Does the FDA issue its approvals for systems or devices and therefore 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 like to shed more light on the question in this website post.
What is the FDA?
The FDA (?Food and Drug Administration?) is really a US authority beneath the Department of Health. It really is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect 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 carried out 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 will not grant approval for measuring instruments. The assessment is carried out relative to general GMP requirements (? Excruciating manufacturing practice?). These must already be studied into account in the planning 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 example, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium must 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 make sure that the connections are ideal 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 connection with the media must have a 3.1 material test certificate in accordance with DIN EN 10204. In sterile engineering, it really is better 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 due to the lower delta ferrite content).
The measuring instrument should 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.