SOP FOR CLEANING OF DISPENSING AREA AND REPLACEMENT OF RISER FILTERS, RLAF FILTERS

1. OBJECTIVE

              To lay down the procedure for cleaning of dispensing area.

• SCOPE

              This SOP is applicable to Cleaning of Dispensing Area and Replacement of Riser Filters, RLAF Filters in Store.

• RESPONSIBILITY

              Operator / House Keeping                  : For cleaning of area

              Engineering                                         : Cleaning and replacement of filters

              Store Personnel                                   : Checking of cleaning of area           

• ACCOUNTABILITY:

Stores In-charge                                  : For system Compliance   

• PROCEDURE
  • Cleaning of dispensing area shall be done as per given below procedure:
  • Type A:
    •       Applicable for product to product change over
      • In case of any major maintenance work / preventive maintenance work carried out which may affect the product quality.
    •      Cleaning Procedure:
      • Write “TO BE CLEANED” on the status board
      • Collect the used utensils in the container marked as “TO BE CLEANED” & transfer to washing area.
      • Remove the any loose dust from tables, balance platform and floor using vacuum cleaner.
      • Mop the weighing balances, RLAF (inner, outer and top surfaces) and tables using wet lint free cloth followed dry lint free cloth.

• Clean the dustbins.
  • Wet mop the area using synthetic fiber mop using 0.1% Teepol solution, followed by disinfectants (Savlon and Dettol) on rotation basis following SOP.
  • Cleaning details shall be entered in the dispensing log for raw materials.
  • Type B:
    •      Batch to batch change over for same product.
      • After dispensing of each Active ingredient
    •      Cleaning Procedure:
      • Collect the used utensils in the container marked as “TO BE CLEANED” & transfer to washing area in case of batch change.
      • Remove the any loose dust from tables, balance platform and floor using vacuum cleaner.
      • Mop the weighing balances, inner surface of RLAF and tables using dry lint free mop.
    • Enter the cleaning details in the Dispensing log book for raw materials.
  • Daily  Cleaning:
    •       Remove the any loose dirt from the area using vacuum cleaner.
    •      Wet mop the area using synthetic fiber mop using 0.1% Teepol solution, followed by disinfectants (Savlon and Dettol) on rotation basis and records shall be maintained on.
    •       Clean the Table, Door, RLAF (External, Internal & Top) and balance using lint free cloth.
    •       Empty the waste bin and clean with clean cloth and place the polythene lined waste bin in the Store area.
  • Weekly Cleaning:
    •        Remove the any loose dirt from the area using vacuum cleaner.
    • Wet mop the walls, ceiling, door, electric switches, glasses, grills (supply & return), RLAF(External, Internal & Top), tables, balances platform using 0.1% teepol solution, followed by disinfectants (Savlon and Dettol) on rotation basis.
    • Wet mop the floor using synthetic fiber mop using 0.1% teepol solution, followed by disinfectants (Savlon and Dettol) on rotation basis.
    • Clean the SOP folders and SS stands with clean lint free cloth.
    • Use Colin liquid if required to clean the glasses.
    • Enter the details in log book. 
  • Cleaning and replacement of Riser Filter or RLAF pre-filter:
    • Store person shall inform the engineering for cleaning of riser filters or RLAF pre-filters.
    • Engineering person shall visit the area along with clean filter(s), packed in polythene bag. Place the filters in material airlock.
    • Engineering person shall enter the area through men entry following respective gowning.
    • Engineering person shall open the grill, dismantle the filter, clean the grille by moping with clean cloth and install the clean filter.
    • Close the grill.
    • Pack the dirty filter in polythene bag and place in material air lock.
    • Exit through men airlock following gowning procedure, and take the filter to filter cleaning area for cleaning.
    • Engineering person shall affix the status label on each riser.
    • Maintain the record in filter clearing format.
    • Frequency: After Sampling & After every batch dispensing.  
  • Cleaning of Vacuum Cleaner:
    •      Cleaning of Vacuum Cleaner shall be done.

       TRAINING

Trainer   : Head – Quality Assurance

            Trainees : Store-Incharge, Workmen 

       DISTRIBUTION

Master Copy                     :           Quality Assurance

Controlled Copy               :           Stores

Display Copy                    :           Stores (if required)

       ATTACHMENTS

Sr. No.	Annexure No.	Title	Format no.
1	NA	NA	NA

•     REFERENCES   

In-house

         ABBREVIATION

Abbreviation	Extended Form
EG	Engineering
SOP	Standard Operating Procedure
QA	Quality Assurance
WH	Warehouse
NA	Not Applicable
MB	Microbiology

      REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.