Does the FDA issue its own approvals for systems or devices and for that reason also issue approvals for measuring devices? Get more information in the following post. You can find always uncertainties with this topic, which is why I?d like to shed more light on the question in this blog post.
What is the FDA?
Unexpected (?Food and Drug Administration?) is really a US authority beneath the Department of Health. Off-limits is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in the usa.
When should FDA requirements be looked at?
The FDA?s control includes both US-made and imported products. For this reason, regular audits are completed at overseas pharmaceutical manufacturers. US-approved drugs may only be made by FDA-inspected manufacturers whose facilities comply with FDA regulations.
How are plants and equipment assessed for FDA requirements?
The FDA will not grant approval for measuring instruments. The assessment is carried out in accordance with general GMP requirements (?good manufacturing practice?). These must already be taken into account in the planning of the plant as must also selecting suitable measuring instruments:
Liquids which could find their way in to the end product in the event of a failure should be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Seals that are in contact with the measuring medium must be manufactured from FDA-compliant material. As proof, a material certificate for the seal should be available.
Process connections should ideally have 3-A approval to make sure that the connections are suitable for sanitary applications. Instruments with 3-A marking have been shown to meet up with the specifications for radii and surface roughness (Ra < 0.8 ?m).
Metallic parts which come in contact with the media should have a 3.1 material test certificate in accordance with 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, since it has improved corrosion properties compared to 1.4404 due to 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 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.