PLASTIC CONTAINER PRODUCT

Abstract

The invention relates to a plastic container product, in particular produced by the blow-molding, filling, and sealing method, having a container wall which can be pierced by means of a cannula in predefinable areas for the purpose of access to the container content. Said plastic container product is characterized in that, in order to avoid punched parts which arise when the container wall is pierced with a cannula, the mathematical product of the container wall thickness in the piercing area and the tensile modulus of the plastic material to ISO 527 is less than 400 MPa.Math.mm, in particular preferably less than 300 MPa.Math.mm.

Claims

1. A plastic container product, in particular produced according to the blow-molding, filling and sealing process, having a container wall which can be pierced by means of a cannula in predefinable regions for the purpose of accessing the container contents, characterized in that, in order to prevent stamped parts, which are produced when the container wall is pierced with the cannula, the mathematical product of the container wall thickness in the piercing region (33) and the tensile modulus according to ISO 527 of the plastic material is less than 400 MPa.Math.mm, particularly preferably less than 300 MPa.Math.mm.

2. The container product according to claim 1, characterized in that, as the plastic material, at least one polymer is used with a high heat resistance, in particular with a melting temperature according to ISO 3146 of at least 130 C., and an average elongation according to ISO 527 of more than 12%.

3. The container product according to claim 1, characterized in that, as the plastic material, a polypropylene, a polypropylene copolymer or a blend with PP-based elastomers is used for the production thereof.

4. The container product according to claim 1, characterized in that the head part (7) of the container is covered with a cap (12), which is firmly connected to the head part (7).

5. The container product according to claim 1, characterized in that at least one pierceable insert (19), preferably formed from elastomer material, is provided between the cap (12) and the head part top side (9) of the container so that, at least during the piercing, said insert presses on the head part top side (9) with a surface pressure of preferably more than 20 N/cm2.

6. The container product according to claim 1, characterized in that at least two pierceable inserts (19, 21) which are different from one another are provided, with said inserts serving different purposes, the one (19) serving for piercing by means of a cannula, and the other (21) serving for piercing by means of a hollow spike.

7. The container product according to claim 1, characterized in that the hardness of at least one elastomer insert (19) is from 20 to 70 Shore A, particularly preferably from 25 to 50 Shore A.

8. The container product according to claim 1, characterized in that the piercing region (33) on the head part top side (9) is from 1 to 70 mm2, particularly preferably from 20 to 50 mm2 and the wall thickness of the container region to be pierced is at least 0.3 mm.

9. The container product according to claim 1, characterized in that the head part (7) of the container (1) has a reinforcing rib (15).

10. The container product according to claim 1, characterized in that the head part (7) of the container (1) has a reinforcing rib (15) and is firmly connected to the cap housing (17).

Description

[0014] The solution according to the invention is explained in detail below with reference to a container product together with cap designs according to the invention for such a container. The drawings show, in schematic and not to scale depictions,

[0015] FIG. 1 a front view, which is depicted slightly magnified compared with a practical embodiment, of a container in the form of an infusion bottle with two access points arranged opposite one another, of which the one depicted at the top in the figure is provided with a head part in accordance with the prior art according to DIN ISO 15759;

[0016] FIG. 2 a perspective oblique view, which is depicted approximately double the size of a practical embodiment, of an exemplary embodiment of a head part of the container according to FIG. 1;

[0017] FIGS. 3 to 5 different cap designs according to the invention, in each case in the form of a longitudinal section, which are welded from above onto the head part of the container.

[0018] FIG. 6 a perspective oblique view, which is depicted approximately double the size of a practical embodiment, of an additional exemplary embodiment of a head part of the container according to FIG. 1;

[0019] FIGS. 7 to 8 different cap designs according to the invention, in each case in the form of a longitudinal section, which are welded from above onto the head part of the container according to FIG. 6.

[0020] FIG. 1 shows an integral container, produced according to a blow-molding, filling and sealing operation, in the form of an infusion bottle 1 as a container product having a top access point 3 and a bottom access point 5. The container product 1 is produced from a plastic material, in particular a polyolefin material. The container product 1 has an integral head part 7 at the access point 3 lying at the top in FIG. 1. The head part 7 which is formed in the depicted example according to the prior art in accordance with DIN ISO 15759:2006-05 can be connected to individual caps according to the invention in accordance with the depictions of FIGS. 3 to 5, for example by means of welding, overmolding or sealing, in the region of the top access point 3 of the filled and sealed infusion bottle 1. A continuously extending head surface 9 or head part top side 9 is provided at the front-side end of the head part 7 for extraction and/or addition operations, which, in the form of a head membrane which can be penetrated by means of a cannula or a piercing spike, spans a transition region 11, at which the head part 7 transitions into the neck part 13 of the container product 1. The head surface 9 formed by this head membrane spans the transition region 11 with a uniformly convex curvature according to the depiction of FIGS. 1 and 2.

[0021] The infusion bottle 1 as a container product which is depicted in FIG. 1 can be produced with the aid of a Bottelpack system of the type bp 364 manufactured by the company Rommelag with an exemplary container size of 500 ml using the blow-molding, filling and sealing process, and said infusion bottle has the above-mentioned head form. The container which was in this respect produced in an integral manner was produced using polyolefins with high heat resistance, i.e. a melting temperature according to ISO 3146 of at least 130 C. and a melt flow rate (MFR230 C./2.16 kg according to ISO 1133) of less than 3 g/10 min. In order to reduce the risk of particle formation or of fragmentation, according to the invention a polymer with an elongation of preferably more than 12% (at 50 mm/min according to ISO 527-1/-2) was selected and for the product the container wall thickness in millimeters in the piercing region and the modulus of elasticity (tensile modulus at 50 mm/min according to ISO 527) of the container polymer are selected, at least at this point, such that the mathematical product (hereafter also referred to as the fragmentation characteristic value) is less than 400 MPa.Math.mm, preferably less than 300 MPa.Math.mm, while the wall thickness in the piercing region should however be at least 0.3 mm.

[0022] A further reduction in the probability of fragmentation can be obtained in the case of selection for the container product according to the invention of a cap according to FIGS. 3 to 5 with a cap housing 17, the respective elastomer sealing element 19, 21 of which, consisting of standard elastomer materials, is pressed onto the container wall on or around the piercing region 33 with a surface pressure of at least 20 N/cm.sup.2 at least when the container wall is pierced with a cannula. After the closing of the head part 7 with formation of the closed head surface 9, the respective assignable cap housing 17 is mounted in a tight manner on the depicted head parts 7 according to FIGS. 3 to 5. An autoclaving then takes place at 121 C. for a period of 20 minutes.

[0023] The respective cap housing 17 is, according to the depictions of FIGS. 3 to 5, circumferentially connected in a tight manner to a circumferentially projecting collar 23 of the container head part 7 of the BFS container 1 (not depicted in full in FIGS. 3 to 5). The cap housing 17 has two access points 25 and 27 at its top side, which are respectively sealed in a microbiologically tight manner by an easily removable tamper-evident closure in the form of sealing foil 29 (FIG. 3) or in the form of detachable tabs 31 (cf. FIGS. 4 and 5). Said access points 25 and 27 serve for piercing with a cannula, and to this extent a cannula access point 25 is realized, with the other access point as a hollow spike access point 27 serving for piercing with a piercing part in the form of a hollow spike, for example a transfusion device according to EN ISO 1135-4. Located beneath the depicted tamper-evident closures 29, 31 are the above-mentioned respective elastomer sealing elements 19 or 21, which are made directly from an elastomer material and which extend between the inner side of the cap housing 17 and the head surface 9 of the infusion container 1.

[0024] The invention provides that at least the elastomer sealing element 19 of the cannula access point 25 is formed such that it is pushed or pressed with a minimum pressure in a firm manner onto a subarea of the container head 7, in other words, the piercing surface area, or simply the piercing region 33. The surface pressure of the elastomer element 19 on the piercing region 33 can be determined in a constructive manner by means of the cross-sectional area and the Shore hardness of the elastomer element 19 and by means of the height of the cap housing 17. Furthermore, material- and/or form changes resulting from the conventionally required autoclaving process at 121 C. and with a 20 minute process time must be considered from a constructive perspective. A sagging of the piercing surface area 33 of 2 to 6 mm can thus occur in particular in the case of containers with a fragmentation characteristic value of less than 300 MPa.Math.mm. In order to guarantee the surface pressure required according to the invention on the piercing region 33, it is optionally possible to advantageously use a bar-like reinforcement, for example in the form of a reinforcing rib 15, as depicted in FIG. 6 and as described in PCT/EP 2014/002076.

[0025] FIG. 6 shows the head surface 9 with a reinforcing rib 15 extending over it, with the convex curvature of said reinforcing rib following the convex curvature of the head surface 9. The reinforcing rib 15 forms a distinctly projecting bar, which spans the head surface 9 lying diametrically therein. This bar-like rib 15 permits the reliable application of the surface pressure needed to reduce the fragmentation in that it increases the resistance against the bending of the curvature of the head surface 9 towards the inside of the container, and this can be further increased by the creation of a firm connection with the cap, for example by means of welding or adhesion.

[0026] In embodiments of the head surface 9 according to FIG. 6, caps according to FIG. 3 and FIG. 4 can be used as is depicted in FIGS. 7 and 8.

[0027] The preferred size of the piercing region 33 is from 1 mm.sup.2 to 70 mm.sup.2, particularly preferably from 20 mm.sup.2 to 50 mm.sup.2. The preferred Shore hardness of the elastomer sealing element 19 is from 20 to 65 Shore A, particularly preferably from 25 to 50 Shore A. The surface pressure should be more than 20 N/cm.sup.2, in order to thus allow the fragmentation risk to be significantly reduced.

[0028] With the container products with the fitted caps according to the designs of FIGS. 3 and 5 and with caps without surface pressure, fragmentation tests were carried out in a manner similar to that described in ISO 15759:2005 or in US Pharmacopoeia, chapter 381 Fragmentation and in each case the quantity of fragments from the container material with 48 punctures with steel cannulas according to ISO 7864 and an external diameter of 0.8 mm was determined. The limit value for fragmentation is 5 fragments according to US Pharmacopoeia, chapter 381 Fragmentation.

[0029] As container polymers, the following 8 different materials B1, B2, LB1, LB2, T1, M1, M2 and M3 were used.

[0030] B1 is a PP copolymer of the type Bormed SB815MO from the company Borealis with a modulus of elasticity (tensile modulus according to ISO 527 at 50 mm/min) of 475 MPa.

[0031] LB1 is a polypropylene of the type Purell SM 170G from the company LyondellBasell with a modulus of elasticity of 650 MPa.

[0032] B2 is a polypropylene of the type Bormed RB845MO from the company Borealis with a modulus of elasticity of 1000 MPa.

[0033] LB2 is a modified random copolymer of the type Purell RP270G from the company Lyondell Basell with a modulus of elasticity of 950 MPa.

[0034] T1 is a polypropylene of the type PPM R021 specifically for medical applications from the company Total with a modulus of elasticity of 1000 MPa.

[0035] M1 is a blend with a modulus of elasticity of ca. 730 MPa produced from 75% of the LB2 material with 25% Vistamaxx 3020, a PP-based elastomer from the company Exxon.

[0036] M2 is a blend with a modulus of elasticity of ca. 680 MPa produced in a similar manner to M1 but with a 30% Vistamaxx 3020 content.

[0037] M3 is a blend with a modulus of elasticity of ca. 640 MPa produced in a similar manner to M1 but with a 35% Vistamaxx 3020 content.

[0038] The addition of functional master batches such as Vistamaxx permits the modification of the mechanical properties. Different materials are also included, of the kind which have become known under the trade names Dow Versify or Melitek meliflex XC Polymer+, etc., with the chemical compatibility for pharmaceutical products needing to be considered.

[0039] The results are summarized in the following table in which they are ordered according to increasing fragmentation characteristic value. They show that from a fragmentation characteristic value of less than 400 MPa.Math.mm the fragmentation behavior is significantly improved, and it can be further improved in a surprising manner by means of a cap according to the invention.

TABLE-US-00001 with cap with cap Fragmentation with cap without according to the according to the average wall characteristic value surface invention invention thickness modul. of elas. pressure FIG. 3 FIG. 5 Test container piercing region wall thickness in quantity of quantity of quantity of No. material in mm MPa * mm fragments fragments fragments 1 B1 0.3 143 2 1 1 2 B1 0.41 195 1 0 1 3 LB1 0.33 215 1 0 0 4 M3 0.34 218 1 0 0 5 M2 0.33 224 1 1 0 6 M1 0.32 234 2 0 2 7 B1 0.53 252 4 1 2 8 LB1 0.39 254 2 2 1 9 M3 0.45 288 2 0 1 10 B1 0.61 290 4 3 2 11 M1 0.4 292 3 0 2 12 M2 0.45 306 3 2 2 13 B1 0.67 318 4 4 4 14 B2 0.32 320 3 3 2 15 LB2 0.34 323 2 2 1 16 T1 0.33 330 4 2 1 17 LB1 0.52 338 3 2 2 18 M3 0.55 352 3 2 0 19 M2 0.52 354 3 1 1 20 B1 0.75 356 4 3 3 21 M3 0.58 371 3 2 2 22 M1 0.52 380 4 3 1 23 LB2 0.4 380 3 2 3 24 LB1 0.59 384 4 2 3 25 T1 0.38 380 3 1 3 26 B1 0.87 413 6 4 4 27 B2 0.42 420 5 3 4 28 M2 0.62 422 5 3 2 29 M3 0.72 461 6 5 4 30 M1 0.64 467 6 5 4 31 M2 0.69 469 7 4 5 32 B2 0.48 480 5 5 5 33 LB1 0.74 481 6 5 5 34 LB2 0.53 504 7 5 4 35 M1 0.69 504 6 6 6 36 T1 0.52 520 6 5 5 37 LB2 0.58 551 6 5 6 38 LB1 0.85 553 7 6 6 39 T1 0.62 620 8 6 6 40 B2 0.64 640 7 7 6 41 LB2 0.72 684 6 5 5 42 T1 0.69 690 10 5 6 43 B2 0.75 750 10 8 9

[0040] The invention described above makes it possible for a container which is produced according to the BSF process and which is autoclavable to be designed in such a way that, both with the cap and without the cap, the probability and quantity of stamped out particles upon piercing of the container wall of the container is minimal. There is no equivalent of this solution in the prior art.