SOP for Cleaning Procedure of Mass Mixer

OBJECTIVE

To lay down a procedure for cleaning of mass mixer.

SCOPE

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

This procedure covers the cleaning of the mass mixer.

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

Batch to Batch Change over Cleaning Procedure:

• Switch ‘OFF’ the electrical mains of the mixer.
• Remove all the powder from the mixer by Scraper.
• Wipe out the mixer with a clean, dry lint-free duster.
• Clean the floor, walls, and glass partition with soap water and finally followed by clean water.
• Fix the ‘Cleaned label’ tag indicating the previous product name and batch number.

ALSO READ: SOP for Operation of Mass Mixer

Product Change over Cleaning Procedure:

• Remove all the powder from the mixer using a vacuum cleaner.
• Dismantle the blades and clean it thoroughly with water/soap/water. Rinse it with Purified water BP three times and wipe it out with a dry lint-free duster.
• Clean the inside of the mass mixer with raw water/Liquid soap till all the powder sticking is completely removed. Use a nylon brush for cleaning. Rinse it with Purified water BP three times and wipe it out with lint free duster.
• Wipe out the blade shaft with soap water and rinse it with Purified water BP three times.
• Care should be taken that all the corners of the mixer are thoroughly brushed & cleaned.
• Wipe all the mixer body with water/soap/water.
• Assemble the blades on the shaft and pour purified water in the bowl. Stir it for 30 minutes. Repeat this process three times
• Clean the floor, walls, and glass partition of the department with water / Soap/water.
• If the cleaned machine is not used within 24 hours or there are signs of dust or powder settled on the outside surface of the equipment should be wiped with a wet duster followed by a clean dry 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

SCP: Standard Cleaning Procedure

No. : Number

P.D: Production

ANNEXURE

Nil.

REVISION HISTORY

Nil.

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