Pharmaceutical and other packaging with low oxygen transmission rate
Processing an evacuated blood sample collection tube or other vessel by plasma enhanced chemical vapor deposition to apply a tie coating or layer ( 289 ), a barrier coating or layer ( 288 ), and optionally one or more additional coatings or layers. The tie coating or layer of SiOxCy is applied under partial vacuum and, while maintaining the partial vacuum unbroken in the lumen, the barrier coating or layer is applied. Then optionally, while maintaining the partial vacuum unbroken in the lumen, a pH protective coating or layer of SiOxCy can be applied. As a result of this processing, a coated vessel is produced having a lower gas permeation rate constant into the lumen than a corresponding vessel made by the same process except breaking the partial vacuum in the lumen between applying the tie coating or layer and applying the barrier coating or layer. Retention features are also described for keeping the vessels stoppered during exposure to reduced ambient pressure.
1. An evacuated blood collection tube comprising:
a thermoplastic vessel wall; and
a stopper;
the thermoplastic vessel wall having
a top defining an opening,
an inside surface defining a lumen, the inside surface having one or more coatings applied by PECVD,
an outside surface, and
a stopper contact area adjacent to the top, the stopper contact area being a portion of the inside surface that contacts the stopper;
the stopper being seated in the stopper contact area and sealing the lumen;
wherein the stopper contact area is tapered inward between 0 and 1.3 degrees and the entirety of the inside surface below the stopper contact area is tapered inward at least 0.1 degree more than the stopper contact area; and
wherein the stopper contact area is continuous with the inside surface below the stopper contact area.
2. The evacuated blood collection tube of claim 1 , in which the entirety of the inside surface below the stopper contact area is tapered at least 1.5 degrees.
3. The evacuated blood collection tube of claim 1 , the stopper maintaining a vacuum level in the lumen, relative to ambient pressure at sea level, sufficient to draw blood from a patient's vein into the lumen.
4. The evacuated blood collection tube of claim 3 , in which the stopper remains seated in the stopper contact area at a vacuum level of 97.5 kPa below ambient pressure.
5. The evacuated blood collection tube of claim 3 , having a shelf life of at least 6 months, the shelf life defined by the amount of time after evacuation the tube maintains a draw volume capacity of at least 90% of the draw volume capacity of a newly evacuated vessel of the same kind.
6. The evacuated blood collection tube of claim 3 , further comprising a fluid composition in the lumen.
7. The evacuated blood collection tube of claim 6 , wherein the fluid composition comprises a blood anticoagulation agent.
8. The evacuated blood collection tube of claim 7 , wherein the blood anticoagulation agent is a buffered sodium citrate solution.
9. The evacuated blood collection tube of claim 3 , having an oxygen permeation rate constant of from 0.0001 to 0.01 micromol O 2 /(day×cm 2 ×atm).
10. The evacuated blood collection tube of claim 3 , in which the wall has a water vapor transmission rate of less than 2.5 g/m 2 /day at 50° C. and 90% relative humidity.
11. The evacuated blood collection tube of claim 1 , wherein the inside surface comprises:
a barrier layer of SiOx applied by a PECVD coating process, wherein x is from 1.5 to 2.9 as determined by XPS, and
at least one of:
a tie layer of SiOxCy applied by a PECVD coating process, and
a pH protective layer of SiOxCy applied by a PECVD coating process.
12. The evacuated blood collection tube of claim 1 , wherein the inside surface comprises:
a tie layer of SiOxCy applied by a PECVD coating process,
a barrier layer of SiOx applied by a PECVD coating process, wherein x is from 1.5 to 2.9 as determined by XPS, between the tie coating or layer and the lumen, and
a pH protective layer of SiOxCy applied by a PECVD coating process, wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, each as determined by XPS, between the barrier layer and the lumen.
13. The evacuated blood collection tube of claim 1 , in which the stopper contact area is tapered inward between 0.3 and 1 degree.