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
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 )
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 )
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 )
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 )
RE: Help needed for a pharma tank cleaning ( CIP / SIP )
Mark Hutton
RE: Help needed for a pharma tank cleaning ( CIP / SIP )
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 )
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 )
@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 )
If you want to talk more jari we could start another thread.
Ed
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P.E. Metallurgy, Plymouth Tube
RE: Help needed for a pharma tank cleaning ( CIP / SIP )
I started thread330-411773: Getting to the facts about surface roughness and passivation for 316(L) with a couple questions. Drop by if you are so inclined.