Validation for new AHU

Hello there,

Our plant has many production rooms and we are using 20 AHUs for them. We have installed 2 new AHUs and now I want to conduct PQ. My question is: do I need to conduct PQ for the 2 new AHUs only, or I need to conduct PQ for all the rest 20 AHUs?

Thank you.

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Only for new two ahu

Performe all AHU PQ bcoz area are modified.

You required only two AHU for validation not for all.
Such test Smock, Velocity, Recovery, Particular counter

First clear me why u are appointing two new AHU…
Is there any problems in some of the 20’s AHU…
or are u replacing …

Actually, our plant has more than 40 rooms. In the past, we used 3 rooms for solid-dosage form and now we want to produce effervescent tablet in that 3 rooms, that’s why we ADD new AHUs.

There is no problem with the old 20 AHUs.

Our plant is designed with dirty corridor which like this: corridor —> SAS —> production room. In my opinion, when the air movement and air condition in the 3 rooms change, in some ways it will impact on the air in the whole rooms of plant.

Actually, our plant has more than 40 rooms. In the past, we used 3 rooms for solid-dosage form and now we want to produce effervescent tablet in that 3 rooms, that’s why we ADD new AHUs.

There is no problem with the old 20 AHUs.

Our plant is designed with dirty corridor which like this: corridor —> SAS —> production room. In my opinion, when the air movement and air condition in the 3 rooms change, in some ways it will impact on the air in the whole rooms of plant.

Hi, From my view point as I Understood that you added three rooms and installed 3 AHU didicated for them, so you only need to validate these three new AHUs only.

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Dear friend
all you need to conduct risk analysis, it will help you to identify whether the change has an impact on your other areas (serving by other AHUs) or not, if it has no impact can proceed qualification for new AHUs only.

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If any changes for all the rest 20 AHU then PQ required for all otherwise only for 2 new AHU

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What is frequency for HVAC requalification?

2020 Draft EU Annex 1: