Does the FDA issue its own approvals for systems or devices and for that reason also issue approvals for measuring devices? Learn more in the following blog post. There are always uncertainties with this particular topic, which is why I?d like to shed more light on the question in this website post.
What is the FDA?
The FDA (?Food and Drug Administration?) is really diaphragm seal beneath the Department of Health. It really is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in the United States.
When should FDA requirements be considered?
The FDA?s control includes both US-made and imported products. For this reason, regular audits are carried out at overseas pharmaceutical manufacturers. US-approved drugs may only be made by FDA-inspected manufacturers whose facilities comply with FDA regulations.
How are plants and equipment assessed for FDA requirements?
The FDA does not grant approval for measuring instruments. The assessment is completed relative to general GMP requirements (?good manufacturing practice?). These must already be taken into account in the look of the plant as must also the selection of suitable measuring instruments:
Liquids that could find their way into the end product in case of a failure should be FDA-compliant. These can, for instance, be transmission fluids or fill fluids.
Seals that are in contact with the measuring medium should be manufactured from FDA-compliant material. As proof, a material certificate for the seal must be available.
Process connections should ideally have 3-A approval to make certain the connections are suitable for sanitary applications. Instruments with 3-A marking have been shown to meet up with the specifications for radii and surface roughness (Ra < 0.8 ?m).
Metallic parts which come in contact with the media must have a 3.1 material test certificate relative to DIN EN 10204. In sterile engineering, it is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For instance, WIKA uses 1.4435 because the standard material for applications in sanitary applications, since it has improved corrosion properties in comparison to 1.4404 due to the lower delta ferrite content).
The measuring instrument must be calibratable and the accuracy ought to be confirmed by 3.1 or DAkkS certificate.
Conclusion
Nothing will stand in the form of the success of your FDA audit, if you take the aforementioned points into account.
Note
Further information on our products are available on the WIKA website.