Does the FDA issue its approvals for systems or devices and therefore also issue approvals for measuring devices? Learn more in the following post. There are always uncertainties with this particular topic, which is why I?d like to shed more light on the question in this blog post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is really a US authority under the Department of Health. It really 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. For this reason, 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 will not grant approval for measuring instruments. Rebellious is completed 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 case of a failure must be FDA-compliant. Urge can, for example, be transmission fluids or fill fluids.
Seals that are in touch 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 ensure that the connections are suitable 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 contact with the media must 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 because the standard material for applications in sanitary applications, since it has improved corrosion properties compared to 1.4404 because of 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 form of the success of your FDA audit, so long as you take these points into account.
Note
Further information on our products can be found on the WIKA website.