Our product must be stored at 8ºC to 12ºC.
We have two coolers; the first one at 10ºC to 15ºC and the second at 2ºC to 8ºC.
I think that we don´t meet the standard.
What do you think about it?.

I agree. Neither cooler meets the requirement.

Where does the requirement come from?

Our product must be stored at 8ºC to 12ºC.
We have two coolers; the first one at 10ºC to 15ºC and the second at 2ºC to 8ºC.
I think that we don´t meet the standard.
What do you think about it?.

Where did the ranges come from? How are temperatures verified?

Thanks for all the answers.
The company decided the specifications, because the shelf-life of product depens of temperature.
All the studies that we need for stability were made at these temperatures.
Our product is OK at these temperatures, but if we increase this, the shelf-life period fall, and this is a requirement of customers.
Spanish Director can´t understand the problem, and I don´t know how change his mind.
Maybe will be auditor who can do the change.

Our product must be stored at 8ºC to 12ºC.
We have two coolers; the first one at 10ºC to 15ºC and the second at 2ºC to 8ºC.
I think that we don´t meet the standard.
What do you think about it?.

I am not sure what your product is - thus if you tell more about the product, I could guide you through :)

Between, I feel the requirements that you mentioned may be incorrect - it could be 8ºC to 15ºC and not 8ºC to 12ºC.

As per United States Pharmacopeia (USP), there are 4 defined storage conditions viz.

Room Temperature - Store at 20ºC to 25ºC with excursions permitted between 15ºC to 30ºC

Cool Storage - Store between 8ºC to 15ºC and this is where I felt that your product could belong to :)

Refrigerator Storage - Store between 2ºC to 8ºC

Freezer Condition - Store between - 25ºC to -10ºC

If your product belongs to COOL storage condition, Cooler 1 would be okay for your usage.

Hello to all.
Our products are Pietri plates for IVD.
Ajit Basrur is in true. The most of our products must be stored at 4 to 8ºC, and some products at 8 to 12ºC.
What do you think about?

Thanks for all the answers.
The company decided the specifications, because the shelf-life of product depens of temperature.
All the studies that we need for stability were made at these temperatures. Our product is OK at these temperatures, but if we increase this, the shelf-life period fall, and this is a requirement of customers.
Spanish Director can´t understand the problem, and I don´t know how change his mind.
Maybe will be auditor who can do the change.

I underlined what I think is key. Why were the products studied at these temperatures? Did they fail at higher or lower temperatures? The two options are (in my opinion) to get a cooler capable of holding the specified temperatures, or to qualify the product to a different temperature range corresponding with one of your coolers. The specs and the conditions must match!