OBJECTIVE:
To lay down a procedure for replacement of cartridge and vent filter of water system.
SCOPE:
This SOP is applicable for replacement of cartridge and vent filter of water system at {Company Name} {Location}.
RESPONSIBILITY:
Technician- Follow the instruction as per procedure.
Engineering Officer/Executive- Execution as per laid down procedure.
Engineering Head- Technical correction, review, training & monitoring of SOP.
ACCOUNTABILITY:
Engineering Head
Quality Assurance Head
ABOUT VENT AND CARTRIDGE FILTER:
In pharmaceutical water systems, vent filters and cartridge filters play crucial roles in maintaining water purity. Vent filters, typically hydrophobic membrane filters like PTFE, are installed on storage tanks to allow air to enter and exit during filling and emptying while preventing microbial contamination and particulate ingress. They safeguard the water from airborne contaminants, ensuring the integrity of the stored purified water or Water for Injection (WFI).
Cartridge filters are used at various points in the system for particle removal, bioburden reduction, and even sterilization. Pre-filters protect downstream equipment, while finer filters remove microorganisms and endotoxins. Point-of-use cartridge filters provide a final barrier against contamination before water is used in pharmaceutical processes. Both vent and cartridge filters are essential components in a multi-barrier approach to ensure the consistent production of high-quality pharmaceutical water.
PROCEDURE:
Precautions & general Conditions:
Ensure no water passing through the filter before opening the filter housing.
Keep ready the filter need to be replaced in advance.
Use necessary safety wear like goggles, gloves and safety shoe if required.
Cartridge filter on Water generation line shall be replaced if the pressure increases above 2.5 kg/cm² of filter or monthly whichever earlier.
Vent filter shall be replaced every six month.
Cartridge filter replacement:
Switch off the main switch of water system from electrical panel.
Opened the TC clamp of the filter housing from both ends of the line.
Remove the filter housing from the holding clamp.
Unscrew the filter housing cap of the filter housing and remove the filter from the filter housing.
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Clean the filter housing cap and bottom body.
Check the new filter visually for the condition of the filter, if any discrepancy found inform to the officer/executive for the same.
Fix the new filter in filter housing cap properly.
Fix the bottom body of the filter housing and tighten the body to the filter housing cap.
After completion of filter replacement process start the water system and check for leakages from the filter housing, if found any arrests them. Remove the air from the filter through the air vent button of the filter housing.
Vent filter replacement:
If the filter is vent filter open the TC clamp of the filter housing and disconnect from the storage tank.
Open the filter housing and pull out the vent cartridge filter.
Clean the filter housing and check the gasket condition of the filter housing.
Fix the new vent cartridge filter in the filter housing by pressing the filter.
Close the filter housing and fix the filter housing assembly on the storage tank.
Update the cartridge filter replacement record as per Annexure-I.
Update the filter replacement status label as per Annexure-II.
REFERENCES:
Not Applicable
ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE |
| Annexure-I | Replacement of Cartridge And Vent Filter of Water System |
| Annexure-II | Filter Replacement Status label |
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
| Controlled Copy No. 1 | : | Quality Assurance Head |
| Controlled Copy No. 2 | : | Engineering Head |
| Master Copy | : | Quality Assurance Department |
ABBREVIATIONS:
| SOP | : | Standard Operating Procedure |
| QA | : | Quality Assurance |
| Kg/cm2 | : | Kilogram per centimeter square |
| TC | : | Tri clover |
| EG | : | Engineering |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
ANNEXURE-I
REPLACEMENT OF CARTRIDGE AND VENT FILTER OF WATER SYSTEM
ANNEXURE-II
FILTER REPLACEMENT STATUS LABEL
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/replacement-of-cartridge-and-vent-filter-of-water-system/