Operation and Maintenance of Tablet Sorter and Inspector

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet sorter and inspector to ensure accurate sorting and inspection 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 and inspector 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 and inspector.

4) Procedure

4.1 Preparation

1. Ensure the tablet sorter and inspector is clean and calibrated before use.
2. Verify the availability of tablets ready for sorting and inspection.
3. Inspect the sorter and inspector, including conveyors and inspection systems, to ensure they are clean and in good working condition.

4.2 Sorting and Inspection Process

1. Set the sorting parameters (e.g., size, shape, color) on the tablet sorter according to batch specifications.
2. Feed the tablets into the sorter and inspect them for defects using the inspection systems.
3. Sort the tablets into approved and rejected categories based on inspection results.

4.3 Cleaning and Maintenance

1. After completing the sorting and inspection process, clean the sorter and inspector thoroughly using approved cleaning agents and procedures.
2. Calibrate the sorting parameters and inspection systems regularly to maintain accuracy.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet sorter and inspector specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet sorter and inspector

8) SOP Version

Version 1.0