Does the FDA issue its approvals for systems or devices and therefore also issue approvals for measuring devices? Learn more in the following 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?
The FDA (?Food and Drug Administration?) is a US authority under the Department of Health. It is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in america.
When should FDA requirements be considered?
The FDA?s control includes both US-made and imported products. Because of this, regular audits are completed at overseas pharmaceutical manufacturers. Thankful -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 carried out relative to general GMP requirements (?good manufacturing practice?). These 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 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 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 the connections are ideal 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 in accordance with DIN EN 10204. In sterile engineering, it 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, because 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 ought to 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.