Could someone perhaps explain how smoke testing of air flows (HVAC System) is conducted. Is there a procedure other than using “smoke sticks”.
Graham DM
vibration level?
[quote=pava_satya]dear All
Interesting…
in my experiance i came to know that the below points during HVAC Qualification.
- if you claim the classification of the room you should qualify entire parameter of HVAC
if you claim it is class 100000 at rest you should check the parameter sequentially at prospective stage
1.air velocity
2.air changes
3.installed filter leak lest
4.again air velocity
5.air changes calculation
6.air flow
7.differentiable pressure
8.Temperature
9.Humidity
8.air born particle counts
9.viable counts
10 recovery test
11 sound level
12.lighting level
13.vibration level
Purpose: though you have claiming the classification as class 100000 , in terms of airbone partcle counts you need to perform all thease tests.
HVAC may have direct impact on the product in some casess.some casess you need to maintain the humidity for the product and to avaid the cross contamination you need to qualify.
and one reason to perform all the tests , if you will not achieve particle counts with in the limits thease test results can be use full for further investigation.
Satya
Qualify Assurance[/quote]
hi guys we cannot conclude that HVAC is indirectly supporting becoz here the product is exposed to the clean air supply from the HVAC even the temperature and Rh plays a crucial role in determining the product quality.
does hold time testing is required in one of my previuos USFDA firm we had done cleanroom hold time to determine the clean hold time study to understand the hold time of clean room to raise a time limit for elctricity back time ,