Tadpole

Unless you subject the box to extreme ambient conditions (worst case testing for your environment) you are not really testing anything by putting a logger in a box. Common sense on frequency of testing..... A cooler has EPS surrounded by plastic. The EPS can crack and you would never know without some frequency of testing. Vacuum panels can leak and loose insulation over time. PUR is very stable over time and if it is inspected for cracks etc there is not much value in retesting an indivudial box. QC checks during manufacturing are important to detect air bubble etc than can occur and reduce R value. Etc.

I would qualify a refrigeration unit IQ, OQ - no requirement for PQ - it is equipment and simple equipment at that- but definitely temperature map full and empty as you have to know where to put the probes and won't know that without mapping. This is with the mindset that you qualify equipment, validate a process.

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.

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.

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.

Has anyone actually seen a change over time in cooler performance with periodic QC? What about insulated cardboard boxes? I know taking temps on recepit is time worn and accepted, but I have seen data using loggers where the product temperature can go out of range during transport and arrive in range. How can reconcile this? This concept that if blood goes out of range for even a minute or so it is trashed --- how did that get started? I know pharma does stability studies and uses Mean Kinetic Temperature so that it is the cumulative deviations that matter, not just an instance in time.

Typical per PDA/ISTA/ASTM would be to do an initial qualification that entails worst case hot and cold ambient profiles with max and min loads and thermocouple probes in simulated product throughout the box showing the box [and that particular packing configuration] can maintain temperatures under typical extreme conditions. This is typically done by an outside vendor as the thermal chambers are computer programmable to vary the ambient conditions. When we do one, it usually runs about $30k for a 48 hour test. Then a process performance qualification whch would utilize temperature devices, typically between two products in the box. [AABB NOW requires a process validation of the shipping PROCESS, which is a lot more than just the boxes]. In years past people would take temperature upon receipt but that is almost worthless data as a box can exceed limits on the tarmac at an airport etc. so the newer approach [much more recent than the old remnants of FDA regulations from the 70s before people were even thinking about validation, or before requiring 'periodic monitoring' is to use RFID data collection devices and download the data for a statistically significant sampling of boxes. IMO, igloo coolers are worthless for more than a few hours based on several years of experience looking at their performance data. Perhaps for transport inside a building or a short jump across town is ok, but that is pretty much it.

I am completely amazed that American hospitals are not mapping or even required to. While not explcity stated in regulations, the FDA has been tightening the screws on American Blood Collection organizaitons to map not only storage units but work areas, incubators, shipping boxes, etc. since approximately 1997 and citing if it is not done, or not done appropriately. Basically, if pharma does it, the expectation is that blood manufacturing facilities will as well as blood is classed both as a drug and a biologic. Basically the blood collection organizations are held, IMO, to much higher standards overall than the hospitals. It is definitely value added for reasons previously stated. The timeframes are variable but mapping is typically done full and empty chamber as airflow can be influenced by loads and then must be redone based on a change assessment after changes are made to the system.

What do you do to verify timers on centrifuges when the vendor does not provide a specification?