Creams: SOP for Heating and Cooling Procedures in Cream Processing – V 2.0

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Creams: SOP for Heating and Cooling Procedures in Cream Processing – V 2.0

Standard Operating Procedure for Heating and Cooling Procedures in Cream Processing

Department Creams
SOP No. SOP/CRM/045/2025
Supersedes SOP/CRM/045/2022
Page No. Page 1 of 6
Issue Date 08/10/2025
Effective Date 13/10/2025
Review Date 08/10/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for heating and cooling during cream processing. Proper control of temperature during these stages is essential to ensure the quality, stability, and consistency of the cream product. This SOP ensures that the heating and cooling processes are carried out within the specified parameters to avoid degradation of sensitive ingredients and to maintain product integrity.

2. Scope

This SOP applies to all cream formulations within the Creams Department that require heating and cooling steps as part of the manufacturing process. It covers the procedures for heating the emulsion base, incorporating ingredients that are sensitive to heat, and cooling the cream to a suitable temperature for further processing or packaging.

3. Responsibilities

  • Formulation Development Team: Responsible for defining the heating and cooling parameters for each cream formulation and ensuring that sensitive ingredients are added at the correct stage of the process.
  • Quality Control (QC): Responsible for monitoring the temperature during the heating and cooling processes, ensuring that the cream formulation remains within specified temperature ranges. QC also verifies that the final cream meets the required consistency and quality.
  • Quality Assurance (QA): Ensures that the heating and cooling procedures are followed in compliance with this SOP and that all necessary documentation is completed. QA also verifies that all equipment is calibrated and operating within specified limits.
  • Production Team: Responsible for carrying out the heating and cooling procedures, ensuring that all process parameters, such as time, temperature, and mixing speed, are strictly followed according to the MFR.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the heating and cooling procedures. The QA Manager is accountable for ensuring that these procedures are conducted in compliance with the SOP and that the final product meets all quality standards.

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5. Procedure

5.1 Heating Procedure for Cream Base

  1. Verify that the cream base is ready for heating. Ensure that all ingredients that require heating, such as emulsifiers and oils, are fully incorporated into the formulation before heating begins.
  2. Set the heating equipment (e.g., heating jacket, steam bath, or water bath) to the desired temperature, typically between 70°C and 80°C, depending on the specific formulation and the ingredients being used.
  3. Gradually heat the cream base to the specified temperature while stirring continuously to ensure uniform heat distribution. Monitor the temperature closely using a calibrated thermometer or temperature probe.
  4. Maintain the temperature for the required time as specified in the MFR to ensure complete melting and incorporation of the ingredients. Overheating or prolonged exposure to high temperatures can cause degradation of heat-sensitive ingredients.
  5. Ensure that the temperature is uniform throughout the mixture. If necessary, use a circulating system to prevent localized overheating.

5.2 Cooling Procedure for Cream Base

  1. Once the heating stage is complete, begin cooling the cream base to room temperature gradually. Use a cooling system (e.g., cooling jacket, chilled water bath) to lower the temperature uniformly.
  2. Monitor the temperature during the cooling process to ensure that it does not exceed the specified limits. Typically, cooling should occur at a controlled rate to avoid separation of emulsified ingredients.
  3. The cooling process should be performed while stirring gently to prevent air entrapment or the formation of lumps.
  4. The cooling temperature should be brought down to approximately 25°C to 30°C before proceeding with further processing, such as the addition of active ingredients.

5.3 Monitoring Temperature and Other Critical Parameters

  1. Continuously monitor the temperature of the cream formulation during both the heating and cooling processes using calibrated thermometers or temperature probes.
  2. Record the temperature at regular intervals in the batch record to ensure that the required temperature ranges are adhered to.
  3. Ensure that the heating and cooling equipment is calibrated according to the equipment maintenance SOPs to guarantee accurate temperature control.
  4. If the temperature deviates from the specified range, corrective actions should be taken immediately, and the batch should be investigated for potential quality issues.
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5.4 Incorporating Heat-Sensitive Ingredients

  1. If the formulation contains heat-sensitive ingredients, such as vitamins, antioxidants, or active ingredients, ensure that they are added after the cream base has cooled to a safe temperature (usually below 40°C).
  2. These ingredients should be added slowly while stirring to ensure uniform distribution and prevent degradation due to excessive heat exposure.
  3. Document the addition of heat-sensitive ingredients in the batch record, including the time of addition and any observations made during the process.

5.5 Cooling After Active Ingredient Addition

  1. After the heat-sensitive ingredients have been added, cool the cream formulation further to its final processing temperature, typically to room temperature (25°C-30°C), if necessary.
  2. Monitor the consistency and stability of the cream during the cooling process to ensure that the formulation does not separate or lose its intended texture.
  3. The final temperature should be verified before the product is transferred to the next stage, such as packaging or filling.

5.6 Final Quality Control Checks

  1. Once the cream has cooled to the desired temperature, conduct the following quality control tests to ensure the product meets specifications:

    • Viscosity: Check that the cream has the desired consistency and texture.
    • pH: Test the pH to ensure it falls within the acceptable range (typically between 4.5 and 6.5).
    • Microbial Testing: Perform tests to ensure the cream is free from microbial contamination.
  2. If the cream passes all required tests, it is ready for packaging. If any issues are identified, corrective actions should be taken, and the batch may need to be reprocessed.

5.7 Documentation and Reporting

  1. Record all heating and cooling parameters, including temperature, time, and any deviations, in the batch record.
  2. Document the results of quality control tests and any corrective actions taken during the process.
  3. The batch record and testing results should be submitted for review and approval by the QA team before moving forward with packaging or further processing.
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5.8 Final Approval and Use of Cream

  1. Once the cream passes all quality control checks and the batch record is approved by QA, it is ready for the final steps in production, including packaging or distribution.
  2. Ensure that all records related to the heating, cooling, and quality control processes are properly filed and retained for future reference and regulatory compliance.

6. Abbreviations

  • QC: Quality Control
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practices
  • API: Active Pharmaceutical Ingredient
  • MFR: Master Formula Record

7. Documents

  1. Heating and Cooling Log (Annexure-1)
  2. Batch Record (Annexure-2)
  3. Quality Control Test Report (Annexure-3)

8. References

  • Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
  • International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • FDA Guidelines for Cosmetic Manufacturing

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 and Cooling Log

Batch Number Process Step Temperature Time Remarks
12345 Heating 75°C 15 min Stable emulsion
12345 Cooling 28°C 30 min Proper cooling

Annexure-2: Batch Record

Batch Number Process Step Time Operator
12345 Heating 08:00 AM Jane Smith
12345 Cooling 08:30 AM John Doe

Annexure-3: Quality Control Test Report

Test Parameter Result Specification Remarks
Viscosity 3200 cP 3000-3500 cP Pass
pH 5.8 4.5-6.5 Pass

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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