SOP for Cleaning of General capsule filling machine - capsule department

1.0.            OBJECTIVE :

1.1              To lay down a procedure for the Cleaning of General capsule filling machine.

2.0.            SCOPE                        :

2.1       This procedure is applicable for the Cleaning of General capsule filling machine.

3.0.            RESPONSIBILITY:

3.1              Operator shall be responsible for cleaning of General capsule filling machine.

3.2              Production Officer shall be responsible for verification of General capsule filling machine.

4.0.            ACCOUNTABILITY :          

4.1              Head of the department

5.0.            PROCEDURE            :

5.1.            FULL CLEANING (TYPE-B CLEANING)

5.1.1.      Remove “To be Cleaned” tag from equipment.

5.1.2.      Remove the residual loose powder from the exterior & interior surfaces of the equipment with the aid of fresh dry lint free cloth or with vacuum cleaner.

5.1.3.      Dismantlepowder tray, sliding attachment plate, top main plate, sliding plate, eccentric bolt, hand lever.

5.1.4.      All dismantle parts  shall be cleaned with running purified water.Remove adhered sticky materials by using nylon scrubber. Use 0.5% SLS solution (If required). Scrub manually for about 2 mins. and then rinse with running purified water for about 2 mins and shall be dried by using compressed air for about 5 mins.

5.1.5.      Clean the General capsule plates by soaking in water for 5 to 10 minutes and clean holes using clean hard nylon brush and water.Use 0.5% SLS solution (If required). Scrub manually for about 2 mins. and then rinse with running purified water for about 2 mins and shall be dried by using compressed air for about 5 mins.

5.1.6.      Cleaning of machine body – clean with purified water and scrub with soft nylon brush. Rinse and thoroughlyclean with purified water.

5.1.7.      All the parts on equipment shall be arranged in reverse order of dismantling. Finally mop the entire equipment with 70 % IPA solution.

5.1.8.      The production officer shall check equipment for cleanliness and affix ‘Cleaned’ label on equipment with filling all details in Label. Record the cleaning activity in operation and Cleaning log of equipment.

 

5.2.            LIMITED CLEANING (TYPE-A CLEANING)

5.2.1.      Remove the residual loose powder from the exterior& interior surface of the equipment with the aid of fresh dry lint free cloth or with vacuum cleaner.

5.2.2.      Clean the floor by using vacuum cleaner.

5.2.3.      Collected powder of vacuum cleaner shall be packed in plastic bag and send to scrap yard for further disposition.

5.2.4.      The production officer shall check equipment for cleanliness and affix ‘Cleaned’ label on equipment with filling all details in Label.Record the cleaning activity in operation and Cleaning log of equipment.

5.3.            CLEANING CRITERIA

FOR LIMITED CLEANING

5.3.1.      For batch change over (maximum up to 10 consecutive batches of same product or 5 days, whichever is earlier)

5.3.2.      Change over from lower strength to higher strength of the same product having same colour.

5.3.3.      If fully cleaned equipment is not used within the prescribed time. (i.e. maximum 2 days after full cleaning).

FOR FULL CLEANING

5.3.4.      For product change over

5.3.5.      After 10 consecutive batches of same product or 5 days, whichever is earlier.

5.3.6.      If limited cleaning is not carried out within 24 hrs of equipment last use.

5.3.7.      If equipment  is not used within 48 hrs of limited cleaning.

5.3.8.      After preventive maintenance.

5.3.9.      Changeover from one strength to another of the same product with different colour.

5.3.10.  Change over from higher strength to lower strength of the same product.