SOP for Cleaning Validation of Empty Capsule Loader

OBJECTIVE

To provide a procedure for cleaning validation of the 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 the Cleaning Procedure of the 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 tests carried out are the description and 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

ALSO READ: SOP for Storage Procedure of In-Process Capsules