Standard cleaning Procedure for a tablet coater after the enteric coating process.
The purpose of this Standard cleaning procedure is to establish a standard cleaning procedure for washing the tablet coater after the enteric coating process.
This SCP is applicable for washing tablet coaters after the enteric coating process in the production area.
3.1 Machine Operator (MO) is responsible for the cleaning process.
3.2 Production Pharmacist is responsible for the implementation of this SCP.
3.3 The Production Manager is responsible for ensuring the implementation of this SCP.
3.4 The Quality Assurance Officer monitors the compliance of this SCP.
4.0 Standard Cleaning Procedure
4.1 Prepare 7.5% sodium hydroxide solution q.s to wash spray guns and accessories.
4.2 Remove the spray gun rod from the tablet coater and dismantle all the spray guns.
4.3 Dip all the parts of the spray guns in sodium hydroxide solution.
4.4 Remove all the spray pipes and circulate sodium hydroxide solution till complete clearance.
4.5 Wash the spray gun installation rod with sodium hydroxide solution to wash it.
4.6 Close the discharge drain of the tablet coater and fill the pan with tap water up to the specified level.
4.7 After filling the coating pan with water add 20 litres of previously prepared 7.5 % sodium hydroxide.
4.8 Rotate the pan for a specified period until the required level of cleanliness is achieved.
4.9 The inlet and exhaust ducts are also washed with sodium hydroxide solution to make it clear.
4.10 When the Pan surface and baffles are washed, drain out the water and fill it again with tap water.
4.11 Prepare 20 liters of 1% food-grade detergent, add it into a coating pan and rotate it for a specified period.
4.12 Wash spray guns and spray pipes with food-grade detergent solution.
4.13 Drain out the water from the coating pan and rinse it with purified water.
4.14 Take rinsing samples for checking pH and Conductivity to ensure that our cleaning is accurate.
4.15 Turn the Heating system on and dry the tablet coating pan.
4.16 When the pan is completely dried, the cleaning activity is recorded in the books.
5.1 SCP: Standard Cleaning Procedure
5.2 HOP:Head Of Production
- The concentration & volume of sodium hydroxide solution can be adjusted according to your in-house requirements.
- The concentration and volume of food-grade detergent can also be adjusted according to requirements.
- In place of sodium hydroxide solution, you can use any basic detergent which is validated for your cleaning process.
- We use basic detergent or Sodium hydroxide solution because enteric coating polymers are removed by basic solutions.