SOP Guide for Pharma

Tablets: SOP for Tablet Drying Process – V 2.0

Auditor

Tablets: SOP for Tablet Drying Process – V 2.0

Standard Operating Procedure for Tablet Drying Process

Department Tablet
SOP No. SOP/TAB/014/2025
Supersedes SOP/TAB/014/2022
Page No. Page 1 of 8
Issue Date 19/04/2025
Effective Date 24/04/2025
Review Date 19/04/2026

1. Purpose

This SOP defines the procedures for drying tablets after processing, ensuring that moisture content is controlled to prevent degradation, enhance stability, and meet product specifications.

2. Scope

This SOP applies to the tablet drying process following compression or coating, covering drying equipment setup, monitoring, and quality control procedures.

3. Responsibilities

4. Accountability

The Production Manager is accountable for the effective operation of the drying process. The QA Manager ensures compliance with regulatory standards and internal specifications.

5. Procedure

5.1 Drying Equipment Setup

  1. Ensure that the drying equipment (e.g., tray dryer, fluidized bed dryer) is clean and free from residue of previous batches.
  2. Verify that all components of the dryer, including air filters and temperature controls, are in good working order.
  3. Set the temperature and airflow parameters according to the product specifications for optimal drying. Typical settings range between 40°C to 60°C, depending on the tablet formulation.
  4. Ensure that the drying trays or baskets are appropriately loaded, ensuring even spacing between tablets to allow proper air circulation.
See also  Tablets: SOP for Batch Record Review and Approval in Tablet Manufacturing - V 2.0

5.2 Loading Tablets into the Drying Equipment

  1. Ensure that tablets are properly inspected and free from cracks, chips, or defects before loading into the drying trays or baskets.
  2. Load the tablets evenly, ensuring they are not overcrowded and have adequate spacing between them for uniform airflow.
  3. Do not exceed the maximum load capacity of the dryer to avoid compromising airflow and drying efficiency.

5.3 Drying Process

  1. Start the drying equipment and allow the tablets to dry according to the set parameters (temperature, airflow, and time).
  2. Monitor the drying process periodically to ensure that tablets are drying evenly. If tablets are sticking together or show signs of excessive moisture, adjust the airflow or temperature settings accordingly.
  3. Ensure that the drying process is continuous, and that tablets are evenly exposed to airflow to prevent any accumulation of moisture.
  4. Check that the drying process is completed within the designated time and that the tablets do not overheat, which could affect tablet integrity or cause coating issues.

5.4 In-Process Quality Control

  1. Conduct moisture content testing at regular intervals during the drying process to ensure tablets meet the required specifications.
  2. Use methods such as Loss on Drying (LOD) or a moisture analyzer to determine the moisture content of the tablets.
  3. Record moisture content results in the batch record (Annexure-1). If the moisture content exceeds the acceptable limit, extend the drying process until the target moisture level is achieved.
See also  Tablets: SOP for Content Uniformity Testing of Immediate Release Tablets - V 2.0

5.5 Final Inspection

  1. After completing the drying process, perform a final inspection to ensure that the tablets are free from excess moisture and do not exhibit signs of damage, such as stickiness or warping.
  2. Verify the moisture content of the tablets using a moisture analyzer to confirm that they meet the required specifications.
  3. If tablets are not within the acceptable moisture range, return them to the dryer and continue drying until the target moisture level is achieved.

5.6 Cooling and Storage

  1. After drying, allow the tablets to cool to room temperature before transferring them to storage containers or the next stage in the manufacturing process.
  2. Store the dried tablets in a dry, cool environment to prevent them from absorbing moisture or being affected by humidity.
  3. Ensure that storage containers are clean and tightly sealed to protect tablets from moisture and contamination.

5.7 Equipment Shutdown and Cleaning

  1. After the drying process is complete, shut down the equipment and clean it according to the cleaning SOP.
  2. Ensure that all components in contact with the tablets (e.g., trays, baskets, airflow ducts) are thoroughly cleaned to prevent contamination between batches.
  3. Record the cleaning activities in the equipment cleaning log (Annexure-2) and ensure all records are completed for regulatory compliance.

5.8 Documentation and Record-Keeping

  1. Document all drying process parameters, including temperature, airflow rate, drying time, and moisture content results, in the batch record.
  2. Ensure that all records are reviewed, signed off, and stored for regulatory compliance.
  3. Document any deviations from the standard process and the corrective actions taken.
See also  Tablets: SOP for Preventive Maintenance of Tablet Manufacturing Equipment - V 2.0

6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Equipment Cleaning Log (Annexure-2)

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: Batch Record

Batch Number Tablet Type Moisture Content Drying Time Temperature Remarks
Batch 001 Tablet A 1.5% 4 hours 50°C Within specifications
Batch 002 Tablet B 2.0% 4.5 hours 55°C Minor adjustment needed

Annexure-2: Equipment Cleaning Log

Equipment Cleaning Date Cleaning Method Personnel
Tray Dryer 1 18/04/2025 Washing with detergent and rinsing with water John Doe
Tray Dryer 2 19/04/2025 Washing with detergent and rinsing with water Jane Smith

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 Drying Process Parameters Optimization of Drying Process QA Head
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