| Operation & Cleaning Of Quarantine Storage Tanks |
1.0 OBJECTIVE: 1.1 To lay down the procedure for Operation & Cleaning of Quarantine Storage Tanks. 2.0 SCOPE: 2.1 This procedure is applicable for formulation plant Operation & Cleaning of Quarantine Storage Tanks. 3.0 RESPONSIBILITY: 3.1 Trained Operators are responsible for operating and cleaning of the Quarantine Storage Tanks as per the procedure mentioned in this SOP. 3.2 Production Officer / Supervisor are responsible for implementation of the procedure as per this SOP. 3.3 Production Head is responsible for compliance of procedure as per this SOP. To read this SOP click here SOP for Operating And Cleaning Procedure For Automatic Liquid Bottle Filling Machine. 4.0 PROCEDURE:(Operation & Cleaning of Quarantine Storage Tanks) 4.1.1 Before starting of operation, visually checks the cleaning of area and Quarantine Storage Tanks with ‘CLEANED’ label duly filled and signed by production department. 4.1.2 Inform IPQA for the verification of cleaning of area and Quarantine Storage Tanks. After clearance by IPQA person, remove the cleaned label and attach in BMR. Also, mention the status of the area on signboard outside the door. 4.1.3 Load the bulk in to the Quarantine Storage Tank & paste the status label. 4.1.4 After unload the bulk paste the label on tank to ‘TO BE CLEANED’ as per SOP No. XXX. 4.1.5 Record the cleaning details in Log Book of Quarantine Storage Tanks. 4.2 Cleaning Procedure For All storage Tanks: 4.2.1 Type – “A” – For Batch to Batch Change Over (Same product): 4.2.1.1 Maintain the cleaning status on sign board outside the door. 4.2.1.2 Clean outer side surface of Quarantine Storage Tanks lid. And outer valves with dry lint free cloth. 4.2.1.3 Insure outer surface seen visually clean by production supervisor/officer. 4.2.1.4 After visual inspection by the production supervisor/officer, mention the cleaning status on the sign board outside the door and affix the cleaning status label on the Quarantine Storage Tank. 4.2.1.5 Record the cleaning details in Log Book of Quarantine Storage Tanks. 4.2.2 Type – “B ” – During Product Change Over: 4.2.2.1 Mention the cleaning status on sign board outside the door. 4.2.2.2 Wash the tank with hot soft water and scrub the inner wall and outlet valve with nylon brush then drain the water through outlet valve. 4.2.2.3 Take 0.1%w/v Teepol solution with soft water and scrub inner and outer surface with the help of nylon brush. Procedure for 0.1%w/v Teepol Solution: 10 gm of Teepol Solution into 10 Liters of potable water in the bowl close the lid of tank and mix the solution for 10 minutes. 4.2.2.4 Drain out the soap solution through the outlet valve. 4.2.2.5 Clean the Tank with sufficient quantity of potable water and finally rinse inner and outer surface with a Purified Water until remove the trace of foam. 4.2.2.6 Ensure that the internal and external surface seen visually clean. 4.2.2.7 Then rinse the internal surface, external surface, lid, and other parts with a Purified Water. 4.2.2.8 Inform IPQA to collect the wash water sample in 100 ml cleaned glass bottle through In-process Analytical Request form / Report. 4.2.2.9 After receiving wash water analysis revolve for compliance, affix a “Cleaned” label duly filled and signed on the equipment as per SOP titled “Procedure for Use of Labels in Manufacturing Department. 4.2.2.10 Record the cleaning details in Log Book of Quarantine Storage Tanks. 4.3 Frequency 4.3.1 Type – “B”: During the product changeover or after completion of consecutive 5 batches of same product or after 72 hours (if machine not in use) 4.3.2 Type – “A”: During the batch to batch Change over (for same product) or after 24 hours. 5.0 ABBREVIATIONS 5.1 Kg : Kilogram 5.2 SOP : Standard Operating Procedure 5.3 IPQA : In – Process Quality Assurance 5.4 BMR : Batch Manufacturing Record 5.5 QA : Quality Assurance |
