CA2091020C - Stopper for reduction of particulate matter - Google Patents
Stopper for reduction of particulate matter Download PDFInfo
- Publication number
- CA2091020C CA2091020C CA002091020A CA2091020A CA2091020C CA 2091020 C CA2091020 C CA 2091020C CA 002091020 A CA002091020 A CA 002091020A CA 2091020 A CA2091020 A CA 2091020A CA 2091020 C CA2091020 C CA 2091020C
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- CA
- Canada
- Prior art keywords
- stopper
- abrasion resistant
- spike
- fluid
- head portion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
Abstract
Disclosed is a stopper for a medical vial suitable for piercings by a spire without producing unacceptable amounts of particulate matter, comprising: a stopper body of an elastomeric material; and an abrasion resistant coating covering the top surface of said stopper.
Description
II~~~~I) ~~h~~, F~I~ ~ ITC,°1'I4t'~
IDF FI~LTIC~.1~~T~ lI~TTEI3, C:E~GII,OO~ TIC I1~T~~TT'i~1~T
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1 0 This invention relates to a stopper for a container and, more particularly, to an improved stopper for a container of parentexal solutions which is suitable for infusion spike penetration without producing unacceptable .amounts of particulate matter.
IDF FI~LTIC~.1~~T~ lI~TTEI3, C:E~GII,OO~ TIC I1~T~~TT'i~1~T
r . held a~f tip Inveaati~a~
1 0 This invention relates to a stopper for a container and, more particularly, to an improved stopper for a container of parentexal solutions which is suitable for infusion spike penetration without producing unacceptable .amounts of particulate matter.
2. Reported I~velopmea~
Stopper systems for vials, bottles and the like are made of materials that are resistant to chemicals and pharmaceuticals such as 2 Q corrosive materials, reagents, parenteral solutions and solid formulations reconstitutable with a solvent prior to use. The most commonly used stopper system for such products has been glass or plastic bottles and vials eguipped with rubber stoppers made of elastomeric materials. The system appears to provide for good 2 5 hermetical seal, safe stoxage and easy access to the content through the elastomeric stopper via the use of an infusion spike when withdrawal of the content is desired. The elastomeric stopper used comprises an elastomeric base; such as natural or synthetic rubber and an inert coating covering at least some portions of the stopper. The coating used 3 0 heretofor includes chlorobutyl rubber, polymeric fluorocarbon resins such as polytetrafluoroethylene (TEFLON) and various thermoplastic films. The coating is intended to insulate the elastomeric stopper base from the content of the container in order to prevent contact and possible chemical reactions therebetween.
One of the major concerns in all products, and especially pharmaceutical parenteral products, is the generation of particulate *Trade-mark ~~~.~~0 foreign matter which may contaminate such products. In order to eliminate macroscopic and microscopic particulates, elaborate measures have been taken to remove them, such as filtration of the product and special washing and drying of the stopper system components. These steps help assure that the products meet the requirements and guidelines of the pharmaceutical industry, such as compendia guidelines, when the products reach the point of use.
However, at the point of use, such as in the case of a parenteral product, new particulate matter is frequently generated by the practitioner when 1 0 the stopper is penetrated by a needle or spike of an infusion set ox an infusion spike. During such penetration a combination of elastic and plastic deformation of the stopper target area increases the stopper contact surface with the infusion spike as it is pressed into the stopper.
Typically, untreated elastomeric stoppers offer a high degree of 1 5 resistance against the exterior surface of the spike as the spike is being pushed into the penetration area. Most frequently, when stopper fragments axe generated, they are the result of the elastomeric por tion of the stopper being abraded off the upper surface of the stopper as it conforms to the shape of,the penetrating spike. The fragments are then 2 0 transported into the interior of the vial as the spike rolls and drags the fragments during penetration.
In addition to the problem of particulate matter produced and carried into the vial during the spiking procedure, there are two other, 2 5 although less frequently occurring, anomalies: stopper push-through into the vial and spike blow-out caused by residual elastic tension of the stopper against the spike which urges the spike outward.
The most common solution to these problems has been the 3 0 application of silicone lubricant to the stopper and/or the spike to reduce the frictional drag between the stopper and the spike. While silicone does reduce particle generation from the spiking procedure, it also increases the risk of product contamination from its own composition.
Another approach proposed in the prior art to reduce the tendency of the stopper to generate particulate matter during manufacturing and storage is to coat the elastomeric core of the stopper with a thermoplastic film on the fluid contacting side thereof. We have found, however, that the use of such construction is less than satisfactory to solve the problem.
The present invention addresses the need to eliminate or at least greatly reduce the particle generation from surface erosion of the 1 0 stopper during spike penetration. In addition, the invention reduces the risk of the push-through and blow-out tendency by minimizing frictional drag and residual elastic tension during spike penetration. These advantages are achieved without the use of a lubricant, such as silicone oil, which could contaminate the product contained in the vial or bottle.
1~
Stopper systems for vials, bottles and the like are made of materials that are resistant to chemicals and pharmaceuticals such as 2 Q corrosive materials, reagents, parenteral solutions and solid formulations reconstitutable with a solvent prior to use. The most commonly used stopper system for such products has been glass or plastic bottles and vials eguipped with rubber stoppers made of elastomeric materials. The system appears to provide for good 2 5 hermetical seal, safe stoxage and easy access to the content through the elastomeric stopper via the use of an infusion spike when withdrawal of the content is desired. The elastomeric stopper used comprises an elastomeric base; such as natural or synthetic rubber and an inert coating covering at least some portions of the stopper. The coating used 3 0 heretofor includes chlorobutyl rubber, polymeric fluorocarbon resins such as polytetrafluoroethylene (TEFLON) and various thermoplastic films. The coating is intended to insulate the elastomeric stopper base from the content of the container in order to prevent contact and possible chemical reactions therebetween.
One of the major concerns in all products, and especially pharmaceutical parenteral products, is the generation of particulate *Trade-mark ~~~.~~0 foreign matter which may contaminate such products. In order to eliminate macroscopic and microscopic particulates, elaborate measures have been taken to remove them, such as filtration of the product and special washing and drying of the stopper system components. These steps help assure that the products meet the requirements and guidelines of the pharmaceutical industry, such as compendia guidelines, when the products reach the point of use.
However, at the point of use, such as in the case of a parenteral product, new particulate matter is frequently generated by the practitioner when 1 0 the stopper is penetrated by a needle or spike of an infusion set ox an infusion spike. During such penetration a combination of elastic and plastic deformation of the stopper target area increases the stopper contact surface with the infusion spike as it is pressed into the stopper.
Typically, untreated elastomeric stoppers offer a high degree of 1 5 resistance against the exterior surface of the spike as the spike is being pushed into the penetration area. Most frequently, when stopper fragments axe generated, they are the result of the elastomeric por tion of the stopper being abraded off the upper surface of the stopper as it conforms to the shape of,the penetrating spike. The fragments are then 2 0 transported into the interior of the vial as the spike rolls and drags the fragments during penetration.
In addition to the problem of particulate matter produced and carried into the vial during the spiking procedure, there are two other, 2 5 although less frequently occurring, anomalies: stopper push-through into the vial and spike blow-out caused by residual elastic tension of the stopper against the spike which urges the spike outward.
The most common solution to these problems has been the 3 0 application of silicone lubricant to the stopper and/or the spike to reduce the frictional drag between the stopper and the spike. While silicone does reduce particle generation from the spiking procedure, it also increases the risk of product contamination from its own composition.
Another approach proposed in the prior art to reduce the tendency of the stopper to generate particulate matter during manufacturing and storage is to coat the elastomeric core of the stopper with a thermoplastic film on the fluid contacting side thereof. We have found, however, that the use of such construction is less than satisfactory to solve the problem.
The present invention addresses the need to eliminate or at least greatly reduce the particle generation from surface erosion of the 1 0 stopper during spike penetration. In addition, the invention reduces the risk of the push-through and blow-out tendency by minimizing frictional drag and residual elastic tension during spike penetration. These advantages are achieved without the use of a lubricant, such as silicone oil, which could contaminate the product contained in the vial or bottle.
1~
SU1~ARY OF THE INVENTION
We have surprisingly found that if a non-reactive, inert, abrasion resistant coating is applied to the upper surface of an elastomeric stopper where spike penetration will take place, particle generation during spiking is all but eliminated and the tendency of push-through as well as blow-out of the spike is greatly reduced.
Accordingly, in its broadest aspect, this invention provides a stopper for medical vials which is highly resistant to abrasion and formation of particulate materials upon spike penetration, comprising:
a stopper body of an elastomeric material having a cylindrical shape and top surface; and an abrasion resistant coating to prevent generation of particles upon spike penetration of the stopper when withdrawal of fluid is desired.
In use, the coating on the top surface of the stopper conforms to the deformation of the stopper caused by the spike penetration procedure. It appears that, upon piercing, the spike is not in contact with the elastomeric stopper body but only with the abrasion resistant coating thereby circumventing abrasion and eliminating the formation of elastomeric particulate materials.
One preferred embodiment of the invention provides an abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprises a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, where the leg portion is to be inserted into the medical vial to hermetically seal the 4a fluid therein, the head portion having a fluid-contacting bottom surface and a top surface having a central pierceable portion, the central portion having a spike-receiving surface, wherein:
the spike-receiving surface is coated with an abrasion resistant film which conforms to edges of a hole created by an infusion spike upon the spike piercing the stopper and provides a barrier between the spike and elastomeric material, thereby preventing mechanical contact between the spike and the elastomeric material and consequent generation of elastomeric particles by abrasion;
and the abrasion-resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, copolymer of vinyl chloride and vinylidine chloride, polymethylene oxide, polyphenylene oxide, polyphenylene sulfone, polyethylene terphthalate, polycarbonate, copolyesters and polycaprolactam.
Another preferred embodiment of the invention provides an abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprises:
a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein, and the head portion comprises a fluid-contacting bottom surface and a top surface having a central spike pierceable portion; and 4b an abrasion resistant film coated on the central pierceable portion of the top surface of the head portion, wherein:
the abrasion resistant film conforms to edges of a hole created by deformation of the stopper body;
the spike gets in contact with only the abrasion resistant film to prevent generation of particles of the elastomeric material upon piercing of the stopper by the spike; and the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
Still another preferred embodiment of the invention provides an abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprising:
[A] a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein:
the elastomeric material is a fluid impervious, resilient and inert material free of additives leachable to the fluid;
4c the head portion comprises a top surface and a circular flange to cover a corresponding planar circular mouth portion of the medical vial; and the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein and has a recess extending from its bottom upward toward the top surface of the head portion such that a thin central pierceable portion is formed in the head portion, and [B] an abrasion resistant film having a thickness of 0.02 to 0.5 mm coated on the top surface of the head portion, wherein:
the abrasion resistant coating covers the thin central pierceable portion of the head portion;
when piercing the thin central pierceable portion of the head portion by the infusion spike, the abrasion resistant film conforms to a deformation of the stopper body and the spike is in contact only with the abrasion resistant coating, thereby preventing generation of particles from the elastomeric stopper body;
the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
We have surprisingly found that if a non-reactive, inert, abrasion resistant coating is applied to the upper surface of an elastomeric stopper where spike penetration will take place, particle generation during spiking is all but eliminated and the tendency of push-through as well as blow-out of the spike is greatly reduced.
Accordingly, in its broadest aspect, this invention provides a stopper for medical vials which is highly resistant to abrasion and formation of particulate materials upon spike penetration, comprising:
a stopper body of an elastomeric material having a cylindrical shape and top surface; and an abrasion resistant coating to prevent generation of particles upon spike penetration of the stopper when withdrawal of fluid is desired.
In use, the coating on the top surface of the stopper conforms to the deformation of the stopper caused by the spike penetration procedure. It appears that, upon piercing, the spike is not in contact with the elastomeric stopper body but only with the abrasion resistant coating thereby circumventing abrasion and eliminating the formation of elastomeric particulate materials.
One preferred embodiment of the invention provides an abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprises a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, where the leg portion is to be inserted into the medical vial to hermetically seal the 4a fluid therein, the head portion having a fluid-contacting bottom surface and a top surface having a central pierceable portion, the central portion having a spike-receiving surface, wherein:
the spike-receiving surface is coated with an abrasion resistant film which conforms to edges of a hole created by an infusion spike upon the spike piercing the stopper and provides a barrier between the spike and elastomeric material, thereby preventing mechanical contact between the spike and the elastomeric material and consequent generation of elastomeric particles by abrasion;
and the abrasion-resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, copolymer of vinyl chloride and vinylidine chloride, polymethylene oxide, polyphenylene oxide, polyphenylene sulfone, polyethylene terphthalate, polycarbonate, copolyesters and polycaprolactam.
Another preferred embodiment of the invention provides an abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprises:
a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein, and the head portion comprises a fluid-contacting bottom surface and a top surface having a central spike pierceable portion; and 4b an abrasion resistant film coated on the central pierceable portion of the top surface of the head portion, wherein:
the abrasion resistant film conforms to edges of a hole created by deformation of the stopper body;
the spike gets in contact with only the abrasion resistant film to prevent generation of particles of the elastomeric material upon piercing of the stopper by the spike; and the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
Still another preferred embodiment of the invention provides an abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprising:
[A] a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein:
the elastomeric material is a fluid impervious, resilient and inert material free of additives leachable to the fluid;
4c the head portion comprises a top surface and a circular flange to cover a corresponding planar circular mouth portion of the medical vial; and the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein and has a recess extending from its bottom upward toward the top surface of the head portion such that a thin central pierceable portion is formed in the head portion, and [B] an abrasion resistant film having a thickness of 0.02 to 0.5 mm coated on the top surface of the head portion, wherein:
the abrasion resistant coating covers the thin central pierceable portion of the head portion;
when piercing the thin central pierceable portion of the head portion by the infusion spike, the abrasion resistant film conforms to a deformation of the stopper body and the spike is in contact only with the abrasion resistant coating, thereby preventing generation of particles from the elastomeric stopper body;
the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
TF~' Fsr-i ~F . DRA'(''_.~
FIG. 1 is a perspective view of one embodiment of the stopper of the present invention;
FIG. 2 is a plan view of the stopper shown in FIG. 1;
FIG. 3 is a cross sectional view of the stopper shown in FIG. 2 taken along the line a - a;
FIG. 4 is a perspective view of another embodiment of the stopper of the present invention;
FIG. 5 is a plan view of the stopper shown in FIG.4;
FIG. 6 is a cross sectional view of the stopper shown in FIG. 2 taken along the line b - b; and FIG. ? is a cross section of a vial containing an injectable liquid 2 0 closed with the stopper of the present invention.
2 5 Referring to FIGS: 1, 2 and 3, numeral 10 shows one embodiment of the stopper of the present invention comprising: a head portion 20 and a leg portion 30. Head portion 20 comprises a flmge 22 which is adapted to cover a corresponding planar, circular mouth portion of a medical vial, while leg portion 30 is adapted for insertion into the neck of the vial 3 0 to tightly seal the content therein. Numeral ~0 shows an abrasion resistant hlm mounted on the center part of the head portion 20 which serves as the piercing area for insertion and withdrawal of a spike or hypodermic needle.
3 5 Referring to FIGS. 4, 5 and 6, numeral 10' shows another embodiment of the stopper of the present invention comprising: a head portion 20' and a leg portion 30'. Head portion 20' comprises a flange 22' which is adapted to cover a corresponding planar, circular mouth portion of a medical vial, while leg portion 30' is adapted for insertion into the neck of the vial to tightly seal the content therein. Numeral 40' shows an abrasion resistant film mounted on the top part of the head portion 20'. In this embodiment recess 32' extends toward the top surface of the head portion 20' forming a thin portion 34' in head portion 20' for facilitating piercing of the stopper by a spike.
FIG. ? illustrates a stopper 10 having an abrasion resistant film 40 covering vial 1. Vial 1 containing an injectable fluid 5 is sealed by stopper (10 or 10') by inserting leg portion 30 of the stopper into the neck 7 1 0 of the vial 1. Flange portion 22 of head portion 20 tightly seals the mouth ~ of vial 1. A thin metal foil 9 is crimped over head portion 20 and flange portion 22 of stopper (10 or 10') to tightly seal and securely hold the stopper in vial 1.
14!Iatgrials c~f Cuxiataraxcta~n The elastomeric material of the stopper body must be a fluid impervious, resilient, and inert material without teachable additives 2. 0 therein in order to prevent any alteration of the product contained in the vial. It rnay be of a single component or a blend of components.
Examples of materials include synthetic or natural rubber, such as butyl rubber, isoprene rubber, butadiene rubber, silicone rubber, halogenated rubber, ethylene propylene therpolymer and the like.
2 S Specific examples of a synthetic elastomeric rubber include the CT32CF2-C~Fs(CgF5I3) and the C2F4-C~F~OCF3 series of elastomers made by duPont under the trade marks VITON~' and CARLEZ~'; the fluoro-silicone rubbers, such as those made by Dow Corning under the ~'ademark SILASTIC~' ~ and polyisobutylenes, such as VTSTANEX'~ MML-100 and 3 0 MML-140; and halogenated butyl rubber, such as CI-TLOROBUTYI~*108F, made by Exxon Chemical Company.
These or other suitable elastomers may be made into the desired stopper configuration by known methods. Such methods conventionally *Trac~e-mark include the use of a curing agent, a stabilizer and a filler and comprise a primary and secondary curing step at elevated temperatures.
The abrasion resistant coating for covering the top portion of the stopper, but at least the center, pierceable portion thereof, may be: a polyolefin, such polypropylene and polymethylpentene; a polyvinyl, such as polystyrene, polyvinyl acetate (PVA), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), a copolymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene and polytetrafluoroethylene (TEFLON); an ether, such as polymethylene oxide, polyphenylene oxide and polyphenylene sulphone; an ester, such as polyethylene terephthalate (PET), polycarbonate and copolyesters; an amide, such as polycaprolactam (Nylon 6), polyhexamethylene adipamide (Nylon 66) and polyundecanoamide (Nylon 11). In certain embodiments, the top portion of the stopper has a region which surrounds the center pierceable portion and is not coated.
The abrasion resistant coating covering at least the center, pierceable portion of the top surface of the stopper is preferably polytetrafluoroethylene sold under the trade mark TEFLON by duPont. The coating thickness will be in the range of about 0.002 to 1.0 mm, and preferably about 0.02 to 0.5 mm. The coating may be applied or bonded to the stopper body in any suitable manner known in the art, such as, but not limited to, by the use of adhesives, solvents, spray applications, radio waves, infrared, microwaves, ultrasonics and heat.
The stopper of the present invention comprising an elastomeric material and a TEFLON coating on the top center 7a portion thereof was tested against another stopper of the same elastomeric material but without the TEFLON coating thereon.
The vials were capped with the stoppers. Each stopper was pierced with a spike and then the spike was removed. The vials were examined for the presence of elastomeric particles caused by the piercing. The result of the spiking is shown in Table 1.
l~Ieau i~ln. ~f ~ P' °ch Present Invention 25 . 0.6 Elastomeric (Control) 25 15.4 i 0 The present invention has been described in connection with the preferred embodiments shown in the drawings, it is to be noted, however, that various changes and modifications are apparent to those skilled in the art.
i5
FIG. 1 is a perspective view of one embodiment of the stopper of the present invention;
FIG. 2 is a plan view of the stopper shown in FIG. 1;
FIG. 3 is a cross sectional view of the stopper shown in FIG. 2 taken along the line a - a;
FIG. 4 is a perspective view of another embodiment of the stopper of the present invention;
FIG. 5 is a plan view of the stopper shown in FIG.4;
FIG. 6 is a cross sectional view of the stopper shown in FIG. 2 taken along the line b - b; and FIG. ? is a cross section of a vial containing an injectable liquid 2 0 closed with the stopper of the present invention.
2 5 Referring to FIGS: 1, 2 and 3, numeral 10 shows one embodiment of the stopper of the present invention comprising: a head portion 20 and a leg portion 30. Head portion 20 comprises a flmge 22 which is adapted to cover a corresponding planar, circular mouth portion of a medical vial, while leg portion 30 is adapted for insertion into the neck of the vial 3 0 to tightly seal the content therein. Numeral ~0 shows an abrasion resistant hlm mounted on the center part of the head portion 20 which serves as the piercing area for insertion and withdrawal of a spike or hypodermic needle.
3 5 Referring to FIGS. 4, 5 and 6, numeral 10' shows another embodiment of the stopper of the present invention comprising: a head portion 20' and a leg portion 30'. Head portion 20' comprises a flange 22' which is adapted to cover a corresponding planar, circular mouth portion of a medical vial, while leg portion 30' is adapted for insertion into the neck of the vial to tightly seal the content therein. Numeral 40' shows an abrasion resistant film mounted on the top part of the head portion 20'. In this embodiment recess 32' extends toward the top surface of the head portion 20' forming a thin portion 34' in head portion 20' for facilitating piercing of the stopper by a spike.
FIG. ? illustrates a stopper 10 having an abrasion resistant film 40 covering vial 1. Vial 1 containing an injectable fluid 5 is sealed by stopper (10 or 10') by inserting leg portion 30 of the stopper into the neck 7 1 0 of the vial 1. Flange portion 22 of head portion 20 tightly seals the mouth ~ of vial 1. A thin metal foil 9 is crimped over head portion 20 and flange portion 22 of stopper (10 or 10') to tightly seal and securely hold the stopper in vial 1.
14!Iatgrials c~f Cuxiataraxcta~n The elastomeric material of the stopper body must be a fluid impervious, resilient, and inert material without teachable additives 2. 0 therein in order to prevent any alteration of the product contained in the vial. It rnay be of a single component or a blend of components.
Examples of materials include synthetic or natural rubber, such as butyl rubber, isoprene rubber, butadiene rubber, silicone rubber, halogenated rubber, ethylene propylene therpolymer and the like.
2 S Specific examples of a synthetic elastomeric rubber include the CT32CF2-C~Fs(CgF5I3) and the C2F4-C~F~OCF3 series of elastomers made by duPont under the trade marks VITON~' and CARLEZ~'; the fluoro-silicone rubbers, such as those made by Dow Corning under the ~'ademark SILASTIC~' ~ and polyisobutylenes, such as VTSTANEX'~ MML-100 and 3 0 MML-140; and halogenated butyl rubber, such as CI-TLOROBUTYI~*108F, made by Exxon Chemical Company.
These or other suitable elastomers may be made into the desired stopper configuration by known methods. Such methods conventionally *Trac~e-mark include the use of a curing agent, a stabilizer and a filler and comprise a primary and secondary curing step at elevated temperatures.
The abrasion resistant coating for covering the top portion of the stopper, but at least the center, pierceable portion thereof, may be: a polyolefin, such polypropylene and polymethylpentene; a polyvinyl, such as polystyrene, polyvinyl acetate (PVA), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), a copolymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene and polytetrafluoroethylene (TEFLON); an ether, such as polymethylene oxide, polyphenylene oxide and polyphenylene sulphone; an ester, such as polyethylene terephthalate (PET), polycarbonate and copolyesters; an amide, such as polycaprolactam (Nylon 6), polyhexamethylene adipamide (Nylon 66) and polyundecanoamide (Nylon 11). In certain embodiments, the top portion of the stopper has a region which surrounds the center pierceable portion and is not coated.
The abrasion resistant coating covering at least the center, pierceable portion of the top surface of the stopper is preferably polytetrafluoroethylene sold under the trade mark TEFLON by duPont. The coating thickness will be in the range of about 0.002 to 1.0 mm, and preferably about 0.02 to 0.5 mm. The coating may be applied or bonded to the stopper body in any suitable manner known in the art, such as, but not limited to, by the use of adhesives, solvents, spray applications, radio waves, infrared, microwaves, ultrasonics and heat.
The stopper of the present invention comprising an elastomeric material and a TEFLON coating on the top center 7a portion thereof was tested against another stopper of the same elastomeric material but without the TEFLON coating thereon.
The vials were capped with the stoppers. Each stopper was pierced with a spike and then the spike was removed. The vials were examined for the presence of elastomeric particles caused by the piercing. The result of the spiking is shown in Table 1.
l~Ieau i~ln. ~f ~ P' °ch Present Invention 25 . 0.6 Elastomeric (Control) 25 15.4 i 0 The present invention has been described in connection with the preferred embodiments shown in the drawings, it is to be noted, however, that various changes and modifications are apparent to those skilled in the art.
i5
Claims (6)
1. An abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprises a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, where the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein, the head portion having a fluid-contacting bottom surface and a top surface having a central pierceable portion, the central portion having a spike-receiving surface, wherein:
the spike-receiving surface is coated with an abrasion resistant film which conforms to edges of a hole created by an infusion spike upon the spike piercing the stopper and provides a barrier between the spike and elastomeric material, thereby preventing mechanical contact between the spike and the elastomeric material and consequent generation of elastomeric particles by abrasion;
and the abrasion-resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, copolymer of vinyl chloride and vinylidine chloride, polymethylene oxide, polyphenylene oxide, polyphenylene sulfone, polyethylene terphthalate, polycarbonate, copolyesters and polycaprolactam.
the spike-receiving surface is coated with an abrasion resistant film which conforms to edges of a hole created by an infusion spike upon the spike piercing the stopper and provides a barrier between the spike and elastomeric material, thereby preventing mechanical contact between the spike and the elastomeric material and consequent generation of elastomeric particles by abrasion;
and the abrasion-resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, copolymer of vinyl chloride and vinylidine chloride, polymethylene oxide, polyphenylene oxide, polyphenylene sulfone, polyethylene terphthalate, polycarbonate, copolyesters and polycaprolactam.
2. An abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprises:
a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein, and the head portion comprises a fluid-contacting bottom surface and a top surface having a central spike pierceable portion; and an abrasion resistant film coated on the central pierceable portion of the top surface of the head portion, wherein:
the abrasion resistant film conforms to edges of a hole created by deformation of the stopper body;
the spike gets in contact with only the abrasion resistant film to prevent generation of particles of the elastomeric material upon piercing of the stopper by the spike; and the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein, and the head portion comprises a fluid-contacting bottom surface and a top surface having a central spike pierceable portion; and an abrasion resistant film coated on the central pierceable portion of the top surface of the head portion, wherein:
the abrasion resistant film conforms to edges of a hole created by deformation of the stopper body;
the spike gets in contact with only the abrasion resistant film to prevent generation of particles of the elastomeric material upon piercing of the stopper by the spike; and the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
3. The abrasion resistant stopper of claim 1 or 2, wherein the abrasion resistant film has a thickness of about 0.002 mm to 1.0 mm.
4. The abrasion resistant stopper of claim 1 or 2, wherein the abrasion resistant film has a thickness of about 0.02 mm to 0.5 mm.
5. An abrasion resistant stopper of any one of claims 1 to 4, wherein the top surface of the head portion has a region which surrounds the coated central portion and is not coated.
6. An abrasion resistant stopper for a medical vial containing a fluid therein, which stopper is to be pierced by an infusion spike and comprising:
[A] a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein:
the elastomeric material is a fluid impervious, resilient and inert material free of additives leachable to the fluid;
the head portion comprises a top surface and a circular flange to cover a corresponding planar circular mouth portion of the medical vial; and the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein and has a recess extending from its bottom upward toward the top surface of the head portion such that a thin central pierceable portion is formed in the head portion, and [B] an abrasion resistant film having a thickness of 0.02 to 0.5 mm coated on the top surface of the head portion, wherein:
the abrasion resistant coating covers the thin central pierceable portion of the head portion;
when piercing the thin central pierceable portion of the head portion by the infusion spike, the abrasion resistant film conforms to a deformation of the stopper body and the spike is in contact only with the abrasion resistant coating, thereby preventing generation of particles from the elastomeric stopper body;
the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
[A] a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, wherein:
the elastomeric material is a fluid impervious, resilient and inert material free of additives leachable to the fluid;
the head portion comprises a top surface and a circular flange to cover a corresponding planar circular mouth portion of the medical vial; and the leg portion is to be inserted into the medical vial to hermetically seal the fluid therein and has a recess extending from its bottom upward toward the top surface of the head portion such that a thin central pierceable portion is formed in the head portion, and [B] an abrasion resistant film having a thickness of 0.02 to 0.5 mm coated on the top surface of the head portion, wherein:
the abrasion resistant coating covers the thin central pierceable portion of the head portion;
when piercing the thin central pierceable portion of the head portion by the infusion spike, the abrasion resistant film conforms to a deformation of the stopper body and the spike is in contact only with the abrasion resistant coating, thereby preventing generation of particles from the elastomeric stopper body;
the abrasion resistant film is made of a material selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, co-polymer of vinyl chloride and vinylidene chloride, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, polytetrafluoroethylene, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate, polycarbonate, copolyesters, polycaprolactam, polyhexamethylene adipamide (nylon 66) and polyundecanoamide.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US86212092A | 1992-04-02 | 1992-04-02 | |
| US862,120 | 1992-04-02 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2091020A1 CA2091020A1 (en) | 1993-10-03 |
| CA2091020C true CA2091020C (en) | 2005-01-25 |
Family
ID=25337719
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002091020A Expired - Lifetime CA2091020C (en) | 1992-04-02 | 1993-03-04 | Stopper for reduction of particulate matter |
Country Status (20)
| Country | Link |
|---|---|
| EP (1) | EP0564037B1 (en) |
| JP (1) | JPH0639017A (en) |
| KR (1) | KR930021174A (en) |
| AT (1) | ATE156088T1 (en) |
| AU (1) | AU666910B2 (en) |
| BR (1) | BR9301388A (en) |
| CA (1) | CA2091020C (en) |
| CZ (1) | CZ54393A3 (en) |
| DE (1) | DE69312545T2 (en) |
| DK (1) | DK0564037T3 (en) |
| ES (1) | ES2108205T3 (en) |
| FI (1) | FI931501A (en) |
| HU (1) | HUT67955A (en) |
| IL (1) | IL105247A (en) |
| MX (1) | MX9301044A (en) |
| MY (1) | MY131318A (en) |
| NO (1) | NO931288L (en) |
| NZ (1) | NZ247323A (en) |
| SK (1) | SK27493A3 (en) |
| TW (1) | TW227523B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USD713931S1 (en) | 2013-01-09 | 2014-09-23 | Central Garden & Pet Company | Sprayer |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6386392B1 (en) | 1999-11-02 | 2002-05-14 | The Procter & Gamble Company | Reservoirs for use with cleaning devices |
| EP1078880B1 (en) | 1999-08-05 | 2003-03-19 | The Procter & Gamble Company | Dispensing device comprising a reservoir and attachment means provided with protected piercing means |
| US6321941B1 (en) | 2000-04-20 | 2001-11-27 | The Procter & Gamble Company | Consumer safe fitment for connecting a reservoir to a dispensing appliance |
| JP4601127B2 (en) * | 2000-06-06 | 2010-12-22 | 住友ゴム工業株式会社 | Medical rubber stopper |
| TWI303565B (en) | 2002-08-16 | 2008-12-01 | Glaxosmithkline Biolog Sa | Closure system,vial having the closure system,method of closing a vial,method of filling a pharmaceutical vial, and vial closure |
| JP4425140B2 (en) | 2002-09-03 | 2010-03-03 | メディカル・インスティル・テクノロジーズ・インコーポレイテッド | Liquid medicine bottle assembly |
| US20090196798A1 (en) * | 2008-02-06 | 2009-08-06 | Robert Sassa | Barrier with Low Extractables and Resealing Properties |
| CN102283776B (en) * | 2011-07-07 | 2013-09-04 | 海南卫康制药(潜山)有限公司 | Puncture-free bottle cork and application method thereof |
| DE102012101509A1 (en) * | 2012-02-24 | 2013-08-29 | Krones Aktiengesellschaft | Pierceable plastic closure for sealing containers |
| CN113474083A (en) * | 2019-01-04 | 2021-10-01 | 仪器实验室公司 | Container stopper for high puncture count applications |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3628681A (en) * | 1969-10-06 | 1971-12-21 | Plastics Consulting And Mfg Co | Stopper |
| US4499148A (en) * | 1983-01-10 | 1985-02-12 | Canton Bio-Medical Products, Inc. | Composite materials of silicone elastomers and polyolefin films, and method of making |
| JP2545540B2 (en) * | 1987-05-29 | 1996-10-23 | 株式会社 大協精工 | Double-sided laminated rubber stopper |
| DE8906346U1 (en) * | 1989-05-23 | 1989-09-14 | Pharma-Gummi Wimmer West Gmbh, 5180 Eschweiler, De |
-
1993
- 1993-02-04 AU AU32805/93A patent/AU666910B2/en not_active Ceased
- 1993-02-22 TW TW082101220A patent/TW227523B/zh active
- 1993-02-25 MX MX9301044A patent/MX9301044A/en unknown
- 1993-03-04 CA CA002091020A patent/CA2091020C/en not_active Expired - Lifetime
- 1993-03-27 AT AT93200885T patent/ATE156088T1/en not_active IP Right Cessation
- 1993-03-27 ES ES93200885T patent/ES2108205T3/en not_active Expired - Lifetime
- 1993-03-27 DK DK93200885.7T patent/DK0564037T3/en active
- 1993-03-27 DE DE69312545T patent/DE69312545T2/en not_active Expired - Lifetime
- 1993-03-27 EP EP93200885A patent/EP0564037B1/en not_active Expired - Lifetime
- 1993-03-29 JP JP5069697A patent/JPH0639017A/en active Pending
- 1993-03-31 KR KR1019930005347A patent/KR930021174A/en not_active Application Discontinuation
- 1993-03-31 CZ CZ93543A patent/CZ54393A3/en unknown
- 1993-03-31 BR BR9301388A patent/BR9301388A/en not_active Application Discontinuation
- 1993-04-01 IL IL105247A patent/IL105247A/en not_active IP Right Cessation
- 1993-04-02 HU HU9300971A patent/HUT67955A/en unknown
- 1993-04-02 NZ NZ247323A patent/NZ247323A/en unknown
- 1993-04-02 FI FI931501A patent/FI931501A/en not_active Application Discontinuation
- 1993-04-02 NO NO93931288A patent/NO931288L/en unknown
- 1993-04-02 MY MYPI93000586A patent/MY131318A/en unknown
- 1993-04-05 SK SK274-93A patent/SK27493A3/en unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USD713931S1 (en) | 2013-01-09 | 2014-09-23 | Central Garden & Pet Company | Sprayer |
Also Published As
| Publication number | Publication date |
|---|---|
| IL105247A0 (en) | 1993-08-18 |
| KR930021174A (en) | 1993-11-22 |
| HUT67955A (en) | 1995-05-29 |
| DK0564037T3 (en) | 1997-09-29 |
| JPH0639017A (en) | 1994-02-15 |
| MX9301044A (en) | 1993-10-01 |
| CA2091020A1 (en) | 1993-10-03 |
| SK27493A3 (en) | 1993-11-10 |
| TW227523B (en) | 1994-08-01 |
| FI931501A0 (en) | 1993-04-02 |
| NO931288L (en) | 1993-10-04 |
| HU9300971D0 (en) | 1993-06-28 |
| MY131318A (en) | 2007-08-30 |
| AU3280593A (en) | 1993-10-07 |
| EP0564037A1 (en) | 1993-10-06 |
| FI931501A (en) | 1993-10-03 |
| BR9301388A (en) | 1993-10-13 |
| NO931288D0 (en) | 1993-04-02 |
| DE69312545D1 (en) | 1997-09-04 |
| NZ247323A (en) | 1996-03-26 |
| DE69312545T2 (en) | 1998-02-19 |
| AU666910B2 (en) | 1996-02-29 |
| ATE156088T1 (en) | 1997-08-15 |
| IL105247A (en) | 1997-04-15 |
| EP0564037B1 (en) | 1997-07-30 |
| ES2108205T3 (en) | 1997-12-16 |
| CZ54393A3 (en) | 1995-11-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |