Does the FDA issue its own approvals for systems or devices and for that reason also issue approvals for measuring devices? Learn more in the following blog post. You can find always uncertainties with this particular topic, which explains why I?d prefer to shed more light on the question in this blog post.
What’s Drowning ?
The FDA (?Food and Drug Administration?) is really a US authority under the Department of Health. It is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to safeguard public health in the usa.
When should FDA requirements be considered?
The FDA?s control includes both US-made and imported products. Because of this, 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 completed relative to general GMP requirements (?good manufacturing practice?). These must already be studied into account in the look of the plant as must the selection of suitable measuring instruments:
Liquids which could find their way in to the end product in case of a failure should be FDA-compliant. These can, for instance, be transmission fluids or fill fluids.
Seals that are in contact 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 ensure 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 connection 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 Searing , WIKA uses 1.4435 as 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 should 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
Further information on our products are available on the WIKA website.