STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/PR/GEN/001-06
SUPERSEDE SOP NO:
IGPL/PR/GEN/001-05
SUBJECT:
DEPT: PRODUCTION
AREA: DOCUMENTATION
CLEANING METHOD FOR EQUIPMENT
AND AREA
Page No
1 of 7
Effective date
03-01-2022
Review date
31-12-2024
1.0
OBJECTIVE
To lay down a procedure for cleaning of equipment and production area and corridors
of the manufacturing Block.
2.0
SCOPE
This procedure is applicable for manufacturing area of Indian Genomix Private
Limited, Cherlapally, Hyderabad.
3.0
RESPONSIBILITY
3.1
Executive-Production
3.2
Head-Production
3.3
Executive-IPQA
3.4
Head-QA
4.0
PROCEDURE
4.1 Equipment Cleaning
4.1.1 Clean the Equipments as per the cleaning Procedures given in the
respective cleaning SOPs of the equipments.
4.1.2 Write the cleaning record as given in the Annexure-1.
4.2 Production Area Cleaning(Tablet, Powder and Liquid sections)
4.2.1 Initially remove the dust from the production area using vacuum cleaner.
4.2.2 Clean the entire walls and floors of the production after covering all the
machines.
4.2.3 Dilute approximately 250 ml of liquid soap to about 10 liters of water
(2.5% v/v) and mix gently to form solution.
4.2.4 Sprinkle the detergent solution on floor and other surfaces and swab with
rubber mops for effective soap action for few minutes. Pour sufficient
water and swab with rubber mop to remove the dirt.
PREPARED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
CHECKED BY
APPROVED BY
STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/PR/GEN/001-06
SUPERSEDE SOP NO:
IGPL/PR/GEN/001-05
SUBJECT:
DEPT: PRODUCTION
AREA: DOCUMENTATION
CLEANING METHOD FOR EQUIPMENT
AND AREA
Page No
2 of 7
Effective date
03-01-2022
Review date
31-12-2024
4.2.5 Prepare the disinfectant solution as per section 4.4
4.2.6 Sprinkle disinfectant solution on the floor and other surfaces which was
already cleaned with soap solution.
4.2.7 After 5 minutes swab cleanly to dry the areas by removing the excess
water with mop.
4.2.8 Change the disinfectant Dettol /Lysol/ Savlon every 10 days as given in
section 4.6.
4.3
Parenteral Area
4.3.1 Initially remove the dust from the production area using vacuum cleaner.
4.3.2 Clean the entire floor of the department after covering all the machines.
4.3.3 Dilute approximately 750 ml of liquid soap to about 30 liters of water
(2.5% v/v) and mix gently to form solution.
4.3.4 Pour 30 liters of above solution into scrubber machine and clean the area.
4.3.5 Prepare the disinfectant solution as per section 4.4
4.3.6 Pour 30 liters of disinfectant solution into scrubber machine and clean the
area.
4.3.7 Change the disinfectant Dettol /Lysol/ Savlon every 10 days as given in
section 4.6.
4.4 Cleaning Agents and Concentration
4.4.1 Cleaning agent composition (Dettol 2.5% V/V, Savlon 5.0% V/V, Lysol
l.0% V/V )
4.4.2 Dettol 2.5%: Dilute approximately 250 ml of disinfectant to 10 liters of
water (2.5% v/v) and mix well to form solution.
PREPARED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
CHECKED BY
APPROVED BY
STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/PR/GEN/001-06
SUPERSEDE SOP NO:
IGPL/PR/GEN/001-05
SUBJECT:
DEPT: PRODUCTION
AREA: DOCUMENTATION
CLEANING METHOD FOR EQUIPMENT
AND AREA
Page No
3 of 7
Effective date
03-01-2022
Review date
31-12-2024
4.4.3 Savlon 5.0%: Dilute approximately 500 ml of disinfectant to 10 liters of
water (5.0% v/v) and mix well to form solution.
4.4.4 Lysol 1.0%: Dilute approximately 100 ml of disinfectant to 10 liters of
water (1.0% v/v) and mix well to form solution.
4.4.5 Isopropyl alcohol: Use 70% Isopropyl alcohol
4.4.6 Record the cleaning solution preparation in annexure-5. The record
consists of Date, Name of the Solution, %Concentration, Quantity
prepared, prepared by (Production), checked by (IPQA) & remarks.
Prepare and use the solution on the same day.
4.4.7 IPA Solution: Place container label on the container with details like Date
of Preparation, Concentration (%), use before and sign as given in the
annexure-6.
4.5 Dirty Equipment Holding Time (DEHT)
4.5.1 Clean the equipment immediately after use and record the same in the
Annexure-1 or else Keep “TO BE CLEANED” label on the equipment or
utensil.
4.5.2 The label consists of Equipment Name or ID, Previous product, Batch No,
Cleaning due date, Cleaned by (Date and signature) and Checked by (Date
and signature).
4.6 Cleaned Equipment Holding Time (CEHT)
4.6.1 Clean the equipment within 72 hours if the equipment is ideal.
4.7 Cleaning Agents Usage
4.7.1 Use the cleaning agents as given below
4.7.1.1 1-10th day : Dettol 2.5% v/v
4.7.1.2 11-20th Day: Savlon 5.0% v/v
PREPARED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
CHECKED BY
APPROVED BY
STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/PR/GEN/001-06
SUPERSEDE SOP NO:
IGPL/PR/GEN/001-05
Page No
DEPT: PRODUCTION
AREA: DOCUMENTATION
CLEANING METHOD FOR EQUIPMENT
AND AREA
SUBJECT:
4 of 7
Effective date
03-01-2022
Review date
31-12-2024
4.7.1.3 21st-End of the month: :Lysol 1.0% v/v
4.8 After cleaning of each equipment “CLEANED LABLE” shall be affixed. Record
the details of cleaning in the respective Equipment Log Book.
4.9 The Cleaned label consists of Equipment, Previous product, Cleaned By (Date and
Signature), Checked by (Date and signature) of the production executive.
5.0 ABBREVIATIONS
5.1 SOP: Standard Operating Procedure
5.2 CCR: Change Control Record
6.0 ANNEXURE
6.1
6.2
6.3
6.4
6.5
6.6
Annexure-1: Equipment Cleaning Log
Annexure-2: Production area cleaning log sheet
Annexure-3: Cleaned Label
Annexure-4: To be cleaned label
Annexure-5: Cleaning Solution preparation record
Annexure-6: Container Label for IPA solution
EQUIPMENT CLEANING LOG SHEET [ANNEXURE-1]
Name of the Equipment:
Name of the
Previous/
Date
Next
Product
B.No
Area:
Batch
Size
Cleaning
Duration
From
To
Done
by
Checked Remarks
by
Note: In cleaning Column, Write “After Cleaning” for Previous Product and “Before Cleaning” for Next
Product
PREPARED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
CHECKED BY
APPROVED BY
STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/PR/GEN/001-06
SUPERSEDE SOP NO:
IGPL/PR/GEN/001-05
DEPT: PRODUCTION
AREA: DOCUMENTATION
CLEANING METHOD FOR EQUIPMENT
AND AREA
SUBJECT:
Page No
5 of 7
Effective date
03-01-2022
Review date
31-12-2024
PRODUCTION AREA CLEANING LOG SHEET [ANNEXURE-2]
Name of the Area:
Date
Month:
Cleaned and Mopped At
AM
PM
PM
Disinfectant
Used
Cleaned By
Checked
By
Note: 1-10th day: Dettol 2.5% v/v, 11-20th Day: Savlon 5.0% v/v and 21st - end of the month: Lysol 1.0% v/v
CLEANED LABEL [ANNEXURE-3]
Equipment: ____________________
CLEANED
Previous Product: __________________
Batch No: ________________________
Cleaning Due Date: ________________
Cleaned by:
Date:
PREPARED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
Checked by:
Date:
CHECKED BY
APPROVED BY
STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/PR/GEN/001-06
SUPERSEDE SOP NO:
IGPL/PR/GEN/001-05
DEPT: PRODUCTION
AREA: DOCUMENTATION
CLEANING METHOD FOR EQUIPMENT
AND AREA
SUBJECT:
Page No
6 of 7
Effective date
03-01-2022
Review date
31-12-2024
TO BE CLEANED LABEL [ANNEXURE-4]
Equipment: ____________________
TO BE CLEANED
Previous Product: __________________
Batch No: ________________________
Cleaned by:
Checked by:
Date:
Date:
CLEANING SOLUTION PREPARATION RECORD [ANNEXURE-5]
Date
Name of the Solution
Concentration (%)
Quantity
Prepared
Prepared
by
Checked
by
Remarks
Note: Prepare and use the solutions on the same day.
PREPARED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
CHECKED BY
APPROVED BY
STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/PR/GEN/001-06
SUPERSEDE SOP NO:
IGPL/PR/GEN/001-05
SUBJECT:
Page No
DEPT: PRODUCTION
AREA: DOCUMENTATION
CLEANING METHOD FOR EQUIPMENT
AND AREA
7 of 7
Effective date
03-01-2022
Review date
31-12-2024
CONTAINER LABEL FOR IPA SOLUTION [ANNEXURE-6]
CONTAINER LABEL FOR IPA SOLUTION
Date of Preparation
Concentration (%)
Use before
Sign
7.0
CHANGE HISTORY
Supersede SOP No.
IGPL/PR/GEN/001-00
CCR No.
CCR/001/12
Reason for revision
No Changes in the Standard Operating System
END OF DOCUMENT
PREPARED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
CHECKED BY
APPROVED BY