Capsule: SOP for Cleaning Sampling Probes Used in Capsule Manufacturing – V 2.0

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Capsule: SOP for Cleaning Sampling Probes Used in Capsule Manufacturing – V 2.0

Standard Operating Procedure for Cleaning Sampling Probes Used in Capsule Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/134/2025
Supersedes SOP/CM/134/2022
Page No. Page 1 of 5
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to provide a standardized method for cleaning sampling probes used in capsule manufacturing. These probes are critical for ensuring that product samples are free from contamination and meet quality specifications. The SOP ensures that sampling probes are cleaned thoroughly between uses to maintain the integrity of the manufacturing process and prevent cross-contamination.

2. Scope

This SOP applies to all sampling probes used in capsule manufacturing. It includes the steps for cleaning probes that are used to collect samples from production batches. The procedure includes pre-cleaning checks, cleaning methods, and post-cleaning inspection.

3. Responsibilities

  • Production Operators: Responsible for cleaning the sampling probes after each use as per this SOP and ensuring that the tools are properly cleaned before the next use.
  • Cleaning Staff: Responsible for performing thorough cleaning of the sampling probes, ensuring that all parts are cleaned properly.
  • Quality Control (QC) Team: Responsible for inspecting the cleanliness of the probes and verifying that no residues remain on the probes before the next use.
  • Quality Assurance (QA) Team: Ensures compliance with GMP and reviews cleaning logs to ensure that the cleaning processes are followed correctly.
  • Production Supervisor: Oversees the cleaning of sampling probes and ensures that the cleaning process is being carried out properly by all relevant staff members.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the sampling probes are cleaned according to this SOP. The QA Manager ensures that the process is compliant with GMP standards and reviews the cleaning logs and inspection reports for completeness and accuracy.

5. Procedure

5.1 Preparation for Cleaning Sampling Probes

Before starting the cleaning process, the following steps must be completed:

  1. Turn Off and Disconnect Equipment

    1. Ensure that all equipment connected to the sampling probes is turned off and disconnected to avoid any electrical hazards during the cleaning process.
    2. Remove any remaining product samples from the probes.
  2. Gather Cleaning Materials

    1. Gather the necessary cleaning agents (e.g., detergents, disinfectants), PPE (Personal Protective Equipment), and cleaning tools (brushes, cloths, sponges, etc.).
    2. Ensure that the cleaning agents are suitable for use on the materials of the probes and are effective in removing residues and contaminants.
  3. Inspect Probes for Damage

    1. Before cleaning, inspect the probes for any visible damage or wear. Ensure that all parts are in good condition and that there are no cracks or defects that could compromise the cleaning process.

5.2 Cleaning Process

Follow these steps to clean the sampling probes:

  1. Initial Rinse

    1. Rinse the sampling probes with warm water to remove any loose residues or product remnants.
    2. Ensure that all surfaces of the probes are adequately rinsed to remove large particles.
  2. Apply Cleaning Solution

    1. Apply a suitable cleaning solution (detergent) to all surfaces of the sampling probes. Use soft brushes or sponges to scrub the probes, ensuring that all residues are removed, especially from difficult-to-reach areas.
    2. Ensure that the cleaning solution is left on the probes for the recommended contact time to effectively break down residues and contaminants.
  3. Rinse with Clean Water

    1. After scrubbing, rinse the probes thoroughly with clean water to remove all traces of the cleaning solution and residues.
    2. Ensure that no cleaning agents remain on the probes and that all surfaces are rinsed thoroughly.
  4. Disinfection (if required)

    1. If necessary, apply a disinfectant to the probes to ensure that any microbial contamination is eliminated. Follow the manufacturer’s instructions for the proper use and concentration of the disinfectant.
    2. Allow the disinfectant to sit on the probes for the required time, then rinse thoroughly with clean water to remove any disinfectant residues.
  5. Drying

    1. After the probes are cleaned and rinsed, use clean, lint-free cloths to wipe them dry.
    2. If necessary, allow the probes to air dry or use a drying oven or compressed air to speed up the process, ensuring that the probes are completely dry before reuse.
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5.3 Post-Cleaning Inspection

After cleaning, perform the following checks:

  1. Inspect for Residual Contamination

    1. Visually inspect the probes to ensure that no residues, cleaning agents, or contaminants remain.
    2. If any residues or contamination are found, repeat the cleaning process and document the discrepancies in the Cleaning Log (Annexure-1).
  2. Ensure Proper Reassembly

    1. If the probes were disassembled during cleaning, ensure that they are properly reassembled and in good working condition before use.
  3. Document Results

    1. Document the cleaning process, including any issues encountered and the results of the inspection, in the Cleaning Log (Annexure-1).

5.4 Documentation

Ensure that all actions are properly documented for traceability and compliance:

  1. Complete Cleaning Log

    1. Document all cleaning activities, including the date, equipment cleaned, operator details, and any issues encountered, in the Cleaning Log (Annexure-1).
  2. Inspection Records

    1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-2).
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Post-Cleaning Inspection Report (Annexure-2)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

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

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Completed cleaning of sampling probe No residue found

Annexure-2: Post-Cleaning Inspection Report

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Sampling Probe 001 02/02/2025 Clean and ready for use Jane Smith 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Updated cleaning and inspection steps Improved cleaning procedures QA Head
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