1) SOP for Setting Up and Operating a Tablet Press

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for setting up and operating a tablet press, including tooling setup and tablet compression, to ensure consistent and high-quality tablet production.

3) Scope

This SOP applies to all personnel involved in the operation of tablet presses within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for setting up, operating, and cleaning the tablet press according to this SOP.
• Supervisors are responsible for overseeing the tablet compression process and ensuring compliance.
• Quality Assurance (QA) personnel are responsible for verifying that procedures are followed correctly and addressing any deviations.

5) Procedure

1. Preparation
   1. Ensure the tablet press area is clean and free of contaminants.
   2. Verify the availability and quality of raw materials as per the batch record.
   3. Check the cleanliness and readiness of the tablet press and tooling equipment.
2. Tooling Setup
   1. Select the appropriate tooling (punches and dies) based on the tablet specifications.
   2. Install the punches and dies into the tablet press according to the manufacturer’s instructions.
   3. Ensure that all components are securely in place and properly aligned.
   4. Set the machine parameters (e.g., tablet weight, hardness, speed) according to the batch record.
3. Tablet Compression Process
   1. Load the raw materials into the tablet press hopper.
   2. Start the machine and monitor the compression process continuously.
   3. Ensure that the tablets meet the specified weight, hardness, and thickness by sampling tablets at regular intervals.
   4. Adjust the machine settings if necessary to maintain consistency.
   5. Document any observations and adjustments made during the compression process.
4. Troubleshooting
   1. If the machine malfunctions, stop the operation immediately and troubleshoot the issue.
   2. Refer to the manufacturer’s manual for troubleshooting guidelines.
   3. Document the issue and the corrective actions taken in the maintenance logbook.
   4. Resume operation once the issue is resolved and the machine is functioning properly.
5. Cleaning and Maintenance
   1. Turn off and disassemble the tablet press according to the manufacturer’s instructions.
   2. Clean all parts thoroughly to prevent cross-contamination.
   3. Document the cleaning process in the cleaning logbook.
   4. Perform regular maintenance checks and document them in the maintenance logbook.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Batch Record
• Cleaning Logbook
• Maintenance Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual

9) SOP Version

Version 1.0