I know that when a product is irradiated, 25 Gy must be in the central portion of bag and at least 15 Gy to the entire bag. I am wondering, does it matter whether using a 25 Gy indicator and placing in central portion of bag or should we use 15 Gy indicator and place in periphery? Wondering what everyone else does. Thanks in advance for the input.

We put 25 Gy indicators towards the top of the unit, above the label.

Scott

Same as SMILLER

I have actually seen places that perform an irradiation "Mapping" of their units - shows the dosage throghout the bag. They place them on the top also.

Are we out of compliance if we use the 15 Gy indicator and place on the edge of the units? Does anyone know? Thanks!!

The gist of the regs seem to be that 25 Gy reach the center of the unit (with at least 15 Gy overall). So if you also have a 25 Gy one there I think you are covered. I am not really sure what we have downstairs here to prove that our system is validated. The only other reg I can see is that you cannot exceed 59 Gy anywhere on the unit.

Scott

We use the Best Theratronics Raycell X-ray Gamma irradiator and since the field is circular, we temporarily place the 25 Gy X-ray irradiation indicator (from ISP Rad Sure) somewhere on the label where it will be in the center of the field during the shot and then move it to above the label (it is approved for direct contact with the blood bag) when labeling the unit after it has been irradiated. The FDA inspectors have been happy with that so far.

We use a 15Gy indicator placed at the top of the bag.

We have been doing irradiation for many years and are inspected by FDA, with no problems as to use of the indicators. My inderstanding is that these are used as QC indicators for the batch and do not actually "measure" the specific amount of irradiation delivered--but rather show that the batch was actually exposed to radiation. The dosimetry which is periodically required (annually for CS137) measures the dose delivered to various parts of the canister and ensures the 2500 Gy at midpoint and 1500 Gy overall.

Thank you to everyone who has replied. I appreciate your input.

We have been doing irradiation for many years and are inspected by FDA, with no problems as to use of the indicators. My inderstanding is that these are used as QC indicators for the batch and do not actually "measure" the specific amount of irradiation delivered--but rather show that the batch was actually exposed to radiation. The dosimetry which is periodically required (annually for CS137) measures the dose delivered to various parts of the canister and ensures the 2500 Gy at midpoint and 1500 Gy overall.

Indeed this is true.

We have been doing irradiation for many years and are inspected by FDA, with no problems as to use of the indicators. My inderstanding is that these are used as QC indicators for the batch and do not actually "measure" the specific amount of irradiation delivered--but rather show that the batch was actually exposed to radiation. The dosimetry which is periodically required (annually for CS137) measures the dose delivered to various parts of the canister and ensures the 2500 Gy at midpoint and 1500 Gy overall.

Agree with Dwharrell, the indicators are not dosimeters. They simply show that the unit was exposed to irradiation. So the placement on the unit should not matter. I believe the indications for use states this.

Agree. Yes put the indicators (anywhere) but the annual mappred dosimetry is required and very reassuring when it returns, it will help you adjust the time if need be,