Monitoring Product Temperatures During Shipping

[Tadpole]

Is anyone doing this on a routine basis? If so, what criteria are you using for managing any data out of spec?

Most of the pharmceutial industry is now putting data loggers in EACH box and accept/reject shipments in part based on data but they have MKT and allowances for time out of desired shipping temperatures based on stability data and we have preset ranges by the FDA and AABB with no specification for time out of spec. Blood and blood products are much more complex than most drugs and temperature is one of MANY variables that could impact product quality.

This question assumes the box configuration has been properly validated under summer and winter conditions but there are those days that certainly exceed the conditions under which the box was tested and boxes cannot be designed for the absolute worst case imaginable due to cost.

I am 100% certain that temperature of product upon receipt is NOT necessarily an indicator that the product maintained the correct temperature during the shipping process because I have seen it with trial data.

I have also seen data where there is still ice in the box upon receipt [Have heard argument that product did not get too hot if there is still ice in the box] but the product experienced transient increase in temperature out of range [with subsequent recovery]

The last thing anybody wants to do is throw out perfectly good product because of a transient temperature anomaly.

[adiescast]

We don't do much shipping and we don't ship very far. When we ship, we put Safe-T-Vues on each unit. Our coolers are validated for winter and summer temperature ranges. We also include a thermometer in the cooler.

[Mabel Adams]

I am looking at using data loggers to capture temps in coolers that go to the heart surgery rooms. Does anyone have experience with how best to place them in the cooler? Mount them on an inside wall, put them in the bottom in a bag, sandwich between units? I don't want them lost or broken but they need to take a good temperature.

[Alternatives]

I am looking at using data loggers to capture temps in coolers that go to the heart surgery rooms. Does anyone have experience with how best to place them in the cooler? Mount them on an inside wall, put them in the bottom in a bag, sandwich between units? I don't want them lost or broken but they need to take a good temperature.

Hello Mabel,

Advices I could give you. First, depending the size of your cooler, don't hesitate to use several data loggers placed at the top, at the bottom, and centrally; temperature might not be homogen everywhere if it's a big trolley cooler. Then, the closest they will be from your product, the more accurate recorded data will be. Don't use a bag or do not wrap your data logger. Indicate on the box that it's monitored by x number of data loggers.

Benoît

[David Saikin]

It's nice to monitor the temp in the cooler BUT how do you know what is happening to your product in the surgical suites? My experience is the blood is removed for extended periods and then replaced. We use HemoTemp II to monitor our shipments (up to 1.5 hr cab rides). At a previous employer we used them on blood going to the OR. They always came back converted (temp >10C) but we were told (by the OR) that they must be defective. Our parallel testing of them never failed.

[Tadpole]

I think if you do a search you will see that the topic of monitoring coolers in ORs - considered storage and not transport has/is being discussed.

My question, and hopefully answers to this thread relate to the ongoing regulatory requirements [for example USP 1079 that is under revision] to MONITOR inside boxes during transport and shipment.

[Alternatives]

Does USP 1079 only focus on pharmacopeial preparations and regulates pharma industry not hospitals and blood centers?

[Tadpole]

Yes, but if pharma is doing it, and they are, it is only a matter of time..........

Think back to temperature mapping of storage units about a decade plus ago.

[Alternatives]

Yes, I am totally agree with you...but as far as I am concerned and after having worked with many hospitals, there is a huge difference between pharma and hospitals. USP1079 is a very clear regulation, as well as PDA report 39, Guidelines 0069 from health Canada...in pharma industry. In hospitals, except sometines for some centers, not every equipment has been qualified with an IOPQ. Temperature profile are not used to qualify packaging system. ISTA profiles neither...etc. I mostly speak in hospital of AABB, JCAHO, WHO, FACT, Z902-04...But, yes, definitely, all pharma regulations, even if they are not in force in hospitals, could be a great source of inspiration !

Benoît

[LoungingAround]

Check out www.deltat.de. Astridge International, Inc. is the US and Canadian distributor.

[Alternatives]

Check out www.deltat.de. Astridge International, Inc. is the US and Canadian distributor.

Lounging, there is a market place section where all your products, could be advertised. I don't think your post is very constructive in this debate...