Applications

1. Applications in upstream and downstream processing:

Description : through-the-wall aseptic transfer of large volume support solutions held in lower classified environments to higher classification clean rooms.

Applications :

  • Media feed to N-2/N-1/bioreactor
  • Buffer feed to chromatography columns
  • Transfer out of higher classified zones: fraction collection, bulk intermediates, bulk final product transferring out of purification.

Our system: The Rapid Aseptic Fluid Transfer (RAFT) Systems is delivered preassembled with Flexboy® or Flexel® 3D bag systems. The complete assembly is Gamma irradiated. The RAFT System provides easy-to-use and reliable through-the-wall aseptic transfer of fluids between manufacturing zones.

The following diagram demonstrates segregation of media and buffer solutions maintained in the materials hall, enabling substantial reduction of high classification clean room areas.

Please click to enlarge image

Description : Contained transfer of powders into formulation vessel
Example of applications : Transfer of powders for buffer and media preparation
Our System : The Biosafe Biosteam Port can be cleaned and sterilized in-place along with the formulation vessel. The Biosafe bags are used for the contained transfer of powders for media and buffer preparation.

 

 

 

 

2. Applications in aseptic processing

Description : Components aseptic discharging from autoclave
Example of applications : Discharge of stoppers
Our System : when installed on autoclaves, the steamable version of the Biosafe Port allows reliable aseptic discharging of the bulk stoppers from the autoclave into double-door Gamma irradiated bags prior to transfer into isolator.


Gamma irradiated double-connector Biosafe Bag

Description : Transfer into isolators or RABS
Example of applications : Transfer of drug products. Entry of stoppers, entry and removal of QC test devices, tools and pumps. Waste removal.
Our Systems :

  • Open & autoclavable Biosafe bag to be filled by end-users prior to autoclave sterilization and aseptic transfer
  • Autoclavable & prefilled Biosafe bag delivered ready-to-sterilize via component suppliers
  • Prefilled Biosafe bag delivered Gamma sterile by component suppliers
  • Closed Gamma irradiated Biosafe Bag for the removal of waste, tools, pumps and QC test devices