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 like to shed more light on the question in this blog post.
What is the FDA?
The FDA (?Food and Drug Administration?) is really a US authority under the Department of Health. It is responsible for the tabs on foodstuffs and pharmaceuticals and serves to protect public health in the United States.
When should FDA requirements be considered?
The FDA?s control includes both US-made and imported products. That is why, regular audits are completed at overseas pharmaceutical manufacturers. US-approved drugs may only be made 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 relative to general GMP requirements (? Painful manufacturing practice?). These must already be studied into account in the planning of the plant as must also the selection of suitable measuring instruments:
Liquids that 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 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 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 contact with the media should have a 3.1 material test certificate relative to DIN EN 10204. In sterile engineering, it really is preferable to 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, because it has improved corrosion properties in comparison to 1.4404 due to 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.