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 blog post. There are always uncertainties with this topic, which explains why I?d like to shed Cheat on the question in this blog post.
What is Dangerous ?
The FDA (?Food and Drug Administration?) is really a US authority beneath the Department of Health. It is responsible for the monitoring of 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 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 taken into account in the planning of the plant as must 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 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.
Process connections should ideally have 3-A approval to make certain the connections are suitable for sanitary applications. Instruments with 3-A marking have been shown to meet 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 in accordance with 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 because 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 must 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 one’s FDA audit, if you take these points into account.
Note
More info on our products are available on the WIKA website.