WO1997003790A1

WO1997003790A1 - Method and apparatus for applying two-piece closure to vial

Info

Publication number: WO1997003790A1
Application number: PCT/US1995/008881
Authority: WO
Inventors: Edward F. Vander Bush, Jr.; William E. Troutman
Original assignee: The West Company, Incorporated
Priority date: 1995-07-14
Filing date: 1995-07-14
Publication date: 1997-02-06
Also published as: AU3233495A

Abstract

Method and apparatus for applying a multi-piece closure (C), consisting of a sealing cap (Cc) and inner (Ci) and outer (Co) axially displaceable cover elements, over a rubber stopper (S) fitted in the discharge opening of a vial (B). The apparatus comprises a sealing head assembly including a plurality of jaws (J) and a pressure head (Bp). The vial is first positioned on a spring-biased pressure pad (P), with the multi-piece closure positioned loosely over the stopper. With the jaws in an open position, the pressure head is then lowered toward the vial, causing a cam surface (122) on the pressure head to contact outer ends (120) of the jaws such that the jaws surround and engage the outer cover element. Continued downward movement of the pressure head affects relative axial movement of the sealing cap and the inner and outer cover elements with respect to the stopper until the sealing cap and cover elements are fully seated about an upper lip (8) of the vial.

Description

METHOD AND APPARATUS FOR APPLYING TWO-PIECE CLOSURE TO VIAL

TECHNICAL FIELD

The present invention relates to method and apparatus for assembling multi-piece plastic closure assemblies to pharmaceuticals vials. BACKGROUND ART

Automatic assembly systems and apparatus for applying a variety of closures to vials or the like are not new per se. Typically injectable pharmaceuticals are packaged in a glass vial. The contents are sealed by a rubber stopper engagable in the discharge opening in the vial, the stopper having a diaphragm pierceable by a syringe to permit withdrawal of the medicament product. A typical closure assembly for holding the stopper tightly in place in the vial is shown in RAVN United States Patent No. 3,071 ,274 issued January 1 , 1963. This closure comprises an aluminum seal having a removable disk portion connected to the seal by fractionable bridges and a plastic button connected to the removable disk portion. The button may be removed which in turn separates the disk portion to expose the diaphragm of the stopper for assertion of the syringe. These closure assemblies are usually applied in a high speed automated operation wherein the aluminum seal is simply placed loosely over the rubber stopper and then the skirt portion of the seal is crimped or rolled under the bottle finish. These systems would not be suitable for applying multi piece plastic closures of the type illustrated and described herein.

DISCLOSURE OF THE INVENTION

The method and apparatus of the present invention are particularly adapted for application of a multi -piece plastic closure to a pharmaceutical vial.

To this end in accordance with the present invention, the method and system of the present invention consist of the steps of placing a vial or bottle on a resiliently biased base

pressure pad, engaging the closure and displacing a cap element of the closure axially downwardly and during the downward displacement pivoting a series of claw members inwardly to engage a skirt portion of another of the closure elements. This action produces relative axial displacement of the elements of the closure and a predetermined compression of the rubber stopper in the vial to a point where the closure is fully seated and wherein locking projections of an intermediate element of the closure engage under the bottle finish to fully seat the closure on the vial or bottle.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects of the present invention and the various features and details of the operation and construction thereof are hereinafter more fully set forth with reference to the accompanying drawings, wherein;

Fig. IA is an exploded side elevational view showing a two piece plastic closure before assembly to a vial for medicaments;

Fig. IB is a side elevational view showing the closure in a partially assembled position on the vial;

Fig. IC is a side elevational view of the closure in a fully seated or assembled position on the vial;

Fig. ID is a top plan view of the assembly shown in fig. IC;

Fig. 2 is an enlarged transverse fragmentary sectional view taken on lines 2-2 of

fig. IB; Fig. 3 is a side elevational view of apparatus in accordance with the present invention for assembling a two piece plastic closure to a pharmaceutical vial;

Fig. 4 is an enlarged bottom plan view taken on line 4-4 of Fig. 3 showing axial alignment ofthe vial and sealing head of the apparatus with the segmental retaining fingers in an open opposition;

Fig. 5 is an elevational view showing details of one of the four retaining fingers;

Fig. 6 is a plan view of the retaining fingers shown in fig. 5;

Fig. 7A is an enlarged fragmentary sectional elevational view of the detailed contained in the box of Fig. 3 with the sealing head in contact with the upper surface of the multi piece plastic closure during the first stage of a closure application cycle;

Fig. 7B is a view similar to Fig. 7 A showing the spring biased pressure block moved downwardly closing the retaining fingers into an engaging position with the outer skirt of the two piece closure in an intermediate stage of the closure application cycle;

Fig. 7C is a view similar to Figs. 7A and 7B in the final stage of the closure assembly cycle showing the sealing head and associated retaining fingers engaging the skirt permitting the pressure block to continue its downward motion snapping the two piece plastic closure together into a locking configuration;

Fig. 7D is a view similar to Figs. 7A - 7C inclusive showing the completion of the closure application cycle with the sealing head pivoted upwardly and away from the sealed vial to its preset rest position; and

Fig. 8 is an enlarged fragmentary sectional elevational view taken on lines 8-8 of Fig. IC showing the interlocking features of the two piece closure in a fully seated state on the vial.

BEST MODE FOR CARRYING OUT THE INVENTION

The system, method and apparatus of the present invention for sealing closures to vials or bottle B is particularly adapted for applying closures C of the type illustrated in the drawings. The closure C comprises a sealing cap consisting essentially of an inner cap element C_j, and an outer cap element C_Q and a cover element C_c.

Considering the details of the closure C more specifically, inner cap part (3) has an upper cover plate (6). Four (4) spring pins on fingers (7), one at each corner of an inscribed square, project at right angles, from the cover plate (6). The pins are molded as a single piece with the plate. At the free end of each of these spring pins (7), there is a retaining projection (8), which is bent inward to project beyond the inside surface of spring pin (7). In the closed position of sealing cap (1), retaining projections (8) of spring pins (7) grip behind or under a ring-shaped shoulder (9), facing away from sealing cap (1) of a ring-shaped bead (10) of vial B. The dimensions of spring pins (7) are calculated in such a way that, between cover plate (6) and the edge area of bottle B adjoining the opening in the bottle, there is room for an outward-projecting flange (11) of a stopper (12), which is designed as a sealing element with a cylindrical part (13), configured to allow the stopper to be pressed tightly into the bottle opening.

Outer cap part (4) of sealing cap (1) is designed essentially as a ring-shaped wall section. On the inside surface of the ring-shaped wall section of outer cap part (4), several locking projections (14), (15) are provided. To prevent spring pins (7) from being shifted radially outward, outer cap part (4) can be slid in such a way onto inner cap part (3) that, in the closed position shown in Figure 8, locking projections (14), (15) are situated at the free ends of spring pins (7).

In the released starting position shown by way of example in Fig. 2, inner cap part

(3) has an inside diameter which is approximately the same as the outside diameter of ring- shaped bead (10) of bottle B. In this released starting position, inner cap part (3) can be set with little or no resistance onto the opening of the bottle. A latching projection (16) is provided on the outside surface of each spring pin (7) (see Fig. 2). Each of these projections has a flank (17) oriented toward the cover part. Each flank is at approximately a right angle to the longitudinal axis of spring pin (7). Opposite flank (18) of each latching projection (16) slants inward and down toward the free end of associated spring pin (7). Each spring pin (7) is assigned its own locking projection (14), the width of which is approximately the same as that of spring pin (7). Flank (19), oriented toward cover part, of each of these locking projections (14) slants inward toward bottle B, whereas opposite flank (20) is at approximately a right angle to the longitudinal axis of outer cap part (4).

As described above, each of the spring fingers (7) has a outwardly directed latching projection (16) spaced upwardly from the retaining projection (8). The inner peripheral surface of the outer cap element C₀ is provided with a series of circumferentially spaced latching ribs (22). In the presence instance, there are two rows of latching ribs (22) which are axially spaced. The latching projection (16) engage the first series of latching ribs

(22a) when the closure assembly is initially placed over the stopper and vial as shown in Fig. 2. It is noted that the parts are in this position when the closure assembly is initially put together before application to a stopper and vial assembly. During the assembly process, when the inner cap element C_j and outer cap element C₀ are activated axially relative to one another, the spring fingers are displaced downwardly so that the latching projections engage the second series of latching ribs (22b) as shown in Figs. 7c and 8.

Considering now the system, method and apparatus of the present invention in broad terms and with reference to the basic components thereof, vials or bottle B are placed on a pressure pad P at a vial sealing station which includes a sealing head H, a

pressure block B and jaws J. The parts are shown in Fig. 7a. in a pre-sealing mode with

the pressure block B in a (recessed) position and the jaws J open and the partially assembled closure C seated loosely over the rubber stopper or seal S engaging in the discharge end of the vial B. In this position, as the pressure block Bp is moved downwardly, the jaws J close to embrace the skirt portion C₀ of the closure C and the pressure block B starts exerting a downward force to displace the vial B on the pressure pad or platen P (see Fig. 7B). Continued downward displacement of the pressure block B as shown in Fig. 7C, causes axial displacement of the cap members Ci and C₀ relative to one another to a fully seated or locked position wherein the locking projection (8) of the intermediate cap portion engage under the bottle finish and the cap is fully seated to and compresses the stopper S in a sealed condition. This assembled relation is best shown in Fig. 8. The pressure pad P is resiliently biased to permit displacement of the vial B during the assembly operation described and ensure balancing of the forces in the system in such a way, that undue forces do not cause bottle or vial breakage. The present invention provides a system, apparatus and method automatically assembling two piece plastic closures of the type described above to the vials. The apparatus comprises a base (40) on which vials are placed with a closure in a partially

assembled condition as shown in Fig. IB and a sealing head generally designated by the numeral (42) above the base having a plurality of jaw members or claws which are normally biased to an extended open position as shown in Fig. 7A. The jaws are pivotly mounted on a pivot ring (43) forming part of the head assembly H and are normally biased to an extended or open position by the cam surface (45) of the pressure block B .

Considering now more specifically the structural details, arrangement and operation of the closure assembly apparatus of the present invention and with particular reference to figs. 3-6 inclusive, the apparatus comprises a base, (50) having a deck (40) and a movable platform (62) for permitting displacement of the vial during a closure application cycle, a column (64) extending upwardly from the base at one side thereof and a sealing head assembly (66) slidably mounted on the column. The sealing head assembly (66) is adjustable vertically on the column (64) by means including a jack screw (68) cooperatively engaging through a follower (70) forming part of the sealing head assembly operatively connecting the sealing head assembly (42) for vertical adjustment. Turning the hand wheel (72) in one direction raises the sealing head assembly (42) and turning it in the opposite direction lowers it. The sealing head assembly (42) may be securely fixed in a desired adjusted position by means of a hand clamp locking handle, generally designated by the numeral (74). The base (50) has an indexing block (51) having a V-Shape cut out (53) to locate the vial B in a proper position at the closure sealing station on the pressure pad P.

The sealing head (66) is actuatable in the manner described above to cycle the jaws J by means of a handle (78) which as illustrated in fig. 3 is pivotally mounted to the sealing head housing (80) by a stub shaft (82) which carries a cam actuator (84) operatively engagable with the pressure block actuating shaft (86) (see Fig. 7 A) normally biased by a spring (88) to an upper or raised position.

The specific details and arrangement of the sealing head are best shown in Figs.

7A-7C inclusive. The sealing head housing includes an internally threaded adapter portion (90) to accommodate sealing heads for different sized vials and closures. The sealing head assembly includes a closure head (92) threadedly received in the adapter (90) having a hollow chamber (94) for a shaft (86) and compression spring (88). The lower face of the base has a cylindrical undercut (100) within which the pressure B block seats as shown in fig. 7A. A cap like support cover (102) depends from the lower end of the base (92) defining a circumferentially extending support a cover for jaw pivot ring (43). In the present instance, there are four jaws J and a garter spring (116) circumscribes the jaws at their inner ends to normally pivot them outwardly as shown in fig. 7A and hold the inner ends of the jaws against the cam surface (45). The cam surface (45) and pivot ring (100) are cooperatively associated to control pivotal movement of the jaws in the manner shown in Figs. 7A-7C inclusive. The pivot ring engages a shoulder (120) formed by the enlarged inner terminal ends of the jaws members on which the garter spring seats. Consider now a typical cycle for applying a closure C of the type describe here above to the vial B having a conventional rubber stopper S engaging in the open end thereof. The vial stopper and closure cap are positioned on the pressure pad (62) of the apparatus in the manner shown in fig. 7 A and the sealing head handle (78) is then pivoted downwardly to position the pressure block over the inner element of the closure. Initially the claws J are in a outwardly pivoted opened position, the coil spring (116) pressing the inner ends of the claws J against the intermediate portion (122) of the pressure block cam surface (45). In this position continued downward pressure on the sealing head handle (78) rotates stubshaft (82) to press cam (84) against the free end of spring biased lever (124) which rest against the upper surface of shaft (86) then against the bias of coil spring (88) to move pressure block B downwardly as shown in fig. 7B. During downward movement of the pressure block, the inner ends of the claws J are displaced radially outwardly by engaging upper cam portion of cam surface (45) to pivot free ends inwardly to embrace the outer sleeve of the closure C₀. The inner ends of the claws then ride on the upper generally cylindrical portion of the cam surface (45) during continued downward displacement of the pressure block which in the later stages effects axial displacement of the inner and outer cap elements C_j and C₀ to a fully seated position. During displacement of the various components in the manner described, the vial displaces the pressure pad P, downwardly against the bias of the pressure pad support spring (126) to prevent damage to the vial during nesting of the closure elements in the manner described. Considering aspects of the cycle described above more specifically, the jaws J embrace the outer closure C₀ in the manner shown in Figs. 7B and 7C and thus support the outer closure C₀ from downward movement during the latter stages of the application cycle. It is noted that in the process step between Figs. 7B and 7C, there is a lost motion due to the compression of the stoppers. In this regard, the closure C is designed to produce a predetermined specific stopper compression. Accordingly, during the initial downward application of pressure through the pressure head, the closure-bottle assembly is displaced a distance Δ X and the X displacement in Fig. 7C is the additional

displacement to lock the closure C under the bottle finish. However, the total downward displacement is not the sum of Δ X and X but only X, the Δ X or lost motion being the actual compression of the stopper. At the completion of the cycle described and as shown in Fig. 7C, the operator simply releases the handle (78) whereby the pressure head assembly pivots upwardly and the spring (126) raises the platen P to its home or elevated position aligned with the table of the base. Note that the jaws J automatically return to their open position for the next closure applying cycle.

Even though particular embodiments of the present invention have been illustrated and described herein, it is not intended to limit the invention, and changes and modifications may be made therein within the scope of the following claims.

Claims

CLAIMSWhat is claimed is:

1. System for applying a closure consisting of a cover element and inner and outer axially displaceable cap element to seal a stopper made of an elastomeric material in the discharge opening of a vial or bottle under pressure consisting of the steps of positioning the vial on a spring biased pressure pad, with the multi -piece closure positioned loosely over the stopper engaging the cover element with a sealing head assembly which includes a plurality of jaws initially in an open position in surrounding relation to the closure actuating the sealing head downwardly whereby the claws are displaced inwardly whereby continued downward displacement effects relative axial movement of the cover element and inner and outer cap elements to a fully seated position engaging under the finish on the vial.

2. Apparatus for applying a closure consisting of a cover element and inner and outer axially displaceable cap elements to seal a stopper made of a elastomeric material over the discharge opening in a vial or bottle comprising a spring biased pressure pad and a pivotly mounted sealing head overlying the pressure pad, the sealing head including a series of pivotly mounted jaw members and a pressure block engagable with the cover element of the closure, a means for actuating said pressure block downwardly relative to the spring biased pressure pad or by the jaws pivot inwardly to displace the inner and outer cap elements relative to one another to a seated or sealed position, said pressure pad providing a yielding movable seat for the assembly during the closure applying cycle.