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Help needed for a pharma tank cleaning ( CIP / SIP )

Help needed for a pharma tank cleaning ( CIP / SIP )

(OP)
Hello Friends..
This is my first thread here, and i started working as chemical engineer in an industrial services company... So i got a new project for Cleaning a Tank in a pharma company.. As i am new into the field can some one help me with some basic tips

Following are the details of the tank to be cleaned

Material Of Construction -Stain Less Steal 316L

Storage tank with the capacity of 8370Lit

All tanks are equipped with CIP (Cleaning in place) SIP (Sterilization in place)

Solution handling : IV Solutions

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

If it is a tank in a pharma plant then they must have a validated procedure in place for CIP/SIP.
And you cannot deviate from that procedure without requalifying the quality of the products.
The procedure will cover chemistry and concentration of the solution, temperature and time of treatment, and the dispersion method (nozzles or spray balls).
Most of these systems will be built to either ASME BPE or EHEDG or both.

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P.E. Metallurgy, Plymouth Tube

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

(OP)
Thanks for the reply,...

As our client's need is that " we need to prepare the procedure for activation and passivation " and they are asking us to send all datas like MSDS of the chemicals used for cleaning to them ...

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

Then start with the mentioned specs. The have sections on what is allowed for this process.
Also ask what kind of testing they will be doing to validated the process. there are various tests that use tracer organic compounds that can be used to quantify the degree of cleaning.

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P.E. Metallurgy, Plymouth Tube

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

Sir good morning, are you looking for a contractor to clean your storage tank? thanks

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

From the post the tank has been in service. What is the service, what has been in the tank? Why are they wanting to "activate and passivate" the tank. Contents and duty of the tank will have some influence on the chemicals and procedure to be used.

Mark Hutton


RE: Help needed for a pharma tank cleaning ( CIP / SIP )

Passivation re-creates the chromium oxide passive layer on the 316 to increase corrosion resistance. Passivation is usually needed because the surface of the vessel is somehow damaged or re-worked. Various acid solutions are used to restore the passive layer.

Make sure you have clarity on the company's cleaning validation and/or cleaning SOPs before you start doing anything (if they have any). It sounds like the tank was decomissioned or just not used for sometime and now they want to use it again...Inspecting for rouge and surface damage could be a good start.


Some more details would help.

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

Unless you have aggressively striped the chromia layer and then held the material in a chemically reducing environment the stainless will readily self passivate. An exposure of 72 hours in air is as passive as you will get without some very involved treatments. This is stainless steel works.
Passivation treatments are actually cleaning. The big concern is microscopic bits of steel (Fe) in the surface from tools, or contamination. The Fe wills start to rust and the resulting local environment may lead to pitting of the stainless.

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P.E. Metallurgy, Plymouth Tube

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

Side note
@EdStainless
It's interesting you say that because I have had many discussions with senior enigneers on my team (all MechE vets of pharma) about reaction rates and such(being a humble ChemE that I am, that's all I have in my toolbelt) because my gut feeling was what you've described about SS. I defer to their experience in not only understanding the phenomena but also what explanations the QA folks (bio, chem, pharmacy majors) are willing to accept and sign for, which I've found to be the limiting factor in certain cases.

RE: Help needed for a pharma tank cleaning ( CIP / SIP )

In the Pharma world there are a lot of myths about passivation, surface roughness, and rouging. I used to hate being in meetings with these guys, in the first two minutes they would say 12 things that were not correct, and it would take me an hour to try to set them straight.
If you want to talk more jari we could start another thread.
Ed

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P.E. Metallurgy, Plymouth Tube

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