SOP Guide for Pharma

Creams: SOP for Operating Automatic Filling Machines for Creams – V 2.0

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Creams: SOP for Operating Automatic Filling Machines for Creams – V 2.0

Standard Operating Procedure for Operating Automatic Filling Machines for Creams

Department Creams
SOP No. SOP/CRM/087/2025
Supersedes SOP/CRM/087/2022
Page No. Page 1 of 6
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to outline the procedure for operating automatic filling machines for creams. The objective is to ensure that the filling process is carried out consistently and accurately, providing the correct amount of cream in each container with minimal errors.

2. Scope

This SOP applies to the operation of automatic filling machines used in the packaging of cream products. It includes the setup, operation, monitoring, and maintenance of these machines to ensure that all products are filled according to the specified volume and weight.

3. Responsibilities

4. Accountability

The Head of Production is accountable for ensuring the correct operation of the filling machines and the accuracy of the filling process. The QA Manager is responsible for reviewing the quality of filled products and ensuring compliance with the filling specifications.

5. Procedure

5.1 Pre-Operation Setup

  1. Ensure that the automatic filling machine is clean and free of any contaminants. Perform a cleaning procedure according to the cleaning SOP.
  2. Check that all parts of the filling machine, including nozzles, valves, and conveyors, are securely assembled and in good working condition.
  3. Verify that the correct containers (e.g., tubes, jars, or bottles) are available and ready for filling, ensuring that they are free from defects and properly aligned on the conveyor system.
  4. Set the desired filling volume on the control panel of the filling machine according to the product specifications and batch records.
  5. Ensure that the cream is prepared and pumped to the filling machine, and the machine is properly connected to the cream supply system.
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5.2 Operating the Filling Machine

  1. Start the automatic filling machine, ensuring that it is operating at the correct speed and pressure settings as per the batch record.
  2. Monitor the filling process to ensure that the correct amount of cream is dispensed into each container. Check for any underfilling or overfilling and immediately stop the machine if discrepancies occur.
  3. Ensure that containers are aligned properly on the filling line and that there is no spillage or leakage from the nozzles.
  4. Periodically check the fill levels using weight or volume verification methods to ensure consistency across all containers.
  5. If the machine stops or malfunctions, identify the cause, document the issue, and notify the maintenance team for corrective action. Record the downtime in the Production Log (Annexure-1).

5.3 Monitoring During Operation

  1. Continuously monitor the automatic filling machine during operation for any issues such as nozzle clogging, inaccurate fill volumes, or misalignment of containers.
  2. Ensure that the filling machine is operating smoothly without excessive noise, vibration, or leakage, and that no product contamination occurs.
  3. Perform regular checks on filled containers to ensure that the correct weight or volume is being dispensed and that the cream is properly filled without any air pockets.
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5.4 Post-Operation Checks

  1. Once the filling process is complete, inspect the filled containers for proper sealing and labeling.
  2. Verify that the filled containers are free from defects such as overfilling, underfilling, or improper sealing.
  3. Ensure that the containers are properly labeled with the correct batch information, expiration dates, and product details as per the labeling SOP.
  4. Record the number of containers filled, any discrepancies in filling volume, and any maintenance performed in the Batch Production Record (Annexure-2).

5.5 Maintenance and Cleaning

  1. After the filling process, clean the filling machine thoroughly to remove any cream residues and prevent cross-contamination between batches. Follow the cleaning SOP for automatic filling machines.
  2. Ensure that all parts, including nozzles, hoppers, and valves, are cleaned and sanitized as required to maintain hygiene standards.
  3. Perform routine maintenance on the filling machine, including inspection of seals, calibration of filling volume, and checking for wear and tear of components. Record all maintenance activities in the Equipment Maintenance Log (Annexure-3).

5.6 Documentation

  1. Record all relevant information about the filling process, including the number of containers filled, batch number, and any discrepancies, in the Batch Production Record (Annexure-2).
  2. Document any maintenance or issues encountered during operation in the Equipment Maintenance Log (Annexure-3) and Production Log (Annexure-1).
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5.7 Final Approval

  1. The QA team must review the filled containers and the batch production records to verify that all products meet the required specifications before they are approved for further processing or packaging.
  2. If any issues or deviations are identified, the batch should be reviewed, and corrective actions should be taken before proceeding to the next production phase.

6. Abbreviations

7. Documents

  1. Annexure-1: Production Log
  2. Annexure-2: Batch Production Record
  3. Annexure-3: Equipment Maintenance Log

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: Production Log

Batch Number Production Date Number of Containers Operator Comments
12345 21/01/2026 5000 Jane Smith No issues encountered

Annexure-2: Batch Production Record

Batch Number Filling Volume Operator Comments
12345 5000 L John Doe Successfully completed filling

Annexure-3: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Type Operator Comments
FM-001 21/01/2026 Inspection, calibration Jane Smith Successfully calibrated

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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