DE1566542A1 - Pierceable closure for medicine bottles - Google Patents

Description

File S β? 215 S / B / Hü

P 15 66 5 * 2.6-35

Pharma - Gummi Hans Wimmer 518 Eschweiler

Pierceable closure for medicine fish

The invention relates to a pierceable closure for Medicine bottles with a flap and with a sealing washer that is anchored on the face of the bottle mouth from at least two different materials and a method for producing them, from at least Sealing washer made of two different materials for a pierceable closure for medicine bottles.

A pierceable closure for medicine bottles with a sealing washer is already known which has an anchorage opposite the bottle mouth; This anchoring is formed by an annular _{ raised protruding bead of the bottle mouth in cooperation with a corresponding annular groove provided in the sealing washer.

These

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This training? has several disadvantages. First of all, providing the mouth of the bottle with such an edge bead is costly and requires not inconsiderable manufacturing tolerances, since glass flakes cannot be produced with great accuracy. In addition, with such a type of anchoring of the sealing washer and bottle mouth, it is not possible to accommodate a second, raitabdicntenden part of the sealing disk. In medicine bottles but it is often desirable that the sealing disk has several materials, of which the bottle interior facing next »I ¹ em c-ee-enüber re bottle contents chemically inert to be, while the kiss <=> re part of the gasket still certain Eliminate the deficiency of the first-mentioned part and / or use a less expensive one because the material is supposed to form a cheaper part of the sealing washer. In addition, in the case of closures of medicine bottles which are used for piercing, an anchoring of the sealing disk that also acts in the radial direction is necessary, since the flanged flap is not able to hold firmly in this direction. In the case of certain drugs, a plastic that is chemically neutral to a large number of substances, as is known in the trade under the trade mark "Teflon", has proven to be particularly suitable as the inner sealing disk portion facing the drug. On the other hand, a perfect seal between a Teflon disc and the end wall of a Flechenjujujuung is practically not possible, since relatively hard plastics such as "Teflon" are

the

109808/0371 _BiniM _,

BATH ORIGINAL

the unevenness of the front of glass bottles is not sufficient '! can adjust so that the surface area on the creep path between the Teflon disc and the face of the Bottle can escape or unstable air can peel from the outside to the inside.

After a previously known one. Process for the production of a Sealing washer made of two different materials a pierceable closure for medicine bottles, ir.fibesoH'iere to attach a Teflon disc to a gumiri plate, it is known to stick these on top of one another and to use an adhesive as an adhesive, as well as that is common in “Junni-Metal!” connections.

A dorarti'-es. Getting lost has the disadvantage that the adhesive easily gums or hardens at the relatively high temperature of the subsequent vulcanization process, which makes it impossible to use such sealing washers as pierceable closures for medicine bottles content is removed by means of a cannula, as when removing oes medicament rubber washer Susanna be pierced with ά <τ Teflon disc must and in this case including piercing the zone between the Teflcnßcheibe and the rubber washer easily remains or parts of the ale Kl-ber vprwendeten adhesive into the interior of Cannula can pcelanren, causing incalculable harm to the patient

will

can be.

The invention is based on the object of creating a pierceable closure for medicine bottles, eg a sealing washer with at least one made of a material that is chemically neutral to many substances, and possibly hard, in particular has an inner part made of Teflon, with above all a reliable seal and also a sufficient one Anchoring of the Dicntungsscheibe is achieved and also the effort for the production of such a medicine bottle and their closure is as cheap as possible, and such a method for the production of at least two to find different materials existing sealing washer, after which preferably a Teflon washer A rubber sheet can be vulcanized on without using an adhesive having to use an adhesive.

To solve this problem, the invention proposes that at a pierceable closure for medicine bottles of this * art «is designed so that the flat face is one Fish mouth closing the bevel formed on its outer edge Sealing washer from one of the bottle opening and about half of the outer and inner diameter the bottle neck at the bottle mouth limited annular Surface of the bottle face covering layer, preferably the Teflon disk and one of the entire bottle face covering, elastomeric, rsstight cover sheet

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be, on the middle area of which the Teflon disc is laminated is, and that the cover plate as an anchor on the outer edge of one of the bevel on the bottle mouth outer edge customized bead bears.

This ensures that the contents of the bottle are essentially can be sealed by means of a previously neutral material, namely a plastic of the Teflon type, this relatively expensive Teflon washer is only made thin must be and on the outer area of the bottle face there is a cover plate that is gas-tight and sufficient is elastic, so that it completes the closure and also in connection with that located on its outer edge Bead and can form an anchor in connection with the flanged flap.

A particularly favorable and secure anchoring is obtained by that the bead of the cover plate is dimensioned and preferably somewhat wedge-shaped that it after the Crimping the sealing washer is fixed in a clamping manner.

The central region of the cover disk carrying the Teflon disk or the like can expediently be surrounded by an annular groove. This not only has the advantage during production that the Teflon plate to be connected to the cover plate can be centered well in a predetermined position in the production form, but the Teflon plate can also be vulcanized on BADORiGINAL ",

Kanieren on the cover pane, straightening its edge a little pull in inside, which also works with her in a radial direction receives an improved hold.

The bevel angle of the bead of the cover plate can be flatter than that of the bevel at the bottle mouth, so that preferably the tip of the bead is in the undeformed state protrudes slightly beyond the remaining diameter of the cover disc.

The Teflon washer can go a little inwards into the ring groove be inflected.

The task of finding a method for vulcanizing a Teflon disk onto a rubber sheet without having to use an adhesive as an aid is achieved by using an elastic raw rubber sheet made of a rubber mixture that has an adhesive effect immediately after its production in the fresh state a Teflon disc or similar film with a roughened surface and is pressed or laminated onto it while it is still fresh, so that in a second operation the side of the Rohgumraiplatte laminated with the Teflon disc) onto an annular cutting tool with a larger diameter than the Inside diameter is placed in a press ring groove located on the cover disc in the finished state and pressed under relatively high pressure until the elastic raw gourameplate is pressed together to such an extent

1Q9808 / 0371 _{or similar}

BAD ORSGlNAL

m -.- nrepresst is that d-> r counter pressure is so great that the riveting tool.die Teflon film and the pressurized RohKurnmiplatte severed, whereupon the after pressure relief ¹ revs up again, decreasing in diameter, with the now over the inside diameter of the later groove protruding Teflon schelbp od. de ·], laminated cover disk blank in one,! third working step into a final uraric plan of the Di critui _; -escneibe appropriate form is introduced and eii.a Vulksr.isetionsvorganp is subordinated, whereby the before-F *; t name. Edges of the Nufkaschierten Teflon disc in the inner area delimited by a circular shaped part forming the cap on the sealing disc.

V --- i der G jnirciBischunp is und-r denr. n ^ ch their Herstellunp aviftretenden "still fresh" derjienii e understood condition ir to: dirse Gunmi Wed Apr on "in the re ~ el still warm, definitely NCCL. un ^ is vmr epudert therefore aufweirt an adhesive effect In certain.. Tres is can materials may the adhesive effect even if. cold. Zustend remain a short time when the s <? n to ~ ^ei% erti ~ te Gumrrimischung still unpepudert. edeine case it is important that the uraaittelbar after Hersteliur. For the G'imrorrischunf, if this is not yet powdered, the Kl '^ beeffekt is used.

The erfinjim ~ S'en «:: P procedure« = · - offers the advantage that the Aufkasc'iierer de "-up o ^; .r.er a'ifcerejr.ten cover disc or foil,

the

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which previously consists of Teflon ^{11 to} fix this foil if it is pressed or laminated onto it immediately after the production of the raw rubber plies consisting of rubber mixture in the fresh state before powdering An adhesive agent as an adhesive with all its mentioned disadvantages is superfluous. First of all, this method of lamination is made possible by the fact that, in the usual way, according to the requirements, the cover disks for the closure came from appropriate media ρπ, selected Gumrainiischuner in the noc ': tear to the ground and unpowdered even before vulcanization ^ shows a very close surface tack, which.

the vulcanisation FationsvofFangr disappears o ^e ^ och to the covered the i'r.fi rauhte Teflon disk and laminated bodies remains, since the presence of air oxygen necessary; is to fix the surface stickiness.

A widely ^c rer advantage of erfindunrsfeaiäßen method is that it is ernÖglicht that the sheet projects slightly over the eus ^ estnnztpn round parts, so that these protruding cards can for better anchoring in Guramjütei] by the pressing pressure to be ^ ebo ^ s »

Further individual pages of the invention are illustrated with reference to the drawing no explained in more detail. They are in different scales:

Fi.fr, 1

109808/0371

Fig. 1 is a vertical longitudinal section through the top of a medicine bottle, which has a pierceable closure has and

2 shows, on an enlarged scale, a partial cross-section through the sealing washer in the area of its annular groove as well

Fig. 3 shows a cross section through the cutting device, in the Teflon sheet and the preformed with the Teflon disc covered raw rubber plate is located, namely immediately before the cutting process;

Fig. 4 the cut out, provided with the Teflon film Disc blank when introduced into the vulcanization mold drawn in section and

5 shows the vulcanization mold in the closed, drawn in section finished sealing washer in section.

A medicine bottle Ί has one designated as a whole by 2 Shutter open. This has a two-part sealing washer 5, which by means of a flanged flap 4 on the whole with 1a designated bottle mouth is attached. The flanged flap 4 has, in a well-known manner, one in the middle area so-called pull tab 4a; by pulling up this pull tab

109808/0371

The central area of the sealing washer is lasered 3 free, so that you can with a hollow spike, a cannula Or. Like. Pierce and then partially 'or fatanz pull off the contents of the bottle. Medicine bottles 1 with such closures 2 often advertise used as infusion bottles, whereby not infrequently a hollow spike of fairly large diameter is pushed through the sealing washer 3.

The end face 5 of the bottle mouth 1a is of the known white, flat design and it belongs to the invention, because it has a ring-shaped bevel 6 on the outside . The seal ^ sscbeibe 3 consists of two parts, namely a cover disc? and a Äünnen Teflon disc 8. The cover? consists of an elastomeric, gas-tight material, for example Bu.thr ^ l-KaV ¹ ^ sc ^ uk. The The middle area of the cover disk, surrounded by a groove 9, is covered with a Teflon disk β, which is fixed by the inventive method. The diameter of the Seflon disk 8 or the inside diameter of the pin groove 9 is dimensioned so that about half of the flakes of the outer and inner diameter of the bottle neck on the ring-shaped surface of the bottle face 5 limited to the mouth of the bottle are still covered by the Teflon disk 8.

As a material for the elastomeric, cased cover disk 7 you can use butyl rubber. The Teflon washer 8

i s t

109808/0371 BAD original

iivt with its edge in the vicinity of the annular groove 9 of the cover plate-It- '. na et above abp-ebocren, as you can see from Fi .pur 2 ^ ut can. As a result, the Teflon disk 8 also has a radial Hich -'- ποτ. a better H-It.

The above-mentioned "" Rirrnit ^, the associated cres, it forming molded part for centering the raw crumb plate? A in the vulcanization mold (Fir. 4 and M is advantageous, also has precedents with open via ^ ce nocvn: Si * ¹ acts there to a certain extent as a labyrinth, if a perfect seal between the Teflon fiber ^v * ¹ ^ d the front wall S of the bottle mouth is practically no ""rrp'rhr, because Teflon or such hard materials never come together : .L fov.ü and can adapt to the unevenness of the glass, Vfrbloirit «m labyrinthi> rti <- *> r inner space between the Teflon disc * i :: a the area of the cover disc 7. This groove has a special effect. "now, wr. '. i her tv NRCH a -το -f" rer pressure aln in Flsch * »* ninn there? ren, eg evacuated bottles. however, it may aucri i in medicine bottles that still € inm to fill iTaste <= l are sterilized, create an overpressure in the groove 9 and initially r:. Oi ^ se pressure differences then impede that on the

e- * ¹ NOCN between bottles ^ tirnwand 5 and Teflonscneibe H lan-StT emerging contents of the bottle once a / chemical Reekt or received with aer Abdecksc ^ e ^ 7 and be an appreciable reaction erftibt the Flaechenihhalt. Small parts of the bottle contents, which - seen in the radial direction outside the Teflon disc 8 eit the cover disc 7, a reaction 109808/0371 BAD ORIGINAL ·

action can essentially take place in the annular groove 9 remain.

The invention provides a medicine bottle with a closure 2, in which chemically neutral, possibly also very hard plastics such as Teflon, which have unfavorable but otherwise very desirable properties for sealing with glass, are also used in sealing. 3 can be used. The manufacture of the medicine bottle 1 as well as the sealing disk and the crimping process remain simple.

An essential part of the invention represents the with the ab- ' bevel 6 of the Piaschenmuzzle 1a cooperating, on the outer edge the cover plate 7 is arranged bead 7b. It is in their dimensions of the bevel 6 on the outer edge of the panel fits, somewhat wedge-shaped bit downward pointing tip formed and sized so that it is when crimping the flange flap 4 -.ut the bottle mouth is clamped will. This achieves both good additional sealing of the cover plate 7 and anchoring it Cover 7 and therewith the entire sealing washer The aforementioned clamping fastening of the cover plate 7 is especially bet the processing of the medicine bottles in fully automatic Crimping machines required for these crimping machines - due to the tolerances on the glass medicine bottle 1 - not always with constant crimping pressure work so that the flanged flap 4 is not inside the

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receives the same crimping pressure and thus the pressure on the crimped glass edge is not always even. Although you can adjust the crimping pressure so that a sufficient liquid seal is guaranteed, a sufficient Glasabdic titung can not be guaranteed. Particularly according to a further development of the invention, according to which the chamfering angle (FIG. 2) of the bead 7a is flatter, possibly considerably flatter than the angle of the chamfering 6 on the bottle mouth 1a, the outer edge of the bottle 6 and the bead 7b is also well sealed when the Abdecicscheibe is pressed 7 by the Bördelklappe 4 is not very firmly on the end face 5 of the bottle mouth 1a _t This safe seal in the region of the bead 7 and is largely independent of the manufacturing tolerance-ene. The bead 7b can easily be carried along by the flanged flap which is still open when it is put on if the tip 7c of the bead 7b protrudes slightly beyond the remaining diameter of the cover disc in the undamaged state.

Made from a Teflon film firmly attached to a rubber disc Existing sealing washer is manufactured using an adhesive as a bonding agent in the following way:

A cover disk 7 is made from a special one that largely meets the requirements of the bottle contents to be sealed composite rubber compound existing raw rubber surface

stickiness

• BATH 10980870371

exhibits stickiness, which only after vulcanization to the exposed to air, usually powdered, twisted, and has the property of being on a roughened Teflon film • to adhere, manufactured. For this purpose, such a raw rubber plate 7a is placed directly in the still hot Zufcand after the manufacture of the same, a Teflon film 8 with the roughened surface facing it is pressed or laminated on.

In order to achieve that the Teflonecheibe is slightly larger than the inner diameter of an annular groove 9 located in the cover plate in the finished condition _t u «later these protruding edges of the Teflon disc 8 in the direction of the Rinrnut 9, to be able to turn for a better grip of the Teflon disc 8 , the side of the raw rubber plate 7a lined with the Teflon disk 8a is placed on a not too sharp cutting tool 8, which is permitted as a circular knife (FIG. 3), on which the round shape is punched out with high pressure. The Teflon film 8a initially absorbs the pressure without the cutting tool S cutting into it. The pressure on the raw rubber plaques compresses the rubber plate until the pressure is so great that the not too sharp lundaesser 2o cuts into the Teflon sheet 8a (Fig. 3). At the same time, the circular knife 2o has the flat pressed, radially somewhat stretched raw rubber plate as a counter-bearing, which rises up again and becomes smaller in diameter, while the punched Tefloh disc 8 retains its shape

109808/0371 bathroom original

(FiP.4-}. As a result, the outer edge of the punched out Teflon washer 8 slightly over the inner diameter of the ring groove 9 before. Then the provided with the Teflon disc 8 is Cover disk 7 introduced into a mold 21, 22 and in this subjected to a vulcanization process, the above Edges of the Teflon disk 8 of which the annular groove blidender Form part f can be pebbled upwards (Fie. 4- and 5)

Oxygen to the nicrt through the Teflon washer 8 covered sides of the disc 7 «disappears the high surface stickiness to the air in contact uncomfortable, en bodies, 'the ^ fff. powdered in a known way can be.

The anchoring of the cover disk and FF * "· an improvement; their sealing takes place through the inventive bead 7b, which is clamped laterally on the bottle bundle at it ti'-t when flanging ~ b is favored that the diameter of the medicine bottles vie all Glaskirper verhältniseässig large Ferti ^ ungstoleranzren h _r b * n, so Dafi the Bördelklappe 4 ·. still some room between it and the outer contour of the ilaschenmvnduuir 1a can, in which then parts the bead is pulled in when flanging and after the brothel attachment is closed, it is fastened there in a sealing and clamping manner

must be pushed or if this process, for example, also medium a cannula several times. In the latter case, it is advantageous that the cover plate 7 is made of an elastomer Material exists, the piercing opening less after pulling it out the cannula od. d ^ l. closes again.

Tn a known manner the Abdeck3cneibe 3, a Wandy rdtinnun ^ * ¹ 12 may have to which a grooving is facilitated.

It should also be mentioned that de? the sealing disc blank 7, 8, which is relefte in the open mold 21, 22 with respect to the, for example, Buttoyt-Katuschufc beeteho ^ e "part 7 is dimensioned so that the depressed material in the closer of the mold parts 21, 2? fills their remaining hollow spaces, as a comparison of Fi °;. ** ■ and 5 shows.

Claims

109808/0371 bathroom original

Claims (6)

Claims ■ 1) Pierceable closure for medicine bottles with a Börciel flap and with one on the face of the bottle mouth anchoring sealing washer made of at least two different materials, characterized in that that one, the flat face (5) one with a bevel (6) formed on its outer edge Bottle neck (1a? Sealing washer (3) from one the bottle opening and about half of the from outer and inner diameter of the bottle neck at the bottle mouth finely limited annular surface of the flat bottle face (5) covering layer, preferably the Teflon disc (8) or the like. Foil and one the bottle opening and the entire bottle face covering elastomeric, gas-tight cover disk (7), on the middle area of which the Teflon disk (8) is laminated is, and that the cover plate (?) as anchoring on the outer edge of one of the chamfer (6) gm bottle mouth outer edge approximately adapted bead (7b) carries. 2) pierceable closure for medicine bottles according to claim 1, characterized in that the bead (7b) of the Cover plate (7) is dimensioned and preferably somewhat wedge-shaped in cross-section that it is after your Flanging is set clamping. 11 _BAD OBiGlNAL 109808 / 037Γ ^ffö88 ° ^ 3) Piercing cap for medicine bottles according to claim 1 or 2, characterized in that the skew angle (<ii) of the bulge (7b) is flatter than that of the bevel (6) on the bottle mouth (1a) and preferably the The tip (7c) of the bead (7a), which is generally undeformed, protruded slightly beyond the remaining diameter of the cover disc (7). 4) A pierceable fastener for medicine bottles after a or more of claims 1 to 3 »characterized in that the Teflon disc (8) or. dpi. load-bearing middle area the cover plate (?) is from an annular groove (9). S) D'.irchstechbaren closure for .Medizinflaschen according to claim 4, characterized in that the Teflohsc'reibe (B) is a little not drawn into the inside of the annular groove (9). 6) Method after producing one, from at least two different ones Materials existing, designed according to one of the preceding claims a sealing washer pierceable closure for medicine bottles, characterized in that one, from immediately after its manufacture In the fresh state, a rubber mixture exhibiting an adhesive effect, an elastic raw rubber plate (7s) with a Teflon disc (8) or dpi. foil covered with atif roughened surface and still fresh State 109808 / ^ 371 ' _BAD original State pressed onto these or laminated vnrd _t that, in a second Arbeitsganf the "ith the Teflon film laminated side of the Rohpufliei-latte an annular Schnittwerk- (2o) old propere * diameter than the inside diameter »R in ready condition on the cover aiba Rinrnut (9) of a press celebrates and under * T ralativ heigh ·· pressure until the elastic RöheuMiplatte (7 *) is so far is that the counter-pressure becomes so "great that the cutting mechanism at up separates the Tefloiiichtibc) foil · and Äoh ^ ieeiplatt * d'jrch, whereupon the after thickening again higher, smaller in diameter," it is now your > T «i *» r- Irr endure hmesaer of the later groove (9> Tor ^ tahenden iVfinnscheihe (f ³ ") _C n. Dfl. Laminated Alxlacktcheibenrohlinc C" e) ir · · ΐηβηί frits workers * n? into a final outline (21,22) of the Dicntungea disc entaprcchande fom 21,2 $ (* "* ei η ρ ·» ·, and «ine« Vulkaniaation is before tmtereogan »where ni *> precede« · ^ Iant «r» The hard Teflon disk is punched into the inner ring-shaped Foretell (f) begranstan Bareich (B) formed by anger C9) on the sealing disk X3) Patent attorney BATH ORIGINAL 109868/0371