SOP for Media Fill Studies

1) Purpose

To establish procedures for conducting media fill studies to evaluate the aseptic manufacturing process and ensure sterility assurance of products in pharmaceutical manufacturing.

2) Scope

This SOP applies to all media fill studies conducted within the pharmaceutical manufacturing facility to validate aseptic processing techniques and identify potential areas for improvement.

3) Responsibilities

Quality Assurance: Responsible for overseeing and approving media fill protocols and monitoring study execution.
Manufacturing: Responsible for conducting media fill studies as per defined protocols.
Microbiology: Responsible for sampling, testing, and interpreting results from media fill studies.
Validation: Responsible for reviewing and approving media fill study reports and recommending corrective actions.

4) Procedure

1. Preparation:
   1. Develop a detailed media fill protocol including acceptance criteria and study design.
   2. Prepare media fill materials including growth medium, containers, closures, and simulated product.
   3. Label containers with batch numbers and study identifiers.
   4. Conduct pre-study environmental monitoring of the aseptic filling area.
2. Execution:
   1. Assemble and prepare personnel involved in the media fill.
   2. Perform media fills under aseptic conditions using simulated product and a growth medium.
   3. Document all activities, including start and end times, interventions, and environmental conditions.
   4. Perform repeat media fills if acceptance criteria are not met.
3. Incubation and Evaluation:
   1. Incubate filled containers under appropriate conditions as per the protocol.
   2. Perform visual and microbiological examination of filled containers at defined intervals.
   3. Record and analyze results, including any microbial growth observed.
   4. Interpret results against acceptance criteria and determine the study outcome.
4. Reporting:
   1. Prepare a comprehensive media fill study report including protocol adherence, results, deviations, and conclusions.
   2. Submit the report for review and approval by quality assurance and validation teams.
   3. Implement corrective actions as necessary based on study findings.

5) Abbreviations, if any

SOP – Standard Operating Procedure

CFU – Colony Forming Units

QA – Quality Assurance

6) Documents, if any

• Media Fill Protocol
• Environmental Monitoring Records
• Media Fill Study Report
• Corrective Action Reports

7) Reference, if any

USP 797: Pharmaceutical Compounding – Sterile Preparations

8) SOP Version

Version 1.0