Standard Operating Procedure for Media Fill Testing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for conducting media fill tests to assess the aseptic processing techniques in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in conducting media fill tests within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for performing media fill tests according to the instructions outlined in this SOP.
• Production Personnel: Responsible for participating in media fill tests and adhering to aseptic processing procedures.

Procedure

1. Preparation of Media:
   • Prepare sterile culture media according to specified formulations and sterilization methods.
   • Dispense the media into sterile containers or vessels suitable for the media fill process.
2. Media Fill Setup:
   • Prepare the filling line and equipment for the media fill test according to standard operating procedures.
   • Ensure that all components of the filling line, including filters, hoses, and filling nozzles, are properly sterilized and assembled.
3. Conducting the Media Fill:
   • Simulate the aseptic filling process using the prepared sterile culture media instead of the actual product.
   • Ensure that all personnel involved in the media fill test follow aseptic techniques and gowning procedures.
   • Monitor the filling process for any deviations or breaches of aseptic conditions.
4. Incubation and Evaluation:
   • Incubate filled containers or vessels under appropriate conditions to promote microbial growth.
   • Monitor the incubated media for microbial contamination or growth over the specified incubation period.
   • Evaluate the media fill test results and document any positive findings or deviations from acceptance criteria.
5. Documentation and Reporting:
   • Document all media fill test activities including preparation, execution, and evaluation processes.
   • Report media fill test results to the appropriate personnel and maintain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents

• Media Fill Test Protocol
• Media Preparation Records
• Media Fill Test Results

Reference

United States Pharmacopoeia (USP) General Chapter Sterility Tests

SOP Version

Version 1.0