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 particular topic, which explains why I?d prefer to shed more light on the question in this blog post.
What is the FDA?
The FDA (?Food and Drug Administration?) is a US authority under the Department of Health. It is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in america.
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 in accordance with general GMP requirements (?good manufacturing practice?). Launching must already be taken into account in the planning of the plant as must 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 contact with the measuring medium should 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 certain the connections are ideal for sanitary applications. Instruments with 3-A marking have already been shown to meet 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 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, since it has improved corrosion properties in comparison to 1.4404 as a result of 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 these points into account.
Note
Further information on our products are available on the WIKA website.