Sterile & Aseptic Facilities

  • Based on the latest developments in the field, Biopharmax has an established and dedicated department that has vast experience in the design installation and validation of aseptic processes with and without terminal sterilization.

  • Including: media and buffer production systems, ultra filtration units, storage tanks and filling, stoppering and capping lines.

 
 

Includes design, installation & validation of:

 
Aseptic filling and packaging lines
(both batch and continues)
  • Washing
  • Sterilization / Depyrogenation
  • Filling
  • Stoppering
  • Capping
  • Visual inspection
  • Labeling
  • Packaging
 

Design
Taking into consideration the different elements which influence the project performance:

  • Efficiency
  • Fast turn around and reaction time
  • Systems integration in the plant
  • Top Down vision
  • Cost/Effectiveness analysis
  • Industrial engineering and process analysis
  • Ergonomics Plant location according to macroeconomics considerations during construction and operation.
  • Cutting edge technology
Dedicated machines
  • Autoclaves Freeze Dryers Depyrogenation ovens
  • Production reactors Batch Continues production
  • Chromatographic columns with automated regeneration. UF automated skids
  Key production elements
  • UF skids and filter systems
  • Sterilizing processes
  • Zero Dead leg accessories
  • SIP for full and empty tanks
  • Process control: temperature, pH, level, pressure, DO etc.
  • Aseptic connections
  • Single use equipment

 

For information about INTREVENOUS INFUSIONS click here

 

To achieve optimal production from start-up it is essential to cooperate with a highly experienced engineering partner.
This is Biopharmax's added value.

 

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