Addition of loop in Qualified water system

Dear all,

What i can do in this case?

My Purified water system is qualified. Now i am going to addition a loop for operational use (due to modification of Production block).

In this case can i do Retrospective validation for this pariticular point / go for complete PQ of water system. I am thinking retrospective validation is sufficient for this.

Plz give your comments.

First thing is that how to connect the additional loop in your existing sytem, which sort of welding will u use either orbital or any other, have you passivate your new loop as well connected loop? then u have to arrange at least two sampling points onbe from before entering the loop and one from after circulating the loop and perform extensive water testing. if u get three days successfull result then u can do validation as concurrent basis and make trend for chemical and microbiological results. One more thing u have to mke sure due to addition of this loop , is there any dead leg create.

thanks and best regards

[quote=Shahnawaz]First thing is that how to connect the additional loop in your existing sytem, which sort of welding will u use either orbital or any other, have you passivate your new loop as well connected loop? then u have to arrange at least two sampling points onbe from before entering the loop and one from after circulating the loop and perform extensive water testing. if u get three days successfull result then u can do validation as concurrent basis and make trend for chemical and microbiological results. One more thing u have to mke sure due to addition of this loop , is there any dead leg create.

thanks and best regards[/quote]

Do you know if this reasoning can be found in any official publication?

Thank you for your help,
Best regards.

I have some questions about this what the regularors will look

  1. What is the length of new line and how many sampling points/User points?
  2. What are the tets done during the welding and testing its integrity( Shahnawaz) ?
    3.What is the Staus of running & impact on the existing line when new line is installed ?
  3. Have you written the change control form and what is the basis of approval?
    6.What is your existing pump head and what is the impact of rate and speed of water circulation in the new loop?
    7.What are new additional equipments in the loop–any UV light at the return port or entry port or user points?
    8.How do you passivate this line and Sanitize this line?

" Any change in equipment or piece of equipment would change the impact on the system totally. Hence it should be completely qualified once agian"

Its like starting a new piece of equipment.