1.0 OBJECTIVE:-
1.1 This SOP is applicable for the procedure to prepare cleaning of IPQA instrument.
2.0 SCOPE: – To ensure error free operation of the equipment IPQA Instrument
This procedure is applicable for cleaning of following instruments. Friability Test
Apparatus. Disintegration Test Apparatus .Weighing Balance. I. R. Moisture Balance.
2.1 Hardness Tester
2.2 Venire Caliper
3.0 RESPONSIBILITY:-
3.1 Execution: Operator.
3.2 Checking: production officer.
3.3 IPQA officer
4.0 ACCOUNTABILITY:
4.1 Production Head
5.0 PROCEDURE:
5.1 Cleaning of Friability Test Apparatus
5.1.1 Ensure that equipment is switched “OFF” & plug is removed
5.1.2 Remove lid by unscrewing the knob.
5.1.3 Clean inner and outer part using lint free clean cloth.
5.1.4 Clean machine surface using lint free clean cloth.
5.1.5 Close the lid by screwing the knob.
5.2 Cleaning of Disintegration Test Apparatus:
5.2.1 Ensure that equipment is switched off & plug is removed. Lift and remove the rod and remove the beaker form its position.
5.2.2 Drain the water in to the sink and clean it using DM water.
5.2.3 Clean the basket and discs using DM water.
5.2.4 Clean machine body using a lint free clean cloth.
5.2.5 Place all parts in their original position.
5.3 Cleaning of Weighing Balance
5.3.1 Ensure that the balance is switched OFF & plug is removed.
5.3.2 Clean the loading pan and platform area using a soft nylon brush taking care of not disturbing the balance level
5.3.3 Clean the glass doors from inside and outside.
5.3.4 Clean outer surface of balance.
5.4 Cleaning of IR moisture balance.
5.4.1 Lift upper jaw of the balance.
5.4.2 Remove aluminum tray and discard the residual granules in dustbin
5.4.3 Clean outer surface of the machine.
5.5 Cleaning of Hardness Tester.
5.5.1 Clean the outer surface of the instrument with lint free cloth.
5.6 Cleaning of Varner Caliper.
5.6.1 Clean the instrument with clean lint free cloth.
5.6.2 Clean the Tablet holding surface with DM Water & dried it.
5.7 Cleaning of surroundings area of in process instruments.
5.7.1 Take a lint free clothes to clean and wipe the surrounding platform.
5.7.2 Clean the platform immediately as and when it is spoiled in production department.
5.8 FREQUENCY: Clean all the instruments after each use.
6.0 ABBREVIATIONS:
6.1 EFF: Effective
6.2 SOP: Standard Operating Procedure
6.3 Mfg.: Manufacturing
7.0 REFERENCE:
7.1 In-house/GMP Guidelines