I wanted to post a question on behalf of a client I am working with. They are compounding in a non-cleanroom. They are only compounding products with a 12 hour or less beyond use date. Is it ok to maintain their room temperature around 25 degrees Celsius (77 degrees F). If it isn't possible to get the temperature down to 20 degrees Celsius, then what would be the recommended temperature they strive for as far as the ambient air temperature of the room goes?
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The room temperature range in the chapter is not an absolute and was established for employee comfort. There is a direct correlation between employee comfort, proper garbing behaviors and work environment temperatures. Personnel working in an ISO Class 5 primary engineering control must be garbed as if they were working in an ISO Class 7 buffer area. The temperature should be as low as possible to make the work environment conducive to complying with the garbing requirements of the chapter. If low temperatures are not attainable, then do the best you can with the situation at hand.
