Does the FDA issue its approvals for systems or devices and therefore also issue approvals for measuring devices? Get more information in the following 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’s the FDA?
The FDA (?Food and Drug Administration?) is really a US authority under the Department of Health. It is responsible for the tabs on foodstuffs and pharmaceuticals and serves to safeguard public health in america.
When should FDA requirements be considered?
The FDA? Sunny includes both US-made and imported products. That is why, regular audits are completed at overseas pharmaceutical manufacturers. US-approved drugs may only be produced 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 studied into account in the look of the plant as must selecting suitable measuring instruments:
Liquids which could find their way into the end product in the event of a failure must be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium should be manufactured from FDA-compliant material. As proof, a material certificate for the seal should be available.
Process connections should ideally have 3-A approval to ensure the connections are suitable for sanitary applications. Instruments with 3-A marking have been shown to meet 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 in accordance with 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, because it has improved corrosion properties in comparison to 1.4404 as a result of lower delta ferrite content).
The measuring instrument should be calibratable and the accuracy should be confirmed by 3.1 or DAkkS certificate.
Conclusion
Nothing will stand in the way of the success of one’s FDA audit, if you take these points into account.
Note
More info on our products can be found on the WIKA website.