I work for a company that installs negative pressure ductwork systems and process equipment in the pharmaceutical industry. When we do an install, we always buy fittings and tubing/piping from Felker bros. or equiv. commercial mfr. Our specifications and notes are clear on this.
Right now, there is an engineer that is telling a shop who does installations to fabricate all fittings in his shop. I think about welds not matching up, full penetration , interior crevices, passivation, etc.
In hearing this, I indicated that this was not a wise decision since this is the inlet air to a machine which processes a high potency drug.
The question is this: What type of issues may come up by doing a job this way? What legal actions might be taken by our company doing this?
Thanks for any advice.
Re: Standard 20" S.S. 12 ga. Piping
6 years 10 months ago #6622
Thank you received: 14
Fact #1 pharmaceutical industry
Fact #2 high potency drug.
Fact #3 we always buy fittings and tubing/piping from Felker bros. or equiv.
Fact #4 Our specifications and notes are clear on this.
Fact #5 an "engineer" that is telling a shop who does installations to fabricate all fittings in his shop
Fact #6 a shop who does installations to fabricate all fittings in his shop
A. What is the background, role, position and authority of this Engineer noted in Fact #5?
B. Does this shop (noted in Fact #6) have the capabilities to fabricate Hygienic fittings?
What type of issues may come up by doing a job this way?
a). The Plant may not pass the "Validation" including the proper use of materials in accordance with the Material Specifications.
b). The FDA may not give the plant Certification to produce.
What legal actions might be taken by our company doing this?
Your company may end up owning a Pharmaceutical Plant that the FDA will not allow to be started up and you will have to build the Client a new plant plus repay the Client for lost profit until the "New" plant becomes productive.
Do it once and Do it Right
Re: Standard 20" S.S. 12 ga. Piping
6 years 10 months ago #6623
Thanks for the advice. In thinking about this, it's most likely that no issues will surface as the ones doing any inspection wouldn't see the pipe interior. The possible contamination is real but this guy is trying to "get the job done" and he is the only guy here to do this. The person who was his boss (the author of specs.) had quit a couple years ago for a brighter future.
The ability to produce a mitered ell. that is comparable to a commercially produced fitting would be extraordinarily expensive as you must know. The shortcuts that will be taken will be counting on full weld penetration to the material from the outside. The idea of then cleaning alone, then passivation is "minimal spray-on at best". The pipe interior along these weldments is where any contaminants would grow.
This guy fancies himself as an all-round expert. Oh, he's also forcing me to add a drain valve on the knee of the ell prior to the hor. center of the ell. entering the process room. I had mentioned adding a pipe within process room at low point, coming out to tech. area so the valve would at least work but was not listened to on this either.
So far, this guy was going to install 35' including 4 extra ells. including 16 flanges (all 20") welded interior/exterior plus supporting it all rather than take my advice of simply putting the new flow element in the place I showed. This would have cost about 15 - 20K more than my way. He went forward with it and now came back saying it's a "budget buster" and wanted more info. on my original concept.
My original design time on this took 3 days. When he mentioned he wanted to build these fittings without field cuts, forced me to do this when I was already done with details, etc. and from what I've indicated above should let you know his piping abilities. I haven't mentioned yet that this guy doesn't think much of me but does have control. of the issues described here. Whether these things come back to bite us or not remains to be seen. I'm keeping my e-mails regarding the entire fiasco though. Need some sort of protection against this foolishness. I could go on but you probably stopped readingg this a while ago anyway. Just a little venting but I guess we all do it on occasion.