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Cleaning Procedure for Enteric Coating Pan
Standard cleaning Procedure for a tablet coater after
the enteric coating process.
1.0 Purpose
The purpose of this
Standard cleaning procedure is to establish a standard cleaning procedure for
washing the tablet coater after the enteric coating process.
2.0 Scope
This SCP is applicable
for washing tablet coaters after the enteric coating process in the production
area.
3.0 Responsibility
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.
5.0 Abbreviations
5.1 SCP: Standard Cleaning
Procedure
5.2 HOP:Head Of
Production
Important Note
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.
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