SOP for Cleaning Procedure of Auto Loader

OBJECTIVE

To lay down a procedure for cleaning the autoloader.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited. This procedure covers the cleaning of the autoloader.

RESPONSIBILITY

The concerned operator is responsible for the implementation of the process.

The production In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

• Type “B” Cleaning Procedure (Product to Product Change Over)

1. Switch off the electrical mains of the machine.
2. De-dust the external surface with a moist cloth.
3. Dismantle Back and front cover, Empty capsule hopper, and Magazine followed by pusher plate and raceway.
4. Scrub the above parts with a liquid soap solution.
5. Rinse with potable water and then Purified Water BP.
6. Wipe the loading platform with a moist duster.
7. Dry all the parts by wiping them with a dry duster.
8. Reassemble all the parts and affix the ‘CLEANED’ status label.

ALSO READ: SOP for Passivation of Stainless Steel Contact Parts of Production Equipments

• Type “A” Cleaning Procedure (Batch to Batch Change Over):

1. Empty the hopper.
2. Remove the back and front covers.
3. Remove empty capsules from the loading platform by brushing.
4. Dry-clean the loader with a clean, dry, lint-free duster.

• All the cleaning details shall be entered in the equipment cleaning log.

REFERENCE

SOP: Preparation, Approval, and Control of Standard Cleaning Procedures for equipment.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No. : Number

P.D: Production

ANNEXURE

Nil.

REVISION HISTORY

Nil.

ALSO READ: SOP for Operating Procedure of Auto Loader