A combination of a bottle and a closure for the bottle

(74) Prosecutor Civil Service. Bjørn H. Christiansen,

JK Thorsens Patentbureau A / S, Oslo.

(54) DESCRIPTION OF THE INVENTION

(30) Priority requested 10.06.32, Switzerland, No 3603 / B2.

(57) Summary

Bottle for sterile washes, able to withstand final sterilization of pharmaceutical quality. The bottle has a closure device comprising a screw capsule (9) on the bottle neck (11) and a locking ring (21) consisting of two parts (23, 25), one above the other, a weakening zone connecting the parts. The upper part (23) is carried by the capsule upon opening the bottle, while the other part (25) is stopped by a shoulder (33) on the bottle neck. The capsule contains a seal (13) of elastomeric material, placed between the bottom of the capsule and the edge of the bottle neck. The seal is prevented from moving axially out of the capsule, and comprises a skirt (17) which, in the closed position of the capsule, presses against the inside of the bottle neck to provide bacteriological sealing along a height sufficient to ensure such sealing until the barrier (21). ) is broken.

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(56) Published publications None.

54995

BACKGROUND OF THE INVENTION The present invention relates to a bottle of screw capsule capable of withstanding final sterilization of pharmaceutical quality. By final sterilization of pharmaceutical quality is meant sterilization of an already filled and closed bottle at a temperature of at least 120 ° C. The bottle has an externally threaded neck, while the capsule has a circumferential rib adapted to protrude down the neck and seal against it, and the capsule has a circumferential wall with internal threads, as well as means to indicate that the capsule has been wholly or partially cut off, which means comprises two rings which are joined axially one after the other in a weakening zone, there being within the capsule a shoulder from which the upper ring is axially locked; while on the neck there is a shoulder from which the lower ring is axially locked, so that unscrewing the capsule causes the rings to move axially apart and the weakening zone ruptures, and the circumferential rib has such an axial height that the seal is maintained at least until the weakening zone is broken.

Bottles of this type have been previously described, namely in FR-PS 2,290,364 and 2,339,541, as well as in US-PS 4,157,144. In the latter patent, however, the parts of the locking ring are arranged radially outside the other.

Due to unavoidable manufacturing tolerances, the locking ring is broken after the capsule unscrewing has started.

A capsule thus partially unscrewed no longer guarantees bacteriological sealing of the bottle, and there is the possibility of contamination of the contents from outside, and without the user being aware of this, because the blocking is still intact. This disadvantage can have serious consequences, e.g. in the case of liquids, such as physiological saline solutions used in operating rooms.

This disadvantage is avoided with the present invention in that the circumferential rib is formed of an elastomeric material, which is disposed towards the inside of the capsule top and forms abutments to the top of the neck and follows the capsule when it is unscrewed, and that the lower ring is completely hidden by the capsule before the weakening zone is broken.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be explained in greater detail below with reference to the accompanying drawings, which show two embodiments of a bottle according to the invention.

Fig. 1 is a side view of a bottle according to the invention in a first embodiment, the bottle being made of plastic material and having a locking ring in the closing device which is still intact.

FIGS. 2 and 3 show axial sections through a section of the bottle and closure of the bottle shown in FIG. 1, shown before and after a first opening of the bottle, respectively.

Fig. 4 is a side view of another embodiment of the bottle, wherein the bottle is made of glass and is shown after the locking ring is broken.

Figs. 5 and 6 show, similar to Figs. 2 and 3, axial section through the bottleneck and closure of the second embodiment shown in FIG. 4.

FIG. 7 is a sectional view, partly in axial section, of a variant of the bottle shown in FIG. 1 to 3.

FIG. 8 is a sectional view taken along line VIII-VIII of FIG. 7.

The bottle 1 shown in FIG. 1 to 3 are made by blow molding a water-repellent, hydrophobic plastic material, e.g. a polyolefin such as polyethylene, polypropylene or an ethylene propylene copolymer capable of withstanding a standard pharmaceutical sterilization process at 120 ° C. The bottle 1 has flattened side portions 3 to simplify handling as well as two circumferential grooves 5, 5 'to allow longitudinal expansion of the bottle when subjected to internal overpressure during sterilization.

The closure device 7 comprises a capsule which can be screwed onto the neck 11. This capsule 9 is molded from a rigid plastic material, such as high-density polyethylene or polypropylene, which preferably contains talc or other mineral. This capsule has sufficient thickness to withstand sterilization temperature and internal pressure without excessive deformation. Furthermore, the threads are asymmetrical and trapezoidal in that the upper flange of the threads of the capsule and the lower flank of the threads of the bottle neck are approximately horizontal when the bottle is vertical, and this is to limit the radial force component which seeks to expand the capsule when it is excessively high. in the bottle. This feature is particularly useful in the case of a glass bottle, to be described hereinafter and subjected to excessive internal pressure.

A seal 13 made of elastomeric material is disposed against the inside of the bottom of the capsule, where it is normally retained due to suction. Furthermore, the seal 13 is held against axial movement by a circular bead 15. By unscrewing the capsule 9, the seal 13 is thus moved together with the capsule and remains attached to it after the bottle is opened.

The elastomer in the seal 13 is selected to withstand sterilization of the bottle without any significant deformation, so that the elasticity does not vary substantially during the storage period and does not alter the composition of the liquid contained in the bottle, and particularly so that it does not release too many particles or particles of oversized dimensions.

The seal 13 comprises an annular skirt 17 which provides a bacteriologically safe seal against the inside of the neck 11 while the capsule is peeled off, until the circumferential edge of the skirt 17 extends beyond the inner edge of the bottle neck. The length requirements for the skirt 17 will be described below. The circumferential edge of the skirt and the inner edge of the neckline are chamfered to facilitate the screwing of the capsule.

The capsule 9 also has a skirt 19 which surrounds a breakable locking ring 21. This is formed of two parts 23 and 25, one above the other, joined together by breakable bridges 27. When unscrewing the capsule, the upper part 23 is held in the capsule by it is gripped by an inner shoulder 29 of the skirt 19, while the lower part 25 is provided with an annular inner tongue 31 which is punched against a shoulder 33 on the neck, so that all the bridges 27 are broken and the lower part 25 of the ring 21 falls downwards bottleneck. When the bottle is closed and the locking ring 21 is still intact, it is completely hidden by the skirt 19 on the capsule. When the bottle is opened for the first time, the locking ring 21 bursts and its lower portion 25 becomes visible, as shown in FIG. 3, even after the bottle is closed again, because it is locked between the neck and the rest of the bottle. While the material in the bridges 27 must be rigid and relatively brittle, the material in the portions 23 and 25 of the ring 21 must be sufficiently resilient to allow placement of the part 21 within the skirt 19 and to allow the tongue 31 to be slid out of the neck when the bottle is closed. first time. This material can be high density polypropylene or any other flexible plastic material that can withstand the sterilization temperature. Furthermore, the material may be colored at least in part of the ring 25, e.g. red or black or any other color that contrasts with the material in the bottle so that it is clearly visible even in poor lighting conditions.

To ensure that the portion 25 of the ring 21 falls down, a sufficient radial clearance is provided on each side of the portion 25, with the skirt 19 being tapered internally and by the neck 11 of the bottle being narrowed below the shoulder 33.

As long as the locking ring 21 is intact, it is important that the first unscrewing of the capsule does not affect the bacteriological seal of the closure device in any position of the bottle. For this purpose, the length of the skirt 17 of the seal 13 is chosen as a function of the axial clearances, determined by manufacturing tolerances, between, on the one hand, part 23 of the ring 21 and the inner shoulder 29 of the skirt 19, and on the other hand between the tongue 31 and the shoulder 33 of the neck 11, taking into account the extensibility of the breakable bridges 27. The length of the skirt 17 is chosen so as to form a sufficient contact surface between the skirt and the inside of the neck 11, both before and after the ring 21 is broken, as shown in FIG.

3.

In order to avoid, after a portion of the contents of the bottle is completely out and the bottle is vertical, that droplets drip along the outside of the neck, which could contaminate liquid which is later poured out, the outer edge of the neck is formed with a rib 35 to stop the drops. Inserted in axial section through the capsule, this rib forms a pointed angle defined by a side which is slightly inclined inward with respect to the vertical direction as well as

154995 ₆ another side which is slightly inclined relative to the horizontal direction, preferably at an angle of 7.5 °. With such a design and in conjunction with the water repellent or hydrophobic plastic material in the bottle, the rib 35 counteracts dripping of liquid on the outside of the neck. The bevel sides cause liquid located on the edge of the bottle neck to be returned to the bottle.

The bottle shown in FIG. 4 to 6 differ from the bottle of FIG. 1 to 3 in that the bottle is made of pharmaceutical grade glass, with a neutral surface. From Fig. 4 it can be seen that the lower part 25 of the broken locking ring 21 lies against the bottle 1 '. Since glass does not have the water-repellent property required to form a rib 35 to stop droplets, the rib is formed of a separate ring 37 made of a hydrophobic plastic material similar to that of the bottle shown in FIG. 1 to 3. The ring 37 is inserted into an outer groove around the edge of the bottle neck, or held by a circumferential bead 39 on the bottle neck, which projects into a circumferential groove in the ring 37. When the bottle is closed, the ring 37 is axially clamped between the seal 13 and a shoulder 41. on the bottleneck, so that the seal is improved.

The other parts of the bottle correspond to the parts shown in FIG. 1 to 3, and are therefore given the same reference numbers. However, the elongation grooves 5 and 5 are left out as they have no purpose on a glass bottle. Although casting preparation does not make it possible to obtain threads on the neck which have as sharp edges as can be obtained with organic plastic material, it is ensured that the lower flanks of the threads on the bottleneck are as horizontal as possible.

The bottle shown in FIG. 7 and 8 are of a similar type as described in connection with FIGS. 2 and 3, and similarly, the bottle is made by mold biasing of a semi-rigid, hydrophobic plastic material. Filling the bottle and screwing the capsule into an automatic machine exposes the bottleneck to considerable axial force and torque, which can cause a deformation of the bottle that prevents proper filling and closing of the bottle. To avoid such deformation, a collar 42 is provided which is integrally molded with the bottle and has a lower, flat surface 43 which, when the bottle is in the process of being closed, rests against an abutment on the machine (not shown). In addition, the surface 43 of the collar 42 has radial recesses 44 distributed around the circumference which engage a corresponding set of teeth on the abutment of the machine, so that the torque applied to the bottle neck is transmitted only to the abutment of the machine and not transferred to the rest of the bottle.

It will be appreciated that the recesses 44 can be replaced by teeth which engage with recesses in the counter support of the machine, or they can be replaced by equivalent means such as crown nuts, radial teeth around the perimeter, etc.

It will be seen that there is a sufficient distance between the collar 42 and the lower edge of the skirt 19 of the capsule when the capsule is fully screwed on, so that after the locking ring is broken, the lower part 25 of the locking ring, even if stopped by the collar 42 , is completely visible and will, because of its contrasting color, easily distinguish itself from the capsule and the bottleneck.

As shown in FIG. 4, the length of the neck is sufficient for a portion thereof to be visible between the portion 25 of the ring which has fallen towards the bottle and the lower edge of the capsule. Thus, the material in the bottle (e.g. glass or polyethylene) is visible on either side of part 25, so that this part, because of its contrasting color, stands out clearly under poor lighting conditions.

In a variant of the bottle of FIG. 1 to 3 made of plastic material, the wall of the bottle 1 comprises a short lower portion with a truncated cone, which extends into the bottom of the bottle, as shown in FIG. 4 to 6. The truncated cone portion is adapted to be gripped by a corresponding truncated cone portion of a machine to hold the bottle against rotation and axial movement during closure.