Does the FDA issue its approvals for systems or devices and therefore 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 website post.
What is the FDA?
Results (?Food and Drug Administration?) is really a US authority beneath the Department of Health. It is responsible for the monitoring of 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. Because of this, regular audits are carried out at overseas pharmaceutical manufacturers. US-approved drugs may only be produced 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 look of the plant as must also the selection of suitable measuring instruments:
Liquids which 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 touch 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 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 must 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 instance, WIKA uses 1.4435 because the standard material for applications in sanitary applications, since it has improved corrosion properties in comparison to 1.4404 due to 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 form of the success of one’s FDA audit, if you take the aforementioned points into account.
Note
More info on our products are available on the WIKA website.