Container with low particulate emission and friction controlled dry sliding surface and methods for producing same
The invention relates to a container comprising a container body having an outer surface and an inner surface, wherein the inner surface contains silicon oxide; and the silicon oxide containing inner surface is at least partially modified with a fluorine containing compound, wherein the fluorine containing compound is chemically bonded to the silicon oxide of the container body via at least one Si—O—Si bond.
1. A container comprising a container body with an outer surface and an inner surface, wherein the inner surface comprises silicon oxide and is at least partially modified with a fluorine containing compound to provide a modified inner surface, wherein the fluorine containing compound is chemically bonded to the silicon oxide via at least one Si—O—Si bond,
wherein the fluorine containing compound is an alkoxysilane compound, the alkoxysilane compound having a structure as follows:
wherein ORe represents an alkoxy group,
wherein the backbone comprises a fluorine containing entity,
wherein the linker includes a functional group selected from the group consisting of at least one of a hydrolyzable group, an amino group, at least one further silane group, an acrylate, and a methacrylate group,
wherein the linker forms bonds between molecules of the alkoxysilane compound,
wherein the linker forms crosslinks between linkers of two or more neighboring fluorine containing compounds in a condensation reaction,
wherein the modified inner surface forms only a partial surface area of the inner surface such that at least one unmodified partial surface remains, and
wherein the at least one unmodified partial surface is bonded to a different material or has an adhesive material is applied.
2. The container as claimed in claim 1 , wherein the container body is a part selected from the group consisting of: a pharmaceutical packaging; a medical device; and a sterile packaging for storing a product.
3. The container as claimed in claim 1 , wherein the alkoxysilane compound has at least one further feature selected from the group consisting of: the alkoxysilane compound comprising a perfluoropolyether as the backbone; the backbone comprising at least one (CF 2 ) 3 chain; the backbone comprising a plurality of (CF 2 ) x entities, for all of which x<8 is met; the backbone comprising [(CF 2 ) x O] n , with 3<n<1000; the backbone comprising further branches in form of linear structures; the backbone comprising further branches in form of branched structures; the backbone comprising further branches in form of cyclic structures; the alkoxysilane compound comprising at least one CF 3 end group; and combinations thereof.
4. The container as claimed in claim 1 , wherein the modified inner surface has a surface density of less than 2,000 particles/cm 2 for any particles of a diameter of ≥2 μm, or wherein in contact with an aqueous solution less than 10,000 particles of a diameter of ≥2 μm per ml of the aqueous solution are released from the modified inner surface into the aqueous solution.
5. The container as claimed in claim 1 , further comprising an elastomeric stopper which is frictionally engaged with the modified inner surface.
6. The container as claimed in claim 1 , wherein the modified inner surface is free of lubricating oils.
7. The container as claimed in claim 1 , wherein the modified inner surface is free of polyorganosiloxane compounds with not more than 5 μg/cm 2 of such compounds normalized to 1 cm 2 of the modified inner surface.
8. The container as claimed in claim 1 , wherein the modified inner surface has at least one feature selected from the group consisting of: a contact angle to water that is greater than 100°; a contact angle to water that is greater than 105°, a contact angle to water that is greater than 110°; a dynamic contact angle that is greater than 110° upon immersion and greater than 90° upon retraction; a dynamic contact angle that is greater than 115° upon immersion and greater than 105° upon retraction; a roll-off angle that is in a range from 1° to 30° as measured for a droplet of 60 μl; a roll-off angle that is in a range from 5° to 20° as measured for a droplet of 60 μl; oleophobic-repellent; protein-repellent; oleophobic; and hydrophobic.
9. The container as claimed in claim 1 , wherein the modified inner surface has friction reducing properties that are maintained even after accelerated storage in water or phosphate buffer of pH 7 at storage conditions of 40° C. and 28 days.
10. The container as claimed in claim 1 , further comprising at least one material or substrate property selected from the group consisting of: the container body being made of glass of hydrolytic class 1 or 2; the container body being made of borosilicate glass; the container body being made of glass with low particulate surface of less than 2,000 particles/cm 2 for any boron or tungsten or silicon containing particles of a diameter of ≥2 μm; the container body being made of cyclic olefin polymer (COP); the container body being made of cyclic olefin copolymer (COC); the container body being made of plastic with low particulate surface of less than 2,000 particles/cm 2 for any particles of diameters ≥2 μm; the container body being in the form of a syringe body; the container body being in the form of a cartridge body; and the container body being in the form of a medical vial.
11. The use of the container as claimed in claim 1 as a device selected from the group consisting of: a syringe system; a cartridge system; a medical device with low particulate emission; a medical device with a friction controlled surface for storing pharmaceutical drug solutions; and a medical device with a friction controlled surface for storing protein-based pharmaceutical drug formulations.
12. A container comprising a container body with an outer surface and an inner surface, wherein the inner surface comprises silicon oxide and is at least partially modified with a fluorine containing compound to provide a modified inner surface, wherein the fluorine containing compound is chemically bonded to the silicon oxide via at least one Si—O—Si bond, wherein the modified inner surface forms only a partial surface area of the inner surface such that at least one unmodified partial surface remains, and wherein the at least one unmodified partial surface is bonded to a different material or has an adhesive material is applied.
13. The container as claimed in claim 12 , wherein the container body is a part selected from the group consisting of: a pharmaceutical packaging; a medical device; and a sterile packaging for storing a product.
14. The container as claimed in claim 12 , wherein the fluorine containing compound is an alkoxysilane compound, the alkoxysilane compound having a structure as follows:
wherein ORe represents an alkoxy group, and wherein the backbone comprises a fluorine containing entity.
15. The container as claimed in claim 14 , wherein the alkoxysilane compound has at least one feature selected from the group consisting of: the alkoxysilane compound comprising a perfluoropolyether as the backbone; the backbone comprising at least one (CF 2 ) 3 chain; the backbone comprising a plurality of (CF 2 ) x entities, for all of which x<8 is met; the backbone comprising [(CF 2 ) x O] n , with 3<n<1000; the backbone comprising further branches in form of linear structures; the backbone comprising further branches in form of branched structures; the backbone comprising further branches in form of cyclic structures; the alkoxysilane compound comprising at least one CF 3 end group; the linker comprising a hydrolyzable group; the linker comprising an amino group; the linker comprising a carboxamide group —OC—NH—; the linker comprising at least one further silane group; the linker comprising an acrylate; the linker comprising a methacrylate group; and combinations thereof.
16. The container as claimed in claim 12 , wherein the modified inner surface has a surface density of less than 2,000 particles/cm 2 for any particles of a diameter of ≥2 μm, or wherein in contact with an aqueous solution less than 10,000 particles of a diameter of ≥2 μm per ml of the aqueous solution are released from the modified inner surface into the aqueous solution.
17. The container as claimed in claim 12 , further comprising an elastomeric stopper which is frictionally engaged with the modified inner surface.
18. The container as claimed in claim 12 , wherein the modified inner surface is free of lubricating oils.
19. The container as claimed in claim 12 , wherein the modified inner surface is free of polyorganosiloxane compounds with not more than 5 μg/cm 2 of such compounds normalized to 1 cm 2 of the modified inner surface.
20. The container as claimed in claim 12 , wherein the modified inner surface has at least one feature selected from the group consisting of: a contact angle to water that is greater than 100°; a contact angle to water that is greater than 105°, a contact angle to water that is greater than 110°; a dynamic contact angle that is greater than 110° upon immersion and greater than 90° upon retraction; a dynamic contact angle that is greater than 115° upon immersion and greater than 105° upon retraction; a roll-off angle that is in a range from 1° to 30° as measured for a droplet of 60 μl; a roll-off angle that is in a range from 5° to 20° as measured for a droplet of 60 μl; oleophobic-repellent; protein-repellent; oleophobic; and hydrophobic.
21. The container as claimed in claim 12 , wherein the modified inner surface has friction reducing properties that are maintained even after accelerated storage in water or phosphate buffer of pH 7 at storage conditions of 40° C. and 28 days.
22. The container as claimed in claim 12 , further comprising at least one material or substrate property selected from the group consisting of: the container body being made of glass of hydrolytic class 1 or 2; the container body being made of borosilicate glass; the container body being made of glass with low particulate surface of less than 2,000 particles/cm 2 for any boron or tungsten or silicon containing particles of a diameter of ≥2 μm; the container body being made of cyclic olefin polymer (COP); the container body being made of cyclic olefin copolymer (COC); the container body being made of plastic with low particulate surface of less than 2,000 particles/cm 2 for any particles of diameters ≥2 μm; the container body being in the form of a syringe body; the container body being in the form of a cartridge body; and the container body being in the form of a medical vial.
23. The use of the container as claimed in claim 12 as a device selected from the group consisting of: a syringe system; a cartridge system; a medical device with low particulate emission; a medical device with a friction controlled surface for storing pharmaceutical drug solutions; and a medical device with a friction controlled surface for storing protein-based pharmaceutical drug formulations.
24. The container as claimed in claim 14 , wherein the linker forms bonds between molecules of the alkoxysilane compound.
25. A container comprising a container body with an outer surface and an inner surface, wherein the inner surface comprises silicon oxide and is at least partially modified with a fluorine containing compound to provide a modified inner surface, wherein the fluorine containing compound is chemically bonded to the silicon oxide via at least one Si—O—Si bond,
wherein the fluorine containing compound is an alkoxysilane compound, the alkoxysilane compound having a structure as follows:
wherein ORe represents an alkoxy group,
wherein the backbone comprises a fluorine containing entity,
wherein the linker includes a functional group selected from the group consisting of at least one of a hydrolyzable group, an amino group, at least one further silane group, an acrylate, and a methacrylate group,
wherein the linker forms bonds between molecules of the alkoxysilane compound,
wherein the modified inner surface forms only a partial surface area of the inner surface such that at least one unmodified partial surface remains, and
wherein the at least one unmodified partial surface is bonded to a different material or has an adhesive material is applied.