sop for for Filtration of Bulk Solution
1.0 OBJECTIVE:
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
3.0 RESPONSIBILITY:
Officer / Production Manager
4.0 ACCOUNTABILITY:
Head Production
5.0 PROCEDURE:
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.
6.0 ABBREVIATION
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
7.0 DISTRIBUTION:
Controlled Copy : Production Department
Master Copy : Quality Assurance
8.0 REFERENCES:
In House
9.0 REVISION HISTORY:
| 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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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