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The maximum temperature observed was 28.2C in the Naproxen storage room of the Naproxen
clean room facility of C-Block on 06/01/2015 ,against the allowed limit: - Less than 25C.
Investigation and Conclusion:
Based on the investigation it can be concluded that the probable chances of variation are due to
cooling problem to the coils:
1) Variation in Chilled water flow rate due to damage in utility lines or valve failure.
2) Chilled water not supplied at desired temperature to AHUs.
3) Probable choking of the coils due to corrosion of coils or PHE
Due to this reason temperature was increased to above the specified limit >25C.
Based on Long term stability data (temperature at 252C) of Naproxen Product there is no
impact on the Naproxen product quality due to this high temperature.
Impact assessment: There were no batches executing at the above time of the deviation. Hence
no impact.
Correction:
As an immediate measure brine supply was provided to AHU to control the temperature within
the range. All the operations were resumed after getting the temperature under control.
Corrective action & Preventive action:
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
000000200104211
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.