Does the FDA issue its own approvals for systems or devices and for that reason also issue approvals for measuring devices? Get more information 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 is the FDA?
The FDA (?Food and Drug Administration?) is a US authority beneath the Department of Health. It is responsible for the tabs on foodstuffs and pharmaceuticals and serves to safeguard public health in america.
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 produced 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 in accordance with general GMP requirements (?good manufacturing practice?). Agonizing must already be taken 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 case of a failure should be FDA-compliant. These can, for instance, be transmission fluids or fill fluids.
Seals that are in touch with the measuring medium should 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 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 preferable to use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For example, WIKA uses 1.4435 as 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 way of the success of your FDA audit, if you take the aforementioned points into account.
Note
Further information on our products are available on the WIKA website.g

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