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, 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 to sterilize the medical adhesive, wherein following sterilization of the medical adhesive, a post-sterilization viscosity of the medical adhesive is within about 5% of a pre-sterilization viscosity of the medical adhesive.