Stoppage need to be evaluated, if all utilities are also stopped including recirculation pump of water system then sanitisation of system and concurrent validation can be done. It will also depend on the shut down duration. Risk assessment will help in this.
sir we are going to extend our user point of wfi as well as the loop line system , So I was asking that the revalidation activity will start from Phase-1 or Phase 2 ??? Please give the answer of my question 🙏🏼
Mr. Vishal, I hope you are talking about the EDI unit replacement as a part of breakdown. You need to do the risk assessment of the water system after change in which you will need technical specs. Of old and new EDI module. If the make and model as well technical specs.are same then it reduces your task if it is different it will trigger requalification of the system.
Sir plz make video on latest WHO and USP guidelines for purified water and system.. parameters online offline linits..like toc conductivity. Frequency of replacement.. flow rate, pressure, temperature,
Very good video.. Lot's of learning.. Thanks
Good explanation sir.. thank you sharing Sir..
Thank you so much sir for designing such a informative video, it's very useful
Nice presentation in short
Thank you very nice information
Wow, it's really great!
Thanks so much
nice to understand
Good knowlegble vedio sir
Good work sir
Such a needfull video thankuh Sir
Nice presentation
Dear in phase 2 we can not use water for manufacturing , we can use for only washing purpose ..... revert pls am I right or not ?
Yes in phase II we can use water for manufacturing as well as washing
@@easyqualitylearning6790 ok thanks
Good work sir.. it can be more detailed
Nice sir but in some time u r explanation not clear other wise nice information and very good information and knowledge.
If any thing is not clear please let me know I will try to make it clear.
THANK YOU SO MUCH
Thank you sir
What if a pharmaceutical industry has stopped working for a period of time? a revalidation of the PW system must be done?
Stoppage need to be evaluated, if all utilities are also stopped including recirculation pump of water system then sanitisation of system and concurrent validation can be done. It will also depend on the shut down duration. Risk assessment will help in this.
If recirculation pump is on then revalidation may not be required, but pump is also closed then concurrent validation can be considered.
It relies on recirculation pump, then.
Thank you sir.
Please, make a video on risk assesment in pharma if you can
@@angeliei I will try may be after some time
If content is useful then share with others also
How to make specifications for soft water, ro 1, ro 2, edi while doing performance qualification??
sir we are going to extend our user point of wfi as well as the loop line system , So I was asking that the revalidation activity will start from Phase-1 or Phase 2 ???
Please give the answer of my question 🙏🏼
First you need to do requalification of physical parameters and once it is ok then it will start from phase I. Risk assessment is must in this.
Sir thankbu so .much
what document required for replace electro deionizer system in purified water system
Mr. Vishal, I hope you are talking about the EDI unit replacement as a part of breakdown. You need to do the risk assessment of the water system after change in which you will need technical specs. Of old and new EDI module. If the make and model as well technical specs.are same then it reduces your task if it is different it will trigger requalification of the system.
If technical spec of EDI unit is same, then risk assessment is sufficient or any other documents required for EDI replace.
In risk assessment evaluate risk and probably you may have to do analysis of out put after EDI and results need to be compared with earlier results.
Vegod sir
Sir plz make video on latest WHO and USP guidelines for purified water and system.. parameters online offline linits..like toc conductivity. Frequency of replacement.. flow rate, pressure, temperature,