EP0297854A2

EP0297854A2 - Pharmaceuticals container

Info

Publication number: EP0297854A2
Application number: EP88305918A
Authority: EP
Inventors: Roy Peter Maunder
Original assignee: SCHUBERT SYSTEMS Ltd
Current assignee: SCHUBERT SYSTEMS Ltd
Priority date: 1987-07-03
Filing date: 1988-06-29
Publication date: 1989-01-04
Also published as: DK365688A; GB8715715D0; DK365688D0; EP0297854A3

Abstract

There is provided a pharmaceuticals container (1) having a hollow neck portion (2) closed by a plastics sealing member (15) friction welded thereto.

Description

This invention relates to containers, more particularly to plastics material containers for pharmaceutical or veterinary substances (hereinafter generally referred to as pharmaceuticals) and to a method of packaging pharmaceuticals in such containers.
Pharmaceuticals for parenteral administration in fluid form are generally packaged in sealed containers which permit the entry of a hollow needle through an entry port. If small, such containers may for example be in the form of glass or plastics injection vials and if large they may for example be in the form of plastics bags, such as those generally referred to as rigid or semi-rigid large volume sterile fluid containers, or of rigid glass or plastics bottles. The needle entry ports in such containers are normally provided with piercable seals, e.g. plastics membranes or, more generally, rubber stoppers or discs. The sealing arrangement must of course be such as to avoid contamination of the pharmaceutical within the container. Rubber stoppers or discs, optionally provided with a plastics coating to minimize contact between the rubber and the pharmaceutical, have been particularly preferred as they serve to grip the needle passing through the port and as they are substantially self re-sealing on withdrawal of the needle.
Thus pharmaceuticals containers, and especially injection vials, have commonly been sealed by placing a rubber disc or stopper over the open neck of the container, by inserting the neck into an open-ended aluminium cap and by crimping the rim of the cap over the rim of the container neck. Such a sealing arrangement is illustrated in Figure 1 of the accompanying drawings which are described further below.
Such use of crimped aluminium caps however is most undesirable since metal dirt is shed and indeed the United States F.D.A. does not generally permit such caps to be applied in the clean room where the pharmaceuticals are filled into the containers. Thus it is common for injection vials to be filled and closed with rubber stoppers in the clean room before being taken out and then sealed by applying and crimping the aluminium caps. This of course is far from ideal since it involves the filled containers being transported while incompletely sealed.
In the case of plastics large volume sterile fluid containers manufactured by blow moulding, it has been known to insert within the mould a pre-formed, ready sealed port unit which attaches to the wall of the container. Such a sealing arrangement is illustrated in Figure 2 of the accompanying drawings. In this case however, the pre-formed port cannot be used for the filling of the container which must therefore be provided with a separate filling port which must be sealed after the container is filled, sealing in that case generally being by heat sealing. Heat sealing of course can give rise to deformation of plastics materials and so this technique is more suited as a method of permanently sealing a filling port than of sealing an extraction port. Furthermore, the preformed port units, generally injection moulded units, are relatively expensive and their use complicates the blow moulding procedure used to manufacture the container body.
Port sealing in plastics pharmaceutical containers using ultrasound has also been contemplated but requires the use of bulky and expensive equipment difficult to fit into automatic pharmaceuticals container filling and sealing machines. Moreover thermoplastics are generally poor conductors which limits the seal depth to a few millimetres and causes adverse heating effects in the plastics especially adjacent the ultrasound emitter.
It is an objective of the present invention therefore to provide pharmaceuticals containers which are sealable without the use of crimped aluminium caps and without heating of the containers at undesired sites and which are and manufacturable without the need for pre-formed, pre-sealed port units or for the provision of separate filling ports.
According to one aspect of the present invention there is thus provided a pharmaceuticals container having a hollow neck portion closed by a plastics sealing member friction welded thereto.
By the use of friction welding to seal the neck portion or port of the container, an acceptable seal can be achieved particularly simply and efficiently without requiring the use of pre-formed pre-sealed port units or of crimped aluminium caps or other potential contaminants.
Friction welding of the plastics of the neck portion and of the sealing member may readily be achieved by pressing the two components together and rotating one relative to the other. Thus the container of the present invention may be manufactured using any sterilizable plastics materials capable of being friction welded together. Generally however the abutting surfaces of the sealing member and of the neck portion will be of the same plastics material, suitable plastics materials including for example polypropylene and polyethylene. The precise pressure conditions required for welding to occur will of course depend upon the particular plastics used.
To facilitate the welding operation by making the neck portion and the sealing member easier to grip and rotate relative to one another, either or both may conveniently be provided on their outer surfaces with projections or recesses engagable by the gripping apparatus of the friction welding equipment. In either case, such projections or recesses will preferably be disposed at or near the outer periphery of the component. Furthermore, to prevent the friction welding operation from causing structural damage to the container, the abutting parts of the neck portion and the sealing member will of course preferably be semi-rigid or rigid.
In the container of the invention, the neck portion is preferably integrally formed with the body of the container; thus for example both the neck portion and the body can be formed in the same moulding process. Alternatively, especially where the body portion is non-rigid, the neck portion may be separately formed, e.g. on a rigid or semi-rigid collar. Containers in the form of PVC bags with neck portions of a harder plastics material may thus be sealed according to the invention.
In a particularly preferred embodiment of the container of the invention, at at least part of the abutting region the neck portion and the sealing member will have circular cross sections tapering to assist the correct location of the sealing member. The taper may be on the outside or the inside of the neck portion as desired.
The sealing member will thus generally have a rigid or semi-rigid annular ring portion, capable of being friction welded to the neck portion of the container body, surrounding a central portion which preferably is readily piercable by a hypodermic needle or by the spike of a giving set. The central portion may comprise a membrane of the same plastics as the ring portion or, especially in the case of containers in the form of injection vials, it may comprise a resilient resealing barrier member, for example of rubber, e.g. a rubber disc sealingly engaged within the annular plastics ring portion.
Use of such a barrier member allows repeated penetrations of the seal to be made without significantly contaminating the pharmaceutical within the container. The barrier member also serves to hold firmly any needle or spike penetrating the seal and to prevent leakage or passage of contaminants along the outer surface of the needle or spike. However rubbers do have a tendency to shed particles and thus to minimize contact between the barrier member and the pharmaceutical, such sealing members are preferably provided with a plastics membrane covering the surface of the barrier member adjacent to the pharmaceutical.
In a particularly preferred embodiment of the present invention, the sealing member is provided with a plastics membrane covering the surface of the barrier member remote from the pharmaceutical. Such a membrane provides a check against tampering as any penetration of the seal will result in a visible perforation in this membrane, particularly if the membrane and the barrier member are of different colours. Furthermore, such an outer membrane provides a surface more readily cleanable before drug administration than is the case where the exposed surface to be pierced is of rubber or of any relatively grainy or porous material.
The sealing members, including the composite sealing members such as are discussed above, may readily be formed by injection moulding. The body of the container may be formed separately by any suitable process;
blow moulding however will generally be preferred. The two components may then be supplied to the pharmaceuticals packager as a kit comprising separate sterile plastics containers and plastics sealing members and such kits are deemed to form a further aspect of the present invention. It will be appreciated that the sterile components of such kits will of course be packaged in sterile fashion; thus for example the sterile containers may be sterile wrapped individually or in bulk or they may each be provided with sterile seal over the neck portion, the seal being removed before the filling of the container.
Thus in this aspect the invention provides a kit comprising a package of sterile plastics containers and a package of plastics sealing members adapted to be friction welded to said containers to effect the sealing thereof.
In a still further aspect, the invention provides a method of packaging pharmaceuticals, said method comprising filling pharmaceuticals into a container through a hollow neck portion thereof and friction welding a plastics sealing member to said neck portion. In a still further aspect, the invention provides containers filled and sealed according to the method of the invention.
Especially in the case of large volume sterile fluid containers, it is not efficient to fill the containers through a port of the same cross-sectional area as would be required were the internal walls of the neck of the container at that port intended to be sufficiently close to grip the spike of a giving set. Thus, as mentioned above, conventional semi-rigid large volume containers have often had two ports, one of large area for filling and one of smaller cross-sectional area for extraction of the pharmaceutical.
In the containers of the present invention however, the need for an extra filling port may be obviated by providing the sealing member with a spike receiving means, e.g. a tubular member along which the spike may pass, the tubular member preferably extending from the central portion of the sealing member towards the container interior.
The spike receiving means should preferably be of an internal diameter comparable to or slightly smaller than the external diameter of the spike, i.e. such as to achieve a sealing and retaining engagement with the spike. The receiving means may if desired protrude out of the outer surface of the sealing member; preferably however it will have its sealed end flush with that outer surface. To give greater rigidity to the neck portion of the container, the walls of the receiving means may if desired engage closely or loosely with the inner walls of the neck portion. In this way the diameter of the filling aperture, the inner diameter of the neck portion may be made to be significantly larger than the diameter of the pharmaceuticals extraction aperture and thus the container may be filled and emptied efficiently through the same port.
Preferred embodiments of the present invention will now be described by way of example and with reference to the accompanying drawings, in which:-

Figure 1 is schematic cross-sectional view of an injection vial sealed in a conventional manner;
Figure 2 is a schematic cross-sectional view of a large volume sterile fluids bag sealed in a conventional manner;
Figure 3 is a schematic cross-sectional view of one embodiment of a pharmaceuticals container according to the present invention;
Figure 4 is a schematic cross-sectional view of another embodiment of a pharmaceuticals container according to the present invention; and
Figure 5 is a schematic cross-sectional view of a third embodiment of a pharmaceuticals container according the the present invention.

Referring to Figure 3, there is shown a pharmaceuticals container 1 according to the invention in the form of an injection vial. The plastics vial has a neck portion 2 closed by a plastics sealing member 15 which is friction welded to the neck portion.
To aid in the correct location of the sealing member on the neck portion, the abutting surfaces of each taper inwards or outwards towards the vial's interior.
The sealing member 15 has an essentially rigid outer ring portion 16 about a piercable centre portion 17. To assist in the friction welding procedure, the rim 18 of the neck portion and/or the ring portion 16 of the sealing member may be provided with projections or recesses 19 which may be engaged by the gripping means of the friction welding apparatus. The projections or recesses 19 are shown in Figure 3 in the upper and lower surfaces respectively of the ring and neck portions but they may if desired alternatively be in the side edges of the ring and neck portions.
The container is filled with pharmaceutical 7 through the neck portion 2, the sealing member 19 is placed over the neck portion and then it is pressed against and rotated relative to the neck portion in order that the two may be friction welded together. The pharmaceutical may be extracted from the container by passing a needle or spike through the relatively thin centre portion 17 of the sealing member.
An alternative sealing member is illustrated in Figure 4. In this embodiment, the sealing member 15 incorporates a resilient barrier member, a rubber disc 20, with plastics membranes 21, 22 above and below. The upper membrane 21 serves to provide a wipe clean surface which will show evidence of any tampering and the lower membrane 22 serves to reduce contact between the rubber disc 20 and the pharmaceutical 7.
In Figure 5 an alternative embodiment for the container of the invention is illustrated. Here the container 1 is in the form of a blow moulded large volume sterile fluids bag having a neck portion 2 sealed by friction welding to a plastics sealing member 15. The internal diameter of the neck portion is large to allow the pharmaceutical 7 to be filled into the container efficiently through the neck portion. To allow the sealing member to seal about and retain the spike of a giving set inserted through the thin centre portion 17 of the sealing member, the sealing member is provided with a tubular spike receiving passage 12 the internal diameter of which will suitably be the same as or very slightly smaller than the external diameter of the spike. In this way the same port can be used efficiently both for filling and for emptying the container.
In contrast to the containers of the invention, in Figures 1 and 2 there are shown conventional pharmaceuticals containers in the forms of an injection vial and a large volume sterile fluids container respectively.
Referring to Figure 1, the container 1, of glass or plastics, has a neck portion 2 closed by a rubber stopper 3 and sealed by an aluminium cap 4 the lower rim of which is crimped over the rim 5 of the neck portion creating a pressure seal between the neck portion and the stopper. The pharmaceutical 7 mav be extracted through a needle inserted through the rubber stopper.
In Figure 2, the container 1, which is of semi-rigid plastics, has a filling port 8 heat sealed along line 9 and a separate, pre-formed extraction port 10. The container is produced by placing the pre-formed extraction port in a mould and blow moulding the body of the container. The pre-formed port 10 comprises an injection moulded plastics collar 11 through which runs a spike receiving passage 12 which is sealed at one end by a plastics membrane 13 and at the other by a removable aluminium foil tab 14. The pharmaceutical 7 is filled into container through filling port 8 which is then heat sealed. The pharmaceutical is extracted by removing tab 14 and passing the spike of a giving set into passage 12, through membrane 13 and through the wall of the container.

Claims

1. A pharmaceuticals container (1) having a hollow neck portion (2) closed by a plastics sealing member (15) friction welded thereto.

2. A container as claimed in claim 1 wherein either or both of said neck portion (2) and said sealing member (15) is provided on an outer surface with engageable projections or recesses (19).

3. A container as claimed in either one of claims 1 and 2 wherein said neck portion (2) is integrally formed with a rigid container body portion.

4. A container as claimed in any one of claims 1 to 3 wherein the abutting surfaces of said neck portion and said sealing member are at least partially tapered.

5. A container as claimed in any one of claims 1 to 4 wherein said sealing member is provided with a spike receiving means (12).

6. A container as claimed in any one of claims 1 to 5 wherein a central portion of said sealing member comprises a plastics membrane (21,22).

7. A container as claimed in any one of claims 1 to 6 wherein a central portion of said sealing member comprises a resilient resealing barrier member (20).

8. A container as claimed in claims 6 and 7 wherein first and second said membranes (21, 22) are disposed over the surfaces of said barrier member (20) adjacent and remote from the interior of said container.

9. A container as claimed in any one of claims 1 to 8 containing sealed therein a pharmaceutical (7).

10. A kit comprising a package of sterile plastics containers and a package of plastics sealing members adapted to be friction welded to said containers to effect the sealing thereof.

11. A method of packaging pharmaceuticals, said method comprising filling pharmaceuticals into a container through a hollow neck portion thereof and friction welding a plastics sealing member to said neck portion.