ISPE Science and Risk..............Equipment

COMPUTER SYSTEM VALIDATION (CSV) GAMP® 5 - GAMP® is owned by ISPE
1

Hello All,

Firstly, sorry to abbreviate the title but i’m sure everyone knows the full titlle.

In ascertaining whether the ‘system’ is direct indirect or no impact a series of questions are answered.

One of the questions reads, ‘the system is used in cleaning, sanitizing or sterilization…’.

Could someone confirm if i am totally wrong when i answer NO to an ultrafiltration/diafiltration system. The system is cleaned but is not used in cleaning.

Thank you all.

2

Yes, UF/DF is not used in cleaning, sanitizing, or sterilization, so the answer would be ‘no’ to that impact assessment question.

UF/DF is typically a direct impact system however since 1) it has direct contact with product, and 2) the performance of the system may impact product quality.

Hope this helps!

Mike