- Objective:
- To lay down a procedure for cleaning of the pre-filters of LAF Unit, garment cubicle, dynamic pass box.
- Scope
- This SOP is applicable for cleaning of pre-filters of LAF Unit, garment cubicle, dynamic pass box.
- Responsibility
- Production Officers / Executive.
- Accountability
- Production Head shall be accountable for the compliance of SOP.
- Abbreviations
- SOP : Standard Operating Procedure.
- WFI : Water for Injection
- LAF : Laminar Air Flow
- Procedure :
- Cleaning of LAF Pre filter:
- Cleaning of the LAF pre filters is to be done on monthly frequency or whenever the differential pressure reading on the megnehelic gauge is found outside the specified limits.
- Switch off the LAF unit from the main switch after the completion of days activities.
- Safely remove the pre-filter unit’s alongwith frames from the laminar air flow unit.
- Transfer the pre-filters to the equipment washing area in a polybag.
- Clean the pre-filters using compressed air.
- Wash the pre-filters with purified water.
- Dry the pre-filters using compressed air in wash equipment area.
- Clean the frame of the pre-filter with lint free duster soaked in WFI.
- Dry the frame with a lint free duster.
- Assemble the pre-filter into the frame and transfer to the respective areas in a polybag.
- Fix the pre-filter assembly to the LAF.
- Switch on the LAF and ensure the differential pressure is within the limits.
- Record the cleaning details in format (specimen attached in Annexure-1) and get it checked by concerned Officer/supervisor.
Above cleaning procedure is applicable for the pre-filters of LAF Unit listed below
| Sr no | LAF description | No of prefilters |
| 01 | Sterilization tunnel LAF preheating zone | 01 |
| 02 | Vial washing LAF | 02 |
| 03 | Garment washing LAF | 02 |
| 04 | Wash equipment area LAF | 03 |
| 05 | Bung processor cum steam sterilizer LAF | 06 |
| 06 | Sampling room LAF | 01 |
| 07 | Vial sealing machine LAF | 03 |
- Cleaning of Dynamic Pass box and Garment cubicle Pre filter:
- Switch off the Dynamic pass box/Garment cubicle from the main switch after the completion of days activities.
- Safely remove the pre-filter unit’s from Dynamic pass box/Sterile Garment cubicle.
- Transfer the pre-filters to the equipment washing area in a polybag.
- Clean the pre-filters using compressed air.
- Wash the pre-filters with purified water.
- Dry the pre-filters using compressed air in wash equipment area.
- Transfer the pre filter to the respective areas in a polybag.
- Fix the pre-filter to the dynamic pass box/Garment cubicle.
- Switch on the dynamic pass box/Garment cubicle and ensure the differential pressure is within the limits
- Record the cleaning details in format (specimen attached in Annexure-1) and get it checked by concerned Officer/supervisor.
- Above cleaning procedure is applicable to the pre filters of dynamic pass boxes and garment cubicle listed below:
| Sr No | Description | Equipment ID No. |
| 01 | Dynamic Pass box (cooling room) | PIDPB-01 |
| 02 | Dynamic Pass box ( filling room) | PIDPB-02 |
| 03 | Dynamic Pass box (sealing room) | PIDPB-03 |
| 04 | Dynamic Pass box (sampling room) | PIDPB-04 |
| 05 | Garment cubicle | PISGC-01 |
- Frequency of pre-filter cleaning.
- Once every month/if the pressure differential is outside the Specified limits.
Annexure-1
Cleaning record of Pre filters
| Date | Prefilter location | Pre-filter ID No. | Cleaned By | Checked by | Remarks |
|
|
Frequency: Monthly/product change over/Differential pressure is outside the limits
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
