1.0 OBJECTIVE
To define a standard cleaning procedure for consistent cleaning of utensils used for dispensing of raw material.
2.0 SCOPE
This SOP is applicable for the utensils used for dispensing of raw material in MDI unit of (Company Name).
3.0 RESPONSIBILITY
3.1 Production officer is responsible to dispense raw materials.
3.2 QA officer is responsible to check the dispensing operation.
4.0 ACCOUNTABILITY
4.1 Head of production
5.0 PRECAUTIONS
5.1 Clean and dry the utensils before use if they were not in use for more than four days.
5.2 Never clean the dispensing utensils in the Mixing Room. Bring all dispensing utensils to the wash bay after manufacturing operation is completed and then initiate the cleaning operation.
5.3 Ensure that the cleaned dispensing utensils are dried before storing them in the storage area.
6.0 PROCEDURE
6.1 General Instructions
6.1.1 Definition: Utensils are tools and /or apparatus that are aiding elements required for dispensing of raw materials. These include Pipette, SS container, SS spoon, spatula, Glass Beaker, Glass Bottle etc.
6.1.2 Clean all the dispensing utensils used for different materials separately in wash bay.
6.1.3 Ensure the dryness of utensils so that no residue of cleaning agent is remaining inside them before storage.
6.1.4 Place all the utensils in poly bags and seal them after cleaning.
6.2 Cleaning Steps.
6.2.1 Take approximately 1.0L of dehydrated alcohol in an SS container and immerse the utensils in the container for approximately ten (10) minutes.
6.2.2 Take out the utensils from the container and rub with a lint free cloth dampened with dehydrated alcohol.
6.2.3 Rinse twice with 0.5L of dehydrated alcohol.
6.2.4 Wipe the utensils with a dry lint free cloth to dry them and ensure no residue of the cleaning agent remains inside.
6.2.5 Store the cleaned and dried utensils in a polythene bag.
6.2.6 Seal the bag of utensils with cable tie and store them at the rack of SS cabinet.
6.2.7 Fill up the “CLEANED” label and get it checked by production officer. Affix on the SS Cabinet.
6.2.8 QA Officer shall inspect the cleaned utensils to verify the cleanliness and shall sign on the “CLEANED” label before using them.
Fill up Equipment log book FRM No. FPG/005 and get it checked by production officer and QA officer.