Sterilized chlorhexidine article and method of sterilizing a chlorhexidine article
The present disclosure provides a sterilized chlorhexidine product for topical disinfection. The product includes a sterilized chlorhexidine gluconate composition, an applicator for facilitating application of the sterilized chlorhexidine composition, and a barrier configured to be compromised to impregnate the applicator with the sterilized chlorhexidine gluconate composition. The sterilized chlorhexidine gluconate composition includes chlorhexidine gluconate and alcohol.
1. A sterilized chlorhexidine product for topical disinfection, said sterilized chlorhexidine product comprising:
a sterilized chlorhexidine gluconate composition;
an applicator for facilitating application of the sterilized chlorhexidine composition; and
a barrier configured to be compromised to impregnate the applicator with the sterilized chlorhexidine gluconate composition;
wherein the sterilized chlorhexidine gluconate composition comprises chlorhexidine gluconate and alcohol.
2. The sterilized chlorhexidine product of claim 1 , comprising the sterilized chlorhexidine gluconate composition in an amount between 0.1 and 100 mL.
3. The sterilized chlorhexidine product of claim 1 , wherein the sterilized chlorhexidine gluconate composition comprises chlorhexidine gluconate in an amount of from 1.5 to 5.0 wt. % based on the total weight of said sterilized antiseptic composition and the alcohol in an amount of at least 50 wt. % based on a total weight of said sterilized antiseptic composition.
4. The sterilized chlorhexidine product of claim 3 , wherein the sterilized chlorhexidine gluconate composition comprises chlorhexidine gluconate in an amount of 2.0 wt. % based on the total weight of said sterilized antiseptic composition and the alcohol in an amount of 70 wt. % based on a total weight of said sterilized antiseptic composition.
5. The sterilized chlorhexidine product of claim 1 , wherein the alcohol is isopropyl alcohol.
6. The sterilized chlorhexidine product of claim 1 , wherein the sterilized chlorhexidine gluconate composition further comprises water.
7. The sterilized chlorhexidine product of claim 1 , wherein the sterilized chlorhexidine gluconate composition further comprises one or more additives selected from the group consisting of a sterilized surfactant, a sterilized pH adjuster, a sterilized odorant, a sterilized colorant, a sterilized stabilizer, a sterilized skin protectant, a sterilized preservative, or combinations thereof.
8. The sterilized chlorhexidine product of claim 7 , wherein the additive is a colorant.
9. The sterilized chlorhexidine product of claim 7 , wherein the additive is a skin protectant.
10. The sterilized chlorhexidine product of claim 1 , wherein said sterilized chlorhexidine article has a sterility assurance level of from 10-3 to 10-9.
11. The sterilized chlorhexidine product of claim 1 , wherein the applicator comprises a foam.
12. A method of using a sterilized chlorhexidine article, said method comprising:
providing a sterilized chlorhexidine article, the sterilized chlorhexidine article comprising:
a sterilized chlorhexidine gluconate composition comprising chlorhexidine gluconate and alcohol;
an applicator for facilitating application of the sterilized chlorhexidine; and
a barrier between the sterilized chlorhexidine gluconate composition and the applicator;
compromising the barrier to impregnate the applicator with the sterilized chlorhexidine gluconate composition; and
applying the sterilized chlorhexidine gluconate composition to a patient's skin using the applicator.
13. The method of claim 12 , wherein the applicator is impregnated with 0.1 to 100 mL of the sterilized chlorhexidine gluconate composition.
14. The method of claim 12 , wherein the sterilized chlorhexidine gluconate composition comprises chlorhexidine gluconate in an amount of from 1.5 to 5.0 wt. % based on the total weight of said sterilized antiseptic composition and the alcohol in an amount of at least 50 wt. % based on a total weight of said sterilized antiseptic composition.
15. The method of claim 12 , wherein the alcohol is isopropyl alcohol.
16. The method of claim 12 , wherein the sterilized chlorhexidine gluconate composition further comprises water.
17. The method of claim 12 , wherein the sterilized chlorhexidine gluconate composition further comprises one or more additives selected from the group consisting of a sterilized surfactant, a sterilized pH adjuster, a sterilized odorant, a sterilized colorant, a sterilized stabilizer, a sterilized skin protectant, a sterilized preservative, or combinations thereof.
18. The method of claim 17 , wherein the additive is a colorant or a skin protectant.
19. The method of claim 12 , wherein said sterilized chlorhexidine article has a sterility assurance level of from 10 −3 to 10 −9 .