SOP for Operation of Mass Mixer

OBJECTIVE

To lay down a procedure for the operation of a mass mixer.

SCOPE

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

RESPONSIBILITY

The operator is responsible for the implementation of the process.

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

PROCEDURE

• Check the cleanliness of the bowl and blades
• Loading of Materials

1. Load the materials from the containers/drums into the bowl as per the sequence specified in the Individual product BMR.

• Close the lid.
• Operation

1. Affix a Status label indicating the batch no, product name, and batch size of the product to be mixed.
2. Put the main switch ON.
3. The operator and other persons involved in the manufacturing should wear clean hand gloves, head caps, and nose masks.
4. After all the required materials are loaded into the mass mixer, it is allowed to run for the required time as per the Individual product BMR

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1. Add the binder/paste–binder solution by opening the lid, then run the mixer to the required time as per the Individual product BMR
2. Racking is done if required and mainly in the center of the bowl
3. After the wet mixing, discharge the wet mass into the S.S. container.
4. Stop the mixer and open the lid and remove the remaining mass by scrapping it with a Teflon scrapper. Ensure that all the material is unloaded.
5. Status Label: Display the status label “TO BE CLEANED” once the mixing operation is over.

• All the operation details shall be entered in the equipment usage and 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

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