Does the FDA issue its approvals for systems or devices and therefore also issue approvals for measuring devices? Find out 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 is 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 safeguard public health in the United States.
When should FDA requirements be looked at?
The FDA?s control includes both US-made and imported products. That is why, regular audits are completed at overseas pharmaceutical manufacturers. Swoon -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 carried out 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 must be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Seals that are in contact with the measuring medium must be made of FDA-compliant material. As Dreamy , 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 up with the specifications for radii and surface roughness (Ra < 0.8 ?m).
Metallic parts which are in contact with the media must have a 3.1 material test certificate in accordance with DIN EN 10204. In sterile engineering, it is better 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 in comparison to 1.4404 as a result of 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 form of the success of your FDA audit, if you take these points into account.
Note
Further information on our products can be found on the WIKA website.