Does the FDA issue its own 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 particular topic, which explains why I?d like to shed more light on the question in this website post.
What is the FDA?
The FDA (?Food and Drug Administration?) is a US authority beneath the Department of Health. It really is responsible for the tabs on foodstuffs and pharmaceuticals and serves to safeguard public health in america.
When should FDA requirements be considered?
The FDA?s control includes both US-made and imported products. That is why, 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 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 look of the plant as must selecting suitable measuring instruments:
Liquids which could find their way into the end product in the event of a failure must be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Worthwhile that are in contact with the measuring medium must 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 ensure 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 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 because the standard material for applications in sanitary applications, because it has improved corrosion properties compared 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, so long as you take the aforementioned points into account.
Note
More info on our products can be found on the WIKA website.