SOP Title: Cleaning and Sanitation in Production Area
- Objective:
To define a procedure for Cleaning and Sanitation to be followed in Production Area.
- Scope:
This SOP is applicable for cleaning of all Production area.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the Cleaning and Sanitation in Production Area.
- Engineering Department: To support for the Maintenance of area and providing required utilities.
- Quality Control Department: To monitor the microbial contamination of the area.
- Quality Assurance Department: To provide line clearances prior to operation.To review and approve the SOP and Annexure. To monitor the activities performed in the area as per SOP.
- Accountability:
Head, Production Department.
Head, Engineering Department.
Head, Quality Assurance.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.
- Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
- Disinfectant: The term Disinfectant refers to Savlon solution or Dettol solution at 2.5% v/v (25 ml of disinfectant in 1000 ml of Potable water) of concentration as per the Scope of this SOP.
- Cleaning Solution: 25 ml of Teepol (soap solution) in 1000 ml of potable water (2.5% v/v).
- Type A Cleaning: Cleaning the area with 2.5% v/v of Cleaning Solution in the following cases:-
- To remove the previous batch residue.
- Before starting the next batch of the same product.
- After End of the shift or before the start of the Shift, if the same product to be continued.
- Type B Cleaning: Cleaning the area with 2.5% v/v of Cleaning Solution followed by Sanitation with Disinfectant solution in the following cases:-
- Removal of traces of the previous product.
- Change in product if any.
- After continuous five batches of the same product.
- Daily at the start of the Shift and at the end of the shift in the area.
- After any repair work carried out in the area.
- Procedure:
- Definition:
| Precautions | ||
| 5.2.1 | Switch “OFF’ the equipments before proceeding to cleaning. | |
| 5.2.2 | During wet cleaning cover the electrical panel, switches and other sensitive components with fresh poly bag. | |
| 5.2.3 | Do not flush the water / solvent on the electrical switches or tube lights. | |
| 5.3 | Cleaning of Production Area: | |
| 5.3.1 | Update the area status board as “Under cleaning”. | |
| 5.3.2 | Remove all the material, documents, and labels of the previous Batch / Product from the area before proceeding for cleaning. | |
| 5.3.3 | Perform either “TYPE A” cleaning or “TYPE B” cleaning as applicable. | |
| 5.4 | TYPE A Cleaning: | |
| 5.4.1 | Remove any spilled material from the area with clean duster / Vacuum Cleaner. | |
| 5.4.2 | Clean the Items as per Annexure with Vacuum Cleaner/dry lint free cloth. | |
| 5.4.3 | After ensuring Step no 5.4.2, clean those items with lint free cloth / Mob soaked in potable water. Followed by clean lint free cloth soaked in 2.5% of cleaning solution. | |
| 5.4.4 | Finally clean with clean lint free cloth soaked in potable water followed by purified water. | |
| 5.4.5 | Record the cleaning activity in the Area cleaning and Sanitisation record as per Annexure. | |
| 5.4.6 | Update the area status board as “TYPE A Cleaned” | |
| 5.4.7 | Allow the area to dry before start of the next batch. | |
| 5.5 | TYPE B Cleaning: | |
| 5.5.1 | Remove any spilled material from the area with clean lint free cloth / Vacuum Cleaner. | |
| 5.5.2 | Before starting cleaning of the area cover the PLC, Electrical fixtures, panel boards of the equipments in the area with clean poly bag. | |
| 5.5.3 | Clean the Area as per Annexure with Vacuum Cleaner/dry lint free cloth. | |
| 5.5.4 | After ensuring Step no 5.5.3, clean those items with lint free cloth soaked in potable water. Followed by clean lint free cloth soaked in 2.5% of cleaning solution. | |
| 5.5.5 | Finally clean with clean lint free cloth soaked in potable water followed by purified water. | |
| 5.5.6 | Allow the floor to dry and sanitize the floor with 2.5% v/v of disinfectant solution. | |
| 5.5.7 | Sanitize the floor with 2.5%v/v of Dettol solution for one week and 2.5% v/v of Savlon solution for the next one week. | |
| 5.5.8 | Follow Step No. 5.5.7 alternatively for every week. | |
| 5.5.9 | Allow the floor to dry before start of the activity. | |
| 5.5.10 | Update the area status board as “TYPE B Cleaned” | |
| 5.5.11 | Record the cleaning activity in the Area Cleaning and Sanitisation record as per Annexure. |
- Abbreviation:
| Abbreviation | Expansion |
| ML | Millilitre |
| QA | Quality Assurance |
| % | Percentage |
| v/v | Volume by Volume |
| PLC | Programmable Logical Control |
*Note – Ready to use SOP available in “DOWNLOAD” Section.