[0001] This invention relates to a stopper for vials, and more particularly to a stopper
for sealing off a vial by a simplified procedure without necessitating the step of
crimping an aluminum cap.
[0002] So-called "flip-off caps" of aluminum are widely used for vials containing pharmaceutical
preparations, especially powders or the like for preparing injection solutions. Such
caps are costly since they are made of aluminum and, moreover, have the drawback of
requiring a cumbersome vial closing process because the aluminum cap must be fitted
to the vial by crimping after the vial has been sealed with a rubber plug pressed
against the flange of the vial.
[0003] According to the present invention these drawbacks are overcome by providing a stopper
for sealing off vials without using any aluminum material and also without resorting
to the cumbersome crimping step needed for aluminum caps.
[0004] Subject matter of this invention therefore is a stopper for a vial having a flange
at its opening portion, characterized by a rubber plug having a top plate fittable
to the flange in pressing contact therewith, a flexible inner cap for receiving the
rubber plug therein and an outer cap fittable over the inner cap, the inner cap having
an upper wall formed with a hole in its center and a side wall formed with at least
one projection on the inner peripheral surface thereof, the projection being fittable
to the lower face of the flange with the top plate of the rubber plug held between
the upper wall and the flange.
[0005] The subclaims 2 to 4 cover preferred embodiments of the stopper of the invention
as defined above and in claim 1.
[0006] A vial stopper embodying this invention will be described below with reference to
the accompanying drawings, in which:
Fig. 1 is a view in vertical section of an outer cap 1;
Fig. 2 is a bottom view of the same;
Fig. 3 is a view in vertical section of an inner cap 2;
Fig. 4 is a bottom view of the same;
Fig. 5 is a view in vertical section of a rubber plug 3;
Fig. 6 is a bottom view of the same';
Fig. 7 is a view in vertical section showing the stopper placed on the vial before
the sealing step; and
Fig. 8 is a view in vertical section showing the stopper after the sealing step.
[0007] The stopper of this invention comprises an outer cap 1, an inner cap 2 and a rubber
plug 3.
[0008] The outer cap 1 includes an upper wlal la and a side wall 1b integral therewith and
formed with a projection 4 on its inner peripheral surface. The projection 4 is engageable
with the outer periphery of the side wall 2b of the inner cap 2 to hold the outer
cap 1 thereon.
[0009] The inner cap 2 includes an upper wall 2a integral with the above-mentioned side
wall 2b. The upper wall 2a is formed in its center with a hole 5 for permitting an
injection needle to penetrate the rubber plug 3. Formed on the inner periheral surface
of the side wall 2b are two projections 6 which are fittable to the lower face of
the flange 11a of a vial 11 with the top plate 3a of the rubber plug 3 positioned
between the upper wall 2a and the flange 11a. Four projections 7 are provided on the
inner surface of the side wall 2b at its upper end for engaging the top plate 3a of
the rubber plug 3 to retain the plug 3 in the inner cap 2.
[0010] The rubber plug 3, which is a rubber stopper heretofore used for vials, comprises
the above-mentioned top plate 3a serving as a packing, and two legs 3b. Each of the
legs has on its outer surface a projection 8 engageable with the opening portion of
the vial 11.
[0011] The outer cap 1 and the inner cap 2 are made of a flexible plastic, which is preferably
polypropylene, polyethylene, polycarbonate or the like.
[0012] The projection 4 on the outer cap 1 and the projections 6 and 7 on the inner cap
2 are not limitative in their arrangement but can be provided as desired insofar as
they are serviceable as contemplated. For example, the projections 6 on the inner
cap 2 may be in the form of a continuous projection extending over the entire inner
periphery of the inner cap side wall 2b like the projection 4 on the outer cap 1,
or may be in the form of dots resembling the projections 7 on the inner cap 2.
[0013] The stopper of this invention will be used in the following manner, for example,
for a vial 11 for containing a freeze-dried preparation for injection.
[0014] . The inner cap 2 is fitted in the outer cap 1 in engagement with the projection
4, with the rubber plug 3 engaged with the projections 7 on the inner cap 2. The stopper-is
then placed on the vial 11 containing an aqueous solution S of the preparation so
that the projections 8 on the rubber plug 3 bear on the opening portion of the vial
11 as seen in Fig. 7. When the stopper is pressed against the vial after the solution
S has been freeze-dried to powder P, the projections 6 on the inner cap 2 strike the
upper edge of the flange 11a on the vial 11, thereby forcing the side wall 2b of the
inner cap 2 radially outward at its lower portion, and thereafter come into fitting
engagement with the lower face of the flange 11a , whereupon the inner cap side wall
2b restores itself. Thus the vial 11 containing the powder P is completely sealed
off as shown in Fig. 8.
[0015] The vial stopper of this invention, for which no aluminum material is used, can be
manufactured at a low cost. The stopper is easy to use since it seals off the vial
completely when simply pressed on. Because the sealing step can be performed subsequent
to freeze-drying within a freeze-drying chamber in a continuous operation, the stopper
is very useful for providing pharmaceutical products free from foreign matter and
having an extremely low water content and a high quality.
1. A stopper for a vial having a flange at its opening portion, characterized by a
rubber plug (3) having a top plate (3a) fittable to the flange (11a) in pressing contact
therewith, a flexible inner cap (2) for receiving the rubber plug (3) therein and
an outer cap (1) fittable over the inner cap (2), the inner cap (2) having an upper
wall (2a) formed with a hole (5) in its center and a side wall (2b) formed with at
least one projection (6) on the inner peripheral surface thereof, the projection (6)
being fittable to the lower face of the flange (11a) with the top plate (3a) of the
rubber plug (3) held between the upper wall (2a) and the flange (11a).
2. The stopper as defined in claim 1, characterized in that at least one projection
(7) engageable with the top plate (3a) of the rubber plug (3) is formed on the inner
surface of the inner cap side wall (2b) at its upper end.
3. The stopper as defined in claim 1 or 2, characterized in that the outer cap (1)
has a side wall (1b) provided on its inner peripheral surface with a projection (4)
engageable with the outer peripheral surface of the inner cap side wall (2b).
4. The stopper as defined in any one of claims 1 to 3, characterized in that the outer
cap (1) and the inner cap (2) are made of polypropylene, polyethylene or polycarbonate.