An FDA investigation of a food contamination incident found a gasket at the root of the problem. Cleaning agents weren’t penetrating small cracks and E. Coli was able to gain a foothold. In their findings, the FDA suggested inspectors should:
- Look at how frequently a food manufacturer inspects and replaces gaskets
- Challenge the effectiveness of Clean-in-Place (CIP) procedures
- Verify that gasket material is FDA approved for use
Responsible food manufacturers conduct rigorous cleaning and inspection regimens. Whenever any doubt exists as to the fitness of a gasket it gets replaced, but that presents those performing the refurbishment with the question of what material to use.
The FDA maintains listings of approved FDA gasket materials. PTFE and many elastomers such as NBR, SBR and EPDM are included, but two points are sometimes overlooked by those shopping for FDA gaskets. First, any markings, such as part numbers or other information used for traceability must also be FDA compliant. Second, any adhesives used to hold the gasket in place must also comply with FDA requirements.
Where should FDA gaskets be used?
Any surface coming into direct contact with food must be manufactured from materials known to be safe. (“Safe” in this context means either materials already listed by the FDA or those it considers “Generally Recognized As Safe” (GRAS).) This includes gaskets used in food preparation equipment such as kettles and mixing vessels, as well as those used in sanitary couplings; the kind of fittings used for moving dairy or brewery products.
How to select appropriate materials?
One approach would be to trawl through the various applicable FDA documents, noting which would work in your application. A less time-consuming approach is to ask your gasket vendor for advice. Describe your application in detail, particularly the temperatures and pressures involved and the cleaning regimens employed, and they’ll know which materials are suitable. You’ll receive FDA gaskets that work in your application and contamination risks will be reduced.
