Blood sample collection tube
A blood sample collection tube and other vessels are described including an article surface and a coating set comprising a tie coating or layer of SiOxCy or SiNxCy applied to the article surface, a barrier coating or layer of SiOx, and a pH protective layer of SiOxCy or SiNxCy. The vessels optionally contain a fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the vessel.
1. A blood sample collection tube comprising:
a wall having a surface and a coating set on the surface comprising a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer;
the tie coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the wall surface and the tie coating or layer having an interior surface;
the barrier coating or layer comprising SiO x , wherein x is from 1.5 to 2.9, from 2 to 1000 nm thick, the barrier coating or layer of SiO x having an outer surface facing the interior surface of the tie coating or layer and the barrier coating or layer of SiO x having an interior surface, the barrier coating or layer being effective to reduce the ingress of atmospheric gas through the wall compared to an uncoated wall; and
the pH protective coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, on the barrier coating or layer, the pH protective coating or layer being formed by chemical vapor deposition of a precursor selected from an acyclic siloxane, a monocyclic siloxane, a polycyclic siloxane, a polysilsesquioxane, a monocyclic silazane, a polycyclic silazane, a polysilsesquiazane, a silatrane, a silquasilatrane, a silproatrane, an azasilatrane, an azasilquasiatrane, an azasilproatrane, or a combination of any two or more of these precursors; and
in which the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH at some point between 5 and 9, is less than the rate of erosion of the barrier coating or layer, if directly contacted by the fluid composition.
2. The blood sample collection tube of claim 1 , in which the pH protective coating or layer as applied is between 100 and 700 nm thick.
3. The blood sample collection tube of claim 1 , in which the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH of 8, is less than 20% of the rate of erosion of the barrier coating or layer, if directly contacted by the same fluid composition under the same conditions.
4. The blood sample collection tube of claim 1 , in which the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH of 8, is from 5% to 20% of the rate of erosion of the barrier coating or layer, if directly contacted by the same fluid composition under the same conditions.
5. The blood sample collection tube of claim 1 , in which the silicon dissolution rate by a 50 mM potassium phosphate buffer diluted in water for injection, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant from the vessel is less than 170 ppb/day.
6. The blood sample collection tube of claim 1 , in which x is between 0.5 and 1.5 and y is between 0.9 and 2.
7. The blood sample collection tube of claim 1 , in which the tie coating or layer on average is between 10 and 100 nm thick.
8. The blood sample collection tube of claim 1 in which the barrier coating or layer on average is between 10 and 100 nm thick.
9. The blood sample collection tube of claim 1 in which the range of thickness of the pH protective coating or layer is between 50 and 400 nm thick.
10. The blood sample collection tube of claim 1 , in which an FTIR absorbance spectrum of the pH protective coating or layer has a ratio greater than 0.75 between:
the maximum amplitude of the Si—O—Si symmetrical stretch peak between about 1000 and 1040 cm−1, and
the maximum amplitude of the Si—O—Si asymmetric stretch peak between about 1060 and about 1100 cm −1 .
11. The blood sample collection tube of claim 10 , in which the ratio is at most 1.7.
12. The blood sample collection tube of claim 1 , wherein the pH protective coating or layer shows an O-Parameter measured with attenuated total reflection (ATR) of less than 0.4, measured as:
O
-
Parameter
=
Intensity
at
1253
cm
-
1
Maxium
intensity
in
the
range
1000
to
1100
cm
-
1
.
13. The blood sample collection tube of claim 12 , in which the O-parameter has a value of from 0.15 to 0.37.
14. The blood sample collection tube of claim 1 , wherein the pH protective coating or layer shows an N-Parameter measured with attenuated total reflection (ATR) of less than 0.7, measured as:
N
-
Parameter
=
Intensity
at
840
cm
-
1
Intensity
at
799
cm
-
1
.
15. The blood sample collection tube of claim 14 , in which the N-parameter has a value of 0.4 to 0.6.
16. A blood sample collection tube comprising:
a vessel having a lumen defined at least in part by a wall, the wall having an interior surface facing the lumen, an outer surface, and a coating set on the interior surface comprising a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer;
the tie coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an interior surface facing the lumen and an outer surface facing the wall interior surface;
the barrier coating or layer comprising SiO x , wherein x is from 1.5 to 2.9, from 2 to 1000 nm thick, the barrier coating or layer of SiO x having an interior surface facing the lumen and an outer surface facing the interior surface of the tie coating or layer, the barrier coating or layer being effective to reduce the ingress of atmospheric gas into the lumen compared to an vessel without a barrier coating or layer;
the pH protective coating or layer comprising SiO x C y or SiN x C y 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 or layer having an interior surface facing the lumen and an outer surface facing the interior surface of the barrier coating or layer,
the combination of the tie coating or layer and the pH protective coating or layer being effective to increase the calculated shelf life of the package (total Si/Si dissolution rate); and
a fluid composition contained in the lumen and having a pH between 5 and 9; wherein the calculated shelf life of the blood sample collection tube more than six months at a storage temperature of 4° C.
17. A blood sample collection tube comprising:
a thermoplastic wall having an interior surface enclosing a lumen;
a fluid contained in the lumen having a pH greater than 5 disposed in the lumen;
a tie coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the wall surface and the tie coating or layer having an interior surface;
a barrier coating or layer of SiO x , in which x is between 1.5 and 2.9, the barrier coating or layer applied by PECVD, positioned between the interior surface of the tie coating or layer and the fluid, and supported by the thermoplastic wall, the barrier coating or layer having the characteristic of being subject to being measurably diminished in barrier improvement factor in less than six months as a result of attack by the fluid; and
a pH protective coating or layer of SiO x C y , in which x is between 0.5 and 2.4 and y is between 0.6 and 3, the pH protective coating or layer applied by PECVD, positioned between the barrier coating or layer and the fluid and supported by the thermoplastic wall, the pH protective coating or layer and tie coating or layer together being effective to keep the barrier coating or layer at least substantially undissolved as a result of attack by the fluid for a period of at least six months.
18. The blood sample collection tube of claim 17 , in which the fluid composition has a pH between 5 and 6.
19. The blood sample collection tube of claim 17 , in which the fluid composition has a pH between 6 and 7.
20. The blood sample collection tube of claim 17 , in which the fluid composition has a pH between 7 and 8.
21. The blood sample collection tube of claim 17 , in which the fluid composition has a pH between 8 and 9.
22. The blood sample collection tube of claim 17 , in which the pH protective coating or layer contacting the fluid composition is between 50 and 500 nm thick two years after the invention is assembled.
23. The blood sample collection tube of claim 17 , in which the calculated shelf life (total Si/Si dissolution rate) is more than 18 months.
24. The blood sample collection tube of claim 17 , in which the calculated shelf life (total Si/Si dissolution rate) is more than 2 years.
25. The blood sample collection tube of claim 17 , having a shelf life, after the invention is assembled, of at least two years.
26. The blood sample collection tube of claim 25 , in which the shelf life is determined at 20° C.