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SOP for Cleaning Validation of Empty Capsule Loader

OBJECTIVE
To provide a procedure for cleaning validation of Empty Capsule Loader.

SCOPE
Covers the procedure for cleaning validation of empty capsule loader.

RESPONSIBILITY
Production chemist
Production In-charge
QA officer

PROCEDURE
  • Clean the Empty Capsule Loader as per the SOP for Cleaning Procedure of Auto Loader.
  • Collect the water sample from the final rinse in a clean glass apparatus (beaker /conical flask) and give it to the QC laboratory for testing (water change over.)
  • The test carried out are – Description, Absence of the active ingredient.
  • Record the observations.
  • Inspect the equipment visually for cleanliness.

PRECAUTION
  • In case of any unusual observation, stop the activity and inform the QA department.

RECORDS / SPECIMEN
Records the results in the Cleaning validation Record

REVISION HISTORY
Nil

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