Standard Operating Procedure for Media Fill Validation

1) Purpose

The purpose of this SOP is to establish a standardized procedure for performing media fill validation to ensure the aseptic manufacturing process is capable of producing sterile products.

2) Scope

This SOP applies to all aseptic manufacturing processes that require media fill validation within the facility.

3) Responsibilities

3.1 Validation Personnel
– Conduct media fill validations as per this SOP.
– Document and report validation results accurately.
3.2 Production Supervisor
– Ensure all validation procedures are followed.
– Review and approve validation records.
3.3 Quality Assurance (QA) Personnel
– Validate media fill methods.
– Ensure compliance with regulatory guidelines.

4) Procedure

4.1 Preparation
4.1.1 Clean and disinfect the manufacturing area and equipment.
4.1.2 Prepare media and ensure all necessary materials are sterile.
4.2 Execution
4.2.1 Simulate the entire aseptic manufacturing process using sterile media.
4.2.2 Perform the media fill under normal operating conditions, including interventions.
4.3 Incubation
4.3.1 Incubate filled media containers at specified conditions (e.g., temperature, time).
4.3.2 Monitor containers for microbial growth during the incubation period.
4.4 Monitoring and Documentation
4.4.1 Record all activities and observations during the media fill process.
4.4.2 Record incubation observations and results in the Media Fill Validation Log.
4.5 Reporting
4.5.1 Compile validation results and prepare a media fill validation report.
4.5.2 Submit the report to QA for review and approval.
4.6 Investigation of Failures
4.6.1 Investigate any positive results to determine the source of contamination.
4.6.2 Implement corrective actions to prevent recurrence.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Media Fill Validation Log
– Media Fill Validation Reports
– Equipment Calibration Records

7) Reference, if any

– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
– European Medicines Agency (EMA) Guideline on Sterile Medicinal Products

8) SOP Version

Version 1.0