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:
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 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.
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 method is provided for treating a surface of a substrate. The method includes treating the surface with plasma comprising one or more non-polymerizing compounds. The converted surface has a biomolecule recovery percentage greater than the biomolecule recovery percentage of the surface prior to treatment according to the method.
Abstract:
Methods and systems for processing a plurality of vessels, for example to provide a gas barrier, are disclosed. The gas barrier may be deposited using pulsed plasma enhanced chemical vapor deposition concurrently in a plurality of vessels where each vessel is within an opening of an RF electrode.
Abstract:
Embodiments of the present disclosure are directed to a vessel comprising a wall at least partially made of a compostable or biodegradable material, having an interior surface enclosing a lumen and an exterior surface; and a PECVD coating set on the interior surface, the exterior surface, or both. The PECVD coating set comprises a barrier coating or layer of SiOx, in which x is from about 1.5 to about 2.9 as measured by XPS. The PECVD coating set optionally further comprises a tie coating or layer comprising SiOxCy, in which x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 as measured by X-ray photoelectron spectroscopy (XPS); a pH protective coating or layer comprising SiOxCy, in which x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 as measured by XPS; or both. The vessel may also include a lacquer coating between the surface of the wall and the PECVD coating set. In some embodiments, the vessel may be a single use coffee or tea pod.
Abstract:
A pharmaceutical package comprises a polymeric wall having an interior surface and an outer surface; and a tie coating of SiOxCy and/or a barrier coating of SiOx and/or a protective coating of SiOxCy on the interior surface. The walls may be formed into the vessel by means of laser welding. The package can be, for example, a rigid container, a bioprocessing bag or a transfer bag, wherein the coatings afford improved barrier properties and/or are effective to block extractables/leachables from the substrate and any coatings thereon and the coatings are able to maintain their desirable characteristics described herein against stretching/elongation conditions. The bag or rigid container can be used in the entire process of the CAR T cell manufacture/therapy. A method of handling the coated packages comprises limiting stretching the packages. The method of monitoring or controlling the internal pressure of the coated packages is also described.
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 polymeric substrate has a plasma treated contact surface which is roughened, hydrophilic and has a higher oxygen atomic content than the interior portion. The treated contact surface has an enhanced cell adhesion, cell growth and cell recovery rate. During the treatment, the contact surface is contacted with a process gas introduced through a gas inlet near the treated surface and radio frequency electrical power is introduced in the process gas, forming a treated contact surface that has improved cell recovery compared to an untreated contact surface. The process gas optionally can be nitrogen gas, oxygen gas, or a gas that contains nitrogen atoms, oxygen atoms, or a combination of nitrogen and oxygen atoms. The process optionally improves cell recovery of a chicken embryo cell culture from the treated contact surface.