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1. WO2020118275 - SYSTÈMES DE SERINGUES ET DE JOINTS AMÉLIORÉS

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

CLAIMS

1. A process for making one or more continuous channels in a film residing on at least a circumferential outer surface portion of a gasket, the gasket comprising a main body made of an elastic material, the main body having a circumferential surface portion and an internal cavity in its center, the cavity being defined by an inner surface portion of the gasket and being open at one end, the process comprising the following steps:

(a) inserting a portion of one end of a mandrel into the open end of the cavity;

(b) securing the gasket to the mandrel;

(c) positioning the mandrel and secured gasket in proximity to a laser; and

(d) applying a laser beam emitted from the laser to one or more selected locations on a surface portion of the film residing on the circumferential outer surface portion of the gasket while rotating the mandrel and the secured gasket along the mandrel’s longitudinal axis to produce one or more continuous channels in the film, the channels extending around the entire circumference of a circumferential outer surface of the gasket.

2. The process of claim 1, wherein the thickness of the film on the surface of the gasket prior to step (d) is about 10-30 microns, about 15-35 microns, about 20-50 microns, or about 20 microns.

3. The process of claim 1 or 2, wherein the film has one or more of good slidability and chemical stability.

4. The process of any one of claims 1-2, wherein the film is capable of preventing migration of components from the elastic material of the gasket.

5. The process of any one of claims 1-4, wherein the gasket is secured to the mandrel by press-fit assembly.

6. The process of claim 5, wherein the diameter of at least a part of the mandrel portion that is inserted into the internal cavity of the gasket is greater than the inner diameter of the cavity.

7. The process of any one of claims 1-6, wherein when more than one channel is produced, the channels are axially spaced.

8. The process of any one of claims 1-7, wherein the one or more channels have axially opposed first and second side walls and a floor.

9. The process of any one of claims 1-8, wherein the one or more channels each independently have an axial width between the side walls selected from 1-100 microns, 5-50 microns, 10-30 microns, and 15-25 microns.

10. The process of any one of claims 1-9, wherein the one or more channels each independently have a radial depth selected from 0-100 microns, 5-50 microns, 10-30 microns, and 15-25 microns.

11. The process of any one of claims 1-10, wherein the one or more channels each independently have a laser-cut depth selected from 20-80 microns, 30-60 microns, 40-50 microns, 50-60 microns, 40-45 microns, 45-50 microns, 50-55 microns and 55-60 microns.

12. The process of any one of claims 1-11, wherein the one or more channels extend through the film into the outer surface portion of the gasket.

13. The process of any one of claims 1-12, wherein the one or more channels comprise a first circumferentially extending lip located adjacent to the first side wall of the channel and extending radially above the film.

14. The process of claim 13, wherein the one or more channels further comprise a second circumferentially extending lip located adjacent to the second side wall and extending radially above the film.

15. The process of claim 13 or 14, wherein the first and second lips independently have a peak height selected from 10-100 microns, 15-60 microns, 20-50 microns, or 30-40 microns.

16. The process of any one of claims 13-15, wherein the first and second lips of each of the one or more channels independently have a peak width selected from 200-1,000 micron,

275-550 microns, 300-400 microns, or 450-500 microns.

17. The process of any one of claims 13-16, wherein each lip comprises film material.

18. The process of any one of claims 13-16, wherein each lip comprises film material displaced from the channel by the laser beam as the channel is produced.

19. The process of any one of claims 13-18, wherein at least one lip is capable of being positioned in a tubular syringe barrel so as to form a seal against the inner surface of the barrel.

20. The process of any one of any one of claims 1-19, wherein the position of the laser relative to the mandrel and secured gasket is controlled by a servo-motor.

21. The process of any one of claims 1-20, wherein the film is a fluoropolymer film.

22. The process of claim 21, wherein the fluoropolymer film is polytetrafluoroethylene (PTFE).

23. The process of any one of claims 1-22, wherein the elastic material comprises bromobutyl rubber.

24. The process of any one of claims 1-23, wherein an inner surface of the film is treated prior to being applied to an outer surface portion of the gasket to promote adhesion to said outer surface portion.

25. The process of claim 24, wherein the inner surface of the film is corona treated.

26. The process of claim 24, wherein the inner surface of the film is chemically treated.

27. The process of any one of claims 1-26, wherein the dimensional tolerance of gaskets capable of being used in the process is selected from ± 100 micron, ± 50 microns, ± 35 microns, ± 25 microns, ± 20 microns, ± 15 microns, ± 10 microns, ± 5 microns, or ± 3 microns.

28. The process of any one of claims 1-27, wherein the gasket has fewer than 300 particles of 2 micron size or more, measured using light obscuration (LO) or microflow imaging (MFI).

29. A matched syringe and plunger system comprising:

(a) a tubular syringe barrel;

(b) a plunger located inside the syringe barrel and being reciprocally movable longitudinally in the barrel; and

(c) a gasket attached to the distal end of the plunger; the gasket comprising a main body made of an elastic material, the main body having a circumferential outer surface portion and an internal cavity in its center, the cavity being defined by an inner surface portion of the gasket and being open at one end, wherein the gasket is characterized by one or more continuous channels made according to a process comprising the following steps:

(i) inserting a portion of one end of a mandrel into the open end of the cavity;

(ii) securing the gasket to the mandrel;

(iii) positioning the mandrel and secured gasket in proximity to a laser; and

(iv) applying a laser beam emitted from the laser to one or more selected locations on a surface portion of the film residing on the circumferential outer surface portion of the gasket while rotating the mandrel and the secured gasket along the mandrel’s longitudinal axis to produce one or more continuous channels in the film, the channels extending around the entire circumference of a circumferential outer surface of the gasket.

30. The system of claim 29, wherein the gasket is attached to the plunger by press-fit assembly.

31. The system of claim 30, wherein the syringe barrel contains an injectable fluid distal of the gasket.

32. The system of any one of claims 29-31, having a container closure integrity (CCI) with a defect rate of no more than 6-sigma.

33. The system of any one of claims 29-32, wherein the plunger and attached gasket has a break loose force between 4 and 20 Newtons (N).

34. The system of any one of claims 29-33, wherein the plunger and attached gasket has a glide force between 4 and 20 Newtons (N).

35. The system of claim 33 or 34, wherein the break loose force or glide force changes less than about 10-30% over a two-year storage life.

36. The system of any one of claims 29-35, wherein the syringe barrel comprises a wall having an inner surface coated with a lubricity layer having the atomic ratios 1 atom of Si:

0.5 to 2.4 atoms of O: 0.6 to 3 atoms of C measured by x-ray photoelectron spectroscopy (XPS).

37. The system of claim 36, wherein the syringe barrel further comprises a trilayer coating between the inner surface of the wall and the lubricity coating, wherein the trilayer comprises a tie coating, a barrier coating, and a pH protective coating; wherein

(a) the tie coating comprising SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating having an outer surface facing the inner surface of the wall and the tie coating having an interior surface facing the lumen of the syringe barrel;

(b) the barrier coating comprising SiOx, wherein x is from 1.5 to 2.9, the barrier coating being from 2 to 1000 nm thick, the barrier coating having an outer surface facing the interior surface of the tie coating and the barrier coating having an interior surface facing the lumen of the syringe barrel; and

(c) the pH protective coating comprising SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating having an outer surface facing the interior surface of the barrier coating and an interior surface facing the lumen of the syringe barrel.

38. The system of claim 36 or 37, wherein the lubricity layer is capable of reducing one or both of the sticktion and sliding friction of the gasket in the barrel, compared to one or both of the sticktion and sliding friction of the gasket in the barrel absent the lubricity layer.

39. The system of any one of claims 29-38, wherein the film is a fluoropolymer film.

40. The system of any one of claims 29-39, wherein the fluoropolymer film is pol ytetrafl uoroethyl en e (PTFE).

41. The system of any one of claims 29-40, wherein the one or more of said channels improve the container closure integrity of the syringe components when assembled to form a prefilled syringe, compared to an otherwise substantially similar prefilled syringe which does not include a channel produced by said process.

42. The system of claim 41, wherein the improvement is a longer shelf life.

43. The system of claim 41 or 42, wherein the improvement is measured by vacuum decay leak detection method.

44. The system of claim 41 or 42, wherein the improvement is measured by a liquid CCI test method.

45. The matched syringe and plunger system of any one of claims 29-44, wherein the syringe barrel has a wall including an inner surface defining a generally cylindrical lumen, the barrel having an inner diameter;

the gasket having a leading face, a side surface, a trailing portion, and an outer diameter;

the gasket configured to be received within any the barrel with the gasket outer diameter located within and movable with respect to the barrel inner diameter; and

the barrel and gasket of the system respectively sized to provide spacing between the smallest barrel inner diameter and largest gasket outer diameter, when assembled, deviating from the nominal spacing by no more than: ± 100 microns, ± 50 microns, ± 35 microns, ± 25 microns, ± 20 microns, ± 15 microns, ± 10 microns, ± 5 microns or ± 2 microns.

46. A gasket comprising

(a) a main body made of an elastic material, the main body having a circumferential surface portion and an internal cavity, the cavity being defined by an inner surface portion of the gasket and being open ended at one end;

(b) a film residing on at least a circumferential outer portion of the gasket; and

(c) one or more continuous channels in the film, the channels extending around the entire circumferential outer surface of the subject;

wherein the gasket has one or more of the following characteristics:

(i) a container closure integrity (CCI) when assembled within a matched syringe and plunger system with a defect rate of no more than 6-sigma;

(ii) a break loose force between 4 and 20 Newtons (N) when assembled within a matched syringe and plunger system;

(iii) a glide force between 4 and 20 Newtons (N) when assembled within a matched syringe and plunger system;

wherein the break loose force or glide force changes less than about 10-30% over a two-year storage life.