INTELLIGENT WORK FORUMS
FOR ENGINEERING PROFESSIONALS

Log In

Come Join Us!

Are you an
Engineering professional?
Join Eng-Tips Forums!
  • Talk With Other Members
  • Be Notified Of Responses
    To Your Posts
  • Keyword Search
  • One-Click Access To Your
    Favorite Forums
  • Automated Signatures
    On Your Posts
  • Best Of All, It's Free!

*Eng-Tips's functionality depends on members receiving e-mail. By joining you are opting in to receive e-mail.

Posting Guidelines

Promoting, selling, recruiting, coursework and thesis posting is forbidden.

Jobs

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

RE: HYGIENIC CENTRIFUGE - STANDARD FDA

(1) Check around the FDA website.  (http://www.fda.gov).  Typically, the FDA will be concerned with materials of construction, traceability (mill certs, weld logs, welder qualifications, etc.), cleanability, drainability, etc.  I don't know that they would have any document specifically discussing centrifuges.
(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

(OP)
Thank you for your response. You are very kind.

Jordi Beltran

RE: HYGIENIC CENTRIFUGE - STANDARD FDA

A very good standard to adhere to is the ASME BPE 2002. This standard is used for bioprocess equipment and purified water plants, it is also accepted by the FDA.
The standard covers welding, design, cleanability and materials.

Regards
Daragh

Red Flag This Post

Please let us know here why this post is inappropriate. Reasons such as off-topic, duplicates, flames, illegal, vulgar, or students posting their homework.

Red Flag Submitted

Thank you for helping keep Eng-Tips Forums free from inappropriate posts.
The Eng-Tips staff will check this out and take appropriate action.

Reply To This Thread

Posting in the Eng-Tips forums is a member-only feature.

Click Here to join Eng-Tips and talk with other members!


Resources


Close Box

Join Eng-Tips® Today!

Join your peers on the Internet's largest technical engineering professional community.
It's easy to join and it's free.

Here's Why Members Love Eng-Tips Forums:

Register now while it's still free!

Already a member? Close this window and log in.

Join Us             Close