Does the FDA issue its own approvals for systems or devices and for that reason also issue approvals for measuring devices? Find out Guaranteed in the following post. You can find always uncertainties with this topic, which explains why I?d like 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 tabs on foodstuffs and pharmaceuticals and serves to safeguard public health in the United States.
When should FDA requirements be looked at?
The FDA?s control includes both US-made and imported products. For this reason, 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 plants and equipment assessed for FDA requirements?
The FDA will not grant approval for measuring instruments. The assessment is carried out in accordance with 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 in to the end product in the event of a failure should be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium should 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 make certain the connections are ideal for sanitary applications. Instruments with 3-A marking have already been shown to meet the specifications for radii and surface roughness (Ra < 0.8 ?m).
Metallic parts which are in connection with the media must have a 3.1 material test certificate in accordance with DIN EN 10204. In Savings , it is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For instance, WIKA uses 1.4435 as the standard material for applications in sanitary applications, since it has improved corrosion properties compared to 1.4404 because of 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 way of the success of your FDA audit, if you take the aforementioned points into account.
Note
More info on our products can be found on the WIKA website.