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 particular topic, which is why I?d prefer to shed more light on the question in this website post.
What is the FDA?
Timely (?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 protect public health in the usa.
When should FDA requirements be considered?
The FDA?s control includes both US-made and imported products. That is why, 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 does not grant approval for measuring instruments. The assessment is carried out relative to general GMP requirements (?good manufacturing practice?). These must already be studied into account in the planning of the plant as must also selecting suitable measuring instruments:
Liquids which could find their way in to the end product in the event of a failure should be FDA-compliant. These can, for instance, be transmission fluids or fill fluids.
Seals that are in touch 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 in accordance with DIN EN 10204. In sterile engineering, it is preferable to 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, because 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 ought to 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 these points into account.
Note
More info on our products are available on the WIKA website.