Dear All,
Some of our finished product must be stored in “Dry Place”, the USP defines dry place as;
"Dry Place:The term “dry place” denotes a place that does not exceed 40% average relative humidity at 20 (68 F) or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value does not exceed 40% relative humidity. Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place."
I am not able to figure out if the store temperature is 25 C, which humidity is accepted at that temperature
At 20 °C and 40 % relative humidity the water vapor pressure is 9.38 mbar. Given that same water vapor pressure (9.38 mbar) the relative humidity is 29.5 % at 25 °C. This means that the amount of water in the air (g/m3) is the same at 20 °C / 40 % and at 25 °C / 29.5 %.
I would be believe so. However, national regulations may apply. For further information I would suggest that you send an e-mail to me directly on info@ellab.com
Finished goods are generally in their final pack. Often stability studies have been done at 40 C/75 % RH (3 to 6 months) and 25 C/60 % RH long term. Which means that the product is stable over at 60 RH over the shelf life. Why should the Warehouse be at 40 % RH. Also, the shipper (cardboard) has apprpx 7 % moisture content. How can you justify 40 % RH and store product in this shipper. Often your warehosue is filled with thousands of shippers that contribute to the moisture (hence high humidity) in the environment. In order to achieve an RH of 40 % you will need a powerful Dehumidifier and a high airchanges considering the size of the warehouse (usually large)
Take some time to conceptualise this. Also, I suggest you seal an empty corrugated shipper and measure the RH within the shipper over a perios of time.