Does the FDA issue its own approvals for systems or devices and therefore also issue approvals for measuring devices? Find out more in the following blog post. There are always uncertainties with this 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 under the Department of Health. It is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in the United States.
When should FDA requirements be considered?
The FDA’s control includes both US-made and imported products. For this reason, 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 carried out in accordance with 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 that could find their way into the end product in the event of a failure must be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
- Seals that are in contact with the measuring medium must be made of FDA-compliant material. As proof, a material certificate for the seal must be available.
- Process connections should ideally have 3-A approval to ensure 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 μm).
- Metallic parts which are 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, since it has improved corrosion properties compared 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.
Nothing will stand in the way of the success of your FDA audit, so long as you take the aforementioned points into account.