FILTRATION OF THE RELEASED BULK SOLUTION.

STANDARD OPERATING PROCEDURE FOR FILTRATION OF THE RELEASED BULK SOLUTION.

          Requirements:          

v  Entire Pre-sterilized Unit, which includes Pressure vessel, filling

v  vessels,  pre-sterilized membrane holder fitted with appropriate fiber

v  glass  filter of  1.5 micron followed by membrane of appropriate porosity as  per product.

v  SS Clamps, Pre-sterilized Silicon Tubings.

v  Pre-sterilized Surgical Hand gloves and air vent filter of 0.2 micron porosity.

v  Centralized supply of Nitrogen gas.

        Precautions & Instructions :

v  Pre-sterilized units components must be handled with warring sterilized hand  gloves.

v  Assembling of the filtration unit must be carried out under laminar air flow lighted on

v  at least 15 minutes before starting actual operation.

v  Bubble Point test must be carried out as per SOP for checking the integrity of the    

v  Membrane used before and after filtration process.

            

     Steps :

v   Transfer all the filtration equipment, vessels and related accessories to the filtration area.

v    Assembled the filtration line in logical way.

v    Carry out the bubble point test, if found OK then only proceed for filtration

               of  the product as per schematic diagram.