Does the FDA Approve Thermostatic Bellows Element Fill in Sanitary Steam Traps?

July 11, 2019 by Karl Lutkewitte

The FDA doesn’t specifically “approve” any valve, steam trap, or their components for use in a pharma plant. However the FDA on it’s own, and in conjunction with ICH, has worked to offer industry guidance as to suitable materials for use in manufacturing items.

Last year, the ICH released their Q3C document regarding classification and use of solvents in pharmaceutical manufacturing. ICH along with FDA, have classified solvents used for pharmaceutical manufacturing as Class 1, 2 or 3 in terms of toxicity to human health. Class 1 solvents are considered the most toxic and are to be avoided in pharma manufacturing.  Class 3 includes no solvent known as a human health hazard at levels normally accepted in pharmaceuticals.

With regards to Clean Steam Traps, Steriflow Valve uses a proprietary mix of alcohols in the bellows fill fluids used in our MK93 series steam traps. The alcohols we use meet the Class 3 solvent classification.  

So…don’t be fooled, no manufacturer can state that the Bellows fill fluid is FDA approved.  We can only state that the Bellows element fill fluid meet the criteria as listed by FDA and ICH Q3C as a Class 3 solvent.

I’m Karl and thanks for watching.  For more information, or any additional questions, please ASK steriflow@richardsind.com.




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