The AABB Technical Manual states "Irradiation dose to the center of irradiation field must be at least 25 Gy and no more than 50 Gy." Is there any regulation that prohibits a dose of more than 50 Gy? I'm asking because I'm concerned that if we irradiate a product more than once, it will have a cumulative dose of slightly over 50 Gy since our initial dose is about 27 Gy. Basically, I'm looking for information to back up my opinion that we shouldn't re-irradiate a product. Any suggestions?

According to the FDA you cannot exceed 5000 cGy. You can irradiate a product more than once as long as you note each irradiation and the cumulative dose is no more than 5000 cGy. I had a similar question several months ago.

Is there any current documentation that FDA won't allow it? The only place I ever recall seeing it in writing was in a Guidance for Industry regarding a pilot licensing program for irradiated products. Unfortunately, I believe that guidance has been removed from use.

I appreciate the help!

Why would you re-irradiate a product?

The only reason I can recall is if there was no Radsure on the product.