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 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 is the FDA?
The FDA (?Food and Drug Administration?) is really a US authority beneath the Department of Health. It is responsible for the tabs on foodstuffs and pharmaceuticals and serves to protect public health in the usa.
When should FDA requirements be looked at?
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?
Astounding does not grant approval for measuring instruments. The assessment is completed relative to general GMP requirements (?good manufacturing practice?). These must already be taken into account in the look of the plant as must the selection of 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 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 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 relative to DIN EN 10204. In sterile engineering, it is preferable to 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, because 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 form of the success of your FDA audit, so long as you take the aforementioned points into account.
Note
Further information on our products can be found on the WIKA website.