Abstract: Medical devices such as medical containers can be formed of glass and annealed which produces a clean device having a low bio-burden, or formed by plastic molding which produces a clean device. The clean devices are immediately transferred to a controlled environment such as a clean room or localized area to avoid the need to maintain cleanliness levels in an entire room. 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. The syringe barrels can be filled with a substance and a closure member attached. While still in the housing assembly the syringe barrels can be formed into an array and placed in a clean outer container, which is then closed and sealed.

Abstract: A bag comprising an envelope closed at one end by an end wall and delimiting a mouth at the other end, containing a charge capable of passing, for example under gravity, through said mouth, when said bag is in the inverted position, said envelope being shaped on itself at said mouth in order to close said bag. At the opposite end to the end wall, the envelope is shaped on itself, in particular folded, to determine, without discontinuity: an outer sleeve which is above the mouth when the bag is in the inverted position; at least one inner closure fold; a neck inside which the inner closure fold is located; and at least one outer closure fold closing said neck.

Abstract: A passive shield system for a syringe including a body, shield, spring and ring which provide an interlock of the shield in the retracted position prior to receipt of the syringe for bulk transportation and processing and wherein the user selects the timing of the release of the shield to its extended position following injection, but which assures shielding of the syringe needle following release of the syringe plunger.

Abstract: A hypodermic syringe barrel and needle cannula assembly is provided that is capable of being dry heat sterilized at temperatures of greater than about 250° C. and up to about 350° C. in which the assembly includes a syringe barrel, a needle cannula and a bonding material, where the bonding material is stable above about 250° C., cures to provide a transparent bond, and affixes the needle cannula into the syringe barrel to provide the assembly with a post-sterilization needle pullout strength of at least about 30 newtons.

Abstract: A method for lubricating a sealing member and a medicament chamber in a drug delivery device includes providing lubricating silicone on the surface of the stopper and within the plastic material of the chamber. The stopper preferably is first washed and rinsed in hot deionized water followed by drying. The dried sealing member is then tumbled with polymeric silicone and then irradiated at a target dose between 2.5 to 4.0 Mrads to cause the silicone molecules to bond with the elastomeric material of the stopper. The irradiated sealing members are then loaded in any of a series of chambers including syringes, pre-filled syringes, drug cartridges, and needleless injector ampules. The chamber preferably is made from a plastic material that has been mixed with a lubricating solution such as silicone when the plastic is compounded.

Abstract: A medicament delivery device for administering a medicament to a user includes a medicament reservoir and an entrance port and an exit port each disposed adjacent the reservoir. A gas chamber disposed adjacent the entrance port. The device includes a pressurizing mechanism operable to pressurize said gas chamber to at least a prescribed pressure. A first frangible membrane extends across the entrance port and separates the reservoir from the gas chamber. A second frangible membrane extends across the exit port. When the pressurizing mechanism is attached, at least one of the first and second membranes is responsive to the prescribed pressure in the gas chamber to burst to allow gas to flow through the entrance port and the reservoir and to carry the medicament through the exit port.

Abstract: A method of making an intradermal injection using a drug delivery device containing the substance to be injected. A device for practicing the method includes a needle cannula having a forward tip and a limiter portion having a skin engaging surface surrounding the needle cannula. The needle cannula is in fluid communication with the substance and the tip of the needle cannula extends beyond the skin engaging surface a distance equal to approximately 0.5 mm to 3.0 mm. The needle cannula includes a fixed angle of orientation relative to the plane of the skin engaging surface. The skin engaging surface limits penetration of the needle tip into the skin so that the substance can be expelled through the needle tip into the dermis layer. Preferably, the fixed angle of orientation of the needle cannula is generally perpendicular relative to the skin surface, and the skin engaging surface is generally flat.

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 method of sealing a medical container such as a vial with a polymeric closure, wherein the polymeric enclosure includes a tubular collar portion and an integral radial portion, which includes disposing the tubular collar portion over the radial rim portion of the container to surround the reduced diameter neck portion and radially deforming the tubular collar portion adjacent its free end into the reduced diameter neck portion and against the adjacent radial rim portion and, wherein the polymer selected for the closure is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain a seal between the plastic closure and the container following radial deformation.

Abstract: A medical injection device is provided which includes a shield system and a syringe which may be coupled to the shield system. The shield system includes a syringe holder, a shield telescopically received in the holder and slidably coupled to the holder and an end fitting which isolates the syringe flange from the holder, preventing damage to the flange. A spring resiliently urges the shield from a retracted position to an extended position. Stop members are provided adjacent the distal end of the holder and the proximal end of the 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 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: A method for surface marking a solid substrate (1), according to which, during an exposures sequence, said substrate is exposed to coherent monochromatic light (2) in order to strip said substrate over an indented surface (3), wherein the exposure conditions, including duration, are set in order to restrict said indented surface to simple abrasion designed for the bonding of a printing medium, and the exposure sequence is followed by a sequence of projecting in discrete form, during which particles (6) of said printing medium, the deposition of which subsequently defines a printing element (4), are projected in targeted fashion into the indented surface (3, 31). A device for marking a surface of a substrate is also provided.

Abstract: A medical package has a tub and a lid. The tub has a four-sided base with walls extending upwards therefrom; the walls terminate at a first flange with extends outwardly. From the first flange, four top walls extend upward and terminate at a second flange which extends outwardly. The tub is formed of a clear, ultraviolet light transmitting plastic. The lid has a gas permeable, microfiber central portion surrounded by a clear, ultraviolet light transmitting plastic film. The film has a high shear resistance and does not produce particulate matter during an opening procedure.

Abstract: A transfer set for transferring fluid from a first container, such as a conventional sealed vial, to. a second container, such as a conventional syringe having a luer connector without a needle canula. The transfer set includes a tubular housing member having a proximate end adapted to be attached to the first container open end, a tubular transfer member located within the tubular housing member, a piercing member telescopically supported in the tubular transfer member, and a cap or closure which in the preferred embodiments releasably retains the distal end of the piercing member prior to removal of the cap. The cap includes a central portion having a tubular connector portion which receives and releasably retains the distal end of the piercing member.

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 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 medical injection device including a shield system and a syringe coupled to the shield system. The shield system includes a syringe holder, a shield telescopically received in the holder and slidably coupled to the holder and an end fitting which isolates the syringe flange from the holder, preventing damage to the flange. A spring resiliently urges the shield from a retracted position to an extended position. Stop members are provided adjacent the distal end of the holder and the proximal end of the 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: An improved transferset assembly for transferring fluids between a first container, such as a medicament vial and a second container, such as a syringe, which includes an integral polymeric transfer assembly having a tubular collar portion, a radial portion overlying the rim of the first container, an outer tubular portion and an inner tubular portion which is integrally joined to the outer tubular portion by a radial intermediate web portion, a piercing member telescopically received in the inner tubular portion having a piercing end to pierce the closure sealing the open end of the first container and a removable closure which seals the open ends of the outer and inner tubular portions of the transfer assembly.

Abstract: A medical transfer or storage device for delivery or storage of a medicament, drug or vaccine, wherein a first component, preferably the major component, is formed of a cyclic olefin polymer, and a second component in contact with the first component is formed of a second polymer which does not chemically interact with the cyclic olefin polymeric component at elevated temperatures, including sterilization. More specifically, the relative energy distance Ra/Ro of the polymer selected for the second component relative to the cyclic olefin polymer is greater than 0.75 and the molecular weight of the second polymer is at least 5,000 to prevent adhesion of the second component to the cyclic olefin component and stress cracking at elevated temperatures. The most preferred embodiment is a syringe assembly having a cyclic olefin polymeric barrel and a resilient stopper formed of the second polymer.

Abstract: A sealed connection device in which, two chambers (“A” and “B”), each has an access opening equipped with a door (2, 3) cooperating with a flange (4, 5) with the interposition of sealing means (12, 14), one (2) of the two doors being articulated with its flange (4). The detection device comprises two grooves (30, 35), formed in the external face of the flange (4) of chamber (A), a seal (36) placed in the groove (35), a network of ducts (31, 32, 33) formed in flange (4) and connecting the inner groove (30) to a coupling (34), a vacuum pump (38) the intake (37) of which is connected to the said coupling, and a sensor (44) measuring the strength of the partial vacuum in the pneumatic circuit leading to the groove (30) and reacting on alarm means (47, 48) if ever the partial vacuum does not reach an appropriate value.