Standard operating procedure for cleaning flexible solution transfer pipes.
1.0 Purpose
The purpose of this SOP is to establish a standard procedure for cleaning of flexible solution transfer pipes.
2.0 Scope
This SOP will be applicable for the procedure used for cleaning of flexible solution transfer pipes used for tablet coating process and oral drops filling area.
3.0 Responsibility
3.1 Operator of the machine is responsible for cleaning the solution transfer pipes.
3.2 Production officials are responsible for implementation of this SOP.
4.0 Procedure
4.1 Type A cleaning
Same product change over with the same color, and ascending potency.
4.1.1 The machine operator shall remove the pipe from the spray guns or filling nozzles.
4.1.2 Wash the flexible pipes with purified water.
4.1.3 Clean the solution transfer pipes with dry lint free cloth.
4.1.4 Affix next product label and record the cleaning activity in logbook marking type A cleaning.
4.2 Type B cleaning
Different products change over,Same product with the different color and descending potency.
4.2.1 The machine operator shall remove the solution transfer pipes from the guns or filling nozzles.
4.2.2 Transfer raw water through a flexible pipe by using a peristaltic pump or filling pump.
4.2.3 Now prepare 1% food grade detergent solution and transfer it through flexible pipes.
4.2.4 Now transfer purified water through flexible pipes to ensure cleaning of flexible solution transfer pipes.(For enteric coating use sodium hydroxide solution)
4.2.5 Remove solution transfer pipes from the peristaltic pump, solution container and wash its outside surfaces with raw water,1% food grade detergent and purified water.
4.2.6 Hang flexible pipes on the hanger to ensure drying.
4.2.7 Close opening of flexible silicone pipes with aluminum foil.
4.2.8 Record the cleaning activity in the logbook.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 QA:Quality Assurance