Dear Experts,
We are in the way of perform the performance qualification of our class 10,000. All are tests we finish apart from Microbial evaluation.
How many days have to be performed during the validation?
What is the frequency?
How many sampling methods to be approached?
We have performed at rest condition. is it required to perform at operation condition also?
What is the frequency of regular monitoring for environmental monitoring?
How we can select the sampling points for evaluation?
I am bit confusing with guidelines. Kindly clarify my doubts.
Thanks in advance
Pulla Reddy Karnati.
Dear Durga Prasad sir,
Kindly clarify my doubts. I am looking your earliest reply. Additionally kindly provide me what are the parameters are required for the PQ of ISO 7 class.
Thanking you.
Parameters required for HVAC System PQ
- Air velocity & Calculation of Air changes (At Fresh air grill & Room, its better to perform grill level also at initial time)
2.Differential pressure
3.Installed Filter Leak test
4.Air flow Direction Test and Visualization
5.Monitoring of Non-Viable Particle Count (At rest & In operation)
6.Temperature and Relative Humidity Mapping
7.Recovery Test
8.Containment Leak Test
9.Monitoring of Viable Particle Count
Good fourm* post. I was checking continuously to this website & I’m so impressed! Very helpful info, especially the 5th section. I really want this kind of knowledge. I used to be looking for this kind of knowledge for a while. Thanks and good luck.
Does the same apply for a PQ of ISO class 8 our company dont do sterile manufacturing
dear Sir,
what shaould be the temperature limit in solid oral dosage facility , as in india we have same facility and we have kept limit is NMT 28° C. . is that ok…is any guideline speak about it…
please revert
with warm regards