SOP for Cleaning Procedure of Semi-Automatic Capsule Filling Machine

OBJECTIVE

To lay down a procedure for cleaning of semi-automatic capsule filling machine.

SCOPE

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

This procedure covers the cleaning of a semi-automatic capsule-filling machine.

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

• Caution: Switch off the mains of the machine and close the vacuum and compressed air supply.

Cleaning procedure for the product-to-product changeover.

1. De-dusting external surface - Use a clean nylon brush and vacuum cleaner. Remove the filter bag of the vacuum placed behind the machine.
2. Dismantling - Remove

ALSO READ: SOP for Cleaning of Manufacturing and Holding Tanks

👉   Filling and Loading turntables

👉   Pusher slide

👉   Rectifier, raceway with the guide block

👉   Magazine

👉   Drug hopper, auger, and stirrer

👉   Peg ring plate

👉   Collect all the above parts in a suitable S.S container.

• Cleaning of parts - Clean the above parts by washing them with the liquid soap solution and scrubbing with a soft clean nylon brush. Rinse with a jet of potable water followed by Purified water.
• Cleaning of capsule plates - Capsule plates are soaked in water for 5-10min. The holes are cleaned using a liquid soap solution. Rinse with Purified water BP.
• Cleaning of machine body - Clean with the liquid soap solution and scrub with a soft nylon brush. Rinse with potable water.
• Drying - The cleaned parts as mentioned in step 5.3 are wiped and dried using a clean lint-free duster. The capsule plates are air-dried and are stored and wrapped in polythene.
• Assembling - Reassemble all the parts of the machine carefully checking for the correctness of assembling and free motion of moving parts. Replace the filter bag in the vacuum can below the machine with a clean filter bag.
• Affix a status label with the name of the person who cleaned and also the product previously taken.

Procedure for cleaning for Batch to Batch Change Over.

1. Remove powder below the powder-filling turntable.
2. The de-dust the external surface of the machine with a vacuum cleaner.
3. Dry clean the machine with a clean lint-free duster.
4. Oil the different moving parts of the machine on the loading side.

ALSO READ: SOP for Reprocessing of Capsules

Procedure to be followed for cleaning at end of shift.

1. Remove empty capsules from the empty capsules hopper.
2. Remove the blend from the powder hopper.
3. De-dust external surfaces with a vacuum cleaner and clean them with a clean lint-free duster.
4. Clean the capsule loading plate as per the procedure.
5. Clean the partial fill attachment as per the procedure.
6. Cover the machine with a suitable polythene sheet.
7. If the machine is to be kept for more than 2 days without operation follow procedure Procedure for cleaning for Batch to Batch Change Over.

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

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 Operation of Capsule Polishing Machine