摘要:
Blood sample collection tubes are described including a tube surface and a coating set comprising a tie coating or layer of SiOxCy or SiNxCy applied to the tube surface, a barrier coating or layer of SiOx, and a pH protective layer of SiOxCy or SiNxCy. The 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 acids from the collected blood sample are described.
摘要:
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 (µm) per mL of solution.
摘要:
A method for preventing or reducing reaction of radiation sterilization-generated free radicals and/or byproducts thereof and/or oxygen with contents of a primary vessel is provided. A radiation sterilized primary plastic vessel contains contents prone to degradation by free radicals and/or byproducts thereof and/or oxygen. The vessel has a coating set deposited on an inner wall. The coating set is effective to protect the contents from degradation by radiation sterilization-generated free radicals and/or byproducts thereof and/or oxygen located in the plastic of the vessel and/or on the inner wall.
摘要:
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.
摘要:
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 exceipients, 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.
摘要:
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.
摘要:
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.
摘要:
A container, for example a syringe, cartridge, vial or similar article including a barrel or other vessel and a stopper, O-ring, plunger tip or piston. The vessel substrate defines a lumen and an internal sliding surface on the vessel substrate adjacent to the lumen. The stopper, O-ring, plunger tip or piston has an external sliding surface slidable in the lumen at least substantially in contact with the internal sliding surface. The internal sliding surface, the external sliding surface, or both are made at least in part of a parylene or halogenated polymer, which can be in the form of a coating or a bulk material. Methods of making the syringe, cartridge, or similar article using chemical vapor deposition, as by depositing the parylene or halogenated polymer directly or with intervening layers to define the external sliding surface, the internal internal sliding surface, or both are disclosed.
摘要:
A method for providing a saccharide based lubricating or protective coating or layer on a substrate surface is provided. In particular, a lubricity and/or protective coating or layer made by said method is provided. Pharmaceutical packages or other vessels coated by said method and the use of such pharmaceutical packages or other vessels protecting a compound or composition contained or received in said vessel with a protective coating against mechanical and/or chemical effects of the surface of the vessel without a protective coating material are also provided.
摘要:
Disclosed are polymer vials and injection stretch blow molding methods for making the same. A polymer vial has a base having a base surface area and a sidewall extending up from the base. The base and sidewall define an interior 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.