Our Project
Assessment of Aseptic Manufacturing / Sterility Assurance Programs
Making STERILITY ASSURANCE Meaningful and Sustainable
Risk Assessment
Aseptic Process Risk Assessment- Design of Area, Equipment and Process
- Validation of Processes and associated changes
- Definition of Sampling / Testing Plan Rationalization of methods
Sterile Product Compliance Risk Assessment (SPCRA)- Processes Evaluation
- Systemic Assessment of Sterility Assurance
- Product Sterility Risk Evaluation
Elemental Review
Media Fills and Study DesignMaterial Transfer ProceduresAseptic Interventions ManagementAseptic Operator QualificationAseptic Core MonitoringSmoke StudiesCleanroom DesignCleaning and DisinfectionSterilization Processes ValidationEnvironmental Monitoring (Viable and Non-viable) TrendsInvestigation related to sterility assurance (Product failures, EM failures / excursions etc,)
Training & Capability
Knowledge, Skills and Attitude based TrainingsAseptic Manufacturing Culture EvaluationCustomized Trainings based on the findings from culture- Basics of Microbiology
- Cleanroom Behaviour
- Cleanroom Gowning
- Media Fill and Aseptic Interventions
- Sterilization
- Cleaning and Disinfection
- Environmental Monitoring
- Behavioural Training