Author Topic: cleaning validaiton- change of equipment  (Read 1568 times)

Md Zhuang

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cleaning validaiton- change of equipment
« on: November 02, 2012, 03:18:43 AM »
Dear forum:
    In the cleaning validation, we introduce a new equipment to replace a tank in the production process . If the new tank represent a worst case, the cleaning efficiency has to be validated. The problem is how we carry the risk evaluation. How the change of the tank effect the validated state since last validation?
    For example, the residual limits of all the equipment will be changed due to the different contact area.  For the unchanged equipment, the detect results in last validation are still below the new limits. So in my opinion, we will only to validate the cleaning efficiency of the new tank.
   Is it right? Can we carry the validation (3 times) as a concurrent validation in the production?

rockybell_77

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Re: cleaning validaiton- change of equipment
« Reply #1 on: November 03, 2012, 07:02:01 AM »
This shall be acceptable. Make an impact assessment report specifying the details of change in criteria and evaluation of previous cleaning validation results and conclude the need/no need for CV.

Rocky
rockybell_77@yahoo.co.in

bharatbuk

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Re: cleaning validaiton- change of equipment
« Reply #2 on: November 08, 2012, 12:33:01 PM »
Cleaning validation is applicable to the cleaning of process manufacturing equipment in the pharma industry.Safty of patient is primary objective and product contamination presents serious liability issues for any pharmaceutical manufacturer or contract organization.

 


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