Purified Water Loop system

Quality Assurance
1

Dear Sir,
Kindly give details of purified water running in loop system in Pharmaceutical sterile manufacturing.
Is it in normal practice that the loop system is running all the time at 80* Celsius.

Muralidhran KK

2

Please visit here

3

Hello sir,
If I keep the WFI water sample s for 2-5 hrs at 2-8degrees storage condition s
any changes occur es
?

4

This will depend upon your hold time study,
You have to make a hold time study to store Water samples in a refrigerator 2-8°C .
Samples can be refrigerated at 2-8°C for 24 hrs, and there are no chances that it will rise your samle count/ bioburden.

5

purified water in loop system in general run <25C.

or loop can be run at 65C.

WFI loop is run at 80C.

1 Like
6

Hello Sir

Loop system is critical to avoid water stagnation and microbial growth in PW tanks, but there are PW jugs style container sold in market for manufacturing of pharma products wouldn’t, the PW present in those jugs subjected to microbial growth and potentially contaminating?

7

Dear,

it is usually good practice to control bioburden,

Also no harm to keep at room temp, provided you must have validated and qualified WPU system with the defined process conditions.

Thanks