I am really surprised that there should be a lower limit of
15 C suggested by anyone for solid dosage forms. I worked in Poland for
several years and believe me, you can have below 15 C with no problem in
an unheated area!!!!! I can also tell you that the only problem I have
ever come across at low temperature is related to dissolution and that
was with a shipment that got stuck on a train in the Ukraine and was held
at minus 20 for over a week!
On Jan 11, 2008 11:02 AM, Alan Longworth
<
alanlongworth@norpharm.ie> wrote:
-
- Dear Forum
-
- I am setting up temperature monitoring devise in a warehouse for
solid dosage product. None of the goods in the warehouse require
refrigeration and most of the goods have storage conditions of "Not
more than 25 deg C".
-
- My concern is not about detecting higher temperatures than 25 deg C
but more about temperatures of less than 15 deg C being recorded in the
warehouse which is unheated.
-
- I understood that for goods labelled for storage "Not more than
25 deg C" there is no recognised lower temperature level of storage
but a recent Irish Medicines Board guidance document (based on a similar
guide from the MHRA) states that storage conditions of "Not more
than 25 deg C" imply a lower limit of temperature of 15 deg C.
-
- I wonder if the Forum have any views on this issue of storage
conditions at lower temperatures for solid dosage forms?
-
- Alan Longworth
-
- Qualified person
--
Malcolm Ross
Generapharm-Training and Consultancy
Thannerstrasse 30
Basel 4054
Switzerland
+41 615 34 64 18
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