20-01-2022 дата публикации
Номер: US20220016348A1
Принадлежит:
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. 1. A primary drug container comprising:a wall having an internal surface defining a lumen; and{'sub': x', 'y', 'z, 'claim-text': x is between 0.5 and 2.4 as measured by x-ray photoelectron spectroscopy (XPS),', 'y is between 0.6 and 3 as measured by XPS; and', 'z is between 2 and 9 as measured by Rutherford backscattering; and, 'a PECVD drug-contact coating on or adjacent to the internal surface and positioned to contact a fluid in the lumen, in which the drug-contact coating consists essentially of SiOCH, in which'}a polypeptide composition contained in the lumen in contact with the PECVD drug-contact coating;the primary drug container containing between a lower limit of 1,000, alternatively 2,000, alternatively 3,000, and an upper limit of 100,000, alternatively 75,000, alternatively 50,000, alternatively 25,000, alternatively 20,000, alternatively 18,000, alternatively 16,000, alternatively 14,000, alternatively 12,000, alternatively 10,000, alternatively 8,000, alternatively 6,000, alternatively 4,000, alternatively 3,000 particles having effective spherical diameters greater than 2 and no more than 10 micrometers (μm) per mL of solution;in which the particle count is measured by filling the primary drug container with 1 mg/mL IVIg in 250 mM glycine pH 4.25 with 0.02% (v/v) PS20 and rotating the primary container end-over end at room temperature for ...
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