Food and Pharmaceutical Design Requirements 1

[Vidaman]

Are there any industry specifications/certifications for valves used in the food and pharmaceutical industries? We are looking at redesigning a couple of our valves for this industry and I've just started to review the industry's requirements. The FDA seems to provide no other guidelines other than material selection. I'm looking for more design/performance criteria.

Any and all help is always appreciated.

-Mike

 

[ICman]

There are references to sterile valves and several food/pharmaceutical companies have internal standards covering valves. I can't find anything specific right now, but you might want to contact some companies directly.

Everyone is always looking for a better/cheaper mousetrap.

 

[mgp]

You should check out the ASME BPE code for Bioprocessing equipment and the ISPE Guidelines


More at

http://www.asme.org

http://www.ispe.org

regards
Mogens

 

[quark]

As far as my knowledge is concerned (and I have been in Pharma Industry for 7 years) there are no standards in black and white except for MOC (SS 316L). globe type valves are allowed only for steam lines.

Either full bore ball valves (second preference) or Diaphragm valves are used. The surface roughness should be not more than 0.6 micron (230 grit) but better if it is in between 0.2 to 0.4 for the size of bacteria is in that range. This smoothness ensures impossibility to settlement of bacterial or fungal colonies. All elastomers used should be of food grade (Silicon and EPDM are generally recommended) and you will be asked for the certificates of mice test. (PTFE is one non elastomer which can be used)

The valve material should be capable of withstanding to sterilization temperature (121⁰C of steam)

Internal parts of the valve should be accessible for cleaning.

For recirculation loops the valves should be of zero dead leg type. In closed condition water should flow through the valve.

Souble diaphragm type valves are in vogue now.

Check the web site of Saunders valves.

Hope this will help.