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Does the FDA issue its approvals for systems or devices and therefore also issue approvals for measuring devices? Find out more in the following post. You can find always uncertainties with this particular topic, which explains why I?d prefer to shed more light on the question in this website post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is 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? Insider includes both US-made and imported products. For this reason, regular audits are completed 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 will not grant approval for measuring instruments. The assessment is carried out relative to general GMP requirements (?good manufacturing practice?). These must already be taken into account in the planning of the plant as must selecting suitable measuring instruments:
Liquids that could find their way into the end product in case of a failure must be FDA-compliant. These can, for instance, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium must 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 ideal 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 connection with the media must have a 3.1 material test certificate in accordance with DIN EN 10204. In sterile engineering, it really is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For example, WIKA uses 1.4435 as the standard material for applications in sanitary applications, since it has improved corrosion properties in comparison to 1.4404 because of the lower delta ferrite content).
The measuring instrument should be calibratable and the accuracy ought to 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.