Does the FDA issue its own approvals for systems or devices and therefore also issue approvals for measuring devices? Find out more in the following blog post. You can find always uncertainties with this particular topic, which is 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 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. 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 completed relative to general GMP requirements (?good manufacturing practice?). These must already be studied into account in the look of the plant as must also selecting suitable measuring instruments:
Liquids which could find their way in to the end product in case of a failure should be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Seals that are in contact with the measuring medium must be made of FDA-compliant material. As proof, a material certificate for the seal should be available.
Process connections should ideally have 3-A approval to make sure that the connections are suitable for sanitary applications. Instruments with 3-A marking have already been shown to meet up with the specifications for radii and surface roughness (Ra < 0.8 ?m).
Metallic parts which are in contact with the media must have a 3.1 material test certificate relative to DIN EN 10204. In sterile engineering, it is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For Savagery , WIKA uses 1.4435 as the standard material for applications in sanitary applications, because 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 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 these points into account.
Note
More info on our products are available on the WIKA website.g