SOP For Cleaning of Primary Production Area

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1.0 Objective:

To lay down a procedure for cleaning of the Primary Production Area.

2.0 Scope                                                                    

2.1 This SOP is Applicable for cleaning of the Primary Production Area.The Primary Production Area is

The Primary Production Area is divided in four parts for the purpose of cleaning:

2.1.1   Processing Rooms

2.1.2   Production Corridor Area

2.1.2   Production Corridor Are

2.1.3   Equipment wash area

2.1.4   Semi finished Product storage area and other areas.

3.0 Responsibility

3.1 Housekeeping Person, Operator, Production Officer.

4.0 Accountability

4.1 Production Head.

5.0 Abbreviations and Definitions

SOP          :          Standard Operating Procedure

No.           :          Number

SS            :           Stainless Steal

%              :           Percent

6.0 Procedures:

6.1 Cleaning aids:

 6.1.1 Dry Vacuum Cleaner        :  It is used for dry cleaning.

6.1.2 Dry wet vacuum cleaner   :  It cleans and driers the floor at a time (small area)

6.1.3 Scrubber cum dryer          :  It cleans and driers the floor at a time

6.1.4 Duster Cloth                      :   For cleaning

6.1.5 Domex / Lysol.                   :   Disinfectant

6.1.6 Aluminum Stick Mop.             :   For ceiling and wall cleaning

6.1.7 Pipe brush                    :   For floor cleaning

6.1.8 Floor cleaning trolley          :   For moping of pipe brush

6.1.9 Nylon Broom            :   For cleaning of change room and packing hall.

6.2 Processing Room

6.2.2 The Processing Room shall be cleaned either at the end of a batch or at the end of the day, which ever is earlier. There are three types of cleaning:

6.2.2.1 Type-A: Applicable for Product to Product change over.

6.2.2.2 Type-B: Applicable for Batch to Batch change over of the same product/if no activity is present.

6.2.2.3 Type-C: Applicable for the processing rooms which are not used during the day otherwise the same batch is going on for the next day.

6.3 Type- A Cleaning

6.3.1 Start cleaning of the area after the cleaning of the equipments.

6.3.2 Start the cleaning operation of ceiling and then to walls from top progressing to downwards.

6.3.3 Clean the door and window glasses using (Disinfectant solution) wet duster.

6.3.4 Clean the doors, door closures, handles and all the hinges of the door using dry followed by wet and again with dry duster.

6.3.5 If weighing balance is present in the processing room, clean it by using wet duster followed by dry duster.

6.3.6 Clean the pallets, trolleys, etc using a wet duster followed by a clean dry duster.

6.3.7 Remove the dust from the switchboards, utility pendants using the vacuum cleaner and wipe with clean dry duster.

6.3.8 Clean the SOP stand using clean dry duster.

6.3.9 Clean the accessories box using the wet duster followed by clean dry duster.

6.3.10 Clean the ceilings of Air Handling Unit (AHU) supply grilles with a pipe brush and vacuum cleaner during a product change over.

6.3.11 Clean and mop the entire floor twice using 1.0% disinfectant solution (Domex / Lysol) using Aluminum stick mop / Scrubber cum drier.

6.3.12 Clean the tube light fixtures using wet duster followed by a clean dry duster.

6.3.13 Clean the coving, corners of the entire area using wet (with disinfectant) duster.

6.3.14 Clean the walls of the entire area using (with disinfectant) wet mop.

6.3.15 Collect all the waste from the waste bin into a poly bag and send to the scrap room. Sanitize the waste bin with (Disinfectant solution) wet duster followed by dry duster.       

6.3.16 Clean the drain parts and drain using 1% Disinfectant solution and 10% sodium Hypochloride solution once a week as per respective SOP scrubbing with scotch brite followed by sufficient quantity of water. Pour 0.5 liters of 1% disinfectant solution into the drain. Close the drain with drain trap, perforated plate and lid.

6.3.17 Enter the cleaning details in the ‘Primary Production area cleaning Record’ as per Annexure No.-I

6.4 Type-B Cleaning:

6.4.1 Follow the steps 6.3.2 to 6.3.9 for cleaning of Processing Room.

6.4.2 Collect all the waste from the waste bin into a poly bag and send to the scrap room. Clean the waste bin with a dry duster.

6.4.3 Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol.) using Aluminum stick mop / Scrubber cum dryer.

6.4.4 Enter the cleaning details in the ‘Primary Production area cleaning Record’ as per Annexure No.-I

6.5 Type -C Cleaning:

6.5.1 Clean the door and window glasses using (Disinfectant solution) wet duster.

6.5.1 Clean the doors, door closures, handles and all the hinges of the doors using wet and dry duster.

6.5.3 Collect all the waste from the waste bin into a poly bag and send to the scrap room. Clean the waste bin with a dry duster.

6.5.4 Clean the SOP stand using clean dry duster.

6.5.5 Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol.) using Aluminum stick mop / Scrubber cum dryer.

6.5.6 Enter the cleaning details in the ‘Primary Production area cleaning Record’ as per Annexure No.-I

6.6 Production Corridor Area

6.6.1 Doors, door closures, handles window glasses, fire extinguishers, emergency lights, switchboards, coving, corners of the entire area cleaned daily.

6.6.2 Clean and mop the entire floor twice a day.

6.6.3 Tube light fixture, walls, ceiling and corner angle cleaned once a week.

6.6.4 Clean the door and window glasses using (Disinfectant solution) wet duster.

6.6.5 Clean the doors, door closures, handles and all the hinges of the doors using wet and dry duster.

6.6.6 Clean the fire extinguishers, emergency lights using dry duster.

6.6.7 Clean the switchboards using dry duster.

6.6.8 Clean the coving, corners of the entire area using wet (with disinfectant) duster.

6.6.9 Clean the ceiling, walls and corner angles using wet duster followed by dry duster.  (Once a week).

6.6.10 Clean the tube lights fixtures using dry duster (Once a week).

6.6.11 Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol) using Scrubber cum dryer  / Aluminum stick mop  at the start  and at the end of the shift or as and when required.

6.6.12 Enter the cleaning details in the ‘Semi Finish Product Storage Area, Production Corridor Area and Equipment Wash Area Cleaning Record’ as per Annexure No.-II

6.7 Equipment wash area

6.7.1 Door, door closures, handles window glasses, emergency lights, switchboards, coving, corners and drain point of the entire area cleaned daily.

6.7.2 Clean and mop the entire floor twice a day.

6.7.3 Tube light fixture cleaned once a week.

6.7.4 Clean the door, window glasses, handles and all the hinges of the doors using (Disinfectant solution) wet duster.

6.7.5 Clean the table using (Disinfectant solution) wet duster followed by dry duster.

6.7.6 Clean the tube lights fixtures using dry duster (Once a week).

6.7.7 Clean the switchboards, utility pendants using clean dry duster.

6.7.8 Collect all the waste from the waste bin into a poly bag and send to the scrap room.

6.7.9 Clean the waste bin using wet duster followed by dry duster.

6.7.10 Clean the SOP stand using clean dry duster.

6.7.11 Cleaning of covings, corners and walls of the entire area using (Disinfectant) wet duster   Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol) using Aluminum stick mop .

6.7.12 At the end of the working shift, clean the drain parts and Pour of 10% Hypochloride solution into the drain. Scrubbing with scotch brite followed by sufficient quantity of water. Close the drain with drain trap, perforated plate and lid.

6.7.13 Enter the cleaning details in the ‘Semi Finish Product Storage Area, Production Corridor Area and Equipment Wash Area Cleaning Record’ as per Annexure No.-II.

 6.8 Semi finish Product storage area and other areas:

6.8.1 Semi finish product storage area include semi finish quarantine-I & II, Granules quarantine I & II and other areas are days packing store, Genitor room, scrap.room and tool rooms.

6.8.1 Door, door closures, handles window glasses, emergency lights, switchboards, SS containers, coving, corners and drain point of the entire area cleaned daily.

6.8.3 Tube light fixture, walls, ceiling and corner angle cleaned once a week.

6.8.4 Clean and mop the entire floor twice a day.

6.8.5 Clean the door, window glasses, handles and all the hinges of the doors using (Disinfectant solution) wet duster.

6.8.6 Clean the table using (Disinfectant solution) wet duster followed by dry duster.

6.8.7 Clean the switchboards, utility pendants using clean dry duster.

6.8.8 Clean the pallets, trolleys, SS containers, In-process Containers etc using a clean dry duster.

6.8.9 Clean the coving, corners of the entire area using wet (with Disinfectant) duster.

6.8.10 If the weight balance is present in Semi finish Product storage area clean it using wet duster followed by dry duster.

6.8.11 Clean the ceiling, walls and corner angles using wet duster followed by dry duster.(once a week)

6.8.12 Clean the tube lights fixtures using wet duster followed by dry duster.( once a week)    

6.8.13 Clean and mop the entire floor using 1% disinfectant solution(Domex / Lysol) using scrubber cum dryer / Aluminium stick mop at the start and at the end of shift or as and when required.

6.8.14 Enter the cleaning details in the ‘Semi Finish Product Storage Areas, Production Corridor Area and Equipment Wash Area Cleaning Record’ as per Annexure No. -II

7.0 Forms and Records (Annexures)

  • Processing room cleaning record                                                          –           Annexure-I
  • Semi Finish Product Storage Areas, change part room , Production Corridors Area And Equipment Wash Area Cleaning Record                                                                 –           Annexure-II

8.0 Distribution

  • Master copy –           Quality Assurance
  • Controlled copies- Quality Assurance, Production, Housekeeping

9.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

 

Annexure-I

Processing Room Cleaning Record

 

Area:______________________

 Disinfectant solution used: _____________________                          Type of cleaning: A /B /C

Sr. No. Area Date  Date  Date  Date  Date Date  Date
Shift Shift Shift Shift Shift Shift Shift
1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
1 Wet Granulation                            
2 Dry Granulation I                            
3 Dry Granulation II                            
4 Blending Room                            
5 Capsule Filling- I                            
6 Capsule Filling- II                            
7 Tablet Compression I                            
8 Tablet Compression II                            
9 Tablet Inspection                            
10 Coating                            
S.n. Area 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
11 Strip Packing                             
12 Blister Packing                            
13 Alu-Alu Packing                            
14 De-cartoning Room                             
15 Air Jet Cleaning                            
16 Dry Syrup Filling and Sealing                            
17 Bulk Packaging Room                            
18 Done By (House Keeping Person)                            
19 Done By (Operator)                            
20 Checked By                            

Note: Write A/ B/ C wherever applicable and write N.A. if not applicable.

Type-A: Applicable for Product to Product change over

Type-B:  Applicable for Batch to batch change over of the same product.

Type-C:  Applicable for the processing rooms which are not used during the day otherwise the same batch is going on for the next day.

Annexure-II

Semi Finish Product Storage Area, Change Part Room, Production Corridor Area and Equipment Wash                                                                                Area Cleaning Record

 

Area:______________________                                Disinfectant solution used: __________________

Sr. No. Area  Date Date Date  Date Date Date Date
Shift Shift Shift Shift Shift Shift Shift
1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
1 Cleaning of door and window glasses using (disinfectant solution) Wet duster                            
2 Cleaning of doors, door closures, handle and all hinges of doors using dry duster followed by wet and again dry duster.                            
3 Cleaning of weighing balance using wet duster followed by dry duster.                            
4 Cleaning of pallets and trolleys using wet duster followed by dry duster.                            

 

S.N Area 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
5 Cleaning of switch boards and utility pendent using vacuum cleaner and wipe with dry duster.                            
6 Cleaning of SOP stand using clean dry duster.                            
7 Cleaning of entire floor using 2.5 % disinfectant solution.                            
8 Cleaning of coving, corner of entire area using (Disinfectant) wet duster.                            
9 Clean the tube light fixture using wet duster followed by a clean dry duster.                            
10 Done by (House keeping person)                            
11 Done By (Operator)                            
12 Checked By                            

 

Note: Write N.A. wherever not applicable.                   [√] Tick mark if the activity is performed.

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