Cleaning method for Equipment and area in production

1.0 OBJECTIVE

To lay down a procedure for cleaning of equipment and production area and corridors in the manufacturing Block.

2.0 SCOPE

This procedure is applicable for manufacturing area of company Name

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 Equipment's as per the cleaning Procedures given in the respective cleaning SOPs of the equipment's.

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.

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 4.7.

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.

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

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.

4.10 Filtration of Disinfectant Solution

4.10.1 Check the filtration LAF is "ON" and magnehelic gauges reading is within the limit

4.10.2 Place the sterilized membrane under LAF

4.10.3 Connect the inlet disinfectant filter to the inlet disinfectant holding vessel ( filtration cessel)

4.10.4 Connect the inlet of disinfectant preparation vessel to nitrogen Supply

4.10.5 Open the regulate nitrogen pressure through pressure vessel regulator gradually to acheive a pressure of 1.0 to 2.0 kg/cm2

4.10.6 Allow the solution to pass through 0.2 micron fliter and collect solution in sterilized filtration vessel

4.10.7 After completion, solution has been filtered, close nitrogen supply

4.10.8 Disconnect all silicon tubes and transfer them to equipment washing area for cleaning

5.0 ABBREVIATIONS

5.1 SOP: Standard Operating Procedure

5.2 CCR: Change Control Record