SOP for Cleaning Procedure of Manual Capsule Filling Machine

OBJECTIVE

To lay down a procedure for cleaning of manual 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 manual 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

Type “B” Cleaning procedure (Product to Product Change Over).

• De-dust the external surface using a moist cloth.
• Dismantle 

1. Powder tray
2. Sliding attachment plate
3. Closing plate
4. Sliding plate
5. Eccentric knob
6. Hand lever.

• Clean the dismantled parts by soaking them for 10 minutes in a liquid soap solution and scrubbing with a nylon brush.
• Wash with potable water and rinse with Purified water BP.
• Wipe with a lint-free cloth and then allow to air dry.
• Attach the ‘CLEANED’ status label.

ALSO READ: SOP for Operating Procedure of Manual Capsule Filling Machine

Type “A” Cleaning procedure (Batch-to-Batch Change Over).

• De-dust the external surface using a moist cloth.
• Dismantle 

1. Powder tray
2. Sliding attachment plate
3. Closing plate
4. Sliding plate
5. Eccentric
6. Hand lever.

• And de-dust with a nylon brush.
• All the cleaning details shall be entered in the equipment cleaning logbook.

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 Setting & Operation of Semi-Automatic Capsule Filling Machine