sop for Handling of Filters
1.0 OBJECTIVE:
To lay down a Procedure for the Handling of Filters.
2.0 SCOPE:
This SOP is applicable for the Handling of Filters of Production area
3.0 RESPONSIBILITY:
Officer / Executive – Production
4.0 ACCOUNTABILITY:
Head – Production
5.0 PROCEDURE:
5.1 After filtration take integrity if it is pass, then transfer to the washing and sterilization area and pass WFI for 15 Minutes.
5.2 If the same filter is to be used in continuation then again transfer the product filter to the filtration Area.
5.3 If the filter is not to be used in continuation proceed for clean the filter with WFI with for 15 minutes.
5.4 After cleaning of filter pass the steam for 5 minutes, followed by 0.2µ filtered compressed air
and Wrap with parchment paper properly & affix the status label.
5.5 Store the properly cleaned & labeled cartridge filter in cupboard provided in “clean equipment Storage room” of washing and sterilization area.
5.6 Whenever to be reuse of above filter pass the Water For Injection for 5 minutes at room temperature and then installed to the filter housing.
5.7 Record the sterilization cycle in (Annexure-II) Filter Integrity and Sterilization Record log book.
6.0 ABBREVIATIONS:
SOP : Standard Operation Procedure
WFI : Water for Injection
No. : Number
Pvt :Private limited
QA : Quality assurance
7.0 ANNEXURES:
Annexure No. Title of Annexure Format No.
Annexure-I : Filter record label
Annexure-II :Filter Integrity and Sterilization record
8.0 DISTRIBUTION:
a) Master Copy : Quality Assurance
b) Controlled Copy : Production department
9.0 REFERENCES:
In House
ANNEXURE – I
| FILTER RECORD LABEL | |
| Filter catalogue Number | |
| Filter Serial Number | |
| Date of installation | |
| Integrity Done On | |
| Integrity Due On | |
| Done By & Date | |
| Checked By & Date | |
ANNEXURE-II
FILTER INTEGRITY AND STERILIZATION RECORD
| Date | Integrity Done On | No. of Sterilization Cycle | Batch No. | Done By (Sign & Date) | Checked By (QA) Sign & Date |
Destruction Detail |
Remark | ||
| Done By (Prod.)
Sign & Date |
Checked By (Prod.)
Sign & Date |
Verified By (QA)
Sign & Date |
|||||||
sop for Execution of Preventive Maintenance
Preparation of Sodium Hydroxide Solution
sop for water cooled chiller operation
cleaning and preventive maintenance of LAF and RLAF
sop for replacement of water system filters
cleaning and preventive maintenance of insectocutor
sop for operation of preventive maintenance
sop for material receiving and consumption record
sop for Preventive maintenance of bottle washing machine
sop for Replacement of Battery of Electronic Devices
sop for Preparation of R.O. Antiscalant Solution
Preventive Maintenance of Rapid Cooling Steam Sterilizer
Preventive Maintenance of Rapid cooling steam Generator
sop for Preventive Maintenance of Dust Collector
sop for Replacement of HVAC filters
SOP for Battery Backup in Mobile Laminar Air Flow Trolley
sop for Replacement of Tube lights
sop for Replacement of UV light of purified water plant
sop for Cleaning of soft water storage tank and RO feed tank
sop for Preparation of Sodium hydroxide Solution
sop for Operation and regeneration of softener plant
Procedure Of Issuance Of material from Engineering Store
sop for Preventive Maintenance of Filter Press
sop for Preventive Maintenance of Sugar Transfer System
sop for Preventive Maintenance of Shrink Sleeve Machine
sop for Preventive Maintenance of ROPP Cap Elevator
sop for Preventive Maintenance of Liquid Transfer Pumps
sop for Preventive Maintenance of Liquid Tanks
Preventive Maintenance of Strip De-Foiling Machine
sop for Preventive Maintenance of Colloidal Mill
sop for Preventive Maintenance of Packing Collator Belt
sop for Checking light intensity
sop for Operation of Fire- Extinguisher
sop for Passivation of WFI Distribution Loop
sop for Analysis of Effluent Treatment Plant Water
sop for Methodology to Dispose ETP Sludge
sop for Action Plan In Case Of Electrical Power Failure
sop for Colour Coding of Piping and Accessories of Utilities
sop for Disposal of Engineering Waste
Filter Cleaning of HVAC System RLAF & LAF
Procedure for Calibration of Magnehelic Gauge
Procedure for Calibration of Vacuum Gauge
Procedure for Calibration of Pressure Gauge
sop for Procedure for Calibration of Temperature Controller
sop for Preventive Maintenance of Infrared Dryer Umbrella Type
sop for Preventive Maintenance of Battery stacker
sop for Preventive Maintenance of Lift
sop for Preventive Maintenance of Vacuum Cleaner
sop for Preventive Maintenance of laminar air flow unit
sop for Preventive Maintenance of Lozenges Manufacturing Line
sop for Preventive Maintenance of Garment Washing Machine
sop for Preventive Maintenance of Multi Column Distillation Plant
sop for Preventive Maintenance of Steam Sterilizer Autoclave
sop for Preventive Maintenance of Pure steam Generator
sop for Preventive maintenance of Depyrogenating Tunnel
sop for Preventive Maintenance of vial sealing machine
sop for preventive maintenance of Powder Filling and Rubber Stoppering machine
sop for Preventive Maintenance of Vial Washing Machine
sop for Preventive Maintenance of Inspection Table
sop for Preventive Maintenance of Hi-Cart
sop for Preventive Maintenance of Turn table
sop for Preventive Maintenance of sticker labeling machine
sop for Preventive Maintenance of Liquid Filling and Sealing Machine
sop for Preventive Maintenance of Linear Bottle Washing Machine
sop for Preventive Maintenance of De-Foiling Machine
sop for Preventive Maintenance of Strip Packing Machine
sop for Preventive Maintenance of Blister Packing Machine
sop for Preventive Maintenance of Capsule Polishing and Sorting Machine
sop for Preventive Maintenance of Capsule Filling Machine
sop for Preventive maintenance of Auto Coater
sop for Preventive Maintenance of Compression Machine
sop for preventive maintenance of packing conveyor belt
sop for Preventive Maintenance of Sifter Cum Multi mill
sop for Preventive Maintenance of Rapid Mixer Granulator
sop for Preventive Maintenance Of Fluid Bed Dryer
sop for Preventive Maintenance of Octagonal Blender
sop for Preventive Maintenance of Lifting and Positioning Device
sop for Preventive Maintenance of Paste Preparation vessel
sop for preventive maintenance of Vibro-Sifter
sop for preventive maintenance of air curtain
sop for preventive maintenance of air handling units
Preventive Maintenance of Diesel Generator
sop for Preventive Maintenance of cooling towers
sop for Preventive Maintenance of Boiler
sop for Preventive Maintenance of Air Compressor
sop for Preventive Maintenance of Chilling Plant
sop for Preventive Maintenance of Transformers
sop for Preventive maintenance of Purified Water System
sop for Break Down maintenance of Machine and Work Requisition
sop for Operation of Dust Extraction System
sop for Operation Of Effluent Treatment Plant
sop for Operation Of Diesel Generator
sop for Operation of Multi Column Distillation Plant
sop for Operation of Pure Steam Generator
sop for Operation of Air Handling Unit
sop for Operation of Cooling Tower
sop for Operation of Air Compressor
sop for Operation of Water Chilling Plant
sop for Cleaning of Pure Steam Generator
Cleaning of Over Head Water Tanks HDPE
sop for Cleaning of Water tanks
sop for Sanitization of multi column plant
sop for Sanitization of Ultrafiltration System
Sop for Chemical Sanitization of Reverse Osmosis
Sop for Sanitization of Hot Sanitization & Electro Deionization unit
sop for Sanitization of Purified Water Loop
sop for preparation of sodium meta bisulphate solution
sop for Testing of Hardness of Soft Water
sop for Operation & back wash of multi grade filter
sop for testing of chlorine contents in water