Creams: SOP for Cleaning Dispensing Equipment – V 2.0

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Creams: SOP for Cleaning Dispensing Equipment – V 2.0

Standard Operating Procedure for Cleaning Dispensing Equipment

Department Creams
SOP No. SOP/CRM/020/2025
Supersedes SOP/CRM/020/2022
Page No. Page 1 of 5
Issue Date 05/06/2025
Effective Date 10/06/2025
Review Date 05/06/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for cleaning dispensing equipment in the Creams Department. Cleaning of dispensing equipment is necessary to prevent cross-contamination, maintain the quality and safety of the products, and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all dispensing equipment used within the Creams Department. It covers cleaning procedures for equipment such as scales, dispensers, mixing tools, containers, and any other equipment used in the dispensing process.

3. Responsibilities

  • Production Personnel: Responsible for following the cleaning procedures for dispensing equipment after each use. Production personnel should also ensure that equipment is properly sanitized before the next use.
  • Quality Control (QC): Verifies that cleaning procedures have been followed correctly and that the equipment is free from contamination before the next use.
  • Quality Assurance (QA): Oversees compliance with this SOP and ensures that cleaning procedures are consistently followed and documented.
  • Maintenance Personnel: Responsible for ensuring that dispensing equipment is in good working condition and promptly repairing any equipment that cannot be properly cleaned or sanitized.

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4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the cleaning procedures for dispensing equipment are carried out according to this SOP. The QA Manager is responsible for overseeing the proper documentation and monitoring of the cleaning process.

5. Procedure

5.1 Pre-Cleaning Preparation

  1. Review the production schedule to identify any equipment that needs cleaning after use.
  2. Ensure that the necessary cleaning agents and tools (e.g., brushes, cloths, water) are available and suitable for the type of equipment being cleaned.
  3. Review the manufacturer’s cleaning instructions (if available) for specific equipment to ensure that the correct cleaning method is used.
  4. Wear appropriate personal protective equipment (PPE), such as gloves and safety glasses, before cleaning any equipment.

5.2 Cleaning Process

  1. Disconnect any electrical or mechanical connections from the dispensing equipment (if applicable) to ensure safety during the cleaning process.
  2. For equipment such as scales or dispensers, wipe down the exterior with a damp cloth to remove any surface residue.
  3. For containers, measuring tools, or other equipment with direct contact with the materials, disassemble the equipment (if applicable) and clean each part individually.
  4. Use appropriate cleaning agents to clean the equipment. Follow the manufacturer’s guidelines for cleaning agents and their dilution ratios to ensure effective removal of residues and contaminants.
  5. Rinse the equipment thoroughly with water to remove any cleaning agents and ensure no residue is left behind.
  6. For equipment used with certain sensitive materials, such as preservatives or colorants, consider using a validated cleaning procedure to ensure complete removal of any potential residue.
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5.3 Post-Cleaning Inspection

  1. Once the equipment is cleaned, conduct a visual inspection to ensure that no residue remains on any surfaces and that the equipment is dry and free of contaminants.
  2. For more complex equipment, such as dispensers or mixers, perform a functional check to ensure the equipment operates as intended and no cleaning agents or residues remain.
  3. Any defective equipment or equipment that cannot be properly cleaned should be reported to the maintenance team for further inspection and repair.

5.4 Documentation of Cleaning

  1. After cleaning, record all cleaning activities in the Cleaning Log. The log should include:

    • Equipment name
    • Date and time of cleaning
    • Cleaning personnel
    • Cleaning agents used
    • Any issues or deviations during the cleaning process
  2. Ensure that the Cleaning Log is signed by the personnel who performed the cleaning and the QC team member who performed the inspection.

5.5 Handling of Contaminated Equipment

  1. If equipment is found to be contaminated or if it cannot be cleaned properly, it must be segregated from other equipment to prevent cross-contamination.
  2. The equipment must be reported to the QA team for further investigation and corrective actions, which may include further cleaning, reprocessing, or disposal if necessary.

5.6 Final Review and Approval

  1. The QA team will review all cleaning records to ensure that cleaning activities were performed correctly and in compliance with GMP requirements.
  2. After successful completion of the cleaning process, the equipment can be released for use in the next batch of production.
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6. Abbreviations

  • QC: Quality Control
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practices

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Material Discrepancy Report (Annexure-2)
  3. Corrective Action 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
  • Internal SOP for Equipment Maintenance and Cleaning

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Equipment Name Date of Cleaning Cleaning Personnel Cleaning Agent Used Any Issues
Dispensing Scale 05/06/2025 John Doe Detergent A No issues

Annexure-2: Material Discrepancy Report

Material Name Batch Number Discrepancy Description Corrective Action Taken Reported By Resolution Date
Preservative B 98765 Residue left after cleaning Re-cleaned equipment Jane Smith 06/06/2025

Annexure-3: Corrective Action Report

Deviation Corrective Action Taken Responsible Person Completion Date
Residue in Dispensing Scale Reviewed procedure, retrained staff John Doe 07/06/2025

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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