Can we heat Versol Sterile water and Sodium Chloride 0.9% for irrigation above 40C?
Versol is a Medical Device containing a sterile apyrogenic solution. The containers are autoclave sterilised at 115C. Stability studies have been carried out at room temperature 25C and 40C for 6 months. Results show Versol is stable for 2 years in all test conditions. Studies have been carried out on Versol bottles heated in a Microwave to check deformation as a result of temperature . Deformation of the bottle and ease of unscrewing the cap was tested. The results show that at temperatures up to 69C all parameters were within Spec. The reason for the statement Do not heat above 40C before use is to make sure the water at point of use is likely to be at or near body temperature. Heating above this temperature may potentially allow the contents to scald users or patients.
