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: 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: 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 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.

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: A protective sealing barrier for a syringe is disclosed. The protective sealing barrier can be configured to safeguard the sterility of the syringe and any contents held therein, as a barrier against leakage of any contents held within the syringe, or both. The syringe includes a luer tip and a collar having terminal ends which are preferably substantially co-planar with one another. The barrier consists of a membrane which is disposed in substantially entire surface contact with the terminal ends of both the luer tip and the collar. The membrane can be selected from a material permitting the syringe to be irradiated or heat sterilized. Likewise, the membrane can be chosen from a material permitting the syringe to be sterilized by various gas sterilization procedures.

Abstract: A medical syringe assembly includes a first opening and a second opening at opposite ends of a tubular barrel having an inner wall. The inner wall includes an inner surface. A stopper having an engagement surface is slidably received in the tubular barrel and includes a portion for engaging the surface of the inner wall of said tubular barrel. A lubricant is disposed over a limited area of at least one member of the inner wall of the tubular barrel and the engagement surface of said stopper, whereby a sufficient amount of the lubricant is available to provide adequate reduction of friction between the surface of the inner wall of the tubular barrel and the engagement surface of the stopper.

Abstract: A connector assembly for a vial is disclosed. The connector assembly features a protective cap, a collar attachable to the rim of the vial, and a crimp cap for securing the collar to the rim. The collar features a flexible skirt provided adjacent the proximal end of the collar that is foldable about the underside portion of the vial rim. One or more ribs are provided adjacent a distal portion of the collar to seal against the stopper obturating the vial. The crimp cap can be supplied preattached to the collar in an uncrimped condition. When crimped, the crimp cap exerts a force against the distal end of the collar and the flexible skirt folded about the rim to secure the collar to the vial.

Abstract: A prefillable syringe includes an elongate barrel having an open distal end and a proximal end with at least one chamber formed therebetween for receiving a substance sensitive to pH shift, such as water for injection. The barrel is made of a low extractable ion glass preferably having a low concentration of sodium of less than 8% and preferably around 4% or less.

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 method for automatically classifying multi-parameter data into cluster groups for the purpose of defining different populations of particles in a sample by automatically defining a position of at least one variable position, geometric boundary surface on a two-dimensional scatter plot so as to enclose a group of the displayed particles in a data cluster; with the boundary surface having a polygonal shape defined by a plurality of vertices about at least one cell cluster created by building at least one histogram from cross sections of the two-dimensional scatter plot. Preferably, each cross section of the geometric boundary includes a rectangular, two dimensional gate. The method is particularly useful in the field of cellular analysis using, for example, flow cytometers wherein multi-parameter data is recorded for each cell that passes through an illumination and sensing region.

Abstract: A hypodermic needle featuring a multi-beveled point geometry is disclosed. In one embodiment, the multi-beveled point features a primary bevel, a pair of tip bevels, and a pair of middle bevels each intermediate the primary bevel and a respective one of the tip bevels. The primary and middle bevels are provided at angles of inclination, measured between the central axis and a reference plane that are substantially identical. The tip bevels are formed at an angle of inclination respective to the central axis which is not equal to the angle of inclination at which the primary and middle bevels are formed. The resulting five-beveled point geometry contributes to a more continuous bevel face free of abrupt intercepts or transitions between the respective bevel faces, lessening the penetration force required to urge the needle point through skin, flesh, or other material.