Sanitary Fittings for Pharmaceuticals


Thread Starter


Does anyone here know what is special about the so called 'Sanitary Fittings' used for instrument connections to process lines in Pharmaceutical projects?


I have worked in the food industry, and we used sanitary fittings there as well. The number one reason for using sanitary fittings is.......... the FDA will come down on you HARD if you don't! The difference between sanitary and non-sanitary fittings is that sanitary fittings are Corrosion-proof (usually stainless steel. They are sealed to prevent foriegn objects from getting to your process. Most are anyway, but these are rated for maintaining a sterile environment. In the applications I used them in, the food product was sterilized as part of the process. The sanitary fittings were able to keep the sterile environment. Finally, and most importantly, the can be cleaned without removing them from the process. When you perform a Clean-In-Place (CIP) procedure, you need to be able to 'prove' to the FDA that any food, chemical, drugs, or whatever that was in the system has been 100% removed from the process piping. Sanitary fittings are designed so that if you move your cleaning solution and rinse water at the rated velocity, the will not keep any 'gunk' in them. Non sanitary fittings are not rated for cleaning. This will show as exposed springs, small, winding channels, etc. Sanitary devices do not have any small areas that will resist rinsing. I would strongly encourage you to use the sanitary fittings whenever you have a question. Especially in food or drug applications. The FDA does not fool around if somebody gets sick or dead and it turns out that it is because you didn't use the proper fittngs. Read personal liability. --Joe Jansen
Easy to remove and clean - many size fittings - no grooves or holes for bugs to live in. All SS products. We (Almeg Controls) offer sanitary fittings tig welded on our level switch products.

Hakan Ozevin

As far as I know, they are usually stainless steel, without any dye or coating. The main idea is using a material which can be easily disenfected and does not create a media for growth of bacteria. Hakan Ozevin

Eric M. Klintworth

Basically, there are no cracks and crevises for anything to build up in--you can flush the pipeline and be comfortable that everything is rinsed out. You will often see such fittings referred to as "3A Dairy". For obvious reasons, the dairy industry has insisted on such fittings for a long time. They are required anywhere "clean in place" (CIP) piping systems are used. In a CIP system, the piping is flushed with cleaner, then rinsed, instead of being manually disassembled and cleaned. You certainly wouldn't want any cleaner mixed in with your milk (or medicine), or cross-contamination. Hope that helps, Eric M. Klintworth

Anthony Kerstens

Well, given the name sanitary, my guess would be they don't have nooks and corners for material/goop to get stuck in and become a contamination/bio hazard to the process. I would also expect they would be able to put up with 95degC water for at least an hour as part of a sanitization process. They otherwise might deteriorate and contaminate the lines. Anthony Kerstens P.Eng.

Roderick K. Duet

Correct, stainless is the sanitary standard. But to add to the answer of why? S.S. is a denser metel not allowing Microbes to settele in pits and its cleanability by use of chemicals is very good, although chlorine concentrations can eat S.S. up and cause pitting. But you may, unless specifically speced, use plastic piping or aluminum in lou of stainless (in some applications it is necessary because of the product). Regarding platic, CPVC etc., one sometimes overlooked item is the required C.I.P. temperatures. There are available plastic ferrules and adapters of the sanitary fitting standards ie Tri-Clamp, bevel seat, pv, and I'm sure there are some I've never seen. I currently work in the food and beverage industry, our company's primary income is from sanitary process design and installation. The process controls are packaged to supplement these systems. In fact there has only been one project out of fifty-five that I have been involved with that the sanitary work is all that was done. Well I'm rambling, thanks for the opportunity to reply.

Van Van't Slot

Just a thought, I have a friend at Thermoplastic Processes, Inc. whose brother owns a company in Andover, NJ that makes food grade and pharm. grade tubing of all types. I don't know the name in Andover, so call Joe Dupont at Thermoplastic, tell him you talked to Van - he'll know, and ask how to get in touch with Bob Dupont ... Should have some answers or possible leads... Van US Technologies, Inc. Depot Electronic Repairs of power supplies and circuit cards. [email protected])
Thank you all for your advice on the above. I have now located a set of catalogues from Fisher Rosemount with details of the sanitary fitings. So i guess my local Fisher Rosemount representative can answer most of my queries now. Regards