Does the FDA issue its own approvals for systems or devices and therefore also issue approvals for measuring devices? Learn more in the following blog post. There are always uncertainties with this particular topic, which explains why I?d like to shed more light on the question in this website post.
What is the FDA?
The FDA (?Food and Drug Administration?) is a US authority under the Department of Health. It really is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect 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 carried out at overseas pharmaceutical manufacturers. US-approved drugs may only be made by FDA-inspected manufacturers whose facilities comply with 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 taken into account in the look 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 should be FDA-compliant. These can, for instance, be transmission fluids or fill fluids.
Scary that are in touch with the measuring medium should be manufactured from FDA-compliant material. As proof, a material certificate for the seal should 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 already been shown to meet up with 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 sterile engineering, it really is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For example, WIKA uses 1.4435 because the standard material for applications in sanitary applications, since it has improved corrosion properties in comparison to 1.4404 as a result of 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 one’s FDA audit, if you take the aforementioned points into account.
Note
Further information on our products can be found on the WIKA website.