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. There are 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 really a US authority under 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. 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 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 completed relative to general GMP requirements (?good manufacturing practice?). Playful must already be studied into account in the look of the plant as must selecting suitable measuring instruments:
Liquids that could find their way in to the end product in case of a failure must 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 must be available.
Process connections should ideally have 3-A approval to ensure 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 are in connection with the media must have a 3.1 material test certificate in accordance with DIN EN 10204. In sterile engineering, it 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 compared to 1.4404 due to the lower delta ferrite content).
The measuring instrument should be calibratable and the accuracy ought to 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
Insane on our products are available on the WIKA website.