Fluid Filled Medical Devices

 

Product Design, Development and Process Validation

  • Product Design (3D, 2D, FEM, dFMEA)
  • Materials Research & Selection
  • Prototyping (Small & Large Bulk)
  • Packaging Design
  • Process Validation (DoE, IQ, OQ, PQ)
  • Liquids, Pastes Gels, Active Ingredients
  • Medical Devices (Class 2b & 3b)

 

Testing

  • Transport Testing
  • Packaging Testing
  • PET & Other Relevant

 

Supply Chain Management

  • Components and Raw Material Sourcing
  • Qualification and Auditing of the Suppliers
  • Incoming Inspection
  • Stock Management
  • Supply Chain Optimisation
  • Vendor Management

 

Packaging

  • Plastic tubes, Aluminium laminate tubes, bottles, and jars (2ml-500ml)
  • Packaging soft , semi-rigid bottles, vials and screw caps
  • Labelling
  • Primary, Secondary and Tertiary Packaging

 

Sterilisation Management

  • Sterilisation Validation Management
  • Sterilisation Management (EO, Gamma, E-beam)