Freezer certification/validation

Hi,

We are in the process of validating a -20 to -30 C freezer and have been running distribution studies using thermocouples (in air). The temperatures range from -18 to -33 but the average remains on target at -25. We also monitor constantly using a temperature sensor within Glycol and the temperature maintains an average of -25 +/- 2 degrees. My questions is, is it ok to have cooling cycles outside the acceptable range of -20 to -30 even though the average is acceptable.

Any thoughts would be appreciated.
Thanks,
Ronyace

The above procedure is accepted.
Along with that if you look the 2 points that I mentioned below will give a broad picture about certification/validation
-Rate of decrease of temperature from 0 degrees relating to time.
-Rate of increase in temerature by 1 degree when power is lost.

In both the processes you must have sensors, identify the coolest and hottest zones in your frezer and plot a graph : Temp Vs Time.

This give you a fair idea where you should keep your critical samples.

Perform 3 such runs. It gives you a great input.
Regards

Thanks for the response. Is there any documented justification you can provide that would satisfy our quality group. They have noted in an audit that our temperatures should cycle within the accepted range at all times (even in air) but we would like to provide justification on the contrary since it is air temperature and the temperature of the sensor in glycol remains in the range at all times.
Thanks

Right now I can send you this attachment.It is not a guideline, but it might act as a guide to your qualification procedure.

Regards


Validating.Refrig.Freezer.pdf (284.3 KB)

Thanks Durga,
That document was very helpful. One last question then I will close the case.

When running thermocouple distribution studies on the freezer, are the thermocouples in glycol, water, or covered in some way or are the wires just left in the open air.

Thanks

Justification I use for placing TCs in damping fluid is that we do not care about air temperature within the freezer. We only care what temperature items in the freezer are at. Therefore, results are more meaningful when TCs are in damping fluid.

Jason

hi,
can anyone provide me Guideline reference (web link) for periodic (annually) perform TEMPERATURE MAPPING of stability chamber, incubators, refrigerators etc.

regards

ANIL SAXENA

Hi,

Thanks for sharing on such a good topic to all.

I had gone through all replies & it seems that ther are a lots of confusion / different opinions on temperature mapping.

In my opinion…

  1. TC must be placed in air [to avoid effect of Convection factor through glycol / water].
  2. It is acceptable to move out of set temp. range but one should evaluate the mean kinetic temp. as well to draw the conclusions.

While writing this reply, One question which is flashing here is that can domestic fridge be validated for uniformity in temp…Is it really designed ?

However, Happy Reading !!

[quote=ronyace]Hi,

We are in the process of validating a -20 to -30 C freezer and have been running distribution studies using thermocouples (in air). The temperatures range from -18 to -33 but the average remains on target at -25. We also monitor constantly using a temperature sensor within Glycol and the temperature maintains an average of -25 +/- 2 degrees. My questions is, is it ok to have cooling cycles outside the acceptable range of -20 to -30 even though the average is acceptable.

Any thoughts would be appreciated.
Thanks,
Ronyace[/quote]

Ronyace, you might want to look at the USP general notice 10 PRESERVATION, PACKAGING, STORAGE, AND LABELING and general chapter 1079 GOOD STORAGE AND SHIPPING PRACTICES.

Alan

I had attempted to reply to this thread earlier, but was thwarted by my IT department’s automated insistence that this forum is not work-related… so I’m trying again,

Temperature Excursions
The acceptability of temperature excursions is based on the impact on the materials stored within the unit. I would not encourage you to take the advice of someone who doesn’t know that impact to judge the excursions as acceptable. Look to stability studies for the determination of the impact on the materials stored within the freezer.

There are a number of things that you can do to improve the temperature profile and response so you don’t need to worry about digging through stability data. I’ll go into some of them here. Note that most of these recommendations assume that you’re using the more common compressor/evaporator type refrigeration system, and not a cold box, which relies on cold walls to keep contents at temp.

Mechanical controls are fairly common on chambers. They are inexpensive, but less reliable. I’ve found that replacing mechanical controllers with digital controllers generally improves chamber performance. You can also look at the offset. The offset is a value that is used to reduce compressor cycles. Fewer cycles keep the compressor running longer. Decreasing the offset will narrow the range in which the compressor cycling is suppressed by the control system, which will allow for a more rapid response, by allowing the compressor to cycle more frequently. This will wear out the compressor more quickly, but is sometimes justified based on the criticality of the materials within the chamber.

I’d also suggest looking at defrost cycles and termination, which may be driving some of the high temperature values. Your evaporators will periodically go into a defrost cycle, which is terminated either on time or temperature. Changing the defrost parameters may give you a better temperature response while still preventing frost build-up on the evaporators. You have to be careful that the defrost is still adequate, however, or the gradual build-up of frost will drive the chamber out of specification and could potentially damage the refrigeration equipment. You may also want to look to modify control to turn off evaporator fans while a defrost cycle is active to prevent the fans from blowing warmer air throughout the chamber during a defrost.

Look at how the probes and product are located within the chamber. It is not good practice to put product directly in front of evaporator fans, as the air coming off them is generally much colder. If you can quarantine an area where your high or low temperatures are located and prevent it from being used, that is a generally accepted practice. That may allow you to cut out the areas where your temperatures are routinely outside of specifications. I would recommend that you physically obstruct the quarantined area with something that is air-permeable (a wire cage, for example), as it is much more difficult for people to ignore than signs and procedures. In high-criticality applications, you may need to remap after installation of a barrier to ensure that you haven’t adversely impacted the chamber’s temperature profile.

Look at where the control probe is located. It should similarly not be located directly in the air stream from the evaporators, or it will lead to much more exaggerated temperature swings and excessive compressor cycling.

I disagree with performing three temperature runs, unless you’re changing conditions, such as control configuration or loading patterns, in between. The data from three consecutive runs is generally similar enough that you won’t gain anything from having the three replicate runs. As long as your runs are long enough to ensure several compressor cycles. 24 hours seems to be widely accepted, but you may be able to make the case for 8- or 12-hour periods as well.

The thermocouple must be placed in the air for mapping to demonstrate the air temperature response. Do not place the thermocouple in contact with anything, such as product or chamber walls, as it will skew results. If you want to monitor and alarm the chamber with a probe in glycol to dampen the effects of door openings to eliminate nuisance alarms, that is generally viewed as acceptable. It is not generally accepted practice to map chambers with probes in fluid, such as alcohol or glycol, for the same reason – it dampens the temperature response.

Since you live within 3 hours drive of me, I may be able to recommend some refrigeration contractors who can help with your problem that are within your range. Contact me if you’re interested.

If you can send your temperature data and mapping configuration, redacted for proprietary and confidential information (rich.paules@roche.com), I may be able to provide some better advice based on your specific situation. If I think of anything else, I’ll try to get back here to update this.

Great answer!!

Hi R Paules,

Thanks for the thorough answer, I appreciate your time. We have already looked at some of the ideas you mentioned. The freezer is a small undercounter unit that has a digital controller already. We spoke with the manufacturer and the tech dept. indicated that the defrost cycle cannot be modified and the offset cannot be changed. Because it is a small unit, all points were going out of spec.

The tech support did mention we can take the controlling temperature probe out of the glycol which did result in much better control of temperatures. The only excursions we get now are every 6 hours when the unit goes into defrost cycle.

If you can think of anything to justify this short excursion ~1 - 2 degrees higher than upper limit without additional stability studies I would be very happy to hear it. If not, we may have to get the supporting data to raise the upper limit of the storage conditions.

Thank you everyone for all the good advice.

Regards,
Ronyace

Hello,

I am validating the ultra-low freezer at -80c, does anyone knows where I can buy the thermocouple wire with calibration at -80 +/-5c?

Thank you