HYGIENIC CENTRIFUGE - STANDARD FDA
HYGIENIC CENTRIFUGE - STANDARD FDA
(OP)
Dear colleagues:
For a project about pharmaceutical centrifuge I need make the centrifuge in accordance with Code of Federal Regulation determined by the United States Federal Food and Drug Administration (FDA).
I this topic I have several questions:
1.What FDA or 3-A regulation has affected the centrifuge?
2.How recommended FDA make the CIP and SIP "Sterilisation of machine"?
3.What type of polishing FDA recommended? Ra, Rz, Tpi, Tpa, Abbot curve etc..
4.How can make the instructions manual? That steps
5.What type of stainless steel recommended the FDA or 3-A? For example the AISI-316L is correct.
6.What type of welding do you recommended? What regulations are for welding FDA or 3-A?
I am grateful for advance
Jordi Beltran
For a project about pharmaceutical centrifuge I need make the centrifuge in accordance with Code of Federal Regulation determined by the United States Federal Food and Drug Administration (FDA).
I this topic I have several questions:
1.What FDA or 3-A regulation has affected the centrifuge?
2.How recommended FDA make the CIP and SIP "Sterilisation of machine"?
3.What type of polishing FDA recommended? Ra, Rz, Tpi, Tpa, Abbot curve etc..
4.How can make the instructions manual? That steps
5.What type of stainless steel recommended the FDA or 3-A? For example the AISI-316L is correct.
6.What type of welding do you recommended? What regulations are for welding FDA or 3-A?
I am grateful for advance
Jordi Beltran





RE: HYGIENIC CENTRIFUGE - STANDARD FDA
(2) Not sure what your question is asking. Yes, they are often CIPed and SIPed. The unit should drain completely.
(3) This varies from company to company and also on the intended application. I typically see a specification of 16Ra(Max). This would be a mechanical polish followed by EP and Passivation. (There is talk about simply electropolishing the standard 2B mill finish followed by passivation. The result seems to be acceptable except for some visible cosmetic flaws that don't effect performance. We still specify 16Ra(Max))
(4)Again, I'm not sure what you are asking here. You might try and contact one of the pharmaceutical centrifuge manufacturers for information...as a customer. We recently purchased several Westfalia centrifuges. Alpha Laval is another manufacturer.
(5) 316L is typically preferred.
(6) Orbital welding by a qualified welder is preferred. A good hand weld with inspection can be acceptable.
RE: HYGIENIC CENTRIFUGE - STANDARD FDA
Jordi Beltran
RE: HYGIENIC CENTRIFUGE - STANDARD FDA
The standard covers welding, design, cleanability and materials.
Regards
Daragh