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21 CFR 111.20(d)(1)(iii) Define "Cool and Dry"


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#1 DuckMan

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Posted 25 October 2013 - 05:37 PM

Hello my fellow support network,

 

Here we go.......

 

Currently I work for a vitamin supplement company.  The FDA regulations "Requires equipment that controls temperature and humidity, when such equipment is necessary to ensure the quality of the dietary supplement". All of our product line is advised to store "In a cool dry place". We have an electronic monitoring system for the warehouse that records temperature and humidity 24/7.

I am in the process of writing an SOP for monitoring the data collected by this system and trying to establish an acceptable spectrum.

 

My question is this;

 

What are the parameters for temperature and humidity regarding "A cool and dry place"?

 

Thank you all for your collective brain power!!

 

Your friend in Dallas,

 

The DuckMan



#2 Hareesh

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Posted 26 October 2013 - 04:03 AM

Normally cool and dry place means 25oC and an R.H of 40 to 60%. 


With Best Regards

Harish


#3 Charles.C

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Posted 26 October 2013 - 09:12 AM

Dear Duckman,

 

Is yr reference out of date ?

 

Compare yr title to -

http://www.accessdat...h.cfm?fr=111.20

 

Regarding "cool,dry place",  from a  purely US Pharmacapoeia POV,  -

http://www.pharmacop...-1_viewall.html

cool (if non-refrigerated) = [8-15degC (46-59degF)] (4 separate lines of text for "dry") (another "spiel"  for "controlled room temperature")

 

Various usages for actual products can be seen, eg - 

http://www.walgreens...d396855-product

[15 – 30°C (59 – 86°F)] (described as for a "controlled room temperature" and sort of matched to above "spiel")

 

Not my speciality but i expect it depends on the particular delivery style / specific contents, eg gel capsule / vitamin A - Z / whatever ? :smile:

 

Rgds / Charles.C


Kind Regards,

 

Charles.C





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