I will be doing a platelet incubator validation. I am struggling with how to make surrogate component bags with thermometers for my maximum load. Any ideas?

Thanks!

Can you use expired platelet?

Thank you, yes I could!!

The fact remains that I need to get a thermometer inside the bag to become a temperature monitoring device. We use to do this all the time with blood bags to do cooler validations. It is a safety issue(breaking the thermometer) for one thing. I was hoping someone had a slick way to get the thermometers inside the bag.

They make dial and electronic thermometers on metal "spikes" that would have no risk of breaking.

We take a thermometer and fold the SDP bag around it and put a rubber band...and take temperature periodically according to our protocol.

Yes the best way is to have thermometer inside the bag...

Anyone try an infrared thermometer for this? Maybe you can just zap the bag from the outside and get the reading. I don't know becasue I don't have one but sounds like something some one with one could try.

I know a lot of folks use them when checking the temp of RBCs brought in or returned from the floors.

There is alot of wailing and gnashing of teeth about the accuracy of IR themometers for use in Blood Banks. Granted, they're not as accurate as a mercury NIST reference thermometer with 0.01C increments, but they register within 1C of the LiG thermometer I used to verify ...

We use an IR thermometer (have been for years) and we have had no issues calibrating it against an NIST thermometer. The trick is that the surface must be reflective (no shooting it into a waterbath, for example)

What I don't understand is why you are going to such lengths to validate the storage chamber. If you can prove that a thermometer in a liquid volume that doesn't exceed your lowest product volume (e.g. 50 cc's) is at the correct temp and stable, what more do you need to do? The difference in thermal properties between a bag of platelets and a bottle of saline will not be detectable with the equipment you are using to track the temperature. Thermometer in liquid levels out the highs and lows as the compressor turns on and off, but ambient isn't going to change. I would only calibrate the unit against a reference thermometer, alarm test it and validate that the temperature at various positions (temperature mapping) within the unit is consistent and be done with it.

We use Data Logger SmartButtons - we validated the buttons against a NIST therm at several temp ranges. Then you just program the button for the time intervals you want (1,2,3......60...240 minutes) and just put it in the cabinet. It logs temps at the interval you program. Let the cabinet run normally (closed) then stress test - load it with outdated plts, leave the doors open, alarm check, etc. Then simply download the button and print the graph. Note on the graph what was going on when temp was out of range. Note temp recovery time. Write it up, you're done. Works for any temp device in the range -40C to 85C. We use them for everything. They are inexpensive and resuable. http://www.microdaq.com/acr/smartbutton/smartbutton.php

Exactly! My kind of validation! Sweet, simple and effective!

I have data loggers that are probably similar to your "buttons" and they are, indeed, handy buggers for anything involving temperatures.

Kate, What a great idea!!!!

If you have your protocol written could you either post it here or send it to me?

Thanks

John

Don't forget about checking the rotator RPM's on each day of use. We have the Helmer Platelet Incubator and the RPM's must be 68 +/- 10%.

We only have a bottle for temp checks. Never saw any requirement for placing a thermometer in a platelet bag.

Gil

We only check the RPMs quarterly. Our incubator/rotator has an alarm if the rotator stops.

You know... I don't think we have ever checked the rpms on the rotator. There is no vendor recommendation for such a check and the standards do not dictate a require RPM, so we have never considered such a check to be necessary.

We just installed a new Helmer incubator/rotator and I did not find any mention in the operator manual about RPM checks so I don't have any intention of doing them. Did not even consider the need.

I don't remember why we started checking this quarterly. (Some inspector's opinion?)

Perhaps we'll drop it.

Linda Frederick

Linda, I just looked closer at the "rotator" and noticed it doesn't "rotate" it just sloshes the platelets back and forth. I could not check the RPMs if I wanted to because it, technically, doesn't have any Rs.

There was a requirement for RPMs when using the round-and-round, end over end type of rotators back in the good old days. I got the number from the ARC way back when an FDA inspector dinged us for it. We have long since gone to the flat type agitator that comes preset from the factory (using that required number no doubt). We are still checking RPMs daily but since the agitator comes preset and the manufacturer makes no recommendation for a daily check, I think maybe the quarterly check would be sufficient to insure that the thing is still functioning within it's parameters. Why is it we make work for ourselves by hanging on to old habits?