SOP Guide for Pharma

Tablets: SOP for Tablet Temperature Control During Compression – V 2.0

Auditor

Tablets: SOP for Tablet Temperature Control During Compression – V 2.0

Standard Operating Procedure for Tablet Temperature Control During Compression

Department Tablet
SOP No. SOP/TAB/141/2025
Supersedes SOP/TAB/141/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for controlling and monitoring tablet temperature during the compression process to ensure proper tablet formation and avoid damage to the active ingredients or excipients.

2. Scope

This SOP applies to the compression process in tablet manufacturing, specifically focusing on controlling the temperature of tablets during compression to ensure uniformity, quality, and stability of the final product.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that tablet temperature is monitored and controlled during the compression process. The QA Manager is responsible for reviewing the temperature control records and ensuring compliance with quality standards.

See also  Tablets: SOP for In-Process pH Testing for Enteric-Coated Tablets - V 2.0

5. Procedure

5.1 Temperature Control Setup

  1. Before starting the compression process, check and set up the tablet press machine to ensure proper temperature control mechanisms are in place, including cooling systems and temperature sensors.
  2. Verify that the temperature sensors are calibrated and functioning correctly. These sensors should be able to monitor tablet temperature in real-time during compression.
  3. Set the target temperature for tablet compression according to the formulation’s requirements. Typical target temperatures range from 20°C to 30°C, but these can vary based on the formulation’s sensitivity to heat.

5.2 Monitoring Tablet Temperature During Compression

  1. During the compression process, continuously monitor the temperature of the tablets using the installed sensors and temperature monitoring system.
  2. Record the tablet temperature at regular intervals, such as every 5 minutes or after every 1000 tablets, depending on the production batch size and the equipment being used.
  3. If the temperature exceeds the set threshold, halt the compression process and investigate the cause of the temperature rise.
  4. Adjust the compression machine’s cooling system or air circulation to bring the temperature back within the acceptable range.

5.3 Corrective Actions

  1. If the tablet temperature is found to be outside the acceptable range, immediately stop the compression process to prevent potential damage to the tablets or active ingredients.
  2. Investigate the root cause of the temperature deviation, such as insufficient cooling, equipment malfunction, or improper compression speed.
  3. Make necessary adjustments to the machine settings, such as reducing the compression speed, increasing the cooling system capacity, or modifying other machine parameters.
  4. Once the issue is addressed, resume the compression process and monitor the temperature continuously to ensure it remains within the specified range.
See also  Tablets: SOP for Process Troubleshooting in Tablet Manufacturing - V 2.0

5.4 Documentation

  1. Document the temperature settings, monitoring results, and any corrective actions taken during the compression process in the batch record (Annexure-2).
  2. Record the temperature deviations and the corresponding corrective actions in the deviation report (Annexure-1).
  3. Ensure that all records are signed, dated, and reviewed by QA to verify compliance with quality standards.

5.5 Acceptance Criteria

  1. The tablet temperature should remain within the specified range during compression, typically between 20°C and 30°C, unless otherwise specified by the formulation or product requirements.
  2. If the tablet temperature exceeds the defined limits, corrective actions must be taken, and the batch may need to be stopped or reprocessed.

5.6 Post-Compression Actions

  1. Once the compression process is complete and the tablet temperature is verified to be within the required range, proceed with the next steps in tablet manufacturing, such as drying, coating, and packaging.
  2. Ensure that the tablet press machine is cleaned and calibrated according to the preventive maintenance schedule after each use to ensure proper functionality for the next batch.
See also  Tablets: SOP for Lamination and Stress Testing in Film Coating Process - V 2.0

6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-1)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Tablet temperature exceeded 30°C Adjusted compression speed and cooling system John Doe

Annexure-2: Batch Record

Sample Number Tablet Temperature Deviation Action Taken
Sample 1 28°C Pass (Deviation: 2%) Accepted

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 temperature control procedure Improved monitoring process QA Head
Exit mobile version