FDA Approval for Clean Steam Trap, or Bellows Fill Fluid? That is Not Exactly the Truth…..January 11, 2019 by Karl Lutkewitte
One of our competitors recently advertised their sanitary steam trap as having “FDA approved element fill”. I was curious as to the validity of their claim, so I did some research. The FDA doesn’t actually “approve” any manufacturers’ valve, steam trap, steam trap bellows fill, or any other component for use in a pharma plant for that matter. However, FDA has worked with the International Council for Harmonization (ICH) to offer industry guidance as to suitable materials for use in manufacturing those items. This approach is similar to what FDA, USP and ISO have done regarding elastomers and thermoplastics used in our industry.
Last year, the International Council on Harmonization released their ICH Q3C document regarding classification and use of solvents in pharmaceutical manufacturing. ICH with FDA, ISO and other international pharma regulatory agencies, have classified solvents used for pharmaceutical manufacturing (and by extension to manufacturers of equipment for pharma use) 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 if possible in pharma manufacturing. At the other end of the scale, “Class 3 includes no solvent known as a human health hazard at levels normally accepted in pharmaceuticals.” 1
Steriflow Valve uses a proprietary mix of alcohols in the bellows fill fluids used in our MK93 series traps. The alcohols we use meet the Class 3 solvent classification. However, we cannot state that our traps or any component are FDA approved. In this case, we and others can only honestly state that the bellows fill fluid meets the criteria as listed by FDA and ICH Q3C as a Class 3 solvent.
- ICH HARMONISED GUIDELINE IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R7), Current Step 4 version dated 15 October 2018
See also U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) August 2018 ICH Revision 4 https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Karl Lutkewitte, Steriflow Valve Product and Sales Manager