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Warehouse temperature and humidity control

#1
Hello,

Storage condition for the finished medical device are -40 to 70 °C and 0 to 100 %RH. Do I need to control the warehouse environment for the temperature and humidity? Normal temperature and humidity of my country fully covered and meet the requirements. I think... what I need to do is.. accumulate the history of the temperature and humidity and make a justification. Please give good advice.

Kind regards,
 
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yodon

Staff member
Super Moderator
#2
You say "normal" temperature is in range but, obviously, it's the excursions that are the biggest concern. Those are pretty extreme temperatures so you're probably right in that you wouldn't need any controls. I would agree with you that it's probably a good idea to set up some monitoring to have objective evidence that your storage conditions are (always) in range.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
To CYA I would go to weather.com or equivalent and check out the past decade highs and lows and RH ranges. Unless you have a steel melting furnace in the building that should be enough to justify no controls needed. Obviously, 70'C is an insanely high temperature. If it is that high your warehouse workers are likely deceased.
 
#4
my point is you don't need to control but you have to set up an alert alrm system in place , for exam you can set temp "-20,55"celsius degree as alert point, this is easy to implement at current technology , as same question why we need to set up fire-fighting system in place but never have outbreak of fire .:)
 

AgnieszkaSz

Involved In Discussions
#5
If your storeroom is susceptible to getting very hot in summer in direct sun (like, under light steel roof), just make sure that the temperature in such places is within limit.
 

dwperron

Trusted Information Resource
#6
Hello,

Storage condition for the finished medical device are -40 to 70 °C and 0 to 100 %RH. Do I need to control the warehouse environment for the temperature and humidity? Normal temperature and humidity of my country fully covered and meet the requirements. I think... what I need to do is.. accumulate the history of the temperature and humidity and make a justification. Please give good advice.

Kind regards,
An auditor is going to say "Prove it".
You will need to produce records that show you have been monitoring environmental conditions.
There are plenty of devices out there that will do the job for you.
 
#7
An auditor is going to say "Prove it".
You will need to produce records that show you have been monitoring environmental conditions.
There are plenty of devices out there that will do the job for you.
Thanks for your comments. My plan is to prepare the monitoring sensor and collect 1-year data. After 1-year, I will prepare the report including justification using the raw data. If there is no deviations during 1-year, I think I don't need to monitor the current temperature and humidity. Hot about this concept?
 

dwperron

Trusted Information Resource
#8
Thanks for your comments. My plan is to prepare the monitoring sensor and collect 1-year data. After 1-year, I will prepare the report including justification using the raw data. If there is no deviations during 1-year, I think I don't need to monitor the current temperature and humidity. Hot about this concept?

You will need to continually monitor the environmental conditions. Even though it is very unlikely that you will ever go outside the environmental limits an auditor will still be looking for proof that you are continually monitoring conditions. It's easy and inexpensive, and it will save you from having to justify why you don't monitor and record the results.
 
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