Validation of CIP system

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
#1

Hi all,

We are currently developing a CIP system for a multiproduct facility. Our system consists of 7 manufacturing vessels & Transfer lines. Is a “one size fits all” recipe approach, a viable option in developing this CIP system for multi products? How is this validated?

In the past i have seen conductivity been used as a parameter in measuring the final rinse water purity during the final rinse phase of the cycle. Is conductivity, as the controlling mechanism, an accurate measurement of a system been clean?
Cleaning agents will not be used as part of the CIP cleaning as all products have aqueous formulations.

Regards

S

#2

Hi SFlan,

usually conductivity is used in routine running of the CIP system but it’s validity is based on the validation programme which generally also looks at product removal, endotoxins, bacterial counts, pH and conductivity of rinse water.
You can try and bracket the products of similar chemical composition - but to be 100% safe you would need to do at least one confirmation run for each product if you go down this route.
One thing to bear in mind is that even if your products are aqueous based - a cleaning agent will remove any residue that may build up with time.

I think you will need at least two cycles - one for vessels and one for transfer lines - you will probably find tha the pressure build up in the transfer lines using the same cycle as the vessels will be prohibitive.

hope this helps

Chris

#3

Good evening to both of You.

I absolutely in aggrement with Mr. Chris that bracketing approach can be applied for validating the CIp system & cleaning agent also can be used for cleaning.

With reference to your query Mr. SFlan, Yes “One size fits all” is a viable option for CIP of Multiproducts. To have this you have to generate a Solid Risk Assessment document, which describe why you had selected the worse case & your bracketing approach & its justification.

You have to go for any chemical test also along with routine pH / Conductivity during validation stage & the test can be selected based on the your productprofile cycle.

In addition to this never miss the Temp / Pressure / Qty. validation while going for CIP validation.

Happy Reading !