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

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.

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!