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Standard Operating Procedure (SOP) for cleaning of Pre-filters, Microvee filters, and cartridge filter of the equipment ( AHU, FDV, Autocoaters, FBD,  RLAF, LAF, and Dust Collector ) installed in the Pharmaceutical Plant.

Procedure for Filter Cleaning

1.0   PURPOSE:

• • The purpose of this SOP is to define the procedure for cleaning Prefilters, Microvee filters, and cartridge filters (i.e. 10µ, 5µ, 3µ) of all the equipment/s.

2.0   SCOPE:

• • This procedure is applicable for cleaning of Prefilters, Microvee filters, and cartridge filters of the equipment ( AHU, FDV, Autocoaters, FBD,  RLAF, LAF, and Dust Collector ) installed in the Pharmaceutical Plant.

3.0   REFERENCES:

• • SOP No.for Cleaning and Operation of Reverse Laminar Air Flow

4.0   RESPONSIBILITY:

• • The user department shall be responsible to maintain the filters Cleaning Record and Update the Filter Cleaning Status Label of the respective department.

• • The engineering department shall be responsible to prepare the filter cleaning schedule and intimate to the concerned department before the planned date.

• • The engineering department shall be responsible to carry out filter cleaning activity and update filter cleaning status Label and schedule.

• • The quality Assurance department shall be responsible to ensure that the filter cleaning work is carried out as per define procedure.

5.0   ABBREVIATIONS – FILTER CLEANING:

• • AHU: Air Handling Unit

• • FBD: Fluid Bed Dryer

• • FDV: Force Draft Ventilation

• • RLAF: Reverse Laminar Air Flow

• • LAF: Laminar Air Flow

• • WC: Water Column

• • DEFINITION:

• • Prefilter: It is washable filters to control the dust particles of 5 micron and above.

• • Microvee Filter: It is washable filters to control dust particles of 3 micron and above.

• • It installed after the prefilters.

6.0   PROCEDURE FOR FILTER CLEANING:

• • The frequency for Cleaning of Filters (Prefilters, Microvee filters, and cartridge filters). *For AHU, FDV, Autocoaters, Dust Collector, FBD :

• • 10 Days ± 2 days or

• • Whenever pressure difference reading is not within limit.

• • The differential working pressure range of AHU filters is 0 to 15 mm WC and DCU filters is 0 to 135 mm Water Coloum

• • The frequency for Cleaning of Prefilters for RLAF:

• • Twice in a month or whenever the pressure difference reading is not within limit. (Differential working pressure range of Reverse Laminar Air Flow filters is 1 to 5 mm)

• Check and Precaution:

• • Ensure that no production activity is being performed while carrying out the filter cleaning.

• • Ensure that the main switch of the respective equipment is put off.

• • After re-fixing the filters ensure that all safety doors are properly closed.

• Cleaning Procedure for Prefilters, microvee filters, and cartridge filters:

• • Affix the label on the respective equipment as “UNDER CLEANING “as per Annexure 1.

• • Switch off the main power of equipment.

• • Open the doors and remove dirty filters from the filter housing and keep inside polybag to avoid the spread of powder in the surrounding area.

• • Properly clean inside the area of equipment and collect any fallen dust on the surface.

• • We need to bring clean filters near the equipment for the immediate replacement of dirty filters.

• • Make sure that clean filters to bring in close polybags to avoid contamination.

• • Take out the cleaned filters from the polybag and fixed their proper position and closed the safety doors.

• • Remove the “UNDER CLEANING “label from the equipment.

• • Put ON the emergency switch and main switch of the respective equipment.

• • Switch on the equipment and ensure any air leakage from the doors. In case of any leakage arrest immediately rectify the leakages.

• • Transfer dirty filters to filter the cleaning area. Make sure all dirty filters packed in polybags to avoid the spread of powders.

• • Put ON the filter cleaning equipment and motor for the water circulation.

• • Keep the filters into the filter’s cleaning tank and clean with dry compressed air in the direction from the cleaned side to the opposite side.

• • After dry cleaning, clean the filters with potable water.

• • Dry the filters by applying dry compressed air.

• • Inspect the filters visually for cleanliness.

• • Repeat the cleaning if required.

• • Inspect the filters visually after the cleaning.

• • If found damaged, replace it with a new equivalent filter and discard the damaged filter.

• • Cleaned filters put on dryer for drying.

• • After drying the cleaned filters, filters wrap with cleaned polybag and transfer to the respective area with a label-” Cleaned Filter”.

• • Update the filter cleaning records, status label, and schedule as per Annexure No.1, 2, 3, 4.

7.0   ANNEXURES – FILTER CLEANING:

Annexure 1: Status Label.

Annexure 2: Filters Cleaning Record.

Annexure 3: Filter Cleaning Status Label.

Annexure 4: Filter Cleaning Schedule.

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