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Optimize your pharmaceutical operations with our SOP for cleaning the Raw Material Dispensing area and replacing filters. Ensure cleanliness and adherence to industry standards. Efficiently clean the Raw Material Dispensing area and replace filters detailed SOP. Stay compliant and maintain a cGMP environment.

Cleaning of Dispensing Area and Return Filters Replacement

1.0   Objective

• • To lay down the procedure for cleaning of Raw Material dispensing area.

2.0   Scope

• • This SOP is applicable to the Cleaning of Raw Material Dispensing Areas and Replacement of Riser Filters, and RLAF Filters in store pharmaceutical drug manufacturing plans.

3.0   Responsibility

• • Operator / House Keeping      :           For cleaning of area

• • Engineering                                :           Cleaning and replacement of filters

• • Store Personnel                         :           Checking of cleaning of area

• • Head Stores                                :           For system Compliance

4.0   Procedure – Cleaning of Dispensing Area and Filter Replacement

• • Cleaning of Raw Material Raw Material dispensing area shall be done as per the given below procedure:

• • Type A Cleaning :

  • To be carried out:

• • After dispensing each Active Pharmaceutical Ingredient (API).

• • In case, the next product/batch is not planned.

• • In case of any major maintenance work / preventive maintenance work carried out which may affect the product quality during production.

• • After dispensing of color.

• • Type A Cleaning Procedure:

• • Write “TO BE CLEANED” on the status board.

• • Collect the used utensils in the container marked as “TO BE CLEANED” & transfer them to the washing area and clean them as per SOP.

• • Perform dry cleaning as per the following sequence,

• • Ceiling → Surrounding Walls of Area → Doors / Door Handles → Top of RLAF → Outer Surface of RLAF → Inner Surface of RLAF including electrical switches and Pre-filter frame cover → weighing balances → Printers/keyboard and connecting wire → Perforated table → SS Stand → SOP Stand → SS Cabinet → floor using dry lint-free cloth/vacuum cleaner.

• • Ensure dry cleaning for the loosely adherence / sticking materials from the perforated table, balance platforms, pre-filter frame cover, and walls if required clean with dry lint-free cloth.

• • Clean the dustbins.

• • Perform wet cleaning by three-bucket cleaning system as per the above sequence using synthetic fiber mop / lint-free cloth wherever required using 0.1% Teepol solution followed by disinfectant (Protasan DS, Savlon, and Dettol) on a rotation basis as per SOP.

• • Ensure that the wet cleaning of instruments/equipment of the area is done, and if required perform the wet cleaning.

• • Cleaning details shall be entered in the Dispensing log for raw materials

• • Type B Cleaning:

• • To be carried out:

• • After dispensing of excipients along with colloidal silicon dioxide in case colour is not a part of the formulation.

• • If the time of Type A cleaning exceeds 72 Hours, re-cleaning of the area shall be done before use following Type B cleaning.

• • Ensure the area is cleaned before use if it is required to re-clean the area follow Type B cleaning.

• • Type B Cleaning Procedure:

• • Collect the used utensils in the container marked as “To Be Cleaned”.

• • Perform dry cleaning as per the following sequence, ceiling → Surrounding Walls of Area → Doors / Door Handles → Top of RLAF → Outer Surface of RLAF → Inner Surface of RLAF including electrical switches and Pre-filter frame cover → weighing balances → Printers/keyboard and connecting wire → perforated table → SS Stand → SOP Stand → SS Cabinet → floor using dry lint-free cloth/vacuum cleaner.

• • Ensure dry cleaning for the loosely adherence / sticking materials from the perforated table, balance platforms, pre-filter frame cover, and walls if required clean with a dry lint-free cloth.

• • Clean the dustbins.

• • Enter the cleaning details in the Dispensing log book for raw materials.

• • Daily Cleaning Procedure:

• • Remove any loose dirt from the area using the vacuum cleaner.

• • Wet mop the area using a synthetic fiber mop using 0.1% teepol solution, followed by disinfectants (Protasan DS, Savlon, and Dettol) on a rotation basis following SOP No.HR-010 and records shall be maintained in Annexure III.

• • Clean the Table, Door, and RLAF (External, Internal & Top) and balance using lint-free cloth.

• • Empty the waste bin and clean it with a clean cloth and place the polythene-lined waste bin in the area

• • Weekly Cleaning Procedure:

• • Remove any loose dirt from the area using the vacuum cleaner.

• • Wet mop the walls, ceiling, door, electric switches, glasses, grills (supply & return), RLAF(External, Internal & Top), tables, and balances platform using 0.1% teepol solution, followed by disinfectants (Protasan DS, Savlon and Dettol) on rotation basis following SOP No.HR-010.

• • Wet mop the floor using synthetic fiber mop using 0.1% teepol solution, followed by disinfectants (Protasan DS, Savlon, and Dettol) on a rotation basis following SOP No.HR-010.

• • Clean the SOP folders and SS stands with a clean lint-free cloth.

• • Use Colin liquid if required to clean the glasses.

• • Enter the details in Annexure I.

• • Cleaning and replacement of Riser Filter and RLAF pre-filter:

• • The store person shall inform the engineer for cleaning of riser filters or RLAF pre-filters.

• • The engineering person shall visit the area along with clean filter(s), packed in polythene bags.

• • Place the filters in the material airlock.

• • The engineering person shall enter the area through men’s entry following the respective gowning SOP.

• • The engineering person shall open the grill, dismantle the filter, clean the grill by moping with clean cloth, and install the clean filter.

• • Close the grill.

• • Pack the dirty filter in a polythene bag and place it in the material airlock.

• • Exit through the men’s airlock following the gowning procedure, and take the filter to the filter cleaning area for cleaning.

• • The engineering person shall write the filter ID No. and date of replacement in Annexure II and sign. under replaced by column.

• • After verification store personnel shall sign under the verified column and write a remark under the remark column.

• • The engineering person shall affix the status label on each riser.

• • Frequency: Weekly, preferably weekend or a holiday.

• • Cleaning of Vacuum Cleaner:

• • Cleaning of the Vacuum Cleaner shall be done following SOP.

• • Important:

• • AHU shall be OFF during the cleaning of Riser Filters.

• • Nut Bolts of RLAF shall be properly tightened.

• • Insulation of RLAF shall be in proper condition.

• • Use Colin liquid if required to clean the glasses.

• • Cleaning Effectiveness Verification:

• • Cleaning of the area shall be done after completion of the dispensing activity and cleaning effectiveness verification shall be recorded as per Annexure-IV.

• • If the cleaning effectiveness verification is not satisfactory then re-cleaning shall be done as per Annexure-IV.

5.0   Annexures – Dispensing Area Cleaning

Annexure – I: Weekly cleaning Record of Raw Material Dispensing area

Annexure – II: Replacement record of Riser Filters and RLAF pre-filters

Annexure – III: Daily cleaning record of the Dispensing area

Annexure – IV: Cleaning Effectiveness Verification