Filter Cleaning, Purpose :
Filter Cleaning, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Cartridge filter in order to comply with cGMP standard.
Filter Cleaning, Scope :
The scope of the procedure is applicable to the Cartridge filter of Dialysis Fluid of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]CIP : Clean In Place
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Operation and cleaning of the cartridge filter.
[][]Maintaining Equipment Log Book.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Head of Quality Assurance
[][]To approve the SOP.
Annexure:
N/A
Precautions :
[][]Hot purified water should be not more than 60oc.
[][]The wash-down valves are in closed position.
[][]Check for any leakage from discharge valve.
Filter Cleaning:
[][]Remove the Filter housing from the Vessel.
[][]Cleaning of filter Cartridge (1.2, 0.45 & 0.2 micron or 1.0, 0.6 & 0.2 micron).
[][]Clean the Cartridge filter (1.2, 0.45 & 0.2 micron or 1.0, 0.6 & 0.2 micron) with potable water.
[][]Soak the Cartridge filter in hot purified water and retain for 30 minutes.
[][]Wash the Cartridge filter 3 times with purified water.
[][]Allow the Cartridge filter to dry in wash bay.
[][]After drying take the Cartridge filter in a Clean poly bag and Stored in Closed ss Cabinet.
[][]After final cleaning affix the ‘CLEANED’ label.