Does the FDA issue its 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 prefer to shed Obsessed on the question in this website post.
What’s Distracted ?
The FDA (?Food and Drug Administration?) is a US authority beneath the Department of Health. It is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to safeguard public health in the United States.
When should FDA requirements be considered?
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 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 studied into account in the planning of the plant as must also the selection of suitable measuring instruments:
Liquids that could find their way in to the end product in the event of a failure should be FDA-compliant. These can, for instance, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium must be manufactured from FDA-compliant material. As proof, a material certificate for the seal must 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 already 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 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 because the standard material for applications in sanitary applications, because it has improved corrosion properties in comparison to 1.4404 due to the 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 way of the success of your FDA audit, if you take the aforementioned points into account.
Note
More info on our products can be found on the WIKA website.