling plates extend along sides of a passage in said base plate through which the container product can pass.
16. The apparatus according to claim 14 wherein said first and second cooling plates have recesses conforming to the container product.
17. A method for producing a blow-molded and filled container product, comprising the steps of: extruding a plastic tube from an extruder; forming a container that is empty and open made from the plastic tube by blow molding in a molding device being located vertically below and downstream of the extruder and having individual molding parts rotatable about a horizontal axis and moveable toward and away from one another in pairs to open and close a manufacturing mold in which the container is molded; filling the container with a container content while the container is still in the molding parts; sealing the container after filling while still in the molding parts to produce the container product; discharging the container product after sealing from the molding parts along a vertical axis; supplying the container product into a post-treatment zone being downstream of and at an exit point of the molding device and extending along the vertical axis; and subjecting the container product to cooling after exiting the molding device and when passing into and completely through the post-treatment zone, a cooling tunnel extending along the vertical axis and having a passage through which the container product is conveyed along the vertical axis within and completely through the passage within tunnel walls of the cooling tunnel that are cooled by a cooling medium flowing through the tunnel walls.
18. The method according to claim 17 wherein the container product is maintained in a same orientation as in the filling.
19. The method according to claim 17 wherein a dwell time of the container product after sealing in the mold parts is set to be less than 7 seconds.
20. The method according to claim 17 wherein the tunnel walls extend parallel to one another and to the vertical axis and define openings at top and bottom ends thereof through which the container product enters and exits, respectively, along the vertical axis.
21. The method according to claim 20 wherein the tunnel walls have a length corresponding to a length of plural container products along the vertical axis.
22. The method according to claim 20 wherein the length of said tunnel walls provides a cooling time of each container product of 40 to 60 seconds.
23. The method according to claim 20 wherein the tunnel walls extend over an entire width of a multi-row container product chain.
24. The method according to claim 20 wherein only two of said tunnel walls are provided.
25. A method for producing a blow-molded and filled container product, comprising the steps of: extruding a plastic tube from an extruder; forming a container that is empty and open made from the plastic tube by blow molding in a molding device being located vertically below and downstream of the extruder and having individual molding parts rotatable about a horizontal axis and moveable toward and away from one another in pairs to open and close a manufacturing mold in which the container is molded; filling the container with a container content while the container is still in the molding parts; sealing the container after filling while still in the molding parts to produce the container product; discharging the container product after sealing from the molding parts along a vertical axis; supplying the container product into a post-treatment zone being downstream of and at an exit point of the molding device and extending along the vertical axis; and subjecting the container product to cooling after exiting the molding device and when passing into and completely through the post-treatment zone by conveyor elements extending and movable along the vertical axis and being cooled by coolant flowing through the conveyor elements.
26. The method according to claim 25 wherein the conveyor comprises a base plate movable between upper and lower positions along the vertical axis.
27. The method according to claim 26 wherein the cooler comprises first and second cooling plates being mounted on the base plate and movable along a horizontal axis between open and closed positions thereof by actuators, the cooling plates being cooled by a cooling medium flowing through the cooling plates.
28. The method according to claim 27 wherein the first and second cooling plates extend along sides of a passage in said base plate through which the container product passes.
29. The method according to claim 27 wherein the first and second cooling plates have recesses conforming to the container product.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Referring to the drawings that form a part of this disclosure:
(2)
(3)
(4)
(5)
DETAILED DESCRIPTION OF THE INVENTION
(6)
(7) As can be seen from this figure, the formed container chain 9 exits along the production line 5 from the demolding device 3 as a container chain 9 at the front exit point 2. As is usual with such devices, the container chain 9 has a large-area shape. A plurality of individual containers, in the present case of ampule-like shape, are adjacent in the container chain 9. For example, the container chain 9 can have eight adjacent ampules. To support the separation of the containers from the walls of the individual mold parts 7 moving away from each other after the molding process, the demolding device 3 applies a deflection movement to the container chain 9, as indicated with the double arrow 13 in
(8) The tappet assembly 15, together with a frame part 19, forms fixed wall parts of a passage channel for the container chain 9, which ends at the exit point 2. The frame part 19 of the tappet assembly 15 is guided on guideways 27 for deflection movements, extending as indicated by the double arrow 13, which, like the motor 17, are mounted on a device or support part 29. Device or support part 29 is in turn mounted pivotably about a pivot bearing 33 on an apparatus frame 31 of the demolding device 3. At a distance from this pivotable mounting, a linear actuator 35 is hinged on the device or support part 29 in the form of a hydraulic or pneumatic working cylinder 28, which in turn is supported on a hinge point 37 on the apparatus frame 31 at a distance from the pivot bearing 33.
(9) Due to the pivotal mounting of the device or support part 29 of the demolding device 3 on the apparatus frame 31, the demolding device 3 can be folded or pivoted from the working position shown in
(10) To avoid damage to temperature-sensitive filling material caused by high processing temperatures, the apparatus according to the invention has a post-treatment device 4. It is disposed along the production line 5 along the container chain 9 after its discharge at the exit point 2 of the demolding device 3. In the first exemplary embodiment of
(11)
(12)
(13) Strips 65 are provided as cooling and conveying elements, having an identical form and each of which extends along a long side of the passage 63 on both sides of the container chain 9 lying therebetween. Each strip 65 is composed of an outer cooling plate 67, which are also formed identically and each of which have a structure corresponding to that of the cooling plates 53 of the cooling tunnel 51 of
(14) As can be seen, the post-treatment in the post-treatment devices 4 shown is preferably carried out each time with the containers located in unchanged position, i.e., in the filling position with the head region of the containers at the top. The boundary layer structure of the filling material/container wall thus remains undisturbed during the post-treatment. As already indicated above, the types of post-treatment devices 4 shown may be provided individually or in combination with one another in any order. Preferably a post-treatment device 4 is disposed immediately downstream of the exit point 2 of the molding device 1.
(15) In examples given below, the results achievable by the post-treatment according to the invention are indicated.
(16) In the examples, a BFS system is used along with post-cooling/post-conditioning, immediately subsequent to the discharge from the BFS machine, which substantially maintains the orientation of the containers (e.g., container head upwards) as during filling. The post-cooling took about 10-60 seconds and was implemented with flat air flows of cooled, blown compressed air. A commercial device “LINEBLOW” (with 60 mm blowing length, manufactured by Karger GmbH, Paul-Ehrlich Str. 60a, D-63128 Dietzenbach, was used together with two “COLDER” cold air generators (cold air temperature −25° C.). Comparable results were achieved with a cooling tunnel, in which the containers are transported in a cold air flow between two cooled plates having an equivalent cooling capacity.
(17) Examples with known temperature-sensitive, liquid pharmaceuticals:
(18) Formulations:
(19) -a- Adalimumab
(20) Machine Bottelpack® blow-fill-seal container manufacturing type 460 (non-synchronized) by Rommelag
(21) Material: low density polyethylene, LDPE Lyondell Basell 3020 D LDPE
(22) Filling volume 0.8 ml; 1.5 ml BFS ampule
(23) Parameters:
(24) TABLE-US-00001 Polymer temperature at tube exit ° C. 180 Filling temperature filling material ° C. 15 Filling time s 1 Time tube free to tube in mold s 5.5 Time tube in mold s 5.5 Mold temperature ° C. 20 Time between molding and filling s 0.6 Time discharge from BFS to 30 post-conditioning s Post-conditioning type flat stream of compressed air, orientation stable, Post-conditioning duration s 30 Cold air flow rate liters per min 150
(25) Formulation: Adalimumab (Humira®) 40 μg in phosphate/citrate buffered, aqueous solution, containing the following stabilizers: mannitol, NaCl and polysorbate 80.
(26) After filling and 1 to 3 and 12 months of storage at 2° C. to 8° C., there was no significant difference in the biological activity/stability (agglomerates, pH, discoloration, precipitation, etc.) compared to a commercially available packaging configuration in glass vials.
(27) If, prior to or in the post-treatment zone, the containers are not moved with stable orientation, i.e., the container is rotated, turned, or tilted, the biological activity is significantly reduced even after 30 days, compared to transportation with a stable orientation, while similar movements in the glass vial packaging or containers manufactured with stable orientation according to the invention showed no significant activity changes.
(28) -b- Epoetin Alfa
(29) Machine Bottelpack® blow-fill-seal container manufacturing type 460 (non-synchronized) by Rommelag
(30) Material: LDPE Lyondell Basell 1840 H
(31) Filling volume 1 ml in 2 ml BFS ampule
(32) Parameters:
(33) TABLE-US-00002 Polymer temperature at tube exit ° C. 170 Filling temperature filling material ° C. 17 Filling time s 1.2 Time tube free to tube in mold s 6 Time tube in mold s 6 Mold temperature ° C. 17 Time between molding and filling s 0.6 Time discharge from BFS to 25 post-conditioning s Post-conditioning type flat stream of compressed air Post-conditioning duration s 50 Cold air flow rate liters per min 200
(34) Formulation: Epoetin alfa: 10,000 IU/ml in phosphate buffered, aqueous solution, containing the following stabilizers: aminoacetic acid, NaCl, and polysorbate 80.
(35) After filling and 1 to 3 and 12 months of storage at 2° C. to 8° C., there was no significant difference in the biological activity/stability compared to a packaging configuration in glass vials.
(36) -c- Interferon Beta-1a
(37) Machine Bottelpack® blow-fill-seal container manufacturing type 321 (synchronized) by Rommelag
(38) Material: LDPE Lyondell Basell 1840 H
(39) Filling volume 0.5 ml in 1 ml BFS ampule
(40) Parameters:
(41) TABLE-US-00003 Polymer temperature at tube exit ° C. 172 Filling temperature filling material ° C. 20 Filling time s 1 Time tube free to tube in mold s 5.5 Time tube in mold s 5.5 Mold temperature ° C. 20 Time between molding and filling s 0.5 Time discharge from BFS to 30 post-conditioning s Post-conditioning type flat stream of compressed air Post-conditioning duration s 30 Cold air flow rate liters per min 40
(42) Formulation: 33 μg/ml Interferon beta-1a in acetate buffered aqueous solution (pH 4), containing the following additional ingredients: poloxamer 188, L-methionine, benzyl alcohol.
(43) After filling and 1 to 3 and 12 months of storage at 2° C. to 8° C., there was no significant difference in the biological activity/stability compared to a packaging configuration in prefilled syringes.
(44) If the containers are not moved in stable orientation prior to or in the post-treatment zone, the biological activity compared to the orientation stable transport was significantly reduced. Similar movements of the container procuded with stable orientation after completion of post-conditioning showed no significant changes in product stability.
(45) -d- Trastuzumab
(46) Machine Bottelpack® blow-fill-seal container manufacturing type 321 (synchronized) by Rommelag
(47) Material: LDPE Lyondell Basell 3020 D
(48) Filling volume 7 ml in 10 ml BFS ampule
(49) Parameters:
(50) TABLE-US-00004 Polymer temperature at tube exit ° C. 180 Filling temperature filling material ° C. 15 Filling time s 1.2 Time tube free to tube in mold s 6 Time tube in mold s 6 Mold temperature ° C. 20 Time between molding and filling s 0.6 Time discharge from BFS to 15 post-conditioning s Post-conditioning type flat stream of compressed air Post-conditioning duration s 50 Cold air flow rate liters per min 400
(51) Formulation: 21 ug/ml Trastuzumab in aqueous solution (pH 6) containing the following additional ingredients: L-histidine, L-histidine a, a-trehalose dihydrate, polysorbate 20.
(52) After filling and 1 to 3 and 12 months of storage at 2° C. to 8° C., there was no significant difference in the biological activity/stability compared to a packaging configuration in glass ampules.
(53) -e- Filgrastim
(54) Machine Bottelpack® blow-fill-seal container manufacturing type 321 (synchronized) by Rommelag
(55) Material: Borealis LE 6601-PH Polyolefin
(56) Filling volume 1.6 ml in 2.5 ml BFS ampule
(57) Parameters:
(58) TABLE-US-00005 Polymer temperature at tube exit ° C. 170 Filling temperature filling material ° C. 20 Filling time s 1 Time tube free to tube in mold s 4.5 Time tube in mold s 4.5 Mold temperature 15 Time between molding and filling s 0.6 Time discharge from BFS to 20 post-conditioning s Post-conditioning type flat stream of compressed air Post-conditioning duration s 60 Cold air flow rate liters per min 100
(59) Formulation: 480 μg Filgrastim aqueous solution, containing the following additional ingredients: sodium acetate, sorbitol, and polysorbate 80 (Tween 80).
(60) After filling and 1 to 3 and 12 months of storage at 2° C. to 8° C., there was no significant difference in the biological activity/stability compared to a packaging configuration in prefilled glass syringes.
(61) -f- Rotavirus Vaccine
(62) Machine Bottelpack® blow-fill-seal container manufacturing type 312 (synchronized) by Rommelag
(63) Material: Polypropylene PP Lyondell Basell Purell SM170G
(64) Filling volume 1 ml in 2.5 ml BFS drinking ampule
(65) Parameters:
(66) TABLE-US-00006 Polymer temperature at tube exit ° C. 192 Filling temperature filling material ° C. 18 Filling time s 1.1 Time tube free to tube in mold s 6.5 Time tube in mold s 6.5 Mold temperature ° C. 18 Time between molding and filling s 0.5 Time discharge from BFS to 35 post-conditioning s Post-conditioning type flat stream of compressed air Post-conditioning duration s 65 Cold air flow rate liters per min 150
(67) Formulation: Human rotavirus (live, attenuated) at least 106.0, CCID50 in aqueous solution, inter alia, with the other auxiliaries, additives: sucrose, dextran, sorbitol, calcium carbonate, as well as xanthan gum.
(68) After filling and 1 to 3 and 12 months of storage at 2° C. to 8° C., there was no significant difference in the biological activity/stability compared to a packaging configuration in a polyethylene tube.
(69) -g- Octreotide Acetate
(70) Machine Bottelpack® blow-fill-seal container manufacturing type 312 (synchronized) by Rommelag
(71) Material: Polypropylene PP Lyondell Basell Purell SM170G
(72) Filling volume 5 ml in 7.5 ml BFS ampule
(73) Parameters:
(74) TABLE-US-00007 Polymer temperature at tube exit ° C. 175 Filling temperature filling material ° C. 1 Filling time s 1.2 Time tube free to tube in mold s 6 Time tube in mold s 6 Mold temperature 20 Time between molding and filling s 0.6 Time discharge from BFS to 25 post-conditioning s Post-conditioning type flat stream of compressed air Post-conditioning duration s 50 Cold air flow rate liters per min 300
(75) Formulation: 4.4 mg/ml octreotide acetate in aqueous solution, inter alia, with the further auxiliaries, additives: mannitol, sodium carboxymethyl cellulose.
(76) After filling and 1 to 3 and 12 months of storage at 2° C. to 8° C., there was no significant difference in the biological activity/stability compared to a packaging configuration in a polyethylene tube.
(77) In a preferred embodiment of the device according to the invention, not shown in further detail, a post-treatment device, such as a cooling device, can be omitted entirely for some filling materials that are not too thermally unstable. For example, it may be sufficient to provide a post-treatment zone after the exit point of the respective container product that allows for convective cooling of the container for at least 20 seconds, preferably for a duration from 20 to 30 seconds. Advantageously, as already explained, that the respective container product has an orientation in the post-treatment zone, which is approximately equal to the orientation of the container product during container filling.
(78) Instead of individual container products which can also be connected in an arrangement beside each other via a carton composite (not shown), the configuration of the container composite is also possible by the container chain 9 arranged one on top of the other, as described above. However, the post-treatment zone discussed, as well as any post-treatment devices, can also be used in devices, in which only individual container products are molded, filled, and sealed and delivered to the exit of a molding device. Regardless, a temperature treatment, particularly in the form of cooling, should only be applied to the container product after it is sealed. Previous cooling could otherwise adversely affect the head-end sealing process of the container product because correspondingly sufficiently high mold temperatures must be present in the plastic material for the respective molding process.
(79) The post-treatment zone, which is aimed at convective ambient cooling of the containers, is not shown directly in the figures. If the cooling device 53 shown for example in
(80) While various embodiments have been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications can be made therein without departing from the scope of the invention as defined in the claims.