Does the FDA issue its own approvals for systems or devices and therefore also issue approvals for measuring devices? Learn more in the following blog post. There are always uncertainties with this topic, which is why I?d prefer to shed more light on the question in this blog post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is 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 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 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 planning 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 touch with the measuring medium should be made of FDA-compliant material. As proof, a material certificate for the seal should be available.
ไดอะแฟรม ซีล 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 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 relative to DIN EN 10204. In sterile engineering, it really is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For instance, WIKA uses 1.4435 because the standard material for applications in sanitary applications, since it has improved corrosion properties in comparison to 1.4404 because of 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 your FDA audit, if you take the aforementioned points into account.
Note
More info on our products are available on the WIKA website.