| Cleaning Procedure For Tanks 1000 Kg And 500 Kg |
1.0 OBJECTIVE: 1.1 To lay down the procedure for Cleaning of Manufacturing Tanks, Water and Oil phase tank of 1000 Kg and 500 Kg. 2.0 SCOPE: 2.1 This procedure is applicable for formulation plant. 3.0 RESPONSIBILITY: 3.1 Trained Operators are responsible for operating and cleaning of the machine 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 Operation and Qualification Of Steam Sterilizer. 4.0 PROCEDURE: 4.1 Cleaning Procedure For Oil phase vessel, Water phase vessel and Manufacturing vessel: 4.1.1 Type – “B ” – During Product Change Over: 4.1.1.1 Mention the sign status board “TO BE CLEANED” outside the door. 4.1.1.2 Switch ‘ON’ the electric from mains supply. 4.1.1.3 Add soft water in water phase vessel and wax phase vessel of its capacity and heat up to 90 – 95°C with continues stirring add 0.1% w/v teepol solution mix for 15 min. 4.1.1.4 Set Anchor speed 30 RPM in control panel then start anchor motor. Spray soft water in inner surface of manufacturing vessel with Dynamic Ball for 8-10 min visually check inner surface is free from products to be manufactured and drain water through drain valve, after drain close valve. 4.1.1.5 Transfer teepol solution from water and wax phase vessel to manufacturing vessel through vacuum by transfer pipe line. 4.1.1.6 Circulate teepol solution in manufacturing vessel by HSE and transfer pipeline through transfer pump for 15 min. Drain circulated teepol solution from manufacturing vessel by product outlet valve. 4.1.1.7 Wash outer surface of water, wax and manufacturing vessel and with 0.1% w/v teepol solution and rinse with soft water till all the traces of soaps removed. 4.1.1.8 Rinse manufacturing vessel by Dynamic Ball with cold soft water till all soaps removed through drain valve. 4.1.1.9 Rinse water and wax phase vessel by spray Ball with cold soft water till all soaps removed through drain valve. 4.1.1.10 Again rinse water and wax phase vessel by spray Ball with cold soft water and transfer in manufacturing vessel start HSE and TP circulation for 4 min and remove rinsed water through drain valve of manufacturing vessel. 4.1.1.11 Dismental all SS pipe, hose pipeline ,TC clamps, sieves, cone and gasket put it in polybag wash it with 0.1% w/v teepol solution with the help of nylon brush and rinse till all sops are removed finally rinse with purified water .connect these parts with vessels. 4.1.1.12 Finally rinse outer surface of water, wax and manufacturing phase vessel with purified water. 4.1.1.13 Finally rinse inner surface of water and wax phase vessel with purified water by Spray Ball and drain water through drain valves. 4.1.1.14 Finally rinse inner surface of Manufacturing vessel with purified water by Dynamic Ball and drain water through drain valve. 4.1.1.15 Clean outer surface of water wax and manufacturing phase vessel with clean and dry lint free cloth. 4.1.1.16 After visual inspection by the production supervisor/officer Inform IPQA to collect the wash water sample in 100 ml cleaned glass bottle through In-process Analytical Request form / Report 4.1.1.17 After receiving wash water analysis report 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. 4.1.1.18 Record the cleaning details in Machine Log Book as per Annexure –I 5.1.2 Type – “A” – During Batch Change Over: 4.1.1.19 Visually check water, wax and manufacturing phase vessel is free from previous batch, all bulk are transferred. .lids and sight glass outer surface is cleaned with dry lint free clothes. 4.1.1.20 Affix the CLEANED label dully filled and signed as per SOP titled procedure for use of label in manufacturing department. 4.2 Frequency: 4.2.1 Type – “B”: During the product changeover or after completion of consecutive 5 batches of same product or after72 hours (if machine not in use) 4.2.2 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 5.6 Mfg. : Manufacturing 5.7 TP : Transfer pump 5.8 JV : Jacket Vent |
