Does the FDA issue its own approvals for systems or devices and for that reason also issue approvals for measuring devices? Find out more in the following post. You can find always uncertainties with this particular 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 under the Department of Health. It is responsible for the tabs on 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. 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 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 completed in accordance with 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 into the end product in case 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 must 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 that 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 contact with the media must have a 3.1 material test certificate in accordance with 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 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 ought to be confirmed by 3.1 or DAkkS certificate.
Desire 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.