Abstract: A vessel including a thermoplastic wall enclosing a lumen is disclosed. The wall supports an SiOx composite barrier coating or layer, for which x is from 1.8 to 2.4, between the wall and the lumen. High Resolution X-ray Photoelectron Spectroscopy (XPS) shows the presence of an interface between the composite barrier coating or layer and the wall or substrate. In one aspect, the interface has at least 1 mol. % O3—Si—C covalent bonding, as a proportion of the O3—Si—C covalent bonding plus SiO4 bonding. In another aspect, the interface has an Si 2p chemical shift to lower binding energy (eV), compared to the binding energy of SiO4 bonding. The result is a tightly adherent composite barrier coating or layer having a high degree of adhesion to the substrate under practical use conditions. Methods of applying the composite barrier coating or layer are also disclosed.

Abstract: A process for producing gaskets with an improved channel for use in matched syringe and plunger systems, preferably prefilled plastic syringe systems. In particular, an improved process for making and inspecting continuous channels in a gasket film by laser treatment. The gaskets are useful in matched syringe and plunger systems with high and consistent container closure integrity (CCI), and consistent break loose and glide forces over time, and sealability.

Abstract: A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.

Abstract: Blood sample collection tubes are described including a tube surface and a coating set comprising a tie coating or layer N of SiOxCy or SiNyCy applied to the tube surface, a barrier coating or layer of SiOx, and a pH protective layer of SiOxCy or SiNyCy. The C tubes optionally contain a fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic tube, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the tube. Processes of collecting high volumes of blood into the tube, and methods of isolating the various types of nucleic N acids from the collected blood sample are described.

Abstract: This disclosure is directed to nucleic acid and cell preservative compositions. Methods of preserving nucleic acids and/or cells in a blood or other biological sample, and kits for preserving nucleic acids and/or cells in a blood or other biological sample are also described.

Abstract: The present disclosure is directed to plastic pharmaceutical vessels, such as vials, pre-filled syringes, and cartridges having an electronic component, such as an RFID tag, embedded in and fully enclosed by a wall thereof. The electronic component may be positioned at a specific site that allows for the component to be concealed by a conventional closure, such as in the neck portion of a vial or the needle or Luer hub of a syringe barrel. The present disclosure is also directed to methods of preparing and using pharmaceutical vessels having an electronic component incorporated therein.

Abstract: The present disclosure is directed to pharmaceutical packages, such as syringes, vials, etc., containing wave-shifting crystals that, when excited, emit light having one or more characteristics by which information about the package, such as a unique package identifier, may be obtained. The wave-shifting crystals may be rare earth doped crystals. In some embodiments, the wave-shifting crystals may be incorporated into or onto a wall of a vessel, e.g. a syringe barrel or vial, in a way that maintains transparency of the vessel wall. In other embodiments, the wave-shifting crystals may be incorporated into or onto a portion of the package that need not be transparent, such as a needle shield, tip cap, or vial closure. The wave-shifting crystals may be used to track and/or authenticate a pharmaceutical package.

Abstract: The present disclosure is directed to pharmaceutical packaging such as syringes, vials, and blood tubes having a thermoplastic wall that is coated with a gas barrier coating in which at least one layer is applied by atomic layer deposition. The gas barrier coating may include, for example, one or more layers of SiO2, one or more layers of Al2O3, or a combination thereof, and may serve as a barrier against a variety of gases including oxygen, water vapor, and nitrogen. The present disclosure is also directed to syringes and vials which are configured for the storage of lyophilized or cold-chain drugs and in particular to maintain container closure integrity throughout the supply and storage conditions associated with such drugs. The present disclosure is also directed to evacuated blood tubes having extended shelf lives.

Abstract: Disclosed are plunger assemblies including various convertible plungers and methods of making the same. Each plunger assembly is configured for disposition within a barrel of a medical container, e.g., a syringe, and displaced within the barrel from an engagement position to a release position. The engagement position is configured to provide a compression seal between a storage sealing section of the plunger and an inner wall of the syringe barrel. In the release position, the compression seal is reduced or eliminated. Also disclosed are methods for making convertible plungers and assembling them into syringes, e.g., pre-filled syringes.

Abstract: A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.

Abstract: A three-position plunger is provided including a sleeve having an opening at a distal end, a pre-load cavity proximal to and in communication with the opening, a first cavity proximal to and in communication with the pre-load cavity, a second cavity proximal to and in communication with the pre-load cavity, and at least one rib. The rib(s) is generally aligned with the first cavity. The plunger further includes an insert configured to be displaced from the pre-load cavity to the first cavity and from the first cavity to the second cavity. The insert is configured to provide support for the compression of the rib(s) when the insert is positioned in the first cavity.

Abstract: A syringe or other vessel having a substrate surface coated by PECVD is provided. The PECVD coating is made by generating plasma from a gaseous reactant comprising an organosilicon precursor and optionally O2. The lubricity, hydrophobicity and/or barrier properties of the coating are set by setting the ratio of the O2 to the organosilicon precursor in the gaseous reactant, and/or by setting the electric power used for generating the plasma. In particular, a lubricity coating made by said method is provided. Vessels coated by said method and the use of such vessels protecting a compound or composition contained or received in said coated vessel against mechanical and/or chemical effects of the surface of the uncoated vessel material are also provided.

Abstract: The present disclosure is directed to a vessel having a lumen defined at least in part by a wall, the wall having an interior surface facing the lumen, and the interior surface comprising a coating. The coating is configured to prevent the leaching of metal ions from the vessel wall into a fluid contained within the lumen and stored in contact with the coating. The vessels are used to store an aqueous drug product, typically an aqueous drug product containing an active agent and one or more excepients, such as a polysorbate stabilizer. The coated vessels are effective to reduce degradation of the active agent and/or one or more excipients, e.g. a polysorbate stabilizer.

Abstract: The present disclosure is directed to pharmaceutical packaging such as syringes, vials, and blood tubes having a thermoplastic wall that is coated with a gas barrier coating in which at least one layer is applied by atomic layer deposition. The gas barrier coating may include, for example, one or more layers of SiO2, one or more layers of Al2O3, or a combination thereof, and may serve as a barrier against a variety of gases including oxygen, water vapor, and nitrogen. The present disclosure is also directed to syringes and vials which are configured for the storage of lyophilized or cold-chain drugs and in particular to maintain container closure integrity throughout the supply and storage conditions associated with such drugs. The present disclosure is also directed to evacuated blood tubes having extended shelf lives.

Abstract: A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.

Abstract: The present disclosure is directed to multi-dose containers, such as eye drop bottles, nasal spray bottles, cosmetic and fragrance containers, and the like, in which at least a portion of an interior wall of the container, which is in contact with a fluid product, is provided with an anti-microbial coating. The anti-microbial coating is effective to inhibit the growth of microbes and/or inactivate or kill microbes, such as bacteria, that may be introduced into the lumen during use of the product. As such, the shelf life of the product after first use may be increased and/or the amount of preservatives or excipients in the fluid product may be decreased. The containers may also include one or more oxygen barrier coatings, which may increase the shelf life of the product prior to first use.

Abstract: A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.

Abstract: A syringe or other vessel having a substrate surface coated by PECVD is provided. The PECVD coating is made by generating plasma from a gaseous reactant comprising an organosilicon precursor and optionally O2. The lubricity, hydrophobicity and/or barrier properties of the coating are set by setting the ratio of the O2 to the organosilicon precursor in the gaseous reactant, and/or by setting the electric power used for generating the plasma. In particular, a lubricity coating made by said method is provided. Vessels coated by said method and the use of such vessels protecting a compound or composition contained or received in said coated vessel against mechanical and/or chemical effects of the surface of the uncoated vessel material are also provided.

Abstract: A method and apparatus for plasma modifying a workpiece such as a syringe barrel, cartridge barrel, vial, or blood tube is described. Plasma is provided within the lumen of the workpiece. The plasma is provided under conditions effective for plasma modification of a surface of the workpiece. A magnetic field is provided in at least a portion of the lumen. The magnetic field has an orientation and field strength effective to improve the uniformity of plasma modification of the interior surface of the generally cylindrical wall. A vessel made according to the process or using the apparatus described above. A pharmaceutical package comprising the syringe barrel or vial containing a pharmaceutical preparation, secured with a closure.

Abstract: A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.