Equipment Troubleshooting Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for troubleshooting equipment issues in metered-dose inhaler (MDI) production to minimize downtime, ensure production efficiency, and maintain product quality.

2) Scope

This SOP applies to all personnel involved in equipment troubleshooting activities within the MDI production facility, including maintenance technicians, production operators, and quality control personnel.

3) Responsibilities

The responsibilities for this SOP include identifying equipment issues, performing troubleshooting steps, documenting findings, and ensuring timely resolution of problems. Specific roles include:
Maintenance Technicians: Conduct equipment inspections and troubleshooting activities.
Production Operators: Report equipment malfunctions and assist in initial troubleshooting efforts.
Quality Control Personnel: Monitor equipment performance and verify resolution of issues affecting product quality.

4) Procedure

4.1 Initial Assessment
4.1.1 Receive notification of equipment malfunction or observe abnormal operation.
4.1.2 Gather information on symptoms and operational history of the equipment issue.
4.2 Troubleshooting Steps
4.2.1 Conduct visual inspections to identify obvious signs of damage or malfunction.
4.2.2 Perform diagnostic tests or checks according to equipment manuals and standard procedures.
4.3 Problem Resolution
4.3.1 Identify root causes of equipment issues based on inspection and diagnostic results.
4.3.2 Implement corrective actions or repairs to resolve identified problems.
4.4 Documentation
4.4.1 Record troubleshooting activities, findings, actions taken, and outcomes in equipment logbooks or maintenance records.
4.4.2 Communicate resolution details to relevant personnel and update equipment status accordingly.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure

6) Documents, if any

Equipment troubleshooting guides, maintenance logs, equipment manuals, and training records should be maintained.

7) Reference, if any

Refer to equipment manufacturer manuals, SOPs for maintenance and troubleshooting, and regulatory guidelines for equipment validation and performance in pharmaceutical manufacturing.

8) SOP Version

Version 1.0