Standard Operating Procedure for Die and Punch Alignment in Tablet Press Machines
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/031/2025 |
| Supersedes | SOP/TAB/031/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 13/07/2025 |
| Effective Date | 18/07/2025 |
| Review Date | 13/07/2026 |
1. Purpose
This SOP outlines the procedure for aligning the die and punch in tablet press machines to ensure the proper formation of tablets. Accurate alignment is critical to preventing tablet defects such as incomplete compression, uneven weight, or damage to tooling.
2. Scope
This SOP applies to all tablet press machines used in the production of tablets. It covers the alignment of the die and punch components before and after each batch to ensure that they are correctly positioned for tablet formation.
3. Responsibilities
- Manufacturing Personnel: Responsible for performing die and punch alignment checks before and after each production run and ensuring the alignment is maintained throughout the tablet compression process.
- Maintenance Personnel: Responsible for ensuring the tablet press machines are properly maintained and that all components are in good condition for alignment. They should also ensure the proper setup of the tablet press machine.
- Quality Control (QC): Verifies that the die and punch alignment is correct and that the tablets meet the required specifications for weight, hardness, and other quality parameters.
- Quality Assurance (QA): Ensures that the alignment process is carried out as per the SOP and that any discrepancies or equipment issues are addressed promptly.
4. Accountability
The Production Manager is accountable for ensuring that the die and punch alignment procedure is performed correctly and that the tablet press machines are set up and functioning properly. The QA Manager is responsible for verifying compliance with this SOP.
5. Procedure
5.1 Pre-Alignment Setup
- Ensure that the tablet press machine is powered off and properly cleaned, with no leftover powder or granules from previous production batches.
- Gather the necessary tools and equipment for alignment, including torque wrenches, alignment pins, and reference gauges.
- Ensure that all components of the tablet press, including the die, punch, and tablet press mechanism, are in good condition and free from any damage.
- Inspect the punch and die for wear or damage. If any issues are found, replace the tooling before proceeding with alignment.
5.2 Alignment Procedure
- Align the die with the punch by ensuring that the die is securely fitted in its position in the machine’s die holder.
- Check the alignment of the punch by manually positioning it in the punch holder, ensuring that it is vertically aligned with the die and seated properly without any movement.
- Use a reference gauge or alignment tool to measure the vertical and horizontal alignment between the die and punch. The punch should be positioned in line with the die to prevent uneven tablet compression.
- Adjust the punch holder as necessary to achieve proper alignment. Ensure that both the upper and lower punches are aligned equally in the tablet press machine.
- Tighten the alignment bolts or screws securely using the appropriate torque settings to ensure that the die and punch remain in position during operation.
5.3 Post-Alignment Verification
- Once the die and punch are aligned, manually rotate the machine to check for any irregular movement or misalignment.
- Perform a test run with the tablet press, compressing a small batch of tablets to check for uniformity in tablet weight, hardness, and appearance. Ensure that the tablets are properly formed and that there are no defects caused by misalignment.
- Verify that the punch and die remain aligned throughout the compression process. If any misalignment is detected, stop the machine and adjust the alignment accordingly.
5.4 Troubleshooting Alignment Issues
- If the die and punch are misaligned during operation, stop the machine immediately and check for any mechanical issues such as loose bolts, worn components, or incorrect settings.
- If alignment issues persist, perform a complete inspection of the machine’s components and consult with maintenance personnel to resolve the problem. Do not attempt to use misaligned tooling for production, as it may result in defective tablets.
- Ensure that any alignment issues are documented and corrective actions are taken to prevent recurrence.
5.5 Equipment Shutdown and Cleaning
- After confirming the alignment, ensure the tablet press is properly shut down according to the equipment shutdown SOP.
- Clean the tablet press machine, including the die and punch components, to remove any powder or granules left from the alignment procedure.
- Document the alignment procedure and any issues encountered during the process in the alignment log (Annexure-1) and batch record (Annexure-2).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Alignment Log (Annexure-1)
- Batch Record (Annexure-2)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Alignment Log
| Batch Number | Tablet Press Machine | Die and Punch Condition | Alignment Status | Remarks |
|---|---|---|---|---|
| Batch 001 | Machine A | Good | Aligned | Alignment checked and confirmed |
| Batch 002 | Machine B | Minor Wear | Aligned | Adjusted punch alignment |
Annexure-2: Batch Record
| Batch Number | Tablet Type | Die and Punch Alignment | Tablet Weight | Remarks |
|---|---|---|---|---|
| Batch 001 | Tablet A | Aligned | 250 mg | Weight within specifications |
| Batch 002 | Tablet B | Aligned | 245 mg | Adjustment made to compression force |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Punch Alignment Procedures | Tooling Wear Monitoring | QA Head |