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 Seriously ?
The FDA (?Food and Drug Administration?) is really a US authority beneath the Department of Health. It really is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to safeguard public health in the United States.
When should FDA requirements be considered?
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 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 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 into the end product in case of a failure should 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 sure that the connections are suitable 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 are in connection with the media should 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 because of 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
Further information on our products are available on the WIKA website.