Terminal sterilization of injectable collagen products

Details Terminal sterilization of injectable collagen products Terminal sterilization of injectable collagen products

2011-03-08

2011-03-08

Desai, Anand U (Department: 1656)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

C435S001300, C435S031000, C435S446000, C435S287400, C530S356000

Reexamination Certificate

active

07902145

ABSTRACT:
Methods of sterilizing dermal fillers and injectable collagen material have been developed which reduce the level of active biological contaminants or pathogens without adversely affecting the material, i.e., wherein the dermal fillers and injectable collagen material retain their same properties before and after its terminal sterilization. In one embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation contains the steps of protecting the filler or material from radiation, and irradiating the filler or material with a suitable dose of radiation for a time and at a rate effective to sterilize the filler or injectable material. In a preferred embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation includes the steps of a) freezing the filler or material at a temperature below its freezing temperature, which is generally below 0° C. and b) irradiating the filler or material with a suitable dose of radiation at an effective rate for a time effective to sterilize the filler or material. The exposure of the radiation differs depending upon the density of the filler or material, but is preferably between 5 kGy and 12 kGy and more preferably between 6 kGy and 8 kGy. These doses result in a sterility assurance level (SAL) of 10−6SAL for the filler or material.

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