Operation and Maintenance of Tablet Defoiling Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet defoiling machine to ensure efficient and safe defoiling of tablets.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the defoiling process.
2. Verify the availability and integrity of tablets ready for defoiling.
3. Inspect the defoiling machine, including feed systems and deblistering units, to ensure they are clean and calibrated.

4.2 Defoiling Process

1. Set up the defoiling parameters such as speed, deblistering pressure, and rejection criteria according to tablet specifications.
2. Load the blister packs or trays containing tablets into the machine feeder.
3. Start the defoiling process and monitor to ensure efficient removal of tablets from blister packs or trays.

4.3 Cleaning and Maintenance

1. Stop the defoiling machine after completing the batch.
2. Clean the feed systems, deblistering units, and conveyor belts thoroughly to remove any tablet residues.
3. Perform routine maintenance tasks such as inspecting blades, adjusting guides, and cleaning sensors.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Defoiling machine specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for defoiling machine

8) SOP Version

Version 1.0