Qualiculture

Our Project

Making STERILITY ASSURANCE Meaningful and Sustainable

Risk Assessment

Aseptic Process Risk Assessment
  1. Design of Area, Equipment and Process
  2. Validation of Processes and associated changes
  3. Definition of Sampling / Testing Plan Rationalization of methods
Sterile Product Compliance Risk Assessment (SPCRA)
  1. Processes Evaluation
  2. Systemic Assessment of Sterility Assurance
  3. Product Sterility Risk Evaluation

Elemental Review

Media Fills and Study Design
Material Transfer Procedures
Aseptic Interventions Management
Aseptic Operator Qualification
Aseptic Core Monitoring
Smoke Studies
Cleanroom Design
Cleaning and Disinfection
Sterilization Processes Validation
Environmental Monitoring (Viable and Non-viable) Trends
Investigation related to sterility assurance (Product failures, EM failures / excursions etc,)

Training & Capability

Knowledge, Skills and Attitude based Trainings
Aseptic Manufacturing Culture Evaluation
Customized Trainings based on the findings from culture
  1. Basics of Microbiology
  2. Cleanroom Behaviour
  3. Cleanroom Gowning
  4. Media Fill and Aseptic Interventions
  5. Sterilization
  6. Cleaning and Disinfection
  7. Environmental Monitoring
  8. Behavioural Training