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The pressures of all the rooms in the Naproxen sodium product blending facility of CBlock have been observed out of the specified limits from the date (07/01/2015).
Investigation and Conclusion:
Based on the investigation it can be concluded that the chances of variation in pressures in the
Naproxen sodium product blending facility of C- Block are probably as a result of choking of
exhaust filter due to particles clog gage. Naproxen sodium being fluffy material, fine particles
must have escaped while transferring material from blender to sifting operation, thus resulting in
choking of exhaust/return filter due to particles clog gage.
Impact assessment: There were no batches executing at the above time of the deviation. Hence
no impact.
Correction: Exhaust/Return filter were cleaned and inserted back. All the pressures obtained
were within the ranges after installation of cleaned filter.
Corrective action & Preventive action: Lots of dusts (fines) are generated during material
transfer from blender to sifter resulting in excessive dust which is clogging the exhaust filters. In
a Closed system, material will be transferred from blender to sifter, and sifting operation will be
carried out without allowing particles escapes into the area on or before 15/03/2015.
Cleaning schedule for VAM Condenser was prepared for every 3 months with reference to
notification 200085486 and CAPA notification No 200097111 and has been implemented.
Temperature & Humidity variation B-Block
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First a word of warning - playing around with a live active HVAC system can be dangerous high
pressure will blow out windows and sometimes doors low pressure can cause the whole structure
to collapse inwards with disastrous results for occupiers. This has happened at several pharma
plants.
It is almost standard practice to measure all the room pressures relative to outside ambient. Your
room differential should all be 15pa plus or minus 3. You will go into alarm when doors are opened,
however it is pretty standard to fit delays so that these transients are ignored.
Three rooms in cascade, I hope you dont mean the same air enter one room and leaves that room
to enter another. That would raise quite a problem about the quality of the air.
You dont know whether the pressure drop over the filters is low because of low flow in the system,
or flow leaving the system.
Measure the flow, there are excellent instruments for the job remove one of the plugs (they are
designed into the system for carrying out these tests) in the trunking and insert a sensor tube for a
flow-meter. Measure the flow as it leaves the fan, compare this to the drawing specification (since it
is pharmaceutical it must be validated so there will be drawings available.
If the flow is Low;Check where the AHU draws its air from, it is common to recirculate a percentage of the air. If
recirculation is used check the recirculation air damper settings.
No luck there then:Go to the air duct inlet filter or screen, there has to be a filter there to stop rodents and birds entering
the system.
It will not be a HEPA filter it might be a fine mesh screen, but they can get blocked with debris
especially foliage and or ice.
Check the bag inlet filters actually on the AHU are clear.
Satisfied the AHU is not getting starved of air, check the bag filter inlet filters actually on the AHU are
clear progress to the AHU fan speed controller.
There are several ways a design engineer will control the air flow in a system such as yours.
Fit an attenuator (silencer) into the system. The air flow through the attenuator causes a small
pressure drop across the attenuator. A sensor is used to measure this pressure drop. A certain flow
will have a certain pressure drop.
The main AHU fan motor is powered from a solid state inverter. The sensor through a controller can
automatically raise or reduce the frequency from the inverter - which (since motor speed is a function
of supply voltage frequency) increases or reduces the fan speed.
Now as the system ages and the HEPA filters progressively clog up the flow in the system is
reduced the reduced flow is sensed by the attenuator sensor, which causes a signal to be sent to
the fan motor speed controlled, which increase the fan speed to reinstate the flow.
Another way is to have the sensor and the attenuator, but have a motorised airflow control valve. So
in this case the when the sensor senses the HEPA filter are reducing the flow - it opens the air flow
controller valve slightly and allows more pressurized fan air into the system.
Obviously any of a series of faults in this system can cause low fan speed. So you must test this
system to ensure it is not the cause of your problem.
If you still have trouble gives us an email and we will take it further.
Hellow everybody,
I am very much excited with the conversation on this specific topic. Let me take participate with the
group.
The process of achieving required pressure within cleanroom associated with adjucent areas are
called pressure balancing. Its a pure engineering work.
Theoretically the pressure differencial is caused due to bleeding of excess air from a specific room to
its adjucent rooms through clearances.
In an equilibrium condition, the incomming air (X) entering in the cleanroom goes out through raisers
(Y) & the additional amount of air (X-Y) is subjected get bleeded out through clearances. This X-Y
amount of air is resposible for pressure diffrencial.
So, if we want to alter the pressure differencial, all we need to increase/decrease the bleed air
quantity. This can be done by following ways:
(1) Increase the cfm of incomming air (enhancement of blower capacity).
(2) Reduce the return air damper opening.
(3) Reduce the clearances (e.g. door clearances, plugging the leakages, etc.)
(4) Reduce the pressure diffrencials of the adjucent rooms by the one of the above methods.
But one thing we should keep in mind that in 1st case, changing the inlet air cfm means significant
change in room air changes which is not desirable due to design considerations.
So, the later two options are more handy.
Hope I am able to make some sense, plz reply.