Our firm initiated RISK BASE APPROACH and FMEA in our facility. while analyzing the temperature effect on the Environmentally controlled areas , there was huge discussion happened and a common question has been raised, just i want to summarize that below.
- Suppose we are operating a fermentor at 30C and Temperature limit for the Classified area is 19-25C. During the activity area temperature found out of limit.i.e 28C.
What will be impact on the batch running in the fermentor?
Why industries typically follow the 19-25 C range for operational areas.
Please share your thoughts.
Thanks in advance…
R.Dasaratha Rami Reddy[/quote]
Dear R.Dasartha Rami Reddy,
the reason for keeping temperature & humidity in classified area is for microbial control. In this temperature microorganisms does not form spores. they form vegetative cells and can be destroyed by disinfection procedure.
As far as your temperature in classified area is concerned, it looks like that you have not done PQ of area properly. Performance Qualification is done when all the machinary are in place and in working conditions. Accordingly HVAC engineer can set the temperature as required.
If you need any help do write to me.
Head, Quality Control,
Haffkine Bio-Pharma Corp.Ltd.
A.D.Marg, Parel,Mumbai 400012