sop for for Filtration of Bulk Solution


sop for for Filtration of Bulk Solution



To lay down a procedure for Filtration of Bulk Solution.

2.0 SCOPE:
This SOP is applicable for Filtration of Bulk Solution in Production Area

Officer /  Production Manager

Head Production


5.1 Clean the Cartridge Filter Housing containing 1.0µ and 0.2µ Cartridge Filters respectively.
5.2 Assemble the Cartridge Filter and housing and check for proper fixing of “O”– Ring to ensure complete tightness of the Filtration assembly.
5.3 Perform Bubble Point Test of Cartridge Filter to ensure its integrity before Sterilization.
5.4 Assembled Cartridge filter housing containing Cartridge Filter of 0.2 µ on product transfer line and perform online SIP.
5.5 Release the nitrogen from filter prior to startup of the filtration operation.

5.6 Start the Batch Filtration after release of the Batch from the QC and as per instructions from Manufacturing Chemist.
5.7 After completion of filtration, carryout CIP then perform the Bubble Point Test of the Cartridge Filter to confirm the Post Filtration Integrity.
5.8 Record the Filtration related details at specified place in respective BMR & Equipment Log as per Format.


SOP             :  Standard Operating Procedure
SIP             :  Sterilization in place

CIP             :Cleaning in place

WFI           :  Water for Injection
Ltd.             :  Limited

QA               :  Quality Assurance
BMR            :  Batch Manufacturing Record


Controlled Copy   : Production Department
Master Copy         : Quality Assurance



In House


Sr. No. Reference Title
01. In-House


Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel


sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area















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