HEPA installation in old Fluid bed granulator

[zhangbd]

I'm working with a supplier to upgrade the air handling unit of our fluid bed granulator, exiting inlet filter(F9) and exhaust filter(F9)will be replaced with HEPA, and fan will also be change accordingly,

Question comes from supplier: to ensure the fan's performance, they said exhaust filter should not be changed to HEPA, F9/EU9 will be enough, but our compliance department did not agree to only change inlet filter due to active ingredient will release out.

Anyone here knows how to configer the filter? or who kowns it in current new granulator?

Regards

bd

 

[HEC]

Insufficient information in your post. Though the required information should not be posted as it would be propriety ans should not be placed in the public domain. To answer your question, I depends upon several factors;
What ingredients are being applied in the granulator?
Is the granulator being used for one active or formulation or are many being used?
What are the consequences of cross contamination or product carry over past the exhaust filter?
A quick analysis of the process, regulatory, safety and exposure issues will determine the need for HEPA filtration. In short generate a small URS for the granulator air handling system.
I suspect that for compliance reasons the HEPA on exhaust is required. As recomended gather the facts and document the decision.

Mark Hutton

 

[MedicineEng]

If I understood well, your compliance department is not only worried with contamination of your product but also with health and safety issues (outlet filter). Did you considered to use a scrubber? Eventually it could five you the same results with for sure less running costs ( I would expect that an outlet HEPA filter in a FBD would be quicly clogged due to the ammount of fine particles).

 

[HEC]

MedicineEng,
My response to zhangbd was to point out that there are other factors outside engineering performance that will determine the use of filters. In this context these are the items that must be considered before removing or reducing the capture efficiency of the outlet filter.
Use of a scrubber in this application would need to be put through the same assesment. There is still some carry over of particulates or other vapour components from a scrubber. In the case of cytotoxic actives for example this would not be acceptable.

Mark Hutton

 

[MedicineEng]

HEC:
You were absolutely right in your assessment.Any change in the current design conditions should be checked in terms of operationality and HSE, besides quality, etc. My only comment regarding the scrubber was point out that there might be other alternatives to HEPA filters in teh exhaust, solution that in my oppinion has high running costs and should only be used if absolute necessary (as in cytotoxic, as you pointed out very well).

 

[lilliput1]

Use VFD fan & consult with FBD manufacturer how best to control. Fixed (set point adjustable) CFM or fixed (set point adjustable) static pressure upstream of the HEPA.