SOP on Shift End Cleaning of Semiautomatic Capsule Filling Machine

1.0 Purpose: This SOP describes the procedure for cleaning of semiautomatic capsule filling machine.

2.0 Scope: This SOP applies to operating staff of the production department.

3.0 Responsibility: It is the responsibility of the Production Supervisor to ensure that the procedure is followed.

4.01 Lint free cloth

4.02 Isopropyl alcohol

4.03 Nylon brush

5.01 The main switch of the machine and the vacuum pump should be put off.

5.02 Powder from the drug hopper, machine top, rotary tables and dust pan should be removed with the help of a brush. The capsules from the capsule hopper should be removed.

5.03 All the parts should be dusted with a clean duster and then wiped clean with the duster soaked in isopropyl alcohol. Alternatively, powder from the machine and capsule loading assembly may be removed with a wet cloth and then dried with a clean, dry duster.

5.04 The ring assemblies should be removed and the top and bottom surfaces scrubbed with a flat nylon brush using a solution of soap. The rings should then be rinsed with water. The rings should then be rinsed with water. The holes should be flushed with hot water and then rinsed with lot of water. The water should be allowed to drain completely. The rings should be immersed in isopropyl alcohol and the isopropyl alcohol drained off by shaking the assembly up and down a few times. The assembly finally allowed to air dry.

5.05 The vacuum bag should be soaked in soap solution for 15 minutes and rinsed free of soap with water. The bag should then be dried in air.

5.06 The Q.C. Chemist should certify the parts as clean before they are assembled.