Liquid ring pumps with mechanical seals are about as low maintenance as you can get. As long as you don’t run seal dry, over/never grease the bearings, or run hard solids through it you’re good for years of industrious usage. A full overhaul would be bearings for the pump/motor, lip seals, a tube of flange sealant for gaskets or orings, a ptfe valve plate, and mechanical seal lapping or replacement. Very few moving parts. Total abuse and complete lack of or incorrect maintenance will be the thing to create downtime.
They make as small as a 5 cfm and go up to tens of thousands of cfm. That covers just about everyone.
In my opinion, I would look for solvent recovery systems that are geared towards the biotech, food, Pharma industries because they have spent a great deal of effort and time ensuring the GMP documentation is provided with the equipment.
Also, they provide Factory Acceptance Tests and Site Acceptance Tests and Commissioning and Qualification. These will become crucial as the GMPs are enforced.
It works a bit different than what you just mantioned.
Basically I can get any machine I want to be GMP approved, not 100% all machines but most.
I get the engineering report for the machine and as long as basic things are met than most likely our consulting company will build a protocol for the device to be approved.
So as long as the system is built using 316SS than most odds it will be approved.
Well, in my years of GMP validation and engineering, I’ve never heard of such easy GMP compliance…I hope your engineer’s ‘reports’ stand up to an FDA audit.
316SS is a good start, but what’s the polish level on the product-contact surfaces?
You have to seal the system with elastomers, what are they made out of?
Have they been tested to relevant standards (USP Class VI, BSE/TSE Free)?
Do you have SOPs for the equipment?
How is the revision process for the SOPs controlled? Do you have a quality department dedicated to document control?
Will you validate the system? What documents have you developed to capture the validation process?
Have you established a cleaning process? What post cleaning processes have you carried out to ensure that the cleaning was adequate? Where do you store this data?
That’s the tiny, tiny tip of the proverbial iceberg.
If you’re GMP certified and you can’t answer those question when the FDA comes through, you’re gonna be in some big trouble. They’ll give you a 483 and shut down your facility.
Good luck on finding the equipment you’re looking for
What do you mean FDA, I dont reside in the US nither is our facility, so FDA is not in the equation.
Do you have SOPs for the equipment? - of course all our equipment has one.
How is the revision process for the SOPs controlled? Do you have a quality department dedicated to document control? - sure we do both inhouse and out sourced.
Will you validate the system? What documents have you developed to capture the validation process? - the process needs to be validated more than the device you use, and yes every experiment is documanted in order to prove and validate a said device.
Have you established a cleaning process? - of course, for every piece of equipment and we do it once every batch so not at the ned of the day, my extractor goes through its cycle once its finished it is then cleaned in a process we developed for that specific device.
Our facility is close to being finished all clean rooms has been setup and even epoxy was laid on the floor, have no worry my friend we are quite keen in building such facilities…