Can anyone share their experience with expirable products that need to be refrigerated? We have dental adhesives that we keep in refrigerators and we check the thermometors daily and initial the chart on the fridge. We have a procedure in place on how to monitor these products.
Has anyone who stores products in a refrigerator had any findings or feedback from an FDA inspector?
Thanks,
Bridget

Can anyone share their experience with expirable products that need to be refrigerated? We have dental adhesives that we keep in refrigerators and we check the thermometors daily and initial the chart on the fridge. We have a procedure in place on how to monitor these products.
Has anyone who stores products in a refrigerator had any findings or feedback from an FDA inspector?
Thanks,
Bridget
I don't have anything like that, but I can imagine being asked what the temperature is the other 1439 minutes of the day.

I had an investigator ask if I had changed the properties of the product that had just been sent thru a heat shrink tunnel. It was a small unitized component made up of OTC product that had temp range requirements. It was exposed to 300 F for 19 seconds during the shrink process. I had to send the product to the lab to have base lines run against the source sample to prove that no properties changed. From this experience I can say that you might have to monitor the temperature around the clock to prove there was no varience....

I have thermometers inside of each fridge that records the highest and lowest temp and when I read it- I reset it. This way I know if it gets too high on the weekends. The material will not necessarily spoil if the temp is above 46° as it is often left out in the doctors office during use. It is not as delicate as medicine or food products.

My notified body auditor wrote a nonconformance last year when she seen the fridge, even though we had just brought it in two days before. This year she seemed like it will be very tough to monitor. I wrote a work instruction and created a daily checklist that appeased her for now but I am really concerned about how a FDA inspector will view this.
So I welcome any stories about this type of storage.
Thanks,
Bridget

I have thermometers inside of each fridge that records the highest and lowest temp and when I read it- I reset it. This way I know if it gets too high on the weekends. The material will not necessarily spoil if the temp is above 46° as it is often left out in the doctors office during use. It is not as delicate as medicine or food products.

My notified body auditor wrote a nonconformance last year when she seen the fridge, even though we had just brought it in two days before. This year she seemed like it will be very tough to monitor. I wrote a work instruction and created a daily checklist that appeased her for now but I am really concerned about how a FDA inspector will view this.
So I welcome any stories about this type of storage.
Thanks,
Bridget
What does your procedure require you to do if you found that the temperature excursion was beyond your stated limits?

I have thermometers inside of each fridge that records the highest and lowest temp and when I read it- I reset it. This way I know if it gets too high on the weekends. The material will not necessarily spoil if the temp is above 46° as it is often left out in the doctors office during use. It is not as delicate as medicine or food products.

My notified body auditor wrote a nonconformance last year when she seen the fridge, even though we had just brought it in two days before. This year she seemed like it will be very tough to monitor. I wrote a work instruction and created a daily checklist that appeased her for now but I am really concerned about how a FDA inspector will view this.
So I welcome any stories about this type of storage.
Thanks,
Bridget

Bridget at my former place of employment we did they same thing. We purchased high/low thermometers (calibrated of course), did they reading once a day and reset them. Thatis what our procedure said and that is what we did and the FDA had no problem with that.

I've seen a similar situation in a company with tooth whitening gel. I believe they used strip chart recorders for the refrigerator temperature. Still, it sounds like what you're doing meets both FDA and ISO 13485 requirements. Check 21 CFR 820.150 - it requires that you "establish and maintain procedures for control of storage areas..." and also "it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate." It is not specific about how you control storage or assess condition.

Good Feedback
Al-my procedure states that if the temp reads to high I can test the materials in a simulated setting to see if they are still good. I have to dispose of the parts that I test and I record the lot numbers and the expiration date.
Aaron-I was hoping someone has had good experience with the FDA. Did you record the temp each day or initial a checklist?
howste-we have a good method for rotation of the product plus I check all of these products each month because I pull them if they are six months from the expiration date.
keithm696-fortunately we do not manufacture these materials, we only have to store them correctly.
Thanks,
Bridget

Good Feedback
Al-my procedure states that if the temp reads to high I can test the materials in a simulated setting to see if they are still good. I have to dispose of the parts that I test and I record the lot numbers and the expiration date.
Aaron-I was hoping someone has had good experience with the FDA.
Thanks,
Bridget

We recorded the temperature each day. I would suggest against just using a checklistto say yes we checked the temperature. They willwant to see hard numbers, if the storage range is 5-10C, they will want assurance that it did not go outside that range or if it did what actions were taken andthe best way is to record the actual temp. That is what we did and they had no problemswith it.

Dear Bridget,

we use data loggers within the range of -40 to 40 points of Celsius. The local authorities are not so strickt concerning the measurement of the temperature, but we have established a procedure like this :

- calibrated and certificated data logger (each year)
- capacity of 4000 measurements
- programmed to record temperature every 15 minutes (almost 40 days
nonstop)
- insert critical limits
- check every day
- if there is a nonconformance (above - below critical limits) must be folowed
by cause and corrective action
- at the end of the measurement (4000 points) print the deviation of the
temperature

i think data loggers are simple and very usefull (and not so expensive, here in Greece one of them with its software the rs232 cable costs 120 euros. Alone costs 60 euros!)

Take care!

vasilist,
thanks for the information. I have heard of the data loggers and there is one sent with the product from finland and we have to send it back to the supplier to read. This one looks like a small button or flat battery and records the temps for two weeks. Is there a website (in english) that advertises the data loggers?

I have set up daily logsheets and have thermometors that record the high and lows and after reading it I have to reset it. And then once a month I take a calibrated Fluke digital thermometer and check the ones in the refigerators. If our products keep growing we may have to try other methods in the future.

:thanx: Thanks to everyone for your help. I feel confident we have this under control.
Bridget

See this is where I usually get into trouble. My experience with temperature in both the defense industry and the medical industry is to monitor the ovens 24/7 using temperature controlled ovens and calibrated chart controllers. Had to have a chart for every day of the week noting on the chart what products at what times and the products were Wire Harnesses and Cables.

Here we have "EXPIRABLE" product and apparently a simple check once every 24 hrs is OK with the FDA! I just don't get it. :nope: :nope: :nope:

I have about 10 years of experience with refrigerated pharmaceuticals. It would be my recommendation to use one of the newer digital recorders now on the market.

Dickson Instruments makes several models. Dickson’s Model SM320 series of Temperature Data Loggers have a Jumbo Display and also: High/Low Alarm, Min/Max Display, Super high-speed USB 2.0 Connectivity, One Step Data Transfer using removable MMC/SD FLASH memory cards (rather than move the entire recorder). Plus they can be calabrated (certified) to a NIST standard. But there are other manufacturers too.

Generally, you would use 2 recorders, placed at the lowest and highest points where product may be located. The digital capability allows you to select your sample time from 1 per second to 1 per day. We found that a sample once every 5 minutes gave the best results (and was never questioned by the FDA)

Hope this helps.

Is there a website (in english) that advertises the data loggers?


Hello Bridget!

Just a few i found :
http://www.microdaq.com/data-logger/temperature.php

http://www.coleparmer.com/catalog/product_list.asp?cls=40348&par=6207,6236&cat=1&sch=521&sku=&sel=

http://www.ebro.de/english/produkte/prod_nav.htm

just some...

Take care! :bigwave:

Vasilist

Bridget, just another thought, have you mapped your units to make sure you are aware of any hot/cold spots intheunit that shouldn't be used?

Hi Bridget,

we manufacture IVDs that need to be kept at either -20°C, 4°C or Room Temp.
we control temp in real time with a system made of calibrated probes linked to a PC. The PC takes one measure every 15 minutes. Min and Max are defined for each store. The temperature can be above the define conditions for 15 mnutes after that we have an alarm ringing and the system calling a list of people even during holydays.
Everything is recorded, the probes are calibrated every-year.
It sounds like **** on Earth but at the end of the day, we sleep well because we know that if something happens we will know it in less than one hour.

The cherry on the cake is that it is not too expensive below 4000 euros for the software and 6 probes plus installation. Calibration is 44 euros per probe and they come to do it in our facility.

We really improve our temp control with this system. It is much better and no more expensive that having probes with memroy that you need to read from time to time.

Hope this helps

V

Vincnet:
Thanks for the information.
Bridget

We have a resorbable product that requires it be kept below 98 degrees. We use a Dickson SR300 Display Pro Logger. It has software that is 21 CFR Part 11 compliant. It is downloaded weekly and an electronic and paper copy is kept. It takes a continuous record of the temperature at intervals that you can set.

Tom

www.dicksonweb.com

I contacted them for a catalog, thanks for the link.
Bridget