Abstract: An article or vessel is described including a vessel surface and a coating set comprising at least one tie coating, at least one barrier coating, and at least one pH protective coating. For example, the coating set can comprise a tie coating, a barrier coating, a pH protective coating and a second barrier coating; and in the presence of a fluid composition, the fluid contacting surface is the barrier coating or layer. The respective coatings can be applied by PECVD of a polysiloxane precursor. Such vessels can have a coated interior portion containing a fluid with a pH of 4 to 8. The barrier coating prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating and pH protective coating together protect the barrier layer from the contents of the vessel. The second barrier coating is comparable to glass surface if needed.

Abstract: A pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, in a pre-filled pharmaceutical package, for example a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained.

Abstract: System of vessels, connectors, or other equipment characterized by at least some common surfaces in contact with a biopharmaceutical product during biopharmaceutical manufacturing, packaging, delivery, and assessment. Methods of producing those systems and customizing contact surfaces for use in them.

Abstract: A primary drug container is described having an injection-molded thermoplastic wall having an internal surface defining a lumen, a PECVD (plasma-enhanced chemical vapor deposition) drug-contact coating, and a polypeptide composition contained in the lumen. The drug-contact coating is on or adjacent to the internal surface, positioned to contact a fluid in the lumen, and consists essentially of SiOxCyHz. The primary drug container contains between a lower limit of 1,000 and an upper limit of 100,000 particles having effective spherical diameters greater than 2 and no more than 10 micrometers (?m) per mL of solution.

Abstract: Disclosed are polymer vials (110, 210) and injection stretch blow molding methods for making the same. A polymer vial has a base (112) having a base surface area and a sidewall (114) extending up from the base. The base and sidewall define an interior (116) configured to house product, the sidewall narrowing at an upper section of the vial to form a neck leading to an opening that provides access to the interior. The vial is optionally round and symmetrical about a central axis, a lower portion of the sidewall including a first surface that is outwardly curved along a first radius having an imaginary center positioned within the vial. The base is positioned below the first surface and is substantially flat such that at least 80% of the base surface area has a standing base surface occupying a single plane.

Abstract: A method of reducing static charge of a plastic container is provided. The method includes providing a PECVD coating of SiCOH, SiOx or SiOH to an external support surface of the container. The PECVD coating reduces static charge of the container compared to a reference container that is essentially identical to the container except that the reference container is uncoated.

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 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 blood sample collection tube and other vessels are described including an article surface and a coating set comprising a tie coating or layer of SiOxCy or SiNxCy applied to the article surface, a barrier coating or layer of SiOx, and a pH protective layer of SiOxCy or SiNxCy. The vessels 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 vessel, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the vessel.

Abstract: Processing an evacuated blood sample collection tube or other vessel by plasma enhanced chemical vapor deposition to apply a tie coating or layer (289), a barrier coating or layer (288), and optionally one or more additional coatings or layers. The tie coating or layer of SiOxCy is applied under partial vacuum and, while maintaining the partial vacuum unbroken in the lumen, the barrier coating or layer is applied. Then optionally, while maintaining the partial vacuum unbroken in the lumen, a pH protective coating or layer of SiOxCy can be applied. As a result of this processing, a coated vessel is produced having a lower gas permeation rate constant into the lumen than a corresponding vessel made by the same process except breaking the partial vacuum in the lumen between applying the tie coating or layer and applying the barrier coating or layer. Retention features are also described for keeping the vessels stoppered during exposure to reduced ambient pressure.

Abstract: A pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, in a pre-filled pharmaceutical package, for example a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained.

Abstract: A method of reducing static charge of a plastic container is provided. The method includes providing a PECVD coating of SiCOH, SiOx or SiOH to an external support surface of the container. The PECVD coating reduces static charge of the container compared to a reference container that is essentially identical to the container except that the reference container is uncoated.

Abstract: An article or vessel is described including a vessel surface and a coating set comprising at least one tie coating, at least one barrier coating, and at least one pH protective coating. For example, the coating set can comprise a tie coating, a barrier coating, a pH protective coating and a second barrier coating; and in the presence of a fluid composition, the fluid contacting surface is the barrier coating or layer. The respective coatings can be applied by PECVD of a polysiloxane precursor. Such vessels can have a coated interior portion containing a fluid with a pH of 4 to 8. The barrier coating prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating and pH protective coating together protect the barrier layer from the contents of the vessel. The second barrier coating is comparable to glass surface if needed.

Abstract: A vessel has a lumen defined at least in part by a wall. The wall has an interior surface facing the lumen, an outer surface, and a plasma-enhanced chemical vapor deposition (PECVD) coating set supported by the wall. The PECVD coating set comprises a water barrier coating or layer having a water contact angle from 80 to 180 degrees, applied using a precursor comprising at least one of a saturated or unsaturated fluorocarbon precursor having from 1 to 6 carbon atoms and a saturated or unsaturated hydrocarbon having from 1 to 6 carbon atoms. Optionally, the coating set includes an SiOx gas barrier coating or layer from 2 to 1000 nm thick, in which x is from 1.5 to 2.9 as measured by x-ray photoelectron spectroscopy (XPS), and optionally other related coatings.

Abstract: A pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, in a pre-filled pharmaceutical package, for example a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained.

Abstract: An article or vessel is described including a vessel surface and a coating set comprising at least one tie coating, at least one barrier coating, and at least one pH protective coating. For example, the coating set can comprise a tie coating, a barrier coating, a pH protective coating and a second barrier coating; and in the presence of a fluid composition, the fluid contacting surface is the barrier coating or layer. The respective coatings can be applied by PECVD of a polysiloxane precursor. Such vessels can have a coated interior portion containing a fluid with a pH of 4 to 8. The barrier coating prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating and pH protective coating together protect the barrier layer from the contents of the vessel. The second barrier coating is comparable to glass surface if needed.

Abstract: A container includes an external package and a sealed flexible bag, adapted to hold liquid contents, retained within the external package. The bag is made from a polymer film, which prior to being formed into a bag, was a two dimensional film to which was applied a PECVD SiOx coating.

Abstract: Cycloolefin polymer (COP) containers, including vials or syringes, having a scratch-resistant and anti-static coating on the external wall results in a reduction or prevention of static charge on the articles. The combination of an anti-scratch and anti-static coating results in the reduction of the attraction of charged particles to the container, leading to decreased particulate contamination while providing scratch resistance.

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 pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, inside the package. A nonlimiting example of the package can be a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. Optionally, the package further comprises a bag, a blister, a pouch or any other vessel. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained. The said pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist is suitable for sterilization (such as for surface and/or terminal sterilization) with sterilization gas residuals being minimal and/or lower than required by ISO 10993-7.