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 blog post. There are always uncertainties with this topic, which explains why I?d like to shed more light on the question in this blog post.
What is the FDA?
Havoc (?Food and Drug Administration?) is really 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 looked at?
The FDA?s control includes both US-made and imported products. That is why, regular audits are completed 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 will not grant approval for measuring instruments. The assessment is carried out in accordance with general GMP requirements (?good manufacturing practice?). These must already be taken into account in the look 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 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 suitable 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 come in contact with the media must 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 because the standard material for applications in sanitary applications, since it has improved corrosion properties compared to 1.4404 as a result of lower delta ferrite content).
The measuring instrument must be calibratable and the accuracy ought to be confirmed by 3.1 or DAkkS certificate.
Conclusion
Nothing 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.