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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 blog post. There are always uncertainties with this topic, which is why I?d prefer 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 monitoring of 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. 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 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 in accordance with 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 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.
ไดอะแฟรม that are in touch with the measuring medium should 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 certain the connections are ideal 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 connection 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 as the standard material for applications in sanitary applications, because 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 your FDA audit, if you take the aforementioned points into account.
Note
Further information on our products can be found on the WIKA website.