Hello,

Did anyone validated a new Irradiator? I was wondering what are requirements for validation,

 

Thank you,

We have a Best Theratronics Raycell X-Ray Irradiator.

We have the paperwork from the technician that installed or repaired the unit - they do extensive testing and verification of the dose delivered. 

We send a test shot phantom (contract with MD Anderson's Radiation Dosimetry Services (RDS@MDAnderson.org) (713-745-8999) twice a year to document the dose delivered.  We would have to have a test shot after any repair too.  You would have to have a documented test shot with documentation of the dose delivered to start operating.

Every time we get a new lot # of indicator tags, I run new tags from each box against tags from the current lot number, to check for duplicate functionality.  

We are FDA inspected - they have never asked for anything else.

Ask your manufacturer - they should have some suggestions too. 

Edited October 13, 20195 yr by carolyn swickard

I forgot - you also have to have a documented training program for all users and establish competency with the irradiator functions and any computer work (relabeling, etc. )  that will need doing on all irradiated units.  

You have to at least REGISTER with the FDA (if in the USA) because irradiation is considered a manufacturing step and that makes you a producer.... (YEAH!! - such fun)

Can anyone give my a ballpark price on purchase of an X-ray irradiator?  Probably not the Raycell unless their parts and service TAT have improved and they have a smaller footprint.  I need an idea if it is $50 or more like $500K.  Thanks.

In 2016 we paid around $250K for a Rad Source 3400 Blood X-ray Irradiator with installation and earthquake bracking plus we pay around $13K for annual PM and services calls (parts, tech and travel included).  They're service is top notch and we're never down for more than 24 hours and it's a workhorse that can irradiate 12 units at once (2 per canister with capacity to irradiate 6 canisters at once).  Oh and you can irradiate blood and platelets at the same time just not in the same canister.  The newer models have a much smaller footprint than the one we have.  https://www.radsource.com/  

No I'm not a spokes person I just really love our irradiator!!