SOP for Cleaning of cone blender - capsule department

 1.0.            OBJECTIVE :

1.1              To lay down procedure for the Cleaning of cone blender.

2.0.            SCOPE                        :

2.1       This procedure is applicable for the Cleaning of cone blender at pharma industry.

3.0.            RESPONSIBILITY:

3.1              Operator shall be responsible for cleaning of cone blender.

3.2              Production Officer shall be responsible for verification of cone blender 

4.0.            ACCOUNTABILITY :          

4.1              Head of the department 

5.0.            PROCEDURE            :

5.1.            FULL CLEANING (TYPE-B CLEANING)

5.1.1.      Turn Off the electrical supply &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.      Clean the equipment with 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 purified water for about 2 mins. and shall be dried by using compressed air for about 5 mins.

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

5.1.5.      Finally mop the entire equipment with 70 % IPA solution.

5.1.6.      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 batchesof 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.

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