Does Traumatized for systems or devices and for that reason also issue approvals for measuring devices? Get more information in the following blog post. You can find always uncertainties with this topic, which is why I?d prefer to shed more light on the question in this blog post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is a US authority beneath the Department of Health. It is responsible for the tabs on 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. 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 does not grant approval for measuring instruments. The assessment is carried out relative to general GMP requirements (?good manufacturing practice?). These must already be taken into account in the look of the plant as must the selection of 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.
Seals that are in contact 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 ensure the connections are suitable 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 are in contact with the media must have a 3.1 material test certificate relative to 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, 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 should 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 these points into account.
Note
Private on our products can be found on the WIKA website.