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 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.
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:
An apparatus and methods for testing the integrity of a barrier coating on a vessel. An off gas test fixture includes a face seal positioned about an opening of the vessel. A side seal is positioned about a portion of the vessel's wall and separated from the face seal by a space. Additionally, a cover may be secured to the fixture that encompasses an interface portion of the fixture and the vessel. Before and/or during testing, gas in the space between the side and face seals may be evacuated, as well as gas present in an interior area of the vessel. The vessel may be exposed to test gas(es) that is soluble by the plastic material of the vessel before and/or after being secured to the fixture. During testing, test gas(es) desorbed by the vessel may be evacuated, with the molecular flow being measured using a mass extraction unit.
Abstract:
A method is disclosed in which a vapor-deposited coating or layer is directly or indirectly applied to at least a portion of the internal wall of the barrel of a capped pre-assembly comprising a barrel, a dispensing portion, and a shield. The shield is secured to the barrel and at least substantially isolates the distal opening of the dispensing portion from pressure conditions outside the shield. A vapor-deposited coating or layer is applied directly or indirectly to at least a portion of the internal wall of the barrel while the pre-assembly is capped. The coating or layer is applied under conditions effective to maintain communication between the barrel lumen and the dispensing portion lumen via the proximal opening at the end of the applying step. The capped pre-assembly can be pressure tested easily and rapidly, for example with a test duration between 1 and 60 seconds, to determine whether it has container closure integrity.
Abstract:
A medical device comprising a wall, a coating of SiO x , and a piezochromic material is disclosed. The piezochromic material is associated with the wall, and changes its appearance when the wall is exposed to mechanical stress exceeding a threshold intensity. Also disclosed is a method of interrogating a closed medical device for processing damage, comprising at least the acts of providing a closed medical device and inspecting the medical device. The medical device is inspected from the exterior for a change in the appearance of at least some of its piezochromic material that is characteristic of exposure of the wall to mechanical stress exceeding a threshold intensity greater than zero. Optionally in any embodiment inspecting is carried out using a spectrophotometer to determine the change in the color of at least some of its piezochromic material.
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:
A method and apparatus for plasma modifying a workpiece such as a medical barrel, medical 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 generally cylindrical interior surface 16 of the generally cylindrical interior surface 16. A vessel made according to the process or using the apparatus described above. A pharmaceutical package comprising the medical barrel or vial containing a pharmaceutical preparation, secured with a closure.
Abstract:
A method for inspecting the product of a coating process is provided. In certain embodiments, the release of at least one volatile species from the coated surface into the gas space adjacent to the coated surface is measured and the result is compared with the result for at least one reference object measured under the same test conditions. Microbalance weighing methods are also disclosed to detect and distinguish among PECVD coatings. Thus the presence or absence of the coating, and/or a physical and/or chemical property of the coating can be determined. The method is useful for inspecting any coated articles, e.g. vessels. Its application on the inspection of PECVD coatings made from organosilicon precursors, especially of barrier coatings, is also disclosed.