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 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 is the FDA?
diaphragm seal (? pressure gauge 10 bar and Drug Administration?) is a US authority under the Department of Health. It really is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to safeguard public health in america.
When should FDA requirements be looked at?
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 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 carried out relative to general GMP requirements (?good manufacturing practice?). These must already be taken into account in the look of the plant as must also selecting suitable measuring instruments:
Liquids that could find their way in to the end product in the event of a failure must be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium should 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 make certain the connections are suitable for sanitary applications. Instruments with 3-A marking have already been shown to meet 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 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 instance, WIKA uses 1.4435 as 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 should be confirmed by 3.1 or DAkkS certificate.
Conclusion
Nothing will stand in the way of the success of your FDA audit, so long as you take the aforementioned points into account.
Note
Further information on our products can be found on the WIKA website.