Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus
A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O 2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.
1. A vessel comprising:
a thermoplastic wall having an interior surface enclosing a lumen;
a barrier coating or layer of SiO x , in which x is between 1.5 and 2.9, positioned between the interior surface of the thermoplastic wall and the lumen, and supported by the thermoplastic wall, the barrier coating or layer being effective to reduce the ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating or layer; and
a passivation layer or pH protective coating of SiO x C y , in which x is between 0.5 and 2.4 and y is between 0.6 and 3, positioned between the barrier coating or layer and the lumen, and supported by the thermoplastic wall, the passivation layer or pH protective coating being effective to decrease the silicon dissolution rate from the vessel.
2. The vessel of claim 1 , wherein the passivation layer or pH protective coating is effective to provide a silicon dissolution rate from the vessel by a 50 mM potassium phosphate buffer diluted in water, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant, that is less than 170 ppb/day.
3. The vessel of claim 2 , wherein the passivation layer or pH protective coating is effective to provide a silicon dissolution rate from the vessel by a 50 mM potassium phosphate buffer diluted in water, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant, that is less than 140 ppb/day.
4. The vessel of claim 3 , wherein the passivation layer or pH protective coating is effective to provide a silicon dissolution rate from the vessel by a 50 mM potassium phosphate buffer diluted in water, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant, that is less than 120 ppb/day.
5. The vessel of claim 4 , wherein the passivation layer or pH protective coating is effective to provide a silicon dissolution rate from the vessel by a 50 mM potassium phosphate buffer diluted in water, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant, that is less than 100 ppb/day.
6. The vessel of claim 5 , wherein the passivation layer or pH protective coating is effective to provide a silicon dissolution rate from the vessel by a 50 mM potassium phosphate buffer diluted in water, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant, that is less than 80 ppb/day.
7. The vessel of claim 1 , wherein the rate of erosion of the passivation layer or pH protective coating, if directly contacted by a fluid composition having a pH of 8, is less than 20% the rate of erosion of the barrier coating or layer, if directly contacted by the same composition under the same conditions.
8. The vessel of claim 7 , wherein the rate of erosion of the passivation layer or pH protective coating, if directly contacted by a fluid composition having a pH of 8, is less than 10% the rate of erosion of the barrier coating or layer, if directly contacted by the same composition under the same conditions.
9. The vessel of claim 8 , wherein the rate of erosion of the passivation layer or pH protective coating, if directly contacted by a fluid composition having a pH of 8, is less than 7% the rate of erosion of the barrier coating or layer, if directly contacted by the same composition under the same conditions.
10. The vessel of claim 1 , further comprising a fluid having a pH greater than 5 disposed in the lumen.
11. The vessel of claim 10 , in which the passivation layer or pH protective coating contacting the fluid is between 20 and 700 nm thick two years after the fluid is disposed in the vessel.
12. The vessel of claim 11 , in which the passivation layer or pH protective coating contacting the fluid is between 100 and 400 nm thick two years after the fluid is disposed in the vessel.
13. The vessel of claim 10 , in which the fluid-containing vessel has a minimum shelf-life, determined at 4° C., of at least one year and the thickness of the passivation layer or pH protective coating is at least 80 nm at the end of the shelf life.
14. The vessel of claim 13 , in which the thickness of the passivation layer or pH protective coating is at least 150 nm at the end of the shelf life.
15. The vessel of claim 10 , in which the fluid removes the passivation layer or pH protective coating at a rate of 1 nm or less of passivation layer or pH protective coating thickness per 44 hours of contact.
16. The vessel of claim 15 , in which the fluid removes the passivation layer or pH protective coating at a rate of 1 nm or less of passivation layer or pH protective coating thickness per 88 hours of contact.
17. The vessel of claim 16 , in which the fluid removes the passivation layer or pH protective coating at a rate of 1 nm or less of passivation layer or pH protective coating thickness per 350 hours of contact.
18. The vessel of claim 10 , the passivation layer or pH protective coating being effective to increase the calculated shelf life (total Si/Si dissolution rate) of the fluid-containing vessel, such that the calculated shelf life of the fluid-containing vessel is more than six months at a storage temperature of 4° C.
19. The vessel of claim 18 , wherein the calculated shelf life of the fluid-containing vessel is more than 1 year.
20. The vessel of claim 19 , wherein the calculated shelf life of the fluid-containing vessel is more than 2 years.