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Faculty: Dr. Tarun Chugh

  • Date: 9/24/2020 09:00 AM - 9/24/2020 12:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


Media fill is one of critical process to establish SAL (Sterility Assurance Level) in aseptic filling of parenteral products. It is reflection of aseptic practices perform in clean area and what level of control are being implemented in practice for aseptic filling process. There are lots of factor which can lead to failure of media fill and so the product failure. Man, Material, Movement is to be controlled with all utilities supplied in the area for controlling contamination.

Why You Should Attend:

Media Fill is the core exercise to prove aseptic process control and nature of contamination occurring in clean area, if any failure happens. This webinar gives an eye opener to all users what could go wrong in Media Fill failure so as to aseptic process which could lead to SAL failure.

Seminar Agenda:

Section 1 
Section 2 
Section 3 
Overview of Media Fill
  • What is Media Fill
  • Importance of Media Fill
  • Regulatory Requirements

Basics of Microbiology

  • Quality Policy and Objectives
  • Responsibility and Authority
  • Internal Quality Audits
  • Management Review

Resource Management

  • Air (HEPA / BMS System)
  • Water
  • Nitrogen
  • Power
  • Part 11 Compliance

Why Sterility?

  • What is Sterility?
  • How to perform Sterility test
  • History and weakness of sterility test
  • What need to make things sterile (Sterilization)
  • How to Achieve SAL?
  • Failure is Panic

Types of Failure in Media Fill

  • Aerobic / Anaerobic
  • Fungus
  • Pathogens

Media Fill SOP Preparation

  • SOP Requirements
  • Pre and Post Cleaning of Area
  • When to take Deviation

How to avoid Media Fill Failure?

Intervention of Media Fill

  • Why intervention is required
  • Types of Interventions
  • Frequency of Intervention

Intervention and people control

  • Entry of intervention in BMR
  • Entry / Exit Reconciliation with Personnel monitoring

Incubation of Media Fill

  • How to reconcile the media fill units
  • Is incubation for rejected vials
  • Is intervention being more than MF

Deviations and Risk Assessment

  • When to raise deviation

Corrective and Preventive Action

  • How to take CAPA for Media failure

Case Studies and industrial example

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Engineering Departments
  • IPQA Departments
  • Microbiology Professionals