Sterilization process design for a medical adhesive
Medical devices, including medical adhesives, need to be sterile before application to a patient. A dry heat sterilization process can sterilize medical adhesives for patient application. The dry heat sterilization process can be validated for particular equipment arrangements and medical adhesives being utilized.
1. A method for sterilizing a medical adhesive, the method comprising:
enclosing the medical adhesive in a first housing, the first housing configured to seal the medical adhesive;
positioning the first housing with the medical adhesive in a tray, the tray configured to secure the first housing in a first predetermined position on the tray;
positioning the tray with the first housing on an oven rack, the oven rack inside an oven; and
operating the oven at a predetermined temperature profile over a time duration to heat the medical adhesive to about the predetermined temperature profile over the time duration sufficient to sterilize the medical adhesive, wherein the predetermined temperature profile includes a temperature range of about 110° C. to about 120° C. and the time duration includes about 2 hours plus a ramp-up time of about 40 minutes, wherein following the sterilization process a post-sterilization viscosity of the medical adhesive is within about 5% of the pre-sterilization viscosity of the medical adhesive.
2. The method of claim 1 , further comprising:
enclosing a biological indicator in a second housing, the second housing configured to seal the biological indicator, the biological indicator configured to indicate whether sterilization has been achieved; and
positioning the second housing with the biological indicator in the tray, the tray configured to secure the second housing in a second predetermined position on the tray.
3. The method of claim 2 , wherein the biological indicator is enclosed in the second housing with the medical adhesive, and wherein the medical adhesive substantially surrounds the biological indicator.
4. The method of claim 1 , further comprising:
enclosing the medical adhesive in a first plurality of housings, the first plurality of housings configured to seal the medical adhesive; and
positioning the first plurality of housings with the medical adhesive in the tray, the tray configured to secure the first plurality of housing in a first plurality of predetermined positions on the tray.
5. The method of claim 4 , wherein the first plurality of housings are heated to substantially a same temperature over the time duration.
6. The method of claim 5 , wherein the first plurality of predetermined positions start at a center of the tray and radiate toward the perimeter as the first plurality of housing are positioned in the tray to help provide the same temperature over the time duration.
7. The method of claim 4 , further comprising:
enclosing a substance not for patient application in a second plurality of housings, the second plurality of housings configured to seal the substance; and
positioning the second plurality of housings with the substance in the tray, the tray configured to secure the second plurality of housing in a second plurality of predetermined positions on the tray;
wherein the second plurality of predetermined positions are substantially at a perimeter of the tray.
8. The method of claim 1 , wherein the medical adhesive comprises a cyanoacrylate.
9. A method for sterilizing a medical adhesive, the method comprising:
enclosing the medical adhesive in a first housing, the first housing configured to seal the medical adhesive;
positioning the first housing with the medical adhesive within an oven; and
operating the oven at a predetermined temperature profile over a time duration to heat the medical adhesive to about the predetermined temperature profile over the time duration sufficient to sterilize the medical adhesive, wherein the predetermined temperature profile includes a temperature range of about 110° C. to about 120° C. and the time duration is no more than about 2 hours plus a ramp-up time of about 40 minutes, wherein following the sterilization process a post-sterilization viscosity of the medical adhesive is within about 5% of the pre-sterilization viscosity of the medical adhesive.
10. The method of claim 9 , further comprising:
enclosing a biological indicator in a second housing, the second housing configured to seal the biological indicator, the biological indicator configured to indicate whether sterilization has been achieved; and
positioning the second housing with the biological indicator in the tray, the tray configured to secure the second housing in a second predetermined position on the tray.
11. The method of claim 10 , wherein the biological indicator is enclosed in the second housing with the medical adhesive, and wherein the medical adhesive substantially surrounds the biological indicator.
12. The method of claim 9 , wherein the medical adhesive comprises a cyanoacrylate.
13. A method for sterilizing a medical adhesive, the method comprising:
enclosing the medical adhesive in a first plurality of housings, the first plurality of housings configured to seal the medical adhesive;
positioning the first plurality of housings with the medical adhesive in a tray, the tray configured to secure the first plurality of housing in a first plurality of predetermined positions on the tray;
positioning the tray with the first plurality of housings on an oven rack, the oven rack inside an oven; and
operating the oven at a predetermined temperature profile over a time duration to heat the medical adhesive to about the predetermined temperature profile over the time duration sufficient to sterilize the medical adhesive, wherein the predetermined temperature profile includes a temperature range of about 110° C. to about 120° C. and the time duration is no more than about 2 hours, wherein following the sterilization process a post-sterilization viscosity of the medical adhesive is within about 5% of the pre-sterilization viscosity of the medical adhesive,
wherein the first plurality of housings are heated to substantially a same temperature over the time duration, wherein the first plurality of predetermined positions start at a center of the tray and radiate toward the perimeter as the first plurality of housing are positioned in the tray.
14. The method of claim 13 , further comprising:
enclosing a biological indicator in a second housing, the second housing configured to seal the biological indicator, the biological indicator configured to indicate whether sterilization has been achieved; and
positioning the second housing with the biological indicator in the tray, the tray configured to secure the second housing in a second predetermined position on the tray.
15. The method of claim 14 , wherein the biological indicator is enclosed in the second housing with the medical adhesive, and wherein the medical adhesive substantially surrounds the biological indicator.
16. The method of claim 13 , wherein the medical adhesive comprises a cyanoacrylate.
17. A method for sterilizing a medical adhesive, the method comprising:
enclosing the medical adhesive in a first housing, the first housing configured to seal the medical adhesive;
positioning the first housing with the medical adhesive within an oven;
measuring a pre-sterilization viscosity of the medical adhesive;
operating the oven at a predetermined temperature profile over a time duration to heat the medical adhesive to about the predetermined temperature profile over the time duration sufficient to sterilize the medical adhesive, wherein the predetermined temperature profile includes a temperature range of about 110° C. to about 120° C. and the time duration is no more than about 2 hours plus a ramp-up time of about 40 minutes; and
measuring a post-sterilization viscosity of the medical adhesive, wherein following the sterilization process the post-sterilization viscosity is within about 5% of the pre-sterilization viscosity of the medical adhesive.
18. The method of claim 17 , further comprising:
enclosing a biological indicator in a second housing, the second housing configured to seal the biological indicator, the biological indicator configured to indicate whether sterilization has been achieved; and
positioning the second housing with the biological indicator in the tray, the tray configured to secure the second housing in a second predetermined position on the tray.
19. The method of claim 18 , wherein the biological indicator is enclosed in the second housing with the medical adhesive, and wherein the medical adhesive substantially surrounds the biological indicator.
20. The method of claim 17 , wherein the medical adhesive comprises a cyanoacrylate.