Capsule: SOP for Addressing Equipment Malfunctions During Encapsulation – V 2.0

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Standard Operating Procedure for Addressing Equipment Malfunctions During Encapsulation

Department	Capsule Manufacturing
SOP No.	SOP/CM/108/2025
Supersedes	SOP/CM/108/2022
Page No.	Page 1 of 6
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 the procedure for addressing equipment malfunctions during the encapsulation process. Identifying and rectifying malfunctions promptly is essential to maintaining production efficiency, product quality, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule manufacturing equipment, including capsule filling machines, encapsulation systems, and related equipment. It covers the procedures for identifying, troubleshooting, and rectifying malfunctions during the encapsulation process.

3. Responsibilities

Production Operators: Responsible for identifying malfunctions during encapsulation, reporting issues promptly, and following the corrective actions outlined in this SOP.
Maintenance Team: Responsible for performing repairs or adjustments to malfunctioning equipment and ensuring that it meets operational specifications before resuming production.
Quality Control (QC) Team: Responsible for verifying that the encapsulation process resumes after repairs and meets product quality specifications.
Production Supervisor: Responsible for overseeing the equipment troubleshooting and repair process, ensuring that all procedures are followed, and coordinating between production, maintenance, and QC teams.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all equipment malfunctions are addressed promptly, and production is not delayed. The Maintenance Manager is accountable for ensuring that equipment repairs are performed effectively, while the QA Manager is responsible for ensuring that product quality standards are met post-repair.

5. Procedure

5.1 Identifying Equipment Malfunctions

The first step in addressing equipment malfunctions is to identify issues as early as possible:

Monitor Equipment Performance
1. Regularly monitor the performance of capsule filling machines and other related equipment during production. Check for abnormalities such as irregular fill volumes, capsule leakage, or incomplete sealing.
2. Ensure that operators are trained to recognize equipment malfunctions, such as strange noises, abnormal vibration, or error messages on the control panels.
Report Malfunctions
1. If an issue is detected, the production operator should immediately report the malfunction to the Production Supervisor and the Maintenance Team.
2. Record the issue in the Equipment Malfunction Log (Annexure-1) with details of the malfunction, time of occurrence, and any relevant observations.

5.2 Troubleshooting Equipment Issues

Once a malfunction is reported, follow the troubleshooting process to identify the root cause:

Consult Equipment Manuals
1. Refer to the equipment manuals and troubleshooting guides for specific machines involved in the malfunction. Follow the manufacturer’s recommendations for addressing the issue.
Perform Diagnostics
1. The Maintenance Team should run diagnostic tests, if available, to detect any electrical or mechanical issues with the equipment.
2. If the malfunction involves a mechanical failure, check for issues such as blockages, wear and tear, or component misalignment.
Identify and Correct the Problem
1. After diagnosing the malfunction, perform the necessary repairs or adjustments. Common fixes may involve recalibration, replacing faulty components, or cleaning the equipment to remove blockages.
2. Ensure that any damaged components are replaced with certified spare parts to maintain equipment performance and ensure GMP compliance.

5.3 Testing and Verifying Equipment after Repairs

Once repairs are made, conduct tests to ensure that the equipment is functioning properly:

Test the Equipment
1. After making repairs, conduct a series of tests to verify that the machine is operating correctly. This may involve running a few test batches to check capsule fill volumes, sealing, and weight consistency.
2. Ensure that all functions of the equipment are restored to their original specifications, such as filling speed, capsule alignment, and sealing integrity.
Document Test Results
1. Record the test results in the Equipment Verification Log (Annexure-2) to confirm that the equipment has passed all tests and is ready to resume production.
2. Ensure that the test results are reviewed and approved by the Production Supervisor and the QA team.

5.4 Resuming Production

Once the malfunction is resolved and the equipment is verified to be functioning properly, proceed with resuming production:

Resume Production
1. Once the equipment passes all tests, production can resume. Ensure that production operators are informed that the issue has been resolved and that they are ready to continue the process.
Monitor the Equipment
1. Monitor the equipment closely during the initial production runs after the malfunction is addressed. Pay attention to any signs that the problem might recur.

5.5 Documentation and Reporting

Proper documentation of the malfunction, corrective actions, and testing is essential for traceability and regulatory compliance:

Document the Malfunction
1. Complete the Equipment Malfunction Log (Annexure-1) with all relevant details about the malfunction, the root cause, and the actions taken to correct the issue.
Complete the Equipment Verification Log
1. After completing the repairs and tests, ensure that the Equipment Verification Log (Annexure-2) is updated to reflect that the equipment is back to its operational state.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
PM: Preventive Maintenance
RM: Raw Material

7. Documents

Equipment Malfunction Log (Annexure-1)
Equipment Verification Log (Annexure-2)
Deviation Log (Annexure-3)
Maintenance Log (Annexure-4)

8. References

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

9. SOP Version

Version: 2
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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 Malfunction Log

Malfunction ID	Batch ID	Description	Root Cause	Corrective Action	Operator	Approval Status
MF-001	Batch 001	Capsule filling machine stopped unexpectedly	Electrical short-circuit in motor	Replaced motor and reset machine settings	John Doe	Approved

Annexure-2: Equipment Verification Log

Test ID	Test Description	Test Result	Operator	Verification Date
TEST-001	Filling accuracy test	Pass	Jane Smith	02/02/2025

Annexure-3: Deviation Log

Deviation ID	Batch ID	Description	Corrective Action	Operator	Approval Status
DEV-001	Batch 001	Irregular capsule weight	Recalibrated the capsule filling machine	John Doe	Approved

Annexure-4: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
Filling Machine 001	02/02/2025	Replaced motor and calibrated sensors	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 troubleshooting and corrective action procedures	Clarified equipment malfunction handling	QA Head