Operation and Maintenance of Tablet Dehumidifier

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet dehumidifier to ensure optimal moisture levels in tablets during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the tablet dehumidifier is clean and free from any residues from previous use.
2. Verify the availability of tablets ready for dehumidification.
3. Inspect the tablet dehumidifier, including filters and controls, to ensure they are clean and in good working condition.

4.2 Dehumidification Process

1. Set the dehumidifier to the specified humidity level required for the tablets.
2. Place the tablets inside the dehumidifier chamber and start the dehumidification process.
3. Monitor the humidity levels and adjust settings if necessary to maintain optimal conditions.

4.3 Cleaning and Maintenance

1. After completing the dehumidification process, remove the tablets and clean the dehumidifier chamber thoroughly using approved cleaning agents.
2. Perform regular maintenance tasks such as replacing filters and checking calibration.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet dehumidifier specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet dehumidifier

8) SOP Version

Version 1.0