Does the FDA issue its approvals for systems or devices and for that reason also issue approvals for measuring devices? Find out more in the following post. There are always uncertainties with this particular topic, which explains why I?d prefer to shed Hostile on the question in this website post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is really a US authority beneath the Department of Health. It really is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in america.
When should FDA requirements be considered?
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 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 (?good manufacturing practice?). These must already be studied into account in the planning of the plant as must also selecting suitable measuring instruments:
Liquids that could find their way into the end product in case 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 should be made of FDA-compliant material. As proof, a material certificate for the seal should be available.
Process connections should ideally have 3-A approval to ensure that 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 must have a 3.1 material test certificate relative to DIN EN 10204. In sterile engineering, it is preferable to use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For example, WIKA uses 1.4435 as the standard material for applications in sanitary applications, because it has improved corrosion properties compared to 1.4404 because of 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 form of the success of one’s FDA audit, so long as you take these points into account.
Note
More info on our products are available on the WIKA website.