Procedure for Aseptic Process Simulation (Media Fill)

1) Purpose

The purpose of this SOP is to outline the procedure for conducting aseptic process simulations (media fills) to validate the aseptic manufacturing process.

2) Scope

This SOP applies to all aseptic manufacturing processes within the facility that require validation through media fill simulations, following regulatory guidelines and internal specifications.

3) Responsibilities

Quality Assurance (QA) Department: Responsible for overseeing and approving media fill activities.
Production Department: Responsible for executing media fills according to validated procedures and maintaining aseptic conditions.

4) Procedure

4.1 Media Preparation:
    4.1.1 Prepare growth media according to specified formulation and sterilization procedures.
    4.1.2 Sterilize media using validated sterilization methods (e.g., autoclaving) and aseptic techniques.

4.2 Filling Process:
    4.2.1 Set up the filling line or equipment in accordance with routine production conditions.
    4.2.2 Fill containers (e.g., vials, ampoules) with sterile growth media under aseptic conditions.
    4.2.3 Seal containers using appropriate closures and labeling as per procedure.

4.3 Incubation:
    4.3.1 Place filled containers in the incubator under conditions that promote microbial growth.
    4.3.2 Incubate containers for the specified time period required for microbial recovery.

4.4 Inspection and Evaluation:
    4.4.1 Inspect containers for any signs of microbial growth or contamination.
    4.4.2 Record and document observations, including any deviations from expected results.
    4.4.3 Evaluate media fill results against predefined acceptance criteria.

4.5 Documentation and Report:
    4.5.1 Compile all data, results, and observations into a Media Fill Report.
    4.5.2 Include detailed records of media preparation, filling process, incubation conditions, and evaluation criteria.
    4.5.3 Obtain QA approval for the media fill report before implementation in routine production.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

Media Fill Protocol
Media Fill Report
Media Preparation Records
Incubation Records

7) Reference, if any

FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
Pharmacopeial standards for media fill simulations

8) SOP Version

Version 1.0