Capsule: SOP for Cleaning High-Shear Mixers for Capsule Granulation – V 2.0

Auditor

2 weeks ago

Standard Operating Procedure for Cleaning High-Shear Mixers for Capsule Granulation

Department	Capsule Manufacturing
SOP No.	SOP/CM/130/2025
Supersedes	SOP/CM/130/2022
Page No.	Page 1 of 7
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to establish a standard procedure for cleaning high-shear mixers used in capsule granulation processes. Cleaning these mixers thoroughly after each batch is critical to prevent cross-contamination and ensure that no residues from previous formulations remain. This procedure helps in maintaining equipment performance, product quality, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all high-shear mixers used in the capsule granulation department. It describes the necessary steps for cleaning the equipment after each production run to ensure that the equipment is free from residues and suitable for the next batch production. The procedure includes pre-cleaning, washing, disinfection (if required), and post-cleaning inspection.

3. Responsibilities

Production Operators: Responsible for initiating and performing the cleaning procedure after each batch and ensuring that the high-shear mixers are cleaned according to this SOP.
Quality Control (QC) Team: Verifies the cleanliness of the high-shear mixers and ensures that no contaminants remain before the equipment is used for the next batch.
Quality Assurance (QA) Team: Ensures compliance with GMP during the cleaning process and reviews the cleaning logs for completeness and accuracy.
Maintenance Team: Ensures that the high-shear mixers are in good working condition and free from mechanical issues before cleaning begins.
Production Supervisor: Oversees the cleaning process, ensures that the SOP is followed, and verifies that the equipment is properly cleaned and ready for use.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the cleaning process is completed according to this SOP. The QA Manager is responsible for ensuring that the process complies with GMP and that the cleaning logs are correctly filled out.

5. Procedure

5.1 Preparation for Cleaning

Before starting the cleaning process, ensure the following steps are completed:

Turn Off the Equipment
1. Ensure that the high-shear mixer is turned off and disconnected from the power supply to avoid any electrical hazards during cleaning.
2. Ensure that no raw materials or batch components are left in the mixer.
Gather Cleaning Materials
1. Collect all necessary cleaning agents, such as detergents, disinfectants, warm water, and cleaning tools (brushes, sponges, lint-free cloths, etc.).
2. Ensure that the cleaning agents are suitable for use on the mixer components and that they effectively remove any residues.
Inspect the Mixer
1. Inspect the mixer for any visible contamination or debris. Ensure that all parts are intact and that there are no mechanical issues that may affect the cleaning process.
Prepare Cleaning Log
1. Prepare the Cleaning Log (Annexure-1) to record all cleaning activities, including operator details, cleaning times, and any issues encountered during the cleaning process.

5.2 Cleaning Process

Follow these steps for cleaning the high-shear mixer:

Initial Rinse
1. Rinse the mixer with warm water to remove any loose material, powder, or granules.
2. Ensure that water flows through all accessible areas of the mixer, including the blades, mixing chamber, and outlet ports.
Apply Cleaning Solution
1. Apply an appropriate cleaning solution (detergent) to all surfaces of the mixer, including the blades and the mixing chamber, and let it sit for the required duration to break down any residues or materials.
2. Use soft brushes to scrub the surfaces and ensure that all material residues are removed, especially from hard-to-reach areas.
Rinse with Clean Water
1. After scrubbing, rinse the mixer thoroughly with clean water to remove all traces of cleaning agents and any remaining residues.
2. Ensure that no cleaning solution or residual material remains in the mixer before proceeding.
Disinfection (If Required)
1. If necessary, apply an appropriate disinfectant to the mixer components and allow it to circulate for the required time to eliminate microbial contamination.
2. Follow the manufacturer’s instructions for the proper use and dilution of the disinfectant.
Final Rinse
1. Perform a final rinse with clean water to remove any disinfectant residues and ensure the equipment is free from cleaning agents.

5.3 Drying the Equipment

After the cleaning process is complete, follow these steps to dry the mixer:

Dry the Equipment
1. Use clean, dry, lint-free cloths to wipe down the mixer, including the blades and the mixing chamber, to remove excess moisture.
2. If necessary, allow the mixer to air dry in a clean and controlled environment to ensure that all parts are completely dry.
3. If applicable, use compressed air or drying fans to speed up the drying process, especially in hard-to-reach areas.

5.4 Post-Cleaning Inspection

After cleaning and drying, perform the following checks:

Inspect for Residual Contamination
1. Inspect the mixer and its components for any visible contamination, cleaning agent residues, or dust. If contamination is found, repeat the cleaning process.
Check for Proper Reassembly
1. Ensure that all parts of the mixer are correctly reassembled and securely fastened before it is put back into operation.
Test Run
1. Perform a test run of the mixer to ensure that it is functioning properly and is free from contamination before the next batch is produced.

5.5 Documentation

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

Complete Cleaning Log
1. Record all cleaning actions in the Cleaning Log (Annexure-1), including operator details, equipment ID, cleaning actions, and any issues or deviations encountered.
Post-Cleaning Inspection
1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-2).

6. Abbreviations

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

7. Documents

Cleaning Log (Annexure-1)
Equipment Inspection Log (Annexure-2)
Maintenance Log (Annexure-3)

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 high-shear mixer	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
High-Shear Mixer 001	02/02/2025	No defects found, fully sanitized	Jane Smith	02/02/2026

Annexure-3: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
High-Shear Mixer 001	02/02/2025	Checked mixer components and replaced filters	John Doe	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 process and added inspection steps	Improved cleaning and inspection	QA Head