SOP Guide for Pharma

Creams: SOP for Temperature Control during Cream Processing – V 2.0

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Creams: SOP for Temperature Control during Cream Processing – V 2.0

Standard Operating Procedure for Temperature Control during Cream Processing

Department Creams
SOP No. SOP/CRM/064/2025
Supersedes SOP/CRM/064/2022
Page No. Page 1 of 6
Issue Date 01/01/2026
Effective Date 06/01/2026
Review Date 01/01/2027

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the guidelines and procedures for controlling and maintaining the temperature during cream manufacturing processes. Temperature control is crucial for maintaining the texture, consistency, and stability of the cream, particularly during mixing, homogenization, and cooling stages. This SOP ensures that all temperature-sensitive operations are carried out effectively and in compliance with GMP standards.

2. Scope

This SOP applies to all stages of cream manufacturing where temperature control is essential, including heating, mixing, cooling, and storage. It covers the use of temperature monitoring devices, the maintenance of appropriate temperature ranges, and the documentation of temperature control processes.

3. Responsibilities

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that this SOP is implemented across the manufacturing process. The QA Manager is accountable for reviewing temperature logs, ensuring compliance with the temperature control process, and approving any deviations.

5. Procedure

5.1 Pre-Operation Checks

  1. Ensure that all temperature control equipment, such as temperature sensors, controllers, and thermometers, are calibrated and functioning correctly.
  2. Verify that the temperature control systems are set to the correct values based on the process requirements for each cream formulation.
  3. Check that the production area is pre-heated or pre-cooled as required for the specific batch being produced.
  4. Inspect all mixing and processing equipment to ensure that it is clean and ready for use, with all necessary components properly installed.
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5.2 Temperature Control during Heating

  1. Gradually heat the ingredients to the required temperature, ensuring that the heating process is controlled to prevent overheating or degradation of ingredients.
  2. Use appropriate heating methods (e.g., steam, electrical heating) depending on the type of ingredients being processed and ensure that the temperature does not exceed the maximum recommended temperature for each ingredient.
  3. Continuously monitor the temperature during heating, using both automated systems and manual checks. Record the temperature at regular intervals in the Heating Temperature Log (Annexure-1).
  4. If the temperature exceeds the specified range, stop the heating process immediately and investigate the cause. Implement corrective actions before resuming heating.

5.3 Temperature Control during Mixing

  1. Once the ingredients have been heated to the desired temperature, transfer them to the mixing vessel. Ensure that the mixing process maintains the required temperature throughout.
  2. During mixing, monitor the temperature to ensure it remains within the desired range. Adjust heating or cooling as necessary to maintain consistency and prevent overheating.
  3. Record the temperature in the Mixing Temperature Log (Annexure-2) at regular intervals, particularly during key stages of the mixing process.
  4. If the temperature deviates from the specified range, immediately stop the process and address the issue before proceeding.

5.4 Temperature Control during Cooling

  1. Once mixing is complete, begin the cooling process according to the formulation’s requirements. Use cooling systems or ambient air to bring the temperature down to the desired level.
  2. Ensure that the cooling process is gradual and controlled to prevent rapid temperature fluctuations that could affect the product’s quality.
  3. Monitor the temperature during cooling and record it at key intervals in the Cooling Temperature Log (Annexure-3). Continue monitoring until the product reaches the required storage temperature.
  4. If any deviation occurs during cooling, stop the process and investigate the cause. Make the necessary adjustments before resuming.
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5.5 Temperature Control during Storage

  1. After cooling, store the cream at the required temperature to maintain its stability and prevent microbial growth or texture changes.
  2. Use temperature-controlled storage units, such as refrigerators or insulated tanks, to store the cream until it is ready for packaging.
  3. Continuously monitor the storage temperature and document it in the Storage Temperature Log (Annexure-4). Record the temperature at regular intervals, particularly when the cream is being moved between storage areas or processes.
  4. Ensure that the storage area is maintained at the specified temperature range at all times. If the temperature falls outside the acceptable range, notify the QA team immediately for corrective actions.

5.6 Documentation

  1. Complete the Temperature Control Logs (Annexures 1–4) for each process step, including heating, mixing, cooling, and storage. Ensure that all temperature readings are recorded accurately and signed by the operator.
  2. If any temperature deviations occur during the process, document them in the Deviation Report Form (Annexure-5) and follow the deviation handling process.
  3. Review the temperature logs periodically to ensure compliance with the required temperature ranges and GMP standards.

5.7 Corrective Actions

  1. If a temperature deviation occurs during any stage of processing, stop the operation immediately. Investigate the cause of the deviation and determine corrective actions.
  2. Once the issue is resolved, document the corrective actions taken in the Corrective Action Log (Annexure-6).
  3. After implementing corrective actions, resume the process and continue to monitor the temperature to ensure that it remains within the required range.

5.8 Final Approval

  1. The QA team must review the temperature logs and ensure that the temperature control procedures have been followed correctly before approving the batch for the next stage of manufacturing.
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6. Abbreviations

7. Documents

  1. Heating Temperature Log (Annexure-1)
  2. Mixing Temperature Log (Annexure-2)
  3. Cooling Temperature Log (Annexure-3)
  4. Storage Temperature Log (Annexure-4)
  5. Deviation Report Form (Annexure-5)
  6. Corrective Action Log (Annexure-6)

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: Heating Temperature Log

Batch Number Start Time End Time Temperature (°C) Operator Comments
12345 08:00 AM 09:00 AM 75°C Jane Smith No issues

Annexure-2: Mixing Temperature Log

Batch Number Start Time End Time Temperature (°C) Operator Comments
12345 09:30 AM 10:30 AM 70°C John Doe No issues

Annexure-3: Cooling Temperature Log

Batch Number Start Time End Time Temperature (°C) Operator Comments
12345 11:00 AM 12:00 PM 25°C Jane Smith No issues

Annexure-4: Storage Temperature Log

Batch Number Storage Start Time Storage End Time Temperature (°C) Operator Comments
12345 12:30 PM 01:30 PM 4°C John Doe No issues

Annexure-5: Deviation Report Form

Deviation Description Time Batch Number Operator Immediate Action
Temperature deviation during cooling 12:15 PM 12345 Jane Smith Adjusted cooling time

Annexure-6: Corrective Action Log

Issue Root Cause Corrective Action Completion Date
Temperature fluctuation during mixing Improper setting of thermostat Re-calibrated thermostat 02/01/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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