Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial

#The present invention relates to heat-sealable caps for medicament vials for use where a sterile medicament must be maintained following temporary introduction of a needle or syringe through the cap, and to apparatus and methods for filling such vials.

#Medicaments such as vaccines are often stored in vials prior to use. Typically, the vials are filled with medicament, and then a cap is installed to seal the medicament in the vial. The cap is typically made of vulcanized rubber or similar resilient material that neither contaminates nor affects the contained medicament. One of the drawbacks associated with this type of filling procedure is that it is difficult to maintain the sterility of the cap during the assembly procedure. In addition, it is difficult to maintain the sterility of the vials and caps during transportation and storage prior to filling.

#In order to overcome this contamination risk, the present inventor has determined that it would be desirable to first assemble the cap to the vial, sterilize the assembled cap and vial, such as by irradiation, and then fill the assembled vial by inserting a needle or like injection member through the cap and introducing the medicament through the needle into the sterilized vial. One of the drawbacks associated with this approach, however, is that when the needle or like injection member is inserted through the cap and then withdrawn, it leaves a tiny hole in the cap. The material of the cap is resilient in order to reduce the diameter of the hole, and therefore the hole is usually small enough to keep the medicament from leaking out. However, the hole typically is not small enough to prevent air or other gases from passing through the hole and into the vial, and therefore such holes can allow the medicament to become contaminated or spoiled.

#Other advantages of the present invention will become readily apparent in view of the following detailed description and accompanying drawings.

#FIG. 1 is a somewhat schematic, partly exploded, cross-sectional view of a prior art end cap for a medicament vial.

#FIG. 2 is a cross-sectional, partly exploded view of a resealable cap embodying the present invention.

#As shown in FIG. 1, a prior art cap for a medicament vial is generally designated by the reference numeral 10. The cap 10 includes a vulcanized rubber base 12, which is slidably received within the open end of a vial 14. The vial 14 is made of glass or like material, and it defines a chamber 16 for receiving medicament. An aluminum locking ring 18 surrounds the periphery of the cap 12 and vial 14, and it is crimped in place to lockably connect and seal the cap to the vial.

#In operation, a hypodermic needle (not shown) is inserted through the vulcanized rubber base in order to deposit medicament within the chamber 16. Once the medicament has been deposited, the needle is withdrawn from the cap 10. Although the hole resulting from insertion of the needle will shrink somewhat from its maximum diameter due to the resiliency of the vulcanized rubber, the resultant hole is typically still large enough to pass gas or vapor and thereby compromise any preservative-free medicament contained within the chamber 16.

#Turning to FIG. 2, a heat-resealable cap embodying the present invention is indicated generally by the reference numeral 110. The cap 110 includes a resilient base 112 made of vulcanized rubber or like material which is known to those of ordinary skill in the pertinent art, and acceptable for use in the manufacture of end caps or the portions thereof placed in contact with, or otherwise exposed to medicaments, such as vaccines. The base 112 defines a lower peripheral wall 115 shaped and dimensioned to be slidably received within the open end of a vial 114. The vial 114 is made of glass or like material, and it defines a chamber 116 for receiving medicament. The base 112 of the cap 110 further defines an upper peripheral wall 117 also shaped and dimensioned to be slidably received within the open end of the vial 114, and a peripheral sealing flange 118 projecting outwardly from the upper end of the peripheral wall 117. The vial 114 is made of glass or other suitable material, and defines at its open end a peripheral flange 120. As shown slighty exploded in FIGS. 2 and 3, the peripheral flange 118 of the base 112 sealingly engages the peripheral flange 120 of the vial 114 to seal the interface between the cap and vial. The base 112 further defines an upper recess 122 formed within the upper peripheral wall 117, and an annular rim 124 projecting inwardly from the upper end of the peripheral wall.