Helmer Freezer Validation

[saralm88]

Hi everyone!!

I am hoping to receive some suggestions I have a new Helmer Freezer and I am going to start validation next week but - I do not have any expired frozen plasmas or any recovered plasmas I can freeze and mimic the presence of real plasma in the freezer - does anyone have any suggestions for me as to how to get the validation completed? (Holding the temp as an empty unit should be no problem).

Any advice is much appreciated!!!

Thanks!!

[R1R2]

I have never used plasma to validate a freezer. I have validated that alarms work, temp is accurate, plugged into proper receptacle, chart works, door seals properly, unit maintains temp etc.

[saralm88]

Really? I come from a hospital that does a freezer validation empty and then also loads it with frozen recovered plasm s and monitors the temperature for 24 hours - mimicing the presence of real plasma. I am glad I am asking this question I would love to hear from others as well

Thanks R1R2

[R1R2]

Really? I come from a hospital that does a freezer validation empty and then also loads it with frozen recovered plasm s and monitors the temperature for 24 hours - mimicing the presence of real plasma. I am glad I am asking this question I would love to hear from others as well

Thanks R1R2

Perhaps you are thinking about temperature mapping?

[Malcolm Needs ★]

I thought that temperature mapping was part of validation?

[saralm88]

That's what I thought as well - and if it is, does anyone have a suggestion as to how I achieve this without using real plasma (in case it fails)

[R1R2]

I thought that temperature mapping was part of validation?

Not that I know of (in the US). Perhaps someone else knows differently?

[Malcolm Needs ★]

Certainly is in the UK - try getting an UNMAPPED fridge/freezer past QA in the UK and they remove bits of your body without anaesthetic!!!!!!!!!!!!

[BANKTECH]

I have never used plasma to validate a freezer. I have validated that alarms work, temp is accurate, plugged into proper receptacle, chart works, door seals properly, unit maintains temp etc.

same here as R1R2

[R1R2]

That's what I thought as well - and if it is, does anyone have a suggestion as to how I achieve this without using real plasma (in case it fails)

If you want to validate that the freezer can circulate cold air when filled with plasma you can use anything to fill the freezer, such as bags of water or saline.

[saralm88]

THe manufacturer has said pretty much the same thing as R1R2 - there is no real need to validate with plasma products in the freezer. We will see how this goes! Thanks for everyone's feedback!!!

[Deb]

As a collection center that prepares and freezes plasma we also simulated different loads of warm units and freeze times. We used small data loggers placed in alternating positions (front/back or left/right) on each shelf/drawer to map what happened to the temps in each area as the freezer was loaded. We did a single unit on each shelf. Six units all at once. Multiple loads placed in the freezer at different time intervals, and one large load that might simulate after a busy day/blood drive. What we found was that certain places were best for quicker freezing and others were better for maintining the frozen temps. We used water bags to test this. If you want more details, feel free to let me know and I can forward more info to you.

[Mabel Adams]

We usually pay Helmer to provide us a validation certificate. I believe this includes temperature mapping. We then validate the alarms, charts, temp stability etc. as described above. We never freeze anything from room temp but only store plasma that arrives frozen.

[anonimmuno]

We do pretty much the same thing that R1R2 does. We do a stress test for funsies: we toss in a bunch of room temp or refrigerated cold packs and see how long it takes to fall back into acceptable range to determine if it matches the curve that the manufacturer provided.

[Eman]

We only mapped freezers that were used to store recovered plasma, since our RP went to an EU company I'm sure that requirement came from them. Monitoring the temp for 24 hours and testing everything R1R2 mentioned was our standard practice for transfusable products. Do an IQ per manufacturer requirements, then make sure it holds temp empty for 24 hours, verify monitor and alarms work and the door seals fine and then load it up, you'll get an alarm if it fails.

[nsfirm]

On 8/28/2012 at 9:19 PM, Deb said:

As a collection center that prepares and freezes plasma we also simulated different loads of warm units and freeze times. We used small data loggers placed in alternating positions (front/back or left/right) on each shelf/drawer to map what happened to the temps in each area as the freezer was loaded. We did a single unit on each shelf. Six units all at once. Multiple loads placed in the freezer at different time intervals, and one large load that might simulate after a busy day/blood drive. What we found was that certain places were best for quicker freezing and others were better for maintining the frozen temps. We used water bags to test this. If you want more details, feel free to let me know and I can forward more info to you.

dear Mam, could you please share more with me? really would like to hear it from you.

[Sonya Martinez]

Attached is the validation plan for the last freezer we bought in 2020 but it was not a Helmer.  Also, if you ask Helmer (it might even be on their website) you can get their temperature mapping they already completed.  Normally it's included on the technical data sheet.  We validate the temp holds for 24 hours empty then 24 hours full of normal stock.  However, we are staffed 24/7 and we use Isensix continuous temperature monitoring (which pages me and the other lab leaders if the temp is out longer than 5 minutes, again at 15 minutes and a third one at 20 minutes) so if it alarms staff know to move the stock back to our second freezer.

Validation Plan NEW Plasma Freezer 05.22.2020.doc Freezer Temperature Mapping.pdf Helmer Refrigerator and Platelet Incubator Temperature Mapping.pdf