SOP Guide for Pharma

Creams: SOP for Melt and Pour Processes in Cream Manufacturing – V 2.0

Auditor

Creams: SOP for Melt and Pour Processes in Cream Manufacturing – V 2.0

Standard Operating Procedure for Melt and Pour Processes in Cream Manufacturing

Department Creams
SOP No. SOP/CRM/063/2025
Supersedes SOP/CRM/063/2022
Page No. Page 1 of 6
Issue Date 27/12/2025
Effective Date 01/01/2026
Review Date 27/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the guidelines and procedures for the melt and pour processes used in the manufacturing of creams. The melt and pour technique is employed to melt solid ingredients and then pour them into the manufacturing tanks, ensuring that the cream formulation maintains its consistency and texture. This SOP ensures that the process is performed consistently, safely, and in compliance with GMP standards.

2. Scope

This SOP applies to the melt and pour process for all cream formulations produced in the Creams Department. It includes procedures for preparing, melting, and pouring ingredients, as well as safety measures to prevent contamination and ensure the quality of the product.

3. Responsibilities

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the melt and pour process is conducted as per this SOP. The QA Manager is accountable for reviewing process records and ensuring that all procedures are followed to meet the required product quality standards.

See also  Creams: SOP for Compatibility Studies of APIs and Excipients in Cream Formulations - V 2.0

5. Procedure

5.1 Preparation for Melt and Pour

  1. Verify that all required raw materials and ingredients for the cream formulation are available, including emulsifiers, thickeners, oils, and active ingredients.
  2. Ensure that the equipment to be used in the melt and pour process, such as the melting tanks and mixing vessels, are clean, sanitized, and properly set up.
  3. Ensure that all necessary protective equipment (PPE) is available and in use, including gloves, goggles, and lab coats, to prevent contamination.
  4. Review the formulation and ensure that all ingredients are specified in the correct proportions for the batch size being produced.

5.2 Melting the Ingredients

  1. Place the solid ingredients (e.g., waxes, butters) into the designated melting tank. These ingredients should be pre-weighed and checked against the formula for accuracy.
  2. Gradually heat the ingredients using a controlled heating system. The temperature should be monitored continuously to ensure it does not exceed the maximum recommended temperature for each ingredient.
  3. Stir the mixture periodically to ensure uniform melting and to prevent overheating or scorching. Monitor the consistency and texture of the melt to ensure it matches the expected result.
  4. Once the ingredients are fully melted and homogenous, verify that the temperature of the melted material is within the specified range for pouring.

5.3 Pouring the Melted Ingredients

  1. After ensuring the melt has reached the correct consistency and temperature, slowly pour the mixture into the designated mixing tank or production vessel.
  2. Pour the mixture in a controlled manner to avoid splashing or contamination. Ensure that all materials are transferred without spills or losses.
  3. If required, the melted ingredients should be mixed with other liquid ingredients in the mixing tank during or after pouring to ensure even distribution.
See also  Creams: SOP for Handling Deviations during Manufacturing - V 2.0

5.4 Monitoring the Process

  1. Continuously monitor the melt and pour process to ensure that the temperature and mixing conditions remain stable throughout. Record the temperatures at regular intervals during the process.
  2. Check the consistency of the melted mixture after it has been poured to ensure that it aligns with the expected quality parameters (e.g., viscosity, uniformity).
  3. If any deviations occur (e.g., if the temperature exceeds the specified limit or if the texture is inconsistent), stop the process immediately, document the issue, and initiate corrective actions as necessary.

5.5 Post-Pour Checks

  1. Once the pour is completed, inspect the batch to ensure that no contamination or irregularities have occurred. Ensure that all raw materials have been incorporated into the cream mixture.
  2. Allow the mixture to cool under controlled conditions, and check the consistency of the cream once it has cooled to ensure it meets the required specifications.
  3. Perform tests (e.g., viscosity, pH, sensory tests) on the batch to verify that the product is within acceptable limits. Record these test results for traceability.

5.6 Documentation

  1. Complete the Melt and Pour Process Log (Annexure-1) for each batch, documenting the batch number, temperature readings, time, and any other relevant information.
  2. If any issues or deviations occur during the melt and pour process, document them in the Deviation Report Form (Annexure-2) and follow the deviation handling procedure as per SOP.
  3. Ensure that all records are signed and reviewed by the QA team before the product proceeds to the next stage of manufacturing.
See also  Creams: SOP for Selecting Packaging Materials for Creams - V 2.0

5.7 Equipment Cleaning

  1. After completing the melt and pour process, clean and sanitize the melting tanks and mixing vessels according to the Cleaning SOP to avoid cross-contamination between batches.
  2. Document the cleaning process in the Equipment Cleaning Log (Annexure-3) to ensure that all equipment is ready for the next production run.

5.8 Final Approval

  1. After all checks and tests are completed, the QA team will review the records and approve the batch for the next stages of production.

6. Abbreviations

7. Documents

  1. Melt and Pour Process Log (Annexure-1)
  2. Deviation Report Form (Annexure-2)
  3. Equipment Cleaning Log (Annexure-3)

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: Melt and Pour Process Log

Batch Number Melting Temperature Pouring Temperature Operator Comments
12345 75°C 65°C John Doe No issues

Annexure-2: Deviation Report Form

Deviation Description Time Batch Number Operator Immediate Action
Overheating during melting 08:45 AM 12345 Jane Smith Stopped heating, adjusted temperature

Annexure-3: Equipment Cleaning Log

Equipment Cleaning Start Time Cleaning End Time Operator Cleaning Verification
Melting Tank 09:00 AM 10:00 AM John Doe 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
Exit mobile version