Standard Operating Procedure of Sops For Cleaning Of Compounding Tank (For Sterile Area) is describe in this post.
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1 PURPOSE
1.1 It is established to assure that the cleaning is thorough and that there is no visible stain or particle.
2 SCOPE
2.1 It is applicable to Liquid Inject able Mfg. of Production Department.
3 RESPONSIBILITIES / AUTHORITIES
3.1 Officer Production
3.2 Supervisor
3.3 Operator
4 REFERENCES
4.1 Quality Management Manual
5 DEFINITIONS
5.1 List of Technical Definition
6 PROCEDURE
6.1 At the end of the day’s process, rinse the tank with distilled water and dry it.
6.2 Before starting of the process rinse with hot distilled water and then drain off all this residual rinse water from the tank using nitrogen.
6.3 Take the tank near the distillation still and remove the lid and place it in a plastic bucket that is previously washed and cleaned with fresh pyrogen free distilled water.
6.4 Start the distillation plant and dump off the initial distillate and check the conductivity of the water and use the water only if the conductivity is within the required limit.
6.5 Wash the inside of the tank by using fresh pyrogen free distilled water directly from the distillation plant, by running the outlet pipe around the mouth, bottom and sides of the tank.
6.6 Now drain off the wash water from the tank by either holding the tank at the sides or turning it upside down or by positive pressure using compressed nitrogen gas.
6.7 Repeat procedure 5 and 6 twice.
6.8 Check the inside of the tank for cleanliness and observe carefully for any stains or particles.
6.9 Now wash the lid of the tank, which is placed in the clean plastic bucket by using pyrogen free distilled water directly from the distillation plant taking extra care to clean the SS outlet tubing by using ling nylon brush and drain off the wash water.
6.10 Repeat procedure 9, two more times.
6.11 Check carefully, the cleanliness of the lid and then close the clean tank with the cleaned lid and label the tank as “Cleaned” with date of cleaning.
6.12 Incase the cleaned tank is required to be stored, then in that case dry the tank and affix a cleaning tag indicating date of cleaning, product name for which last used and “To be cleaned before use”.
6.13 Send the final rinse of water to QC for testing.
7 DOCUMENTS / RECORDS
7.1 Machinery Equipment Cleaning Log
7.2 Equipment/Utensil Cleaning Analytical Report
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