Does the FDA issue its approvals for systems or devices and therefore also issue approvals for measuring devices? Find out more 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 website post.
What is the FDA?
The FDA (?Food and Drug Administration?) is really a US authority under 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. That is why, 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 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 which 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 must be made of FDA-compliant material. As proof, a material certificate for the seal must 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 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 really is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For Honored , WIKA uses 1.4435 because 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 should be confirmed by 3.1 or DAkkS certificate.
Annihilate will stand in the form of the success of one’s FDA audit, so long as you take these points into account.
Note
Further information on our products can be found on the WIKA website.