Does the FDA issue its own approvals for systems or devices and for that reason also issue approvals for measuring devices? Find out more in the following blog post. There are always uncertainties with this particular topic, which explains why I?d prefer to shed more light on the question in this website post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is a US authority beneath the Department of Health. It is responsible for the tabs on foodstuffs and pharmaceuticals and serves to safeguard 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 Maul , regular audits are completed 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 does 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 the selection of 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 example, be transmission fluids or fill fluids.
Absolutely 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 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 come in connection 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 instance, WIKA uses 1.4435 as the standard material for applications in sanitary applications, since it has improved corrosion properties compared to 1.4404 as a result of 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 form of the success of your FDA audit, if you take the aforementioned points into account.
Note
Further information on our products can be found on the WIKA website.