Creams: SOP for Setting Parameters for Jar Filling Machines – V 2.0

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Creams: SOP for Setting Parameters for Jar Filling Machines – V 2.0

Standard Operating Procedure for Setting Parameters for Jar Filling Machines

Department Creams
SOP No. SOP/CRM/097/2025
Supersedes SOP/CRM/097/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to define the procedure for setting the parameters on jar filling machines in the Creams Department. The objective is to ensure that the machines are set up correctly to fill jars with the required volume of cream while maintaining product quality and minimizing errors.

2. Scope

This SOP applies to all jar filling machines used in the Creams Department for filling cream products into jars. It includes procedures for setting the machine parameters, including fill volume, filling speed, and other operational settings, to ensure proper filling.

3. Responsibilities

  • Production Team: Responsible for setting the machine parameters correctly before each production run and ensuring that the machine is operating properly during production.
  • Maintenance Team: Responsible for checking and maintaining the jar filling machines, including verifying machine calibration and adjusting parameters when necessary.
  • Quality Control (QC): Ensures that the filled jars meet the required volume and quality standards and verifies that the machine settings are correctly configured before production begins.

4. Accountability

The Head of Production is accountable for ensuring that jar filling machines are set up and operated according to this SOP. The QA Manager is responsible for ensuring the accuracy of the filling volume and verifying that the jar filling machines are functioning within the specified parameters.

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5. Procedure

5.1 Pre-Operation Setup

  1. Ensure that the jar filling machine is clean and properly maintained according to the cleaning SOP.
  2. Verify that the appropriate jars, lids, and labels are available and free of defects.
  3. Ensure that the cream product to be filled is properly mixed, homogenized, and at the correct temperature for filling.
  4. Check the filling machine settings, including speed, pressure, and filling volume, to ensure they are set according to the production requirements.
  5. Ensure that all necessary tools and materials are readily available and accessible for easy setup and operation.

5.2 Setting the Fill Volume

  1. Check the specified fill volume for the cream product. This should be noted in the production batch record or master formula.
  2. Adjust the fill volume on the jar filling machine according to the required specifications. Use the machine’s control panel to set the correct volume for each jar.
  3. Perform a trial run with a sample jar to ensure that the fill volume is accurate. If the volume is outside the acceptable tolerance, adjust the machine settings and repeat the test until the correct volume is achieved.

5.3 Setting the Filling Speed

  1. Set the filling speed on the machine according to the production requirements. The filling speed should be optimized for both machine efficiency and product quality.
  2. Ensure that the filling speed does not compromise the filling accuracy or lead to spillage or overfills. Adjust the speed settings as necessary to ensure smooth and consistent operation.

5.4 Calibration Check

  1. Perform a calibration check on the machine to ensure that the filling volume and speed are within the specified limits.
  2. If necessary, adjust the calibration settings on the filling machine. This may include checking the calibration of the filling nozzle and verifying that the correct volume is dispensed for each jar.
  3. Document the calibration settings and any adjustments made in the Equipment Calibration Log (Annexure-1).
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5.5 Machine Operation

  1. Start the machine and monitor the filling process. Ensure that the jars are properly positioned under the filling nozzles and that the cream is being filled into each jar accurately.
  2. Check for any issues such as spillage, underfilling, or overfilling. If any issues are detected, stop the machine and adjust the settings as needed.
  3. Perform regular checks during production to ensure that the filling process remains consistent and that the jars are properly filled without any issues.

5.6 Monitoring During Production

  1. Regularly inspect a sample of filled jars during the production run to verify that the filling volume remains consistent.
  2. Ensure that the jars are being filled correctly and that there is no spillage or underfilling. If any deviations are observed, stop the machine and make necessary adjustments.
  3. Document any issues, corrective actions, and adjustments in the Production Log (Annexure-2).

5.7 Post-Operation Shutdown

  1. Once the production run is complete, turn off the jar filling machine following the manufacturer’s shutdown procedure.
  2. Clean the filling nozzles, tubes, and all other components that came into contact with the cream. Follow the cleaning SOP for the jar filling machine.
  3. Ensure that the machine is free from product residues and is properly sanitized before the next production run.
  4. Document the shutdown time and cleaning activities in the Equipment Maintenance Log (Annexure-1).

5.8 Documentation

  1. Record the machine settings, including the fill volume, filling speed, and calibration results, in the Production Log (Annexure-2).
  2. Document any adjustments made to the machine settings during the production run in the Equipment Maintenance Log (Annexure-1).
  3. Ensure that any discrepancies encountered during the operation are noted, and corrective actions are recorded.
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5.9 Final Approval

  1. The QA team must review the documentation, including the Production Log and Equipment Maintenance Log, to verify that the jar filling machine is functioning according to the specified parameters.
  2. If the parameters are within the required range, approve the machine for the next production run. If deviations are found, take corrective actions before resuming production.

6. Abbreviations

  • GMP: Good Manufacturing Practices
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Annexure-1: Equipment Calibration Log
  2. Annexure-2: Production Log

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 Equipment Calibration and Operation

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Calibration Log

Equipment ID Calibration Date Calibration Type Operator Comments
FM-001 21/01/2026 Filling Volume Calibration John Doe Calibration successful, within tolerance

Annexure-2: Production Log

Batch Number Start Time End Time Operator Comments
12345 08:00 AM 04:00 PM Jane Smith Machine running smoothly, no issues

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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