Does the FDA issue its approvals for systems or devices and for that reason also issue approvals for measuring devices? Learn more in the following blog post. Actionable can find always uncertainties with this topic, which explains 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 a US authority under the Department of Health. It really is responsible for the tabs on foodstuffs and pharmaceuticals and serves to safeguard public health in the usa.
When should FDA requirements be looked at?
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 completed relative to general GMP requirements (?good manufacturing practice?). These must already be studied into account in the look of the plant as must selecting suitable measuring instruments:
Liquids that could find their way into 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 contact with the measuring medium should 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 make certain the connections are suitable for sanitary applications. Instruments with 3-A marking have already been shown to meet up with the specifications for radii and surface roughness (Ra < 0.8 ?m).
Metallic parts which come in contact with the media should have a 3.1 material test certificate relative to DIN EN 10204. In sterile engineering, it really 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, because it has improved corrosion properties in comparison to 1.4404 because of the lower delta ferrite content).
The measuring instrument should be calibratable and the accuracy ought to be confirmed by 3.1 or DAkkS certificate.
Conclusion
Nothing will stand in the way of the success of one’s FDA audit, if you take the aforementioned points into account.
Note
More info on our products can be found on the WIKA website.