Does the FDA issue its approvals for systems or devices and for that reason also issue approvals for measuring devices? Find out more in the following blog post. You can find always uncertainties with this topic, which explains 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 really is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to safeguard public health in the usa.
When should Quick-start 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 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?). These must already be taken into account in the look of the plant as must 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 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 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 are 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 as 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 way of the success of your FDA audit, so long as you take these points into account.
Note
Further information on our products can be found on the WIKA website.