GinaG

Well, I'm happy to hear someone else is doing that, taking out a unit periodically when testing multiple units in a cooler. I wanted to see if someone else was using the same thought process. That is what I have been doing when testing 6 units over 12 hours; opening the cooler every hour to two and taking out a unit without the probe until one unit is left at 12 hours. When initially setting up our cooler configuration, I validated a number of different ways, including testing 6 units for the entire duration. Then, the temps held 1-6C for 16-24 hours. Opening and closing the cooler, removing a unit periodically, we were able to validate the coolers for 10 hours, using 12 hour trials. We had our AABB/CAP/FDA inspections in the fall and so far this has been ok with them. But, talking to someone at another institution recently, they were just opening and closing their coolers during validation, not removing units. So, it's interesting to see how others approach this. Thank you.

Hi - We use coolers for blood storage (1-6C) in the O.R. and some select locations in the hospital. Validation is performed when new, once/year, and as needed, using LogTag temp recorders with probes inserted in expired RBCs. Two trials per cooler, min (1 RBC) and max (6 RBCs) are performed. When 6 RBCs are validated, one LogTag on either end unit and one in the middle. I was wondering, for those sites using similar type validations, when you test your max capacity, do you open the lid intermittently during the trial or do anything else to try to mimic actual use? Thank you.

Do folks use their cesium irradiator pending dosimetry testing results? We test following annual PM and repairs to the turntable and currently wait for the results that can take up to 10 days.

Hi, Brenda - I work a UCSF. We just purchased two Erytras that are going to be delivered soon. I'm going to be writing the IQ/OQ validation plan (someone else will be writing the PQ), and would like to know if you could share your experience with Grifols regarding their installation/ operational plans. Did you go to their training before creating your validation plan? Did you incorporate Grifols IQ/OQ plans into your validation and get that approved prior to the company coming in and performing the IQ/OQ? I've validated a lot of equipment, just never an analyzer, so any help regarding the best way to proceed with this would be really valuable. Thank you