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SOP for Cleaning of Manufacturing and Holding Tanks

OBJECTIVE
To ensure that tanks are properly cleaned.
To avoid cross contamination during product change over.

SCOPE
This procedure shall be applied to all the manufacturing and holding tanks in oral liquids.

RESPONSIBILITY
It is the responsibility of each and every individual cleaning the tanks to follow the procedure.
It is the responsibility of the supervisor to ensure that the procedure is followed.
The QC Executive will be responsible for checking the cleanliness of tanks.

PROCEDURE
Batch Change Over:
  • Cleaning the tanks to be done after three consecutive batches of the same product.
  • Flush the tank with water and surfactant to remove traces of previous batch
  • Rinse with purified water.
  • Wipe with 70% Alcohol.
  • Rinse again with purified water.
  • Take the rinse sample to QC for testing.
  • Repeat the cleaning procedure in case the results are not satisfactory.
  • The valves of the tanks to be dismantled and cleaned in the same manner using surfactant, purified water and 70% Alcohol.
  • The lid of the tank also to be cleaned in the same manner using surfactant, purified water and 70% Alcohol.
  • The stirrers must be cleaned in the same manner using surfactant, purified water and 70% Alcohol.
  • Plastic poly wiped with alcohol shall be used to cover the tank’s mouth till next batch is commenced.
  • The tank must remain closed until the next batch is ready.
  • After cleaning, if the tank is not used within 72hours, repeat the cleaning procedure before use.

Product change over
  • Cleaning of tanks must be done after each and every product change over.
  • Clean the tanks as per above steps.
  • Plastic poly wiped with alcohol shall be used to cover tank’s mouth till the next batch is commenced.
  • The tank must remain closed until the next batch is ready.
  • After cleaning, if the tank is not used with 72 hours, repeat the cleaning procedure before use.

REVIEW HISTORY
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