Sterilization process design for a medical adhesive

摘要

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.

主权项

1. A method for sterilizing a medical adhesive, the method comprising:
enclosing the medical adhesive in a first housing; 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; and operating an 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 10% or less of a pre-sterilization viscosity of the medical adhesive.