Title:- STANDARD OPERATING PROCEDURE GT/SOP/PD/030 Revision No.

: “001”
Revision Date: N/A Issue Date:26-09-2018
Subject: SOP For Operating Dry Granulator Effective Date: 26-09-2018 Next Rev Date: 26-09-2021

Page No. Page 1 of 3

CONTENTS

1. Purpose
2. Scope
3. Responsibility
4. Material and Equipment
5. Operational Procedure
6. List of Recipient

1. Purpose:

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Title:- STANDARD OPERATING PROCEDURE GT/SOP/PD/030 Revision No.: “001”
Revision Date: N/A Issue Date:26-09-2018
Subject: SOP For Operating Dry Granulator Effective Date: 26-09-2018 Next Rev Date: 26-09-2021

Page No. Page 2 of 3

1.1 To describe standard procedure for operating the dry granulator.

2. Scope:
2.1 This is applicable in Solid Dosage Forms
3. Responsibility:
3.1. It is the responsibility of manufacturing supervisor and workers to follow this SOP as it
are written.
3.2. It is the responsibility of production pharmacist to follows this SOP as it is written and update as
necessary.
3.3. It is the responsibility of Production manager to monitor that this SOP is followed in its entirety.
4. Material and Equipment:
Granulator, S. S sieve No.8, 12, 16, 30, S. S container, Polythene bags, surgical gloves, Mask,
Product to be granulated.
5. Operating Procedure:
5.1. Startup & Operation
5.1.1 Assemble all the parts and check that the machine is free.
5.1.2 Adjust the discharge shutter and put a collecting container underneath it.
5.1.3 Switch “ON” the main power supply and start the machine.
5.1.4 Add powder in the hopper and collect the granules in the container.
5.1.5 Operate the machine until the required amount of granules is obtained.
5.2. Stop Over
5.2.1 Switch “OFF” the machine and disconnect the main power supply.
5.2.2 Carry out the cleaning procedure as described in SOP.
5.2.3 Machine operator will maintain the machine log sheet.

6. List of Recipient:
6.1 Q.A Department.
Prepared by Reviewed by Approved by
Designation
Sign

Date
Title:- STANDARD OPERATING PROCEDURE GT/SOP/PD/030 Revision No.: “001”
Revision Date: N/A Issue Date:26-09-2018
Subject: SOP For Operating Dry Granulator Effective Date: 26-09-2018 Next Rev Date: 26-09-2021

Page No. Page 3 of 3

6.2 Production Department.

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Designation
Sign

Date