Standard Operating Procedure for Metal Detection Process

Purpose

The purpose of this SOP is to establish procedures for the effective use of metal detection equipment to ensure the detection and removal of metallic contaminants from pharmaceutical products, maintaining product safety and compliance with regulatory standards.

Scope

This SOP applies to all personnel involved in the metal detection process, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for operating and monitoring the metal detection equipment according to established procedures.
• Technicians: Responsible for maintaining and calibrating the metal detection equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for overseeing the metal detection process, reviewing results, and ensuring compliance with the SOP.

Procedure

1. Inspect the metal detection equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, free from residues, and calibrated before starting the metal detection process.
3. Verify that all products to be inspected are properly labeled and approved for use.
4. Set up the metal detection equipment according to the approved specifications for product type, size, and sensitivity.
5. Initiate the metal detection process and monitor the equipment to ensure the detection and removal of metallic contaminants.
6. Perform periodic checks on the metal detection equipment using test samples containing metallic contaminants of known size and type.
7. If adjustments to the metal detection parameters are necessary, document the changes made and the reason for the adjustments.
8. Transfer products through the metal detection equipment, ensuring proper spacing and alignment for effective detection.
9. Inspect and document any products flagged by the metal detection system for further investigation.
10. If metallic contaminants are detected, initiate an investigation, document findings, and implement corrective actions as needed.
11. Complete the logbook or batch record with all pertinent information, including any adjustments made during the metal detection process.
12. Clean and sanitize the metal detection equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Metal Detection Logbook
• Calibration Records
• Deviation and Corrective Action Logs
• Training Records

Reference

USP General Chapter <1207> – Sterile Product Packaging – Integrity Evaluation

SOP Version

Version 1.0