Dear how are you?if the manufacturer is manufacturing sterile product and if the manufacturer switch off the HVAC system,first, can he switch off or not. second if switch off the HVAC what will do as inspector.Thank you
Dear Debalke,
First of all, we welcome you in this pharmaceutical forum…
As sterile product is manufactured in critical areas, and HVAC system need to work 24*7 to maintain the particular Class environment of C,B,A, temperature, RH, DP,air flow, air changes, recovery- cleaness level as per particle count.
It is not advisable to switch off HVAC system…
If it’s switch off, the classification of air will be no more, we can’t do manufacturing and filling, we will have to do fogging, cleaning, disinfectant area after switch on…
Thanks
4 Likes
Dear Md.Asif Hussain, thank you so much for your prompt replied!
2 Likes
You mention sterile manufacturing, or do you mean aseptic manufacturing.
Sterile removes or destroys all forms of living microorganisms and aseptic is the condition that is free from pathogenic, harmful bacteria, viruses, or harmful spores.
Please clarify your operation to understand the situation.
But it is correct to have the HVAC system on during operation to maintain cleanliness level