Operation and Maintenance of Tablet Crushing Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet crushing machine to ensure effective crushing of tablets during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Verify the availability of tablets ready for crushing.
2. Inspect the crushing machine for cleanliness and proper functioning.
3. Ensure safety measures are in place, including wearing appropriate personal protective equipment.

4.2 Crushing Process

1. Load tablets into the crushing chamber according to batch requirements.
2. Set the crushing parameters (e.g., speed, pressure) based on tablet specifications.
3. Start the crushing process and monitor for uniform particle size.

4.3 Cleaning and Maintenance

1. After completing the crushing process, clean the machine thoroughly to remove any tablet residues.
2. Inspect and replace crushing components as per maintenance schedule.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet crushing machine specifications

7) Reference, if any

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

8) SOP Version

Version 1.0