SOP For Cleaning of Prefilter of Laminar Air Flow (LAF)
1.0 Objective
1.1 To establish a procedure for the cleaning of prefilters of Laminar Air Flow (LAF) units to ensure proper airflow and maintenance of a clean environment.
2.0 Scope
2.1 This SOP is applicable to the cleaning of prefilters installed in Laminar Air Flow units in the Production Department.
3.0 Responsibility
3.1 Operator – Production
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Responsible for carrying out the cleaning of LAF prefilters as per this SOP.
3.2 Officer or Above – Production
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Responsible for preparation of SOP and monitoring of cleaning activities.
3.3 Executive or Above – Production
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Responsible for review of SOP and ensuring compliance.
3.4 Head – Production or Designee
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Responsible for implementation and adherence to this SOP.
3.5 Head – Quality Assurance (QA)
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Responsible for approval of this SOP.
4.0 Accountability
4.1 Head – Production
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Accountable for overall implementation of this SOP.
5.0 Definition & Abbreviations
5.1 Definitions
5.1.1 Standard Operating Procedure (SOP)
A written authorized document providing step-by-step instructions to perform routine activities consistently and effectively.
5.1.2 Laminar Air Flow (LAF)
A system designed to provide a particle-free working environment by passing air through filtration systems and delivering it in a uniform laminar flow.
5.2 Abbreviations
| Abbreviation | Description |
|---|---|
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| LAF | Laminar Air Flow |
| PRD | Production Department |
| WFI | Water for Injection |
| EHS | Environment, Health and Safety |
6.0 Precautions, Safety & EHS
6.1 Ensure that the Laminar Air Flow unit is switched OFF before starting the cleaning activity.
7.0 Materials & Equipment
7.1 Materials
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0.1% v/v Teepol solution
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Purified Water
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Cool Water for Injection (WFI)
7.2 Equipment
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Vacuum Cleaner
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Nylon Brush (if required)
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Compressed Air Supply
8.0 Procedure
8.1 Switch OFF the LAF unit before starting the activity.
8.2 Remove the prefilters from the LAF unit and inspect their physical condition. Replace the filters if any damage is observed.
8.3 Transfer the filters to the designated washing area and clean them using a vacuum cleaner to remove loose dust and particles.
8.4 Wash the filters with 0.1% v/v Teepol solution. If required, gently scrub using a nylon brush to remove adhered contaminants.
8.5 Rinse the filters thoroughly with purified water to remove detergent residues, followed by a final rinse with cool WFI.
8.6 Dry the filters by blowing compressed air until completely free from moisture.
8.7 Reinstall the cleaned filters in the LAF unit.
8.8 Switch ON the unit and verify the pressure differential to ensure proper functioning.
8.9 Record the activity in the LAF Prefilter Cleaning Record.
9.0 Annexures
| Annexure No. | Title |
|---|---|
| Annexure I | LAF Prefilter Cleaning Record |