Abstract: A drug delivery system for administering preset doses of a substance such as a drug, vaccine or the like is provided. The drug delivery system includes a holder and a pre-filled drug container such as a syringe which is securely retained in the holder. The drug container includes a barrel for containing the substance, a movable stopper situated within the barrel, and a blunt end having an opening through which the substance within the barrel can be expelled. The holder includes a distal portion and a proximal portion, each configured to accommodate the drug container, with the distal portion being able to be assembled to the proximal portion, which acts as a plunger rod during activation of the delivery system.

Abstract: A tip cap assembly is provided for positive sealing engagement with the tip of a syringe barrel of a syringe. The tip cap assembly includes an inner cap formed from an elastomeric material dimensioned for sealing engagement with the tip of the syringe barrel. The tip cap assembly further includes an outer cap engaged with the inner cap, and a collar for mounting the tip cap assembly to the syringe barrel. In addition, the outer cap includes a plurality of frangible portions for evidencing tampering and for connecting the outer cap to the collar.

Abstract: A medical device is provided which includes a shield system and a syringe which is coupled to the shield system. The shield system includes a syringe holder and a shield which is slidably coupled to the holder. A spring resiliently urges the shield from a retracted position to an extended position. Stop members are provided on the holder and shield for maintaining the shield in the retracted position. The syringe is slidably coupled to the holder, and extends within the shield. Axial movement of the syringe with respect to the holder causes disengagement of the stop members, allowing the spring to move the shield to the extended position. Detents are provided on the holder for maintaining the shield in the extended position.

Abstract: A bottle having a sterility seal and a method for producing same are disclosed. The bottle, which can be configured to retain a medicament in powder or tablet form, features a protective cap configured to engage a transfer assembly associated with the bottle. The cap includes one or more raised ridges on an interior surface engageable with a portion of the transfer assembly. A band or layer configuration of a sealing material such as silicone is applied to the transfer assembly prior to insertion of the cap thereover. As the cap comes into surface contact with the sealing material, the ridges cause the material to “roll up” into a toroidal O-ring configuration, thereby forming a seal between the cap and the bottle adapted to the dimensional variations of those components.

Abstract: Clean syringe barrels from forming device immediately transferred to a controlled environment to maintain a clean work area. The work area can be a clean room or localized area to avoid the need to maintain cleanliness levels in an entire room. A localized area uses a housing assembly having a HEPA filter coupled to an air inlet to filter the air entering the housing. An air blower is coupled to the air inlet to feed filtered air into the housing assembly and to maintain a positive air pressure in the housing assembly to prevent unfiltered outside air from entering. Syringe tip closures can be introduced into the housing assembly, where syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. A thin coating of lubricant is applied to the inner surfaces of the syringe barrels. The syringe barrels or medical container can be filled with a substance and a closure member is attached.

Abstract: A housing assembly is provided to define a locally controlled environment to maintain a localized clean work area without the need to maintain cleanliness levels in an entire room as in conventional clean rooms. The housing assembly includes a HEPA filter coupled to an air inlet to filter all of the air entering the housing. An air blower is coupled to the air inlet to feed filtered air into the housing assembly and to maintain a positive air pressure in the housing assembly to prevent unfiltered outside air from entering. Prefillable medical containers, such as syringe barrels and syringe tip closures, are introduced into the housing assembly where the syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. A thin coating of a lubricant is applied to the inner surface of each of the syringe barrels. The syringe barrels can be filled with a substance.

Abstract: Trays for grouping together articles, for example syringes which are to be filled, and the tray including a flattened body, with the body being elongate in a first direction, and a plurality of housings which are open on the first face for the articles, respectively, each arranged in a second, transverse direction, the housings being distributed in the first direction. The flattened body includes a plurality of gripping studs, designed to come into contact with, respectively, gripping suction cups, arranged and distributed over the second face, the studs each including flats whose level is located inside the flattened body.

Abstract: A method and apparatus for attaching a connector assembly onto a vial is disclosed. The connector assembly features a protective cap, a collar attachable to the rim of the vial, and a locking ring disposed about the collar. A vial access device is contained within the collar. One or more ribs are provided adjacent a distal portion of the collar to seal against the stopper obturating the vial. The collar is provided with one or more slits which render the collar flexible in directions radial and axial to the central axis of the vial to compensate for variations in tolerances or dimensions present in the various components. Locking structure between the locking ring and the collar assures that the collar remains fixed to the vial.

Abstract: A transfer set assembly for transferring fluids between a first container, such as a conventional medical vial, having a sealed open end and a second container such as a conventional IV infusion bag. The transfer set includes a collar having a proximate tubular end portion for securement to the container, a needle cannula and holder assembly, which is telescopically received in a distal tubular portion of the collar, and a closure including a tubular body portion having an open proximate end which is telescopically received over the needle cannula and holder assembly and the distal tubular portion of the collar, a closed distal end portion and an inner tubular portion which is integral with the closed distal end. The inner tubular portion includes a free end having spiral camming surfaces which mate with spiral camping surfaces on the inside surface of the tubular distal portion of the needle cannula holder.

Abstract: A method for lubricating a sealing member in a drug delivery device includes the steps of washing and rinsing the sealing members in hot deionized water following by drying the sealing members. The dried sealing members are tumbled with polymeric silicone and then irradiated at a target dose between 2.5 and 4.0 Mrads. The irradiated sealing members are then utilized in a variety of drug delivery devices including syringes, pre-filled syringes, drug cartridges, and needleless injector ampules.

Abstract: A tip cap assembly is provided for positive sealing engagement with the tip of a syringe barrel of a syringe. The tip cap assembly includes an inner cap formed from an elastomeric material dimensioned for sealing engagement with the tip of the syringe barrel. The tip cap assembly further includes an outer cap engaged with the inner cap, and a collar for mounting the tip cap assembly to the syringe barrel. In addition, the outer cap includes a plurality of frangible portions for evidencing tampering and for connecting the outer cap to the collar.

Abstract: A lockable safety shield assembly for a prefillable syringe is provided. The design of the lockable safety shield assembly enhances pharmaceutical manufacturers' ease of assembling the various components as part of its filling or processing of the prefillable syringes in normal practice, while at the same time minimizes difficulties in mating parts made from different materials. A tube is placed around the outside surface of the syringe barrel and affixed thereto. A collar is provided on the tube adjacent the distal end of the syringe barrel. A safety shield is axially slidable over the tube between a retracted position, wherein the distal end of the piercing element associated with the prefillable syringe is exposed, and an extended position, wherein the safety shield is locked to the collar to protectively cover the distal end of the piercing element. The safety shield includes locking structure configured so that the shield can be easily fitted over the tube.

Abstract: Glass medical devices such as medical containers are manufactured and annealed by heating in an oven which produces a clean device having a low bio-burden. Plastic medical devices and medical containers are formed by plastic molding devices which produce a clean device. The clean devices are immediately transferred to a controlled environment to maintain a clean work area. A localized area uses a housing assembly having a HEPA filter coupled to an air inlet to filter the air entering the housing. An air blower is coupled to the air inlet to feed filtered air into the housing assembly and to maintain a positive air pressure in the housing assembly to prevent unfiltered outside air from entering. Syringe tip closures can be introduced into the housing assembly, where syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. A thin coating of lubricant is applied to the inner surfaces of the syringe barrels.

Abstract: The improved vial transfer assembly or vial transferset may be attached to a vial under sterile conditions and used to transfer fluid to or from a conventional vial. The transferset includes a tubular transfer member which is sealingly supported on the rim portion of a vial stopper, a piercing member having a piercing end reciprocally supported by an internal surface of the transfer member, a cap enclosing the tubular transfer member and a collar preferably formed of a malleable material which secures the assembly on the stopper, which is crimped beneath the vial rim. The piercing member has a generally longitudinal external channel which, upon piercing the planar portion of the stopper, establishes fluid communication with the vial through the tubular transfer member. The distal end of the tubular transfer member includes a Luer lock for establishing fluid communication to a syringe, IV set or the like.

Abstract: A tip cap is provided for positive sealing engagement with the tip of a syringe barrel. The tip cap includes an inner cap formed from an elastomeric material dimensioned for sealing engagement with the tip of the syringe barrel. The tip cap further includes an outer cap engaged with the inner cap to limit or prevent both axial movement and rotational movement therebetween. The outer cap includes an array of threads for threaded engagement with a luer collar. The luer collar may be a separate component mountable to a syringe barrel or an integral part of the syringe barrel.

Abstract: A resealable vial featuring a connector assembly having a membrane and a pusher for selectively opening or sealing the fluid passageway between the bottle and the connector end of a luer hub. The connector assembly includes a body disposed on said bottle, and means for communicating fluid such as a luer connector hub which may be separately provided with the body or formed integrally therewith. The luer connector hub features a connector end open for access by medical delivery instrument, and an opposed end which is disposed for fluid communication with a recess defined by the body. The body defines a recess having a fluid path with the open top of the bottle. A membrane, preferably formed from an elastomeric material, is secured across both the recess and the open top of the bottle, and may be retained between the top surface of the bottle and the body.