1.0 OBJECTIVE
To lay down a procedure for shut down of Ultra Filtration System.
2.0 SCOPE
This SOP is applicable to Formulations Units.
2.1.0 AREAS
Ultra filtration Room.
3.0 RESPONSIBILITY
Jr. Technical Officer / Executive (Production).
4.0 ACCOUNTABILITY
Manager - Production.
5.0 PROCEDURE
5.1 Shut down of the Ultra filtration System to be done in the
following cases.
5.2 If the microbial count is above 80 cfu/ml.
5.1.2 If any problem arises in pumps (P1,P2,P3)
5.2 Ultra filtration system consist of Ultra filtration unit & closed circulating loop.
5.2.1 Shut down of Ultra Filtration unit.
5.2.1.1 Close the valve V23 and open V24.
5.2.1.2 Stop the pump P1.
5.2.1.3 If the shut down is more than 48 hours following procedure has to be adopted.
5.2.1.3.1 Close the valve V18
5.2.1.3.2 Stop the pump P1
5.2.1.3.3 Close the valve V16
5.2.3 SHUT DOWN OF CLOSED CIRCULATING LOOP
5.2.3.1 Press the push button on the control panel P2/P3 stop.
Note: Users should modify this SOP according to their DQ of the equipment
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