Operation and Maintenance of Tablet Sorter

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet sorter to ensure accurate sorting of tablets during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the sorting process.
2. Verify the availability and integrity of tablets ready for sorting.
3. Inspect the tablet sorter, including sorting trays, sensors, and controls, to ensure they are clean and in good working condition.

4.2 Sorting Process

1. Set up the tablet sorter as per the specifications of the tablet characteristics.
2. Calibrate the sorter to accurately identify and separate tablets based on size, shape, or other criteria.
3. Start the sorting process and monitor for accurate sorting of tablets into designated containers or packaging.

4.3 Cleaning and Maintenance

1. Stop the sorting process after completing the batch.
2. Remove and clean sorting trays and sensors using approved cleaning agents.
3. Perform regular maintenance tasks such as lubrication of moving parts and inspection of sensors.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet sorter specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet sorter

8) SOP Version

Version 1.0