SOP on Cleaning of Semi-Automatic Capsule Filling Machine

SOP on Cleaning of Semi-Automatic Capsule Filling Machine

 

 

Objective : To describe  cleaning procedure for Semi- automatic capsule filling machine.

 

 

Scope : To ensure that the equipment is clean and free from any starting materials of previous batch or product residues.

 

 

Responsibility : 1.It  is the responsibility of operating staff to clean the equipment.

2. Production Chemist to ensure that procedure is followed.

 

Materials & Equipment :

1.      Cleaning agent: Teepol or liquid soap.

2.      Mops / brush / lint free cloth

 

Procedure

 

(1)               Switch ‘OFF’ the mains of machine and vacuum pump.

(2)               Remove any visible material from the machine with the help of a jet of compressed air.

(3)               Dismantle the hopper & stirrer assembly, pin plate from the inner unit and the powder-filling turntable. Keep all the dismantled parts in a plastic tub containing 10 liters of boiled tap water.

(4)               Remove any visible material from surfaces of all the dismantled parts with the help of nylon brush or scrubber and drain the washings.

(5)               Prepare a Teepol solution (10ml à 10 liters water) or liquid-soap (50gm à 5 liters water) and clean the surfaces of dismantled parts by mopping.

(6)               Wash all the dismantled parts with running tap water for 10 minutes and drain the washings. Repeat the procedure for another 5 minutes.

(7) Wash the inner surfaces of all the dismantled parts by using 10 liters of purified water for 10 minutes and drain the washings.

(8)   Finally rinse all the dismantled parts with previously boiled purified water and drain it completely.

(9)               Send the wash water for analysis of residual active ingredients of previous product.

(10)           Let all the parts dry in air or dry with a clean, lint free cloth.

(11)           Remove the dust receiving bag and take to the washing area. Clean the external surface of the bag with boiled tap water. Then turn the bag inside-out and again wash with boiled tap water. Clean the bag using detergent solution with the help of a scrubber. Wash the bag by running tap water for 30 minutes, squeeze and again wash with 10 liters of boiled purified water & squeeze. Place the bag on a hanger and allow to dry in air.

(12)           Re-assemble all the cleaned parts in the reverse order of dismantling and put a label “Cleaned” or “Ready for use”.