Operation and Maintenance of Tablet Deduster Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet deduster machine in the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the tablet deduster machine in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the tablet deduster machine.

4) Procedure

4.1 Preparation

1. Verify the availability of tablets and batch records.
2. Inspect the tablet deduster machine for cleanliness and ensure proper functioning of dedusting brushes, vibration settings, and controls.
3. Ensure all safety protocols are followed, including checking dust extraction systems.

4.2 Dedusting Process

1. Set up the machine according to tablet size and batch specifications.
2. Feed tablets into the deduster hopper and initiate the dedusting process.
3. Monitor the process to ensure efficient removal of dust and debris from tablets.

4.3 Cleaning and Maintenance

1. After completing the dedusting process, clean the machine thoroughly to remove any residual dust.
2. Inspect and replace dedusting brushes as necessary.
3. Document cleaning and maintenance activities in the logbook.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet deduster machine specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet deduster machine

8) SOP Version

Version 1.0