Any kind of FDA-approved measuring instruments?

Does the FDA issue its approvals for systems or devices and for that reason also issue approvals for measuring devices? Find out more in the following post. You can find always uncertainties with this topic, which explains why I?d prefer to shed more light on the question in this blog post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is a US authority beneath the Department of Health. It is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in the usa.
When should FDA requirements be considered?
The FDA?s control includes both US-made and imported products. Because of this, regular audits are carried out at overseas pharmaceutical manufacturers. US-approved drugs may only be produced by FDA-inspected manufacturers whose facilities adhere to FDA regulations.
How are plants and equipment assessed for FDA requirements?
The FDA does not grant approval for measuring instruments. The assessment is carried out in accordance with general GMP requirements (?good manufacturing practice?). These must already be taken 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 case of a failure must be FDA-compliant. Is Here can, for example, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium must be made of FDA-compliant material. As proof, a material certificate for the seal must be available.
Process connections should ideally have 3-A approval to ensure that 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 should have a 3.1 material test certificate relative to DIN EN 10204. In sterile engineering, it really is preferable to 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 compared to 1.4404 due to the 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 form of the success of one’s FDA audit, so long as you take the aforementioned points into account.
Note
More info on our products are available on the WIKA website.

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