In order to meet your production constraints, SOFAST offers custom-made solutions capable of integrating all of its manufacturing experience and know-how for the preparation of pharmaceutical products.

Sterile and contained bioprocessing skids

These complete packages are entirely custom-made according to the needs of the process.

  1. From Sterile Bioprocessing Skids to filling machine/ freeze-dryer/
  2. From Sterile Bioprocessing Skids to freeze dryer
  3. From Contained Bioprocessing Skids under glove box
  • Packages manufactured and tested in our workshops
  • FAT/SAT protocols
  • IQ/OQ qualifications performed on site as per protocol validated by the final Customer

One process, one solution

 

Préparatoire sur mesure pour fabrication de produits pharmaceutiques

Integrating complete modules

  1. Process equipment
    1. Storage tanks and sharing of bulk raw materials
    2. Preparation tanks
    3. Storage tanks and sharing of finished products until distribution
    4. Glove boxes (for contained bioprocessing skids)
    5. Tank for the temperature maintenance of raw materials
  2. Distribution lines to
    1. Filling machine
    2. Small tank
    3. Freeze dryer
  3. Process piping
  4. Support and access platforms

Are also integrated:

  1. Fluid distribution loops
    1. WFI
    2. sterile air
    3. nitrogen
    4. pure steam
  2. Bridging table
  3. CIP
    1. Sterilizing filtration online with CIP/SIP
  1. Programming of the line according to the functional analysis
  2. Supervision device compliant with the recommendations of the 21 CFR part 11 standard integrating a traceability software allowing:
    1. Configuration of the application
    2. Management of recipes
    3. Archiving of manufacturing and CIP/SIP cycles
    4. Editing reports and curves

More information about our solutions?

Example of Bioprocessing Skid

Preparation line, storage, transfer to filling machine of a solute at a temperature of 5°C maintained by the circulation of ice water.

Equipped with a CIP and SIP device for the 3 tanks with computer traceability and monitoring on animated synoptic.

Préparatoire pour industrie pharma