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:
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
ICT122
