|20040004829||Illuminating, heating or cooling a consumer product||January, 2004||Policappelli|
|20060102585||Bottle pocket||May, 2006||Richardson|
|20050224442||All purpose water bottle with safe||October, 2005||White|
|20080223810||Multipurpose Lid, Especially for Liquids, Including Paint Cans||September, 2008||Garcia|
|20090301990||STAINLESS STEEL CONTAINER AND PLASTIC CAP WITH FINGER LOOP AND STAINLESS STEEL PLUG||December, 2009||Cresswell et al.|
|20050247659||Insulated bottle holder||November, 2005||Passman et al.|
|20030000910||Cap for packing-bottle capable of packing auxiliary internal medicine||January, 2003||Jang et al.|
|20060180585||Twist up spout for beverage container||August, 2006||Cunningham et al.|
|20090261057||Closure with Barrier Liner||October, 2009||Druitt et al.|
|20040124168||Artificial nipple||July, 2004||Silver|
|20090050595||TETHERED TWO PIECE NESTABLE BOTTLE||February, 2009||Lackey|
 The invention also relates to a method for producing such a moulding.
 Mouldings of this type often have aesthetic defects. Such irregularities, impairing the visual appearance, may occur in the form of frayed fibres and primarily form also in the region of the injection point. Therefore, there has already been a change in the way in which stoppers for instance are produced, arranging the injection point in a concealed position, for example in the region of a cavity within a stopper. Such an arrangement entails difficulties, however, since the nozzle of the injection device also requires a certain amount of space. Flow defects at sealing locations, for example at a flange-like edge region of such a stopper, facing the end edge of the flanges, may even cause sealing problems.
 In addition, mouldings of this type also have to meet high technical requirements in other respects. For instance, during piercing, if at all possible there must not be any crumbling away of parts of the material, which could be entrained. Piercing must also be possible without any hindrance. In the case of protective caps, for instance, good material cohesion is also required, important also for instance in the case of the other configurations of the moulding.
 On this basis, the invention is concerned with the object of providing a moulding suitable for pharmaceutical uses which is as homogeneous as possible and as free from defects as possible. Furthermore, the invention is concerned with the object of providing a production method suitable for this.
 With regard to the moulding, the object is achieved firstly and substantially by the respective subject matter of claims 1 and 2, it firstly being of significance, claim 1, in addition to the features already specified, that the moulding consists, at least in a subregion, of a thermoplastic elastomer material with a mineral filler content of 30% or more and this subregion has a hot-runner injection point which is formed as a smooth-surfaced mark. In addition, claim 2, it is also of significance that, in the case of a second part of the moulding, the latter consists of a different plastics, for example a conventional injection-moulding plastics, such as PP, PE or the like, which is then used to inject over the injection point of the first subregion. In such a case, the injection point of the subregion formed from the flexible elastomer material in particular can then also be formed as a hot-runner injection point, which is then, again preferably, also formed as a smooth-surfaced mark. According to the invention, it has been recognized that a thermoplastic elastomer material with a mineral filler content of 30% or more is suitable for meeting the material requirements of pharmaceutical mouldings of this type. This is so at least when, in the case of outward exposure on the moulding, the injection point is formed by a hot-runner injection point and a smooth-surfaced mark is created. Disturbing streaking or instances of material unevenness, in particular in the region of the injection point, can no longer be found. Nevertheless, such a moulding can be efficiently produced by customary injection-moulding processes, but with hot-runner injection. It is preferable in this context that the mark which is created on the moulding by the hot-runner injection point goes over into the moulding wall surrounding it without being offset outwards. In particular, it is preferred for the smooth-surfaced mark to go over into the moulding wall surrounding it in a co-planar manner. Furthermore, however, it may also be recommendable in special cases for the mark to be raised with respect to the moulding wall surrounding it, that is to say it is offset outwards. This is so for example if, as is the aim also of claim 2 explained above, the two-component injection-moulding process is being used or the moulding consisting of the elastomer material is part of a multi-part article, in which the injection point is covered by a further part or is even encapsulated therein. This is so because a raised mark may also be recommendable for positive engagement in a further part.
 The moulding may altogether be of a multi-part form, by being produced for instance in the multi-component injection-moulding process, it being possible for the individual parts to adhere to one another directly in the manner of welding, or else to be separable or separate from one another after completion of the injection process. In such a multi-part moulding, such as that described further below in detail, the part consisting of thermoplastic elastomer material is then a subregion of the same.
 Furthermore, it is also preferred for such a moulding, or the corresponding subregion of the moulding, to be formed with thick walls, at least in the region of the injection point. Thick walls are understood here in particular with regard to a length of the flow path of the injected material in relation to the wall thickness. The length is measured from the injection point. Here, furthermore, a mean value over the entire moulding is used as the wall thickness. If a value of <5 is obtained, the walls are considered to be thick in the sense of the present patent application.
 The moulding, or the corresponding subregion of the moulding, takes the form of a homogeneous body. The specified mixture produces an elastomeric structure with good piercing behaviour. The requirements for after-sealing, for instance in the case of pulled-out cannulas, are also satisfied.
 The added mineral filler content acts with a flow-retarding effect, which advantageously supports an aimed-for uniform distribution of the plastics in the course of the injection process. The hot-runner injection, which is preferably also performed in a central region, or preferably also on an outer surface, that is to say not in a cavity region of the moulding, likewise promotes balanced distribution of the plastics in the course of an injection-moulding operation. The predominantly thick-walled formation of the moulding, or the corresponding subregion of the moulding, also leads to substantially the same situation with respect to shrinkage, although this is comparatively very slight in the case of the specified material. The filler is preferably a silicate. In may be, for example, magnesium silicate (tallow). This filler has the effect of advantageous flow retardation. Nevertheless, in absolute terms, the filling of a corresponding mould cavity takes place very quickly. With the customary size of stoppers concerned here, for instance, or other articles of a comparable size, the filling time is about 0.1 second. There is moreover, with respect to the thermoplastic elastomer material described, to which a plasticizer is possibly added, a surprisingly low dependence of its properties on the temperature. The filling of a cavity can be achieved to the greatest extent independently of the filling temperature, without the occurrence of a so-called spaghetti effect. The Shore hardness A lies between 45 and 60, preferably at 55.
 More specifically with respect to a stopper concerned here, with regard to good penetrability with the cannula of a syringe it is provided that the stopper top has a central region of lesser wall thickness and an edge region of greater wall thickness, measured in the vertical direction. In the use in question, the edge region is enclosed by a flanged cap of a corresponding infusion-bottle fastener. Possibly enclosed with a clamping action.
 The closure top is connected downwards in the vertical direction with a stopper collar. This stopper collar likewise preferably has, in any event in its initial region connected with the stopper top, a greater wall thickness than the stopper top in its central region. At the same time, the stopper collar is consequently preferably connected with the region of greater wall thicknesses of the edge region of the stopper. It is further preferred for the hot-runner injection to be performed with regard to the injection-runner closure with a ram-like needle head, the planar end face of the needle head in the shut-off state of the injection mould going over in a co-planar manner into the surrounding nozzle wall, forming part of the wall of the moulding. It can correspondingly also be stated that the smooth-surfaced injection point, that is to say the injection area, goes over in a co-planar manner into the surrounding surface of the moulding. A smooth-surfaced mark of the ram-like needle head is obtained on the moulding, effectively avoiding even extremely small instances of roughness or fissuring. The moulding is produced without any secondary finishing. The said configuration has the particular advantage in the case of the stopper that no fractionation particles, caused for instance by inaccuracies, can be carried away through the cannula and get into the bottle. The fully formed smooth surface consequently exists also and in particular with respect to the injection point itself, approximately the size of a pin head.
 A further embodiment of such a moulding for pharmaceutical uses is a protective cap for medical syringes. This protective cap is fitted over the cannula of a syringe, in order to protect the latter with regard to instances of mechanical impairment or else soiling. In a corresponding way, such a protective cap also consists of a thermoplastic elastomer material which has a mineral filler content of 30% or more. In the region of a cap hat of the protective cap there is a hot-runner injection. Here, the same properties are achieved, in particular with regard to the exterior of the protective cap, as already explained with respect to the stopper. With regard to the material, the moulding formed as a protective cap can also contain a proportion of plasticizer. Here, too, the hot-runner injection is preferably performed centrally, in the region of the tip of the cap hat. Consequently, the explanation as provided before in detail with regard to the ram-like needle head, which is preferably used on the injection-moulding machine side, and the advantages achieved by this, also apply with respect to the protective cap.
 A further article which may be embodied by such a moulding serving for pharmaceutical uses is a sealing element, as used in the case of so-called “bottle-pack” bottles. In this respect, reference is made in particular to the disclosure of German Patent Applications 195 00 460 and 196 20 196, the contents of which are hereby also incorporated in full, also for the purpose of including features of these prior publication in claims of the present patent application. Such a sealing element customarily has a peripheral flange of a smaller wall thickness or, on the upper side and/or underside, a peripheral groove associated with the edge and a central region of greater wall thickness. Here, too, the injection preferably takes place centrally in the upper outer surface. Moreover, the geometrical features described also apply here, for instance with regard to the thickness of the walls, and the features regarding the purity and freedom from streaks, as already explained before with respect to the moulding in general and the other uses. In particular, such an article may also be produced in the multi-component injection-moulding process, the one subregion, for instance the subregion of rigid plastics forming the outer cap, then forming the mould (again at least partially) for the subsequently injected elastomer-material subregion. It is also possible, however, to adopt the reverse procedure. In particular in the latter case, it is possible, and may even be appropriate, to produce the hot-runner injection point in such a way that it is raised with respect to the surrounding moulding wall of elastomer material, but in the end depressed with respect to the moulding wall of a second subregion of another plastics component, in particular a rigid plastics component.
 The invention also relates to a method for producing a moulding serving for pharmaceutical uses, such as for instance a stopper for pharmaceutical bottles, a protective cap for medical syringes or a sealing element for pharmaceutical containers. In this respect, it is provided in one embodiment that a thermoplastic elastomer material with a 30% or more admixed mineral filler content is used as the material and that a central hot-runner injection is performed in the region of a moulding top or a moulding tip. In a further embodiment, it is provided that in any event a subregion is produced from a thermoplastic elastomer material with a mineral filler content of 30% or more and this subregion is configured by an injection having an injection point, which injection point is injected over by another plastics, forming a second subregion of the moulding. Used here in particular is a customary plastics for moulded parts, such as for instance PP, PE etc. To be specific, as before in respect of the features constituting the subject matter, a corresponding filler content in per cent by weight is provided. Advantageously, a proportion of plasticizers is also added to the thermoplastic elastomer material. With regard to a stopper, it may be provided that the central hot-runner injection is performed in the region of the stopper top, formed predominantly with a thick wall. The stopper collar may also be formed with a greater wall thickness than the stopper top in its central region. With respect to a seal, the injection may be performed in the upper outer surface, preferably centrally there. It is further preferred, in respect of all the embodiments, that the hot-runner closure can be used in the form of a ram-like needle head, the planar end face of which in the shut-off state goes over into the surrounding nozzle wall, forming part of the wall of the moulding, in a co-planar manner or offset into the interior of the moulding with respect to the said nozzle wall. This makes it possible to achieve a smooth-surfaced injection point and for the injection area of the injection point to go over into the surrounding moulding wall in a co-planar manner or offset in terms of depth.
 When forming a protective cap for medical syringes in the plastic injection-moulding process specified above, a solid cap hat and a comparatively thin-walled cap neck is moulded. In an advantageous way, the hot-runner injection takes place centrally on the cap hat. Otherwise, from a production engineering viewpoint, the same features as also already described above with respect to the production of the stopper or the seal are preferred.
 The subject matter of the invention is explained in more detail below on the basis of two exemplary embodiments illustrated in the drawing, in which:
 The stopper
 A thermoplastic elastomer material of rubber-like elasticity and nevertheless adequate inherent rigidity is used.
 The stopper
 The bottle
 The bottle
 The stopper
 The stopper
 The piercing region
 Taking into consideration the conditions in
 In spite of these partial differences in wall thicknesses, the stopper
 The protective cap
 The neck end has the least wall thickness. In this region, the moulding, kept substantially cylindrical over its circumferential wall, has a prominent annular shoulder
 The injection point lies at the exposed point of the cap hat
 Represented in
 The bottle body consists of plastics, for example PE, with a penetrable wall thickness, for penetration by means of cannulas or spikes, for example.
 This closure wall of the bottle
 In the case of the exemplary embodiment of
 In the case of the exemplary embodiment of
 The mouldings in the form of the stopper
 The injection point A (cf. for instance
 The central access of the injection moulding compound M (cf.
 The filling process is in each case valve-controlled. For this purpose, a vertically movable needle
 The ram-like needle head
 Referring to
 In the case of the article of
 With respect to the mouldings described, the list of requirements in terms of the material also take into account that such mouldings should be autoclave-resistant. They withstand temperatures of 120° over a relatively long period of time. In spite of the admixture explained, the material remains outstandingly suitable for injection moulding. The required compromise has been found. Moreover, plasticizer is also added to the thermoplastic elastomer material.
 The needle
 The nozzle wall
 Because of the described planarity of the end face
 Customary drafts on the moulding have been taken into account.
 Shown in
 In the case of the embodiment of
 All disclosed features are (in themselves) pertinent to the invention. The disclosure content of associated/attached priority documents (copy of the prior application) is hereby fully incorporated into the disclosure of the patent application, also for the purpose of including features of these documents in claims of the present patent application.