Does the FDA issue its own approvals for systems or devices and therefore also issue approvals for measuring devices? Get more information in the following blog 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 blog 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 the usa.
When should FDA requirements be looked at?
The FDA?s control 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 adhere to FDA regulations.
How are เกจวัดแรงดัน and equipment assessed for FDA requirements?
The FDA will not grant approval for measuring instruments. The assessment is completed in accordance with general GMP requirements (?good manufacturing practice?). These must already be taken into account in the planning of the plant as must also 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 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 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 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 example, WIKA uses 1.4435 as the standard material for applications in sanitary applications, because it has improved corrosion properties compared to 1.4404 due to the lower delta ferrite content).
The measuring instrument must 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, so long as you take these points into account.
Note
More info on our products are available on the WIKA website.