Operation and Maintenance of Tablet Blister Packing Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet blister packing machine to ensure accurate and efficient packing of tablets into blister packs.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the packing process.
2. Verify the availability and integrity of blister packs and tablets ready for packing.
3. Inspect the tablet blister packing machine, including feeding systems and sealing stations, to ensure they are clean and operational.

4.2 Packing Process

1. Set up the packing parameters such as blister pack size, tablet count per pack, and sealing temperature according to product specifications.
2. Load the tablets into the feeding system and start the packing process.
3. Monitor the packing process to ensure proper placement of tablets into blister packs and sealing of packs.

4.3 Cleaning and Maintenance

1. Stop the tablet blister packing machine after completing the packing batch.
2. Clean the feeding systems, sealing stations, and packing area thoroughly to remove any packaging material residues.
3. Perform routine 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, Blister pack specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet blister packing machine

8) SOP Version

Version 1.0